PENTAX MEDICAL
Video Processors
EPK-i7010 and EPK-i5000 Video Processors Addendum Additional Information Sheet Jan 2019
Addendum Additional Information Sheet
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The additional information for PENTAX Medical Video Processor EPK- i5000/ EPK- i7010 to comply with IEC60601-1-2: 2014: Medical electrical equipment, IEC standard This processor is intended to be used in a medical facility (including the place where the high frequency generator is used) and in the electromagnetic environment specified by the “Electromagnetic disturbances”. If the product is used in an unintended environment, the following abnormalities may occur. • Excessive light is emitted from the distal end of the endoscope • Excessive high amount of air is fed into the body lumen unintentionally • Images displayed on the monitor rotate unintentionally • Live images from the endoscope are switched to saved still or video images unintentionally ██ System configuration (For EPK- i7010) For the illustration of “Medical Cart”, refer to the below table.
Error
Correct
Illustration shown
Illustration deleted
██ Installing the processor in a cart
Warning Do NOT install other devices near the processor or install devices in a stack as it may cause abnormal operation of the processor due to adverse effect mutually caused by each device. When devices are required to be installed in close proximity due to inevitable reasons, ensure in advance that there are no abnormalities to occur in each device. Use the cart that conforms to IEC60601-1. ██ Connecting peripheral devices
Warning Use only cables that are specified in this IFU to connect a peripheral device to a device. If cables that are NOT specified in this IFU are used, it may have adverse effect on other devices or may be unfavorably affected by other devices due to change in resistance to electromagnetic wave of devices. ██ Connecting other peripheral devices
Warning Use the products complied with CE marking for computers connected to this product. However, if “CISPR32 Class A” device is connected and used, electromagnetic interference may occur. ██ Connecting other peripheral devices /connecting a microphone (For EPK- i7010) Model / Manufacturer: AT9900 /audio -technica ██ Replacing the fuses (For EPK- i7010)
For warning of the fuse, refer to the below table. Error
Correct
T3.15AH, 250V
T6.3AH, 250V
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Electromagnetic disturbances The following description applies to the products that start with serial numbers below. Model EPK- i5000
Serial “N” or later.
Model EPK- i7010
Serial “D” or later.
This product as the endoscope system, the endoscope with the video processor or the light source conforms to IEC60601-1-2: 2014: Medical electrical equipment, IEC standard.
Guidance and manufacturer’s declaration - electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment. Table 1 Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 - 3 -2 Voltage fluctuations / flicker emissions IEC 61000 - 3 - 3
Compliance Group 1
Electromagnetic environment- guidance This product 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.
Class B This 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.
Class A Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment. Phenomenon ELECTROSTATIC DISCHARGE Radiated RF EM fields Proximity fields from RF wireless communications equipment RATED power frequency magnetic fields
Table 2: Enclosure Port Basic EMC standard IMMUNITY TEST LEVELS ±8 kV contact IEC 61000 - 4 -2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air 3 V/m IEC 61000 - 4 - 3 80 MHz to 2,7 GHz 80 % AM at 1 kHz IEC 61000 - 4 - 3
Refer to Table6
IEC 61000 - 4 - 8
30 A /m 50 Hz or 60 Hz
Table 3: Input AC Power Port Basic EMC standard IMMUNITY TEST LEVELS ±2 kV Electrical fast transients / bursts IEC 61000 - 4 - 4 100 kHz repetition frequency Surges Line - to - line IEC 61000 - 4 - 5 ±0.5 kV, ±1 kV Surges Line - to - ground IEC 61000 - 4 - 5 ±0.5 kV, ±1 kV, ±2 kV 3V Conducted disturbances induced 0.15 MHz to 80 MHz IEC 61000 - 4 - 6 by RF fields 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz 0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle Voltage dips IEC 61000 - 4 -11 and 70 % UT; 25 / 30 cycles Single phase: at 0° Voltage interruptions IEC 61000 - 4 -11 0 % UT; 250 / 300 cycles Note: If this product has the single rated voltage, UT is the rated voltage. If the rated voltage has the range, UT is the lowest voltage and the highest voltage in the voltage range. Phenomenon
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Table 4: PATIENT coupling PORT Phenomenon
Basic EMC standard
IMMUNITY TEST LEVELS
ELECTROSTATIC DISCHARGE
IEC 61000 - 4 -2
±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Conducted disturbances induced by RF fields
IEC 61000 - 4 - 6
3V 0.15 MHz to 80 MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz
Table 5: Signal input /output parts PORT Phenomenon
Basic EMC standard
IMMUNITY TEST LEVELS
ELECTROSTATIC DISCHARGE
IEC 61000 - 4 -2
±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transients / bursts
IEC 61000 - 4 - 4
±1 kV 100 kHz repetition frequency
IEC 61000 - 4 - 6
3V 0.15 MHz to 80 MHz 6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz
Conducted disturbances induced by RF fields
Immunity to proximity fields from wireless communications equipment Table 6: Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency (MHz)
Band (MHz)
Modulationa)
Maximum power (W)
Distance (m)
Immunity test level (V/m)
385
380 to 390
Pulse modulationa) 18 Hz
1.8
0.3
27
450
430 to 470
FMb) ±5 kHz deviation 1 kHz sine
2
0.3
28
704 to 787
Pulse modulationa) 217 Hz
0.2
0.3
9
800 to 960
Pulse modulationa) 18 Hz
2
0.3
28
1700 to 1990
Pulse modulationa) 217 Hz
2
0.3
28
2400 to 2570
Pulse modulationa) 217 Hz
2
0.3
28
5100 to 5800
Pulse modulationa) 217 Hz
0.2
0.3
9
710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785
a) The carrier shall be modulated using a 50 % duty cycle square wave signal. b) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
Note • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. • Interference may occur in the vicinity of equipment marked with the following symbol:
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Note • Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a) should be less than the compliance level in each frequency range.b) 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 this product is used exceeds the applicable RF compliance level above, this product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re - orienting or relocating this product. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and this product
This product is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communications equipment. Warning Portable RF communications equipment should be used no closer than 30 cm to any part of this product or the peripheral equipment connected to this product, including cables specified by this IFU. Otherwise, degradation of the performance of this product could result.
Note • At 80 MHz and 800 MHz, the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ██ Fuse replacement (For EPK- i5000)
Note The service life period of this product is 6 years. Follow the instructions given in the IFU on care after use, maintenance, and usage of this product. If the processor is improperly used and /or maintained, it could shorten the service life of a product. Some consumable components of this product have the service life of less than 6 years. Contact your nearest PENTAX Medical service facility every 3 years for the inspection and maintenance of all consumable components except the lamp and fuse. Replacement of consumable components may be necessary. If the product is kept being used without periodic maintenance, it might cause a problem in switching between modes from the exposure control mode to the observation mode. ██ Additional information of the compatible endoscope (for EPK- i5000 / i7010) 75K endoscope is compatible with EPK- i5000 and EPK- i7010.
Symbols
**If this bar code symbol is displayed on the product, see the following explanation. Symbol
Description This is a UDI (Unique Device Identification) code required by Unique Device Identification System designed to adequately identify devices through distribution and use. The following information is coded in 2D bar code (GS1 Data Matrix). - (01) GS1 Commodity code (Global Trade Item Number) - (11) Production date - (21) Serial number
LCPM: 01/ 2019/ 02 / 35202102
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