PENTAX MEDICAL
Colonoscopes
Pentax Endoscopes Various Models Electromagnetic Disturbances Warning Addendum Sheet Jan 2019
s Warning Addendum Sheet
4 Pages
Preview
Page 1
The additional information for PENTAX Medical Endoscopes to comply with IEC60601-1-2: 2014: Medical electrical equipment, IEC standard.
Warning This product is intended to be used in the electromagnetic environment specified by “Electromagnetic disturbances”. Using the product in an unintended environment may result in incorrect exposure control of the light emitted from distal end of the endoscope due to electromagnetic interference. The following models are intended to be used in a medical facility (including the place where the high frequency generator is used). EB15‑J10, EB19‑J10, VNL15‑J10, ECY‑1575K, EG34‑J10U, EG38‑J10UT, ED34‑i10T, EG‑2990Zi, EC‑3890LZi, EC‑3890FZi, EC‑3890MZi, EG27‑i10, EG29‑i10, EG29‑i10N, EG‑2990i, EG‑2490K, EG‑2790K, EG‑2990K, EG‑3490K, EG‑3890TK, EC34‑i10F, EC34‑i10M, EC38‑i10F, EC38‑i10F2, EC38‑i10M, EC38‑i10M2, EC34‑i10L, EC38‑i10L, EC‑2990Li, EC‑3490TLi, EC‑3490TFi, EC‑3490TMi, EC‑3890Li, EC‑3890Fi, EC‑3890Fi2, EC‑3490LK, EC‑3490FK, EC‑3490MK, EC‑3890LK, EC‑3890FK, EC‑3890FK2, EC‑3890MK, EC‑3890TLK, ED‑3490TK, EC34‑i10TF, EC38‑i10NL, EC38‑i10NF, FB‑15V, FB‑18V, FB‑19TV, FC‑38LV, FC‑38FV, FD‑34V2, FG‑16V, FG‑24V, FG‑29V, FS‑34V The compatible high frequency generators are listed below. Category
Description ICC Series
High Frequency Generator VIO Series
Model Name
Brand Name
ICC 350 ICC 200 VIO 300D VIO 200S
ERBE
Electromagnetic disturbances (The following description applies to the products that start with serial number “N” 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
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000 - 3 -2
Complies Class A at power input 220 V, 230 V and 240 V with operating frequency 50 Hz or 60 Hz Otherwise, not applicable
Voltage fluctuations / flicker emissions IEC 61000 - 3 - 3
Complies at power input 50 Hz, 220 to 240 V Otherwise, not applicable
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.
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.
1 /4
2019. 01 F416 R01
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. Table 2: Enclosure 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
Radiated RF EM fields
IEC 61000 - 4 - 3
3 V/m 80 MHz to 2,7 GHz 80 % AM at 1 kHz
Proximity fields from RF wireless communications equipment
IEC 61000 - 4 - 3
Refer to Table6
RATED power frequency magnetic fields
IEC 61000 - 4 - 8
30 A /m 50 Hz or 60 Hz Table 3: Input AC Power Port
Phenomenon
Basic EMC standard
IMMUNITY TEST LEVELS
Electrical fast transients / bursts
IEC 61000 - 4 - 4
±2 kV 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
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 0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
Voltage dips
IEC 61000 - 4 -11
0 % UT; 1 cycle 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. 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
2 /4
2019. 01 F416 R01
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)
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
Modulationa)
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:
• 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.
3 /4
2019. 01 F416 R01
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.
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 / 35202302
4 /4
2019. 01 F416 R01