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Safety precautions

Table 1 Emissions

Emissions test

Compliance

Electromagnetic environment - guidelines

RF emissions

CISPR 11

Group 1

Class B

Dedicated medical facility environment

Harmonic emissions

IEC 61000-3-2

Class A

Dedicated medical facility environment

Voltage fluctuations/flicker 

emissions

IEC 61000-3-3

Complies

Dedicated medical facility environment

Table 2 Immunity

Phenomenon

Basic EMC standard or test 

method

Immunity test levels

Electrostatic discharge

IEC 61000-4-2

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated RF EM fields

IEC 61000-4-3

3 V/m

80 MHz - 2.7 GHz

80 % AM at 1 kHz

Proximity fields from RF 

wireless communications 

equipment

IEC 61000-4-3

See the following table “Test specifications for Enclosure port 

immunity to RF wireless communications equipment”

Electrical fast transients / 

bursts

IEC 61000-4-4

±2 kV input d.c. power port

±2 kV input d.c. power port

±1 kV signal input/output parts port

100 kHz repetition frequency

Surges

IEC 61000-4-5

±0.5 kV, ±1 kV line-to-line

±0.5 kV, ±1 kV, ±2 kV line-to-ground

Conducted disturbances 

induced by RF fields

IEC 61000-4-6

3 V

0.15 MHz - 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz 

a

80 % AM at 1 kHz

Rated power frequency 

magnetic fields

IEC 61000-4-8

30 A/m

Voltage dips

IEC 61000-4-11

0 % U

T

; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % U

T

; 1 cycle

and

70 % U

T

; 25/30 cycle 

b

Single phase: at 0°

Voltage interruptions

IEC 61000-4-11

0 % U

T

; 250/300 cycle 

b

[NOTE]  U

T

 is the a.c. mains voltage prior to application of the test level.

a  The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz 

to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

b  E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.

Summary of Contents for AeroDR SKR 4000

Page 1: ...EN 02...

Page 2: ......

Page 3: ...2 2 Component names and functions 26 2 2 1 DR Detector 26 2 2 2 Battery 27 2 2 3 Battery Charger 27 2 2 4 DC Power Cable 28 Chapter 3 Chapter 3 General Operations 29 3 1 Startup and shutdown 30 3 1 1...

Page 4: ...r 6 Specifications 51 6 1 Specifications 52 6 1 1 DR Detector 52 6 1 2 Battery 53 6 1 3 Battery Charger 53 6 1 4 AC Adapter 54 6 1 5 DC Power Cable 54 6 1 6 SKR 4000 54 6 2 Characteristics and perform...

Page 5: ...ative This operation manual provides instructions on the basic functions for operation of this device Those operating this device for the first time should read this manual beforehand Also store this...

Page 6: ...to the console the image processing controller with wireless communication There are two ways to supply the power to the DR Detector from removable Battery and wired connection through the AC Adapter...

Page 7: ...sume any liability relating to the following events arising due to systems in fected by computer viruses worms and other malicious software potentially harmful to computers hereunderre ferred to as ma...

Page 8: ...8...

Page 9: ...9 Chapter 1 Safety Precautions Warnings...

Page 10: ...e Graphic symbols Explanation Indicates that full caution is required when handling this device This indicates to reference to the instruction manual for general information Indicates that it is neces...

Page 11: ...are there to make sure that the user recognizes potential hazards when operating this device IMPORTANT If a warning label is too dirty or damaged to read contact Konica Minolta technical representati...

Page 12: ...se follow the rules and regulations of your relevant authorities in the disposal of this product accessories options consumables media and their packing materi als A 15 minute warm up operation is req...

Page 13: ...attery to leak In respect to Battery pay attention to the followings to pre vent heating explosion and fire Do not expose Battery to strong impact dropping the battery from an elevated location or thr...

Page 14: ...e between each DR Detector for at least 30 cm When using the DC Power Cable observe the following Remove the cable by holding the connector housing Do not let the cable get pinched by doors and do not...

Page 15: ...the limits for medical devices in IEC 60601 1 2 2014 These limits are designed to provide reasonable pro tection against harmful interference in a typical medi cal installation The device generates u...

Page 16: ...transmitters frequen cy Wireless standard IEEE802 11a b g n ac Frequency 2 4G 2 412 2 4835 GHz 5G 5 15 5 85 GHz Modulation 802 11b CCK DQPSK DBPSK 802 11a g 64 QAM 16 QAM QPSK BPSK 802 11n 64 QAM 16...

Page 17: ...ess communications equipment Electrical fast transients bursts IEC 61000 4 4 2 kV input d c power port 2 kV input d c power port 1 kV signal input output parts port 100 kHz repetition frequency Surges...

Page 18: ...ency MHz Modulation Immunity test level V m 385 Pulse modulation 18 Hz 27 450 Frequency modulation 5 kHz deviation 1 kHz sine 28 710 Pulse modulation 217 Hz 9 745 780 810 Pulse modulation 18 Hz 28 870...

Page 19: ...y additional research DR Detector has been tested and found to comply with FCC IC radiation expo sure limits set forth for controlled equipment and meets the FCC radio frequency RF Exposure Guidelines...

Page 20: ...g to compulsory certification of Electrical Equipment Subject to Sanitary Surveillance by ANVISA RDC No 27 dated 21 06 2011 and Nor mative Instruction No 11 dated 16 12 2014 The highest SAR value repo...

Page 21: ...DR Detector If you directly apply or spray disinfecting solution on the DR Detector the solution will enter the instrument through exterior gaps causing a failure Dampen a lint free soft cloth with di...

Page 22: ...22...

Page 23: ...23 Chapter 2 Product Overview...

Page 24: ...ss point Communicates with the DR Detector Provided by a general purpose product 5 Image processing controller Controls the reception management and output of image data Up to 2 DR Detectors can be re...

Page 25: ...w of this device Connection example 2 X ray Wireless connection 1 DR Detector Wireless connection 1 DR Detector Exposure room 2 Battery Charger 3 DC Power Cable X ray device operation panel 5 Image pr...

Page 26: ...eless modes 3 Triangular mark Indicates the direction to place the DR Detector in during exposure 4 Antenna Displays the place where a wireless antenna is attached 5 Exterior Protects the internal par...

Page 27: ...1 Battery connector port Connects to the DR Detector or Battery Charger 2 Insertion direction indication mark Indicates the insertion direction of the Battery 2 2 3 Battery Charger 1 2 Number Name Fu...

Page 28: ...tions 2 2 4 DC Power Cable 1 2 3 4 Number Name Functions 1 Wired connection connector Connects to the DR Detector 2 LED Display the DC Power Cable status 3 AC Adapter Used to supply power to the DC Po...

Page 29: ...29 Chapter 3 General Operations...

Page 30: ...ting a charged Battery to the DR Detector Connecting the DC Power Cable to the DR Detector and the AC Power Cable to the power outlet Battery Charger 1 Connect the AC Power Cable to a wall out let and...

Page 31: ...31 Battery Charger 1 Disconnect the AC Power Cable from the wall outlet and confirm that the Power LED green is off Power LED green DC Power Cable 1 Disconnect the AC Power Cable from the wall outlet...

Page 32: ...is dis played on the image processing control ler HINT When inserting the DR Detector to the wall stand or table an exposure operation can be performed with the DC Pow er Cable connected Press the Pow...

Page 33: ...riangular mark is to the left or right HINT The blue lines also helps you identify the top bottom orien tation of the DR Detector To carry out exposures in portrait orientation turn the DR Detector so...

Page 34: ...y Grid ratio Conver gence distance Angle error AeroDR NS 1417 40 lp cm Variety Variety 5 0 or less High dose exposure When high dose exposures are performed continu ously afterimages of the last expos...

Page 35: ...a location near a de vice that emits electromagnetic wave noise may ap pear on the image When performing exposure turn off that device or move that device away from DR Detector Waterproof performance...

Page 36: ...rection indication mark on the Battery with the DR Detector battery connector port and then insert the Battery Insertion direction indication mark Battery connector port 3 Slide the battery lock and l...

Page 37: ...DC Power Cable 6 hours or less if not expose 3 4 1 Charging with Battery Charger IMPORTANT Handle the Battery carefully when inserting and removing the Battery The battery connector port may be damage...

Page 38: ...Power Cable When charging starts the Battery LED green orange on the DR Detector blinks When charged more than 11 the Battery LED green blinks Battery LED green orange HINT The DR Detector will be cha...

Page 39: ...ecrease When the Battery is removed if the DC Power Cable is connected and the DR Detector is turned on the Battery LED green turns up LINK LED Display pattern Lighting color Status Shutdown condition...

Page 40: ...arger Charging LED Power LED Fully charged LED Power LED green Display pattern Status Shutdown condition Operating Charging LED orange and Fully charged LED green Charging LED Fully charged LED Status...

Page 41: ...ffix the labels only in the recommended places Failure to do so may cause the labels to come off or image uneven ness to occur Position to affix DR Detector identification label XXXXXXXXXXXXXXXX 1 2 H...

Page 42: ...42...

Page 43: ...43 Chapter 4 Troubleshooting...

Page 44: ...e Status LED green does not light Ready is not displayed on the image processing controller System error is occurring If the status LED green does not turn on after approx 10 minutes restart the DR De...

Page 45: ...ms Did you perform exposure in Ready status Are the exposure conditions correct Was X ray output lowered Was X ray voltage set to a lower value 2 Perform the following procedures Increase the voltage...

Page 46: ...46...

Page 47: ...47 Chapter 5 Maintenance...

Page 48: ...aning the Battery Charger Weekly Full charge of the Battery 6 months 5 1 2 Cleaning IMPORTANT Be careful not to apply any cleaning chemical or liquid onto the wired connection connectors the Power SW...

Page 49: ...ed it may affect the quality performance and safety of the DR Detector Because the antiseptic solution is a chemical agent adhere to the precautions provided by the pharmaceutical manu facturer If bod...

Page 50: ...50...

Page 51: ...51 Chapter 6 Specifications...

Page 52: ...luding the Battery Pixel size 150 um Image area size 345 6 420 mm 2 304 2 800 pixels AD conversion 16 bit Maximum patient weight Point load 100 kg 40 mm Face load 150 kg effective image area overall D...

Page 53: ...atus 2 5 hours Without sleep 7 6 hours With sleep 6 1 2 Battery Item Description Product name BATTERY KV made by iRay Technology Co Ltd Battery type Lithium Ion Battery Rated capacity 4180 mAh standar...

Page 54: ...35 RH to 85 RH ensure no water con densation 35 RH 85 RH 700 hPa to 1060 hPa 700 hPa 1060 hPa Temperature change should be less than 1 C min Pressure change should be less than 1 0197 10 4 Pa min When...

Page 55: ...87 870 8700 0 0 5 1 1 5 2 2 5 3 0 1000 2000 3000 4000 0 0001 0 001 0 01 0 1 1 10 100 1000 Air Kerma Gy Density Pixel Value Exposure Dose mR P 41 REGIUS210 QR 250 SRO 500 SR G right axis MTF 0 0 0 2 0...

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Page 60: ...ia Private Ltd Office No 201 2nd Floor Atrium 2 Next to Courtyard Marriott Hotel Andheri Kurla Road Chakala Andheri East Mumbai 400093 India TEL 91 22 61916900 Konica Minolta Business Solutions Canada...

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