PTW CONNY II T11007 User Manual

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User Manual
CONNY II T11007
Firmware version 1.2 or higher
Contents
Operating Manual
Technical Manual
Service Manual
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General Information

General Information
– The product bears the CE-mark "CE 0124"
in accordance with the Council Directive 93/42/EEC about Medical Devices and fulfills the essential requirements of Annex I of this directive. The product is a class IIb device (MDD).
– The product was granted the type approval for
legal calibration in accordance with § 40 of the Austrian Measurement and Verification Act (Maß- und Eichgesetz, MEG) by the Austrian Federal Office of Metrology and Surveying (Bundesamt für Eich- und Vermessungswe­sen, BEV) in Vienna. For detailed information, refer to section "Technical Specifications".
Product standards
The product fully complies with the require­ments of the following standards: – IEC 61674
Electrical Safety
The product fully complies with the require­ments of the following standards: – IEC 61010-1
Electromagnetic compatibility
The product fully complies with the require­ments of the following standards: – IEC 61326-1
– Operator safety, specified measuring accu-
racy, and interference-free operation can only be guaranteed if original products and parts are used. Furthermore, only the acces­sories listed in this manual are approved by PTW-Freiburg and only they or other acces­sories whose use has been expressly permit­ted by PTW-Freiburg may be used in con­junction with the product. Safe operation and proper product performance are not guaran­teed if accessories or consumables from other manufacturers are used.
– PTW-Freiburg cannot be held liable for dam-
age resulting from the use of accessories or consumables from other manufacturers or when the user ignores the instructions and information given in this manual.
– The warranty period is 1 (one) year and begins
on the day of delivery. It is unaffected by repairs covered by the warranty regulations.
– PTW-Freiburg only considers itself responsi-
ble for the safety, reliability, and performance of the product if the assembly, extension, read­justment, modification, or repair is carried out by PTW-Freiburg or by persons authorized by PTW-Freiburg, and if the product is used in compliance with the technical documentation.
– The user manual is an integral part of the prod-
uct. It should always be kept near the product. Observance of the manual is a prerequisite for proper product performance and correct oper­ation.
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– In case of any questions concerning the ser-
vice, support, or warranty, please contact your supplier.
– This manual is in conformity with the product
specifications and all applicable safety stan­dards that are valid as at the printing date. All rights are reserved for devices, circuits, tech­niques, software, and names as referred to in the manual.
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General Information
– PTW-Freiburg reserves the right to make mod-
ifications. Please contact PTW or your local representa­tive for the most current information concern­ing the products of interest.
– No part of the technical documentation may
be reproduced without written permission from PTW-Freiburg.
– PTW-Freiburg is a registered manufacturer
according to the ElektroG (Elektro- und Elek­tronikgeräte-Gesetz). Elektro-Altgeräte-Register (EAR). Registration number DE15599992
PTW-Freiburg
Physikalisch-Technische Werkstätten Dr. Pychlau GmbH Lörracher Str. 7 79115 FREIBURG Germany Tel.: +49 761 49055-0 Fax: +49 761 49055-70 info@ptw.de www.ptw.de
– PTW-Freiburg works in strict accordance with
a quality management system that is contin­uously updated according to the national and international standards.
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Table of Contents

Table of Contents
General Information........................................................................................................2
Table of Contents........................................................................................................... 4
List of Figures.................................................................................................................5
Intended Use................................................................................................................... 6
Safety Information.......................................................................................................... 7
Operating Manual...........................................................13
1 Device Description.................................................................................................... 13
2 Putting into Operation.............................................................................................. 16
3 Measuring...................................................................................................................17
4 Error Messages......................................................................................................... 20
Technical Manual...........................................................21
5 Technical Specifications.......................................................................................... 21
Service Manual...............................................................25
6 Cleaning......................................................................................................................25
7 Preventive Maintenance........................................................................................... 26
8 Inserting Batteries.....................................................................................................28
9 Disposal of the Product........................................................................................... 29
Literature........................................................................................................................30
Index...............................................................................................................................31
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List of Figures

List of Figures
Figure 1: Definition of the patient environment...............................................................................................12
Figure 2: CONNY II, front panel..................................................................................................................... 15
Figure 3: Detector of the CONNY II............................................................................................................... 16
Figure 4: Preferred direction of radiation........................................................................................................ 17
Figure 5: Attaching the detector to the NORMI MAM analog test object....................................................... 18
Figure 6: Battery compartment on the back of the device............................................................................. 28
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Intended Use

The CONNY II diagnostic dosemeter is a dose and dose rate meter for constancy tests of X-ray installations in diagnostic radiology.
CONNY II is suitable for constancy test of medical X-ray installations for radigraphy, fluoroscopy and mammogrphy.
Note: In the United States, federal law restricts
this device to sale by or on the order of a physician.
Intended Use
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Safety Information

Safety Information
This is the safety alert symbol. It is used to alert the user to potential hazards. Obey all safety messages that follow this symbol to avoid any possible bodily injury or equipment damage.
All safety messages consist of the following com­ponents: – Safety alert symbol and signal word – Type of danger – Source of danger – Consequence – Measures to prevent hazards.
Signal Words
DANGER
Indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.
WARNING
Indicates a hazard. If not avoided, the hazard can result in death or serious injury.
CAUTION
Indicates a potential hazard. If not avoided, the hazard can result in minor or moderate injury.
NOTICE
Indicates a potential hazard. If not avoided, the hazard can result in product damage.
HINT
Provides application tips or other useful infor­mation to ensure that you get the most from your equipment.
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Safety Information
Safety Information
Strictly observe the following safety informa­tion concerning the signal words DANGER and WARNING. Failure to do so endangers the lives of the patient, user, and other persons involved.
DANGER
Operation in areas where an explosion may occur or in oxygen-enriched atmospheres.
Explosion Hazard!
Do not operate the product in areas of risk where an explosion may occur. Explosion hazards may be caused, for example, by the use of combustible anesthetics, skin-cleansing agents, and disinfectants.
Do not operate the product in oxygen- enriched atmospheres. The atmosphere is considered to be oxygen-enriched when more than 25 % of oxygen or nitrous oxide is added to the ambient air.
DANGER
Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately.
Shock Hazard!
– Switch on products on which moisture con-
densation has developed as a result of tem­perature changes only after they are com­pletely dry.
– Liquids must not enter the product. If liquids
have entered the product, dry the product or wait for it to dry completely. The prod­uct must be thoroughly inspected by service personnel before being used again.
– Do not use extension cords.
DANGER
Electricity is a source of risk, particularly when the product is not in perfect operating condition or when it is operated inappropriately.
Shock Hazard!
– Before using the product, verify that it is in
correct working order and operating condi­tion.
– Before putting the product into operation,
inspect all connection cables, connectors, housing, and covers for signs of damage. Replace damaged cables and connectors immediately.
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Safety Information
DANGER
Electricity is a source of risk, particularly when the product is operated inappropriately.
Shock Hazard!
Exclusion of operation in the patient envi­ronment:
Do not operate the product nor any periph­eral devices in the patient environment (see
Figure 1).
Exclusion of operation with patient contact:
The product is not intended for use in direct contact with the patient. Ensure that neither the product nor any peripheral devices come into contact with the patient.
DANGER
Electricity is a source of risk, particularly when the product is operated inappropriately.
Shock Hazard!
Use of peripheral devices:
Connect only peripheral devices (PC, printer) that meet the requirements of the standard IEC 60950-1 (UL 60950-1) or the standard IEC 61010-1.
Connect devices to other devices or to parts of systems only if it has been ascertained that this connection does not impair the safety of the patient, the operator, or the environment.
If the device specifications do not contain infor­mation regarding the connection of the device to other equipment, consult, for example, the manufacturers of the other equipment or other informed experts to verify that the connection does not impair the safety of the patient, oper­ator, or environment. Always observe the stan­dard IEC 61010-1.
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Safety Information
WARNING
Improper handling.
Hazards to Persons!
The product is a medical device and must only be handled by persons who are trained in the use of such equipment and are capable of applying it properly. The operator must be trained in the use and operation of the product.
WARNING
Magnetic and electrical fields are capable of interfering with the proper performance of the product.
Product Failure!
– When operating the product, make sure that
all external devices operated in its vicin­ity comply with the relevant EMC require­ments. X-ray equipment, MRI devices, radio systems, cell phones, etc. are possible sources of disturbance as they may emit higher levels of electromagnetic radiation. Keep the product away from these devices and verify its performance before use.
– Do not use cables longer than specified.
This might impair the electromagnetic com­patibility characteristics of the product.
WARNING
Radiation is a source of risk, particularly when the product is operated inappropriately.
Risks to Persons!
Exclusion of operation as a controlling instrument:
Use the product as a measuring device only. Do not use measuring results to control an equip­ment that produces radiation, e.g., a radiodiag­nostic equipment or a radiotherapy unit.
WARNING
Application for uses other than those stated in the user manual.
Bodily Injury! Equipment Damage!
Always apply the product in compliance with its intended use.
Failure to do so may lead to severe or even fatal injuries and/or equipment damage and may void the warranty.
WARNING
Hazards originating from other system compo­nents.
Hazards to Persons! Equipment Damage!
– Do not use the product in the immedi-
ate vicinity or placed on top of or below other equipment. However, if the applica­tion requires an arrangement of devices as described above, the product should be monitored in order to ensure its proper func­tioning in the specific arrangement.
– Make sure that the product is used in an
electromagnetic environment as described in IEC 61326-1.
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Observe the safety information provided in the user manuals of the system components.
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Safety Information
CAUTION
Use of the product without observing the user manual.
Bodily Injury! Equipment Damage!
Always use the product in compliance with the user manual. Otherwise, the provided protec­tion may be impaired.
Use the product only in conjunction with the products approved by PTW for this pur­pose and/or the products listed in the section "Intended Use".
Use the product within the rated range of use as indicted in the section "Technical Specifica­tions".
Handle the product with care.
NOTICE
To avoid damage to the cables and connectors, observe the following points:
– Do not kink the cables. Observe the stated
minimum bend radius of the cables. Never exert pressure on the cables. Do not step on the cables. Do not roll trolleys over the cables. Do not pull or twist the cables.
– Disconnect the cables from the devices dur-
ing transport and when the devices are not in use. Do not let the cables hang down unrestrained.
– The connectors must always be clean. Do
not allow connectors to lie on the floor. Always protect connectors when pulling them through cable conduits.
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Safety Information
HINT
Observe the user manuals of all connected devices!
HINT
Set up the device so that the operator has a clear, unobstructed view of the indicators and controls and can operate the controls easily.
Symbols on the Nameplate
Symbol Description
Refer to the user manual!
The product bears the CE-mark.
The product was granted the type approval for legal calibra­tion under Austrian law. For detailed information, refer to sec­tion "Technical Specifications".
Manufacturer and date of manu­facture
Reference number
Serial number
Separate collection for electrical and electronic equipment! (refer also to the section "Dis­posal of the Product")
Figure 1: Definition of the patient environment
Labeling according to "Administration on the Con­trol of the Pollution caused by Electronic Information Products (ACPEIP)" (China RoHS) (refer also to the "Appendix")
For a description of additional symbols, if applicable, please refer to the equipment description.
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Operating Manual - Device Description

Operating Manual

1 Device Description

1.1 Application

The diagnostic dosemeter CONNY II is suitable for measurements free in air or at the radiation entrance side of the test object.
The CONNY II can be used with medical X-ray equipment for radiography, fluoroscopy, and mammography (anode-filter combinations: W/2.5 mm Al at 70 kV and 100 kV as well as with Mo/30 µm Mo at 30 kV).
The CONNY II can be used for image quality assurance in diagnostic X-ray departments for constancy tests according to DIN 6868-3, -4, -7, and -13. For this purpose, a test object comply­ing with the requirements of the standards shall be placed in the path of the X-rays, and the dose occurring at the radiation entrance side of the test object during radiography shall be measured. At X-ray systems used for fluoroscopy, the dose rate at the radiation entrance side of the test object shall be determined by measuring the dose for a defined period of time.
When operated within the rated range of use, the CONNY II fulfills the requirements for diagnostic dosemeters set forth in IEC 61674.
The CONNY II consists of a battery operated electrometer and an undetachable semiconductor detector.
It can be used in combination with test objects of the NORMI series.
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Operating Manual - Device Description

1.2 Features

The CONNY II consists of a battery operated elec­trometer with a connected semiconductor detec­tor.
During a measurement, the measuring quantity chosen before starting the measurement is dis­played. After termination of the measurement the measured dose, the mean dose rate or irradiation time can be displayed.
Features:
– Battery operated measuring instrument with
voltage monitoring (LOW BAT message)
– Display of the firmware version for approx. 2 s
after switching on the device
– Automatic zeroing after switching on the
device
– After termination of the measurement: display
of the measured dose, mean dose rate or irra­diation time by toggling with the MODE key
– Display of a mean dose rate value for irradia-
tion times of more than 8 s
– Measures Gy, Gy/s and s
– Over range message (OL)
– Auto-Shutoff after 5 min without irradiation or
key operation
– Auto start and Auto reset functions
– Toggling between the 30 kV and 70/100 kV
voltage range possible
– Two measuring ranges (LOW and HIGH);
manual selection of a measuring range
– Display of the measuring quantity selected
with MODE during the measurement
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Operating Manual - Device Description

1.3 Operating Controls and Indicators

Figure 2: CONNY II, front panel
Operating controls and indicators Symbol
1
Display of the measuring value and unit
2
Display of selected kV range, measuring mode and measuring range
3
Key for selection of the kV range
4
Key for selection of the measuring range
5
Key for selection of the measuring mode
6
Key to turn on or to switch off the device
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---
---
kV
RANGE
MODE
ON / OFF
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Figure 3: Detector of the CONNY II
Operating Manual - Putting into Operation

2 Putting into Operation

The CONNY II is battery operated and features a voltage monitoring function. If the battery voltage decreases below a lower limiting value the device switches off automatically. The battery lifetime for continuous operation is approximately 18 hours. A battery symbol appears behind the measuring value approximately 3 hours before the auto shut­off.
HINT
When rechargeable batteries are used the LOW BAT message is displayed earlier.
Switching on
Turn the CONNY II on with the ON/OFF switch.
During the display of the firmware version,
all measuring ranges are zeroed automati­cally.
After zeroing, the CONNY II is ready for
operation.
Default values:
Radiation quality: 70/100 kV Measuring range: HIGH Measuring mode: DOSE
Start a measurement by irradiating the detector (refer to 3 "Measuring ").
The CONNY II features an auto shutoff function which switches off the device after 5 min without irradiation or key operation.
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3 Measuring

Operating Manual - Measuring

3.1 General Information

Default settings
After power-up, the following default values are preset in the CONNY II:
– Radiation quality: 70/100 kV
– Measuring range: HIGH
– Measuring mode: DOSE
Before starting a measurement, the defaults can be adapted to the measuring conditions with the kV, RANGE, and MODE keys.
– Fluoroscopy:
measuring range LOW (5 µGy/s ... 3 mGy/s)
– Radiograpy:
measuring range HIGH (0.5 ... 300) mGy/s
Detector
The detector of the CONNY II can be attached to the test object by means of the supplied reclos­able fastener. The detector surface must be irra­diated perpendicularly (Figure 4), and the entire detector must be located in the radiation beam.
Figure 4: Preferred direction of radiation
Measuring quantities
The CONNY II can be used to measure the fol­lowing measuring quantities:
– air kerma rate (dose rate mode)
– air kerma (dose mode)
– time (irradiation or exposure time)
Measuring ranges, refer to 5 "Technical Specifi-
cations"
When fastening the detector to the test object, take care not to cover measuring areas or test structures with the detector cable.
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Figure 5: Attaching the detector to the NORMI
MAM analog test object
Operating Manual - Measuring

3.2 Performing a Measurement

Place the CONNY II on the patient couch
outside the radiation beam and fold out the bracket at the back of the device if necessary.
Before the measurement, attach the detector
of the CONNY II to the test object. The detec­tor must be irradiated perpendicularly, and it must be completely located in the radiation beam; the reference point is at the center of the entrance window.
Use the ON/OFF switch to turn the CONNY II
on; at the same time, all measuring ranges will be zeroed automatically.
Adapt the preset parameters to the measur-
ing conditions with the kV, RANGE, and MODE keys.
– Measuring range for fluoroscopy:
LOW (dose rates in the range from 5 µGy/s to 3 mGy/s)
– Measuring range for radiography:
HIGH (dose rates in the range from
0.5 to 300 mGy/s)
Start a measurement by exposing the detector
to radiation. The CONNY II features an auto­start function, which means that a measure­ment will start automatically when the detector detects radiation. The zero adjustment of the last switch-on will be taken into account.
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Operating Manual - Measuring
Measurement readout
While a measurement is in progress, the keyboard of the device is locked and the parameter set with the MODE key is displayed. For the duration of the measurement, the letter M is visible in the upper left of the display.
HINT
About dose rate measurements:
If the selected measuring quantity is dose rate, the mean dose rate will be displayed first after the radiation is switched off. The first and the last 3 seconds of the measuring interval are not included in the calculation. The minimum measuring time is 8 seconds (effective measuring time of 2 s + waiting period of 2 x 3 s that is not taken into account). The value is averaged over a maximum of 20 seconds (t
the minimum measuring time is reached, the flashing label "Time" will be displayed in addi­tion to the dose rate. If a measurement is termi­nated during this period, the readout is reset to
0.00 mGy/s. If the measurement takes longer, the message "Time" will be displayed perma­nently. After the end of the measurement, the mean dose rate will be displayed with the label "mean".
The measured value should always be displayed with a minimum resolution of 1 % (100 digit). If this resolution is not available in the HIGH mea­suring range, switch to the LOW measuring range. If measurements in the LOW measuring range exceed the maximum dose rate, a condition indi­cated by the message OL, switch to the HIGH measuring range.
–23 s to t
end
– 3 s). Before
end
Interrupting a measurement
If a measurement is interrupted for less than 3 seconds, it will continue after the interruption. If the interruption lasts longer than 3 seconds, the measurement will be canceled and the current measured value will be displayed. If a measuring signal becomes available again afterwards, the readout will be reset to zero and a new measure­ment will be started (auto-reset). The values of the previous measurement are no longer available in this case!
Terminating a measurement and reading the measured values
After the measurement, the measured parame­ters dose, dose rate, and time can be displayed by pressing the MODE key. The last parameter set with the MODE key will be displayed during the next measurement if the device remains switched on.
The CONNY II features an auto-shutoff function, which means that the device switches off if no radiation is detected and no key is pressed for a period of 5 minutes.
HINT
All measured values will be lost when the CONNY II is switched off. Therefore, be sure to read off the measured values within 5 minutes after the measurement!
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4 Error Messages

Operating Manual - Error Messages
Mes­sage
OL instead of the measuring value dose measurement:
L-Err instead of the measuring value
T-Err instead of the measuring value
Position on the display Remarks
over range of the (dose) range (9.999 Gy), max. dose rate in the measuring range exceeded
dose rate measurement: during over range of the dose rate range
time measurement: over range of the (time) range (999.9 s); measurement of dose and dose rate still possible
irradiation time measurement not possible because signal (only irradiation time measure­ment)
(only irradiation time measure­ment)
is too low, an estimated value for the irradiation time is dis-
played
irradiation time measurement not possible (no rectangular
pulse)
E1 upper left part zeroing not possible (e.g. irradiation during switching on)
E2 upper left part calibration factor exceeds the limit
E3 upper left part check sum error;
send the CONNY II back to PTW-Freiburg for repair
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Technical Manual

Technical Manual

5 Technical Specifications

Only values with specified tolerances or limits are guaranteed. Values without tolerances are for informa­tional purposes only.
Device designation Diagnostic dosemeter CONNY II T11007
Manufacturer PTW-Freiburg
Intended use Dose and dose rate measurement for constancy tests of X-ray
installations for radiography
Type approval certificate in Austria
Mode of operation continuous operation
Display LCD 4 digits
Detector semiconductor detector with entrance window 16 mm x 9 mm, ref-
as Dosemeter for constancy checks in diagnostic
X-ray applications
at Austrian Federal Office of Metrology and Sur-
veying (Bundesamt für Eich- und Vermes­sungswesen, BEV)
according to § 40 des Maß- und Eichgesetzes (MEG),
BGBl. Nr. 152/1950, in der geltenden Fassung
approval sign
issued to PTW-Freiburg
erence point in 5.7 mm depth under the center of the window
Nominal useful energy range in mode 70/100 kV 30 kV
Energy dependence of the dis­play within the nominal useful range
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70/100 kV ± 10 % (W anode 2.5 mm Al) 30 kV ± 10 % (Mo anode 30 µm Mo)
± 5 % with variation of tube voltage by ± 10 %
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Technical Manual
Device designation Diagnostic dosemeter CONNY II T11007
Measuring quantities air kerma in Gy,
air kerma rate in Gy/s, irradiation time [s]
Measuring ranges and resolution
Range LOW 70/100 kV
Range LOW 30 kV
Range HIGH 70/100 kV
Range HIGH 30 kV
Dose measurement:
resolution lower limit upper limit
20 nGy 2 µGy
9.999 Gy
50 nGy 5 µGy
1)
9.999 Gy
1)
2 µGy 200 µGy
9.999 Gy
5 µGy 500 µGy
1)
9.999 Gy
Dose rate measurement:
resolution lower limit upper limit (typ.)
50 nGy/s 5 µGy/s 3 mGy/s
100 nGy/s 10 µGy/s 5 mGy/s
5 µGy/s 500 µGy/s 300 mGy/s
10 µGy/s 1 mGy/s 500 mGy/s
Time measurement
resolution lower limit upper limit
10 ms 1 s
999.9 s
10 ms 1 s
1)
999.9 s
1)
10 ms 1 s
999.9 s
10 ms 1 s
1)
999.9 s
1)
Leakage ≤ 2 Digit in all dose rate ranges (for at least 1 min acc. to IEC
61674). The zero point is measured and compensated each time the device is switched on. The auto-reset/auto-start function ensures that leakage will not occur after a dose measurement.
1)
Repeatability ≤ 1 %
Linearity of the dose measure-
± 2 %
ment
Long-term stability max. 2 % p. A.
Nominal useful ranges
Temperature Humidity Atmospheric pressure Maximum operating altitude
1)
limited by display range
(10 ... 40) °C (10 ... 80) % rel. humidity; 20 g/m³ max. (700 ... 1060) hPa 3000 m above sea level
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Technical Manual
Device designation Diagnostic dosemeter CONNY II T11007
Quantities influencing the response
Dose rate Dose Direction of incident radiation Power supply Atmospheric pressure Temperature Humidity Electrical interferences
≤ ± 2 %
- 5 % at 3.5 kGy (60Co) ≤ ± 3 % at changes by ± 5° ≤ ± 2 % ≤ ± 3 % ≤ ± 3 % ≤ ± 3 % ≤ ± 5 %
Power supply 4 alkaline-batteries; voltage: 1.5 V; size: AA
Operation time typ. 18 h
Lifetime of the non-volatile mem-
typ. 10 years
ory for calibration data
Transport and storage conditions
Temperature Relative humidity
(-20 ... +60) °C, (-4 ... +140) °F (10 ... 85) %, no condensation (max. 20 g/m³ absolute humidity)
Atmospheric pressure
(600 ... 1200) hPa
Electromagnetic compatibility suitable for operation in a basic electromagnetic environment
according to IEC 61326-1
Dimensions 100 mm x 180 mm x 45 mm
Weight approx. 500 g including batteries
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Technical Manual
The product fully complies with the following requirements of standard IEC/CISPR 11.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions IEC/CISPR 11
RF emissions IEC/CISPR 11
Group 1 The product uses RF energy only for its internal func-
tion. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby elec­tronic equipment.
Class B The product is suitable for use in all establishments,
including domestic establishments and those directly connected to the public low-voltage power supply net­work that supplies buildings used for domestic pur­poses.
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Service Manual - Cleaning

Service Manual

WARNING
Improper execution of service tasks.
Hazards to Persons! Equipment Damage!
Ensure that the service tasks described below are only performed by specialized staff.
In addition, ensure that all other service tasks are only performed by PTW-Freiburg or by a person authorized by PTW-Freiburg.
WARNING
Improper execution of service tasks.
Hazards to Persons! Equipment Damage!
Before carrying out any service tasks on the CONNY II, de-energize the device.
Do not open the housing of the CONNY II.

6 Cleaning

General Information on Cleaning
DANGER
Liquids have entered the product.
Shock Hazard! Erroneous Measurements!
Have the product inspected by service person­nel before putting it into service again.
NOTICE
To avoid surface damage, do not use disinfec­tants on a phenol base or peroxide compounds to disinfect the surface.
The product cannot be sterilized or completely disinfected.
Clean the product simply by wiping it down with a dry or slightly moistened cloth. Use water or a mild soap solution.
Alternatively, you can use a common disinfection agent for medical instruments which is specified in the list of disinfectants of your national hygiene institute (e.g., VAH in Germany). If your country does not provide such a list, we recommend either a solution on an aldehyde base or a solution with a quaternary ammonium compound.
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Service Manual - Preventive Maintenance
Surfaces and Connection Cable
Clean the surfaces and the connection cable as follows:
Only wipe the product down. Liquids must
not be allowed to enter the product. Do not immerse the product in water or other liquids. Do not apply spray to the product.

7 Preventive Maintenance

Below, you will find a list of the maintenance mea­sures and inspections necessary for the product.
Check before each use
Before each use, visually inspect the product
and cables for signs of mechanical damage.
If damage or malfunctions are identified, the
product must be repaired before it is used again.
Repair
Repairs may only be carried out by PTW-Freiburg or by persons/companies authorized by PTW­Freiburg.
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Service Manual - Preventive Maintenance
Safety Inspections
Only regularly inspected products are fail-safe. To preserve the functional security and operational safety, a safety inspection is to be executed at regular intervals according to the national regula­tions.
These inspections must only be performed by independent persons with adequate training and experience.
It is recommended to execute the safety inspec­tions every 2 years.
Technical Inspection of the Measuring System
The product must be inspected at regular inter­vals according to the national regulations. It is rec­ommended to perform technical inspections of the measuring system every 5 years at PTW-Freiburg or a qualified calibration laboratory.
Calibration
The exact calibration factor and supplementary data are included in the calibration certificate.
It is recommended to have the product calibrated every 2 years at PTW-Freiburg or by specially trained staff on site.
Inspections must also be performed after repairs or after each influence that may have changed the behavior of the product.
D594.131.00/03 en 27
Page 28

8 Inserting Batteries

DANGER
Improper handling of batteries.
Explosion Hazard!
Service Manual - Inserting Batteries
Remove the lid from the battery compartment
on the underside of the device.
Remove the four batteries.
Do not throw the batteries into a fire.
WARNING
Improper handling of batteries.
Bodily Injury!
If electrolyte leaks from the battery, avoid con­tact with skin or clothes. Immediately clean skin or clothes with water if they have come in con­tact with electrolyte. In case of eye contact, immediately rinse eyes with water and consult doctor.
Do not open batteries.
WARNING
Improper handling of batteries.
Risk of Fire or Skin Burns!
Never short-circuit batteries.
Insert new batteries into the device. Observe
the correct battery polarity Figure 6. Use only AA size batteries (refer to section 5 "Technical
Specifications").
Reinstall the lid of the battery compartment.
The batteries must be disposed of in compli-
ance with the applicable regulations.
NOTICE
Observe the following points to avoid equip­ment damage: – Do not open batteries. – Never expose batteries to water. – Store and use the batteries at the ambient
conditions (temperature, relative humidity) specified for the device.
– Remove discharged batteries as soon as
possible because leaking electrolyte may damage the device.
Proceed as follows to replace the batteries:
Switch off the device.
28 D594.131.00/03 en
Figure 6: Battery compartment on the back of
the device
The CONNY II can also be used with AA size rechargeable batteries. The CONNY II does not provide a charging function.
The safety information set forth above also applies to the use of rechargeable batteries.
Page 29
Service Manual - Disposal of the Product

9 Disposal of the Product

The typical lifetime of the product is approx. 10 years.
At the end of the product lifetime, the components of the product must be disposed of in compliance with the applicable waste control regulations. The different materials must be separated and recy­cled as appropriate.
The electronic components must be recycled according to the local regulations.
The product does not contain hazardous materi­als.
The rechargeable batteries must be disposed of in compliance with the applicable regulations.
D594.131.00/03 en 29
Page 30

Literature

Literature
[1] Council Directive 93/42/EEC concerning medical devices
(Medical Device Directive - MDD)
[2] Council Directive 97/43/EURATOM on health protection
of individuals against the dangers of ionizing radiation in
relation to medical exposure
[3] IEC 61674
Medical electrical equipment -
Dosimeters with ionization chambers and/or semi-con-
ductor detectors as used in X-ray diagnostic imaging
[4] DIN 6868-3
Image quality assurance in diagnostic X-ray departments
-
Part 3: Tests for constancy in direct radiography
[5] DIN 6868-4
Image quality assurance in diagnostic X-ray departments
-
Part 4: Constancy testing of medical X-ray equipment for
fluoroscopy
[10] IEC/CISPR 11
Industrial, scientific and medical equipment -
Radio-frequency disturbance characteristics - Limits and
methods of measurement
[11] ISTA 2A
ISTA 2 Series
Partial Simulation Performance Test Procedure -
Part 2A: Packaged-Products 150 lb (68 kg) or less
[6] DIN 6868-7
Image quality assurance in diagnostic X-ray departments
-
Part 7: Constancy testing of mammographic Xray equip-
ment
[7] DIN 6868-13
Image quality assurance in diagnostic X-ray departments
-
Part 13: RöV constancy test of projection radiography
systems with digital image receptors
[8] IEC 61010-1
Safety requirements for electrical equipment for mea-
surement, control and laboratory use -
Part 1: General requirement
[9] IEC 61326-1
Electrical equipment for measurement, control and labo-
ratory use - EMC requirements -
Part 1: General requirements
30 D594.131.00/03 en
Page 31

Index

Index
A
Application............................................................... 13
B
Batteries
Batteries: insert........................................................ 28
C
Calibration................................................................ 27
Cleaning................................................................... 25
D
Device description................................................... 13
Disposal................................................................... 29
E
Error messages....................................................... 20
F
Features................................................................... 14
S
Safety information...................................................... 7
Safety inspections................................................... 27
Symbols................................................................... 12
T
Technical inspections of the measuring system....... 27
Technical specifications........................................... 21
G
General information................................................... 2
I
Indicators and operating controls............................ 15
Intended Use............................................................. 6
L
List of figures............................................................. 5
Literature.................................................................. 30
M
Maintenance............................................................ 26
Measurement, perform............................................ 18
Measuring................................................................ 17
P
Putting into operation.............................................. 16
R
Repair...................................................................... 26
D594.131.00/03 en 31
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