KG MedTEST system | Denkei Corporation Americas

Medical device safety standard compliance system

MedTEST is a system designed to provide a complete testing solution for medical device manufacturers who must comply with international certification standards (such as IEC/UL60601-1 3rd Edition).
MedTEST can be customized to meet specific test requirements, such as withstand voltage, earth bond, insulation resistance, and leakage current testing (including live testing) for all Type B, Type BF, and Type CF applied parts. Additionally, the SC6540 matrix scanner allows for multi-switching between various measurement points, allowing tests to be performed sequentially without changing the measurement points on the test leads, reducing overall test time.

Medical device safety standard compliance system

Maker:

Keisoku Giken

Features

All medical safety tests are packaged. The most advanced standard safety system

Safety Compliance Analyzer (8207)

Extensive basic specifications

In addition to the conventional withstand voltage test (AC, DC) and insulation resistance test, earth continuity test and touch current test are also included as standard.

AC withstand voltage	DC withstand voltage	Insulation resistance	Earth Continuity	Touch Current	RUN test	AC power supply
5kV 50mA	6kV 20mA	1000V 50GΩ	40A 600mΩ AC8V	16A/277Vac DC, 15Hz-1MHz 10mArms/10mAp-p MD7 circuit built-in	Standard equipment	Built-in as standard equipment (500VA)

Withstand voltage test possible while power is on

It is possible to perform voltage withstand tests while the DUT (device under test) is powered on, and complies with Chinese standard GB/T 12350-2009 for more demanding quality testing.

Dual check function that reduces test time

Earth continuity tests (GB) and withstand voltage tests (ACW, DCW), which were previously performed separately, can now be performed simultaneously. This reduces the total test time and allows for more efficient testing.

Current measurement function compliant with IEC60601

Previously, touch current (leakage current) measurements were made by combining AC and DC, but now, in compliance with the measurement standards of IEC60601 (safety standards for medical electrical equipment), it is possible to measure AC and DC separately from the AC+DC measurement value.

RUN test function: Power measurement function

Is the device broken after a withstand voltage test? Measures voltage, current, and power. Equipped with a function that judges the device as NG if the threshold value for normal products is exceeded.

Supports supply test voltage up to 277V

General testers are limited to 240V, and cannot perform 110% voltage application tests for export medical devices. This tester supports a maximum of 277V, allowing testing at 110% of 240V, or 264V. The input current rating is 16A.

Built-in 500VA isolated AC power supply

Built-in VVVF isolated AC power supply of 0 to 277V/0 to 4.2A/500VA

Freely designable external MD circuit available

A removable external MD is provided, allowing you to freely create simulated circuits. You can quickly support simulated circuits of new standards.

MD circuit unit

Visualization of MD circuits (human body simulated resistance)

The circuit unit, which was previously a black box, can now be detached. The circuit can be visually checked (error range and circuit pattern). When receiving approval for type testing from a certification body, error ranges and other information can be made visible and open.

Equipped with uninterruptible polarity switching function

Switching the input polarity is the same as a power outage if the voltage is dropped. Air conditioners and refrigerators take time to stabilize after a power outage, making it impossible to test immediately. Switching the polarity of the measurement side, rather than switching the polarity, allows for uninterruptible electrode switching.

Matrix scanner (SC6540)

Uses a matrix scanner system for easy switching

The matrix scanner method allows the scanner to be set to one of three states: H: High voltage side, L: Return side (GND), and X: Open, as a switching method for the voltage and insulation resistance scanner.With a wide range of rated voltages of AC5kV/DC6kV, it can be used for multiple purposes, such as leakage current (touch current) and 110% AC voltage application required for medical device testing, in addition to withstand voltage and insulation resistance.

**SC-6540 Series HV Settings**
ch	situation
ch1	H
ch2	L
ch3	×
ch4	H
ch5	L
ch6	×
ch7	×
ch8	×

Multi-function, slim AC power supply (8500 STD series)

Capacity can be expanded using AC power supply (8500 STD series)

The Safety Standards Analyzer 8207 can supply up to 500VA with its built-in AC power supply, but by expanding the AC power supply with the Touch Current Tester 620L, it can support medical equipment up to single-phase 40Arms.

Compliant with Annex K of IEC62354. Pre-operation inspection jigs for safety testers and leakage current testers are provided.

– TVB-2

The TVB-2 is a fixture box for verifying that the safety tester is functioning properly. It is used before starting withstand voltage, insulation resistance, and earth bond tests to check that the safety tester is operating correctly.

TVB-2

– LVB-2

LVB-2 is a jig box for checking that the leakage current tester is functioning properly. It is used before starting a leakage current test to check that the leakage current tester is operating correctly.

LVB-2

Composition

8207+SC6540 System Standard Type

Standard all-in-one test system
(AC/DC withstand voltage, earth bond, insulation resistance, leakage current)
Built-in 500VA isolated AC power supply
Multipoint switching test using SC6540 (8ch or 16ch)

For 8207 product information, click here

For SC6540 product information, click here.

AC withstand voltage	DC withstand voltage	Insulation resistance	Earth Continuity	Touch Current	RUN test	AC power supply	Multipoint
5kV 50mA	6kV 20mA	1000V 50GΩ	40A 600mΩ AC8V	16A/277Vac DC, 15Hz-1MHz 10mArms/10mAp-p MD7 circuit built-in	Standard equipment	Built-in as standard equipment (500VA)	8ch or 16ch

8206+SC6540+8500 STD system extended type

All-in-one test system with expanded AC power supply
(AC/DC withstand voltage, earth continuity, insulation resistance, leakage current)
Built-in 500VA isolated AC power supply
Multipoint switching test using SC6540 (8ch or 16ch)

For 8207 product information, click here

For SC6540 product information, click here.

For more information on the 8500 STD product, click here.

AC withstand voltage	DC withstand voltage	Insulation resistance	Earth Continuity	Touch Current	RUN test	AC power supply	Multipoint
5kV 50mA	6kV 20mA	1000V 50GΩ	40A 600mΩ AC8V	16A/277Vac DC, 15Hz-1MHz 10mArms/10mAp-p MD7 circuit built-in	Standard equipment	500VA to 6kVA external power supply	8ch or 16ch

8204+620L+SC6540+8500 STD system full expansion type

All-in-one test system compatible with 40 Arms input current
(AC/DC withstand voltage, earth bond, insulation resistance, leakage current)
Flexible selection of 500VA to 6kVA isolated external AC power supplies
Can be mounted in a 19-inch rack
Input current measurement and fault condition simulation up to 40Arms
Multipoint switching test using SC6540 (8ch or 16ch)

For more information on the 620L product, click here.

For 8207 product information, click here

For SC6540 product information, click here.

For more information on the 8500 STD product, click here.

AC withstand voltage	DC withstand voltage	Insulation resistance	Earth Continuity	Touch Current	RUN test	AC power supply	Multipoint
5kV 50mA	6kV 20mA	1000V 50GΩ	40A 600mΩ AC8V	40A/277Vac DC, 15Hz-1MHz 20mArms/30mAp-p MD7 circuit built-in	Standard equipment	500VA to 6kVA external power supply	8ch or 16ch

Specifications

For full expansion type

Input Line Conditions
Polarity Reversal Switch	Polarity inversion setting on/off/Auto switch
Neutral switch	Single-fault neutral on/off switch
Ground Switch	Single fault class I grounded on/off switch
Probe Settings
Probe-Hi to Probe-Lo	Externally applied part or chassis-to-chassis leakage current
Probe-Hi to Line	Contact or patient leakage current
Ground to Line	Earth Leakage Current
Touch current limit setting
Touch Current Upper/Lower Limit Settings (RMS)	Range: 0.0uA to 999.9uA / 1.000uA to 9.999uA / 10.00mA to 20.00mA
Touch Current Upper/Lower Limit Settings (RMS)	Resolution: 0.1uA/1uA/0.01mA
Touch Current Upper/Lower Limit Settings (Peak)	Range: 0.0uA to 999.9uA / 1.000uA to 9.999uA / 10.00mA to 30.00mA
Touch Current Upper/Lower Limit Settings (Peak)	Resolution: 0.1uA/1uA/0.01mA
Measurement Circuit Module
MD1	UL544NP, UL484, UL923, UL471, UL867, UL697,IEC60990 Fig4 U1
MD2	UL544P
MD3	IEC 60601-1
MD4	UL1563
MD5	IEC60990 Fig4 U2, IEC 62368, IEC60335-1, IEC60598-1, IEC60065, IEC61010
MD6	IEC60990 Fig5 U3, IEC60598-1
MD7	IEC62368, IEC61010-1 FIG.A(2kΩ) for Run function
External MD	Basic measurement element 1MΩ
MD voltage limiter MD component idiom	70Vpeak or 70Vdc
MD part precision	Capacitor ±5%, Resistor ±1%
DUT power supply
AC voltage and current	0.0 to 277.0V
AC current	Maximum continuous 40Arms
AC voltage upper/lower limits	Range: 0.0~277.0V
AC voltage upper/lower limits	Resolution: 0.1V
AC voltage measurement	Range: 0.0~277.0V
	Resolution: 0.1V
	Accuracy : ±(1.5% of reading + 2 counts), 30.0 to 277.0 V
Delay time setting	Range: 0.5~999.9sec
Delay time setting	Resolution: 0.1sec
Test time setting	Range: 0.5~999.9sec
	Resolution: 0.1sec
	Accuracy : ±(0.1% of reading + 0.05 second)
Protection Features	Neutral – V: Indicates if voltage is present on the neutral. Line – OC: 40 Amp
Voltage Withstand Test
Output Rating ^*	5kV@50mA AC 6kV@20mA DC
setting	Range: 0~5.000V AC, 0~6.000V DC
	Resolution: 1V
	Accuracy : ±(2% of Setting + 5V)
Upper/lower limits	AC Current (Total)	Range: 0.000~9.999mA
		Resolution: 0.001mA
		Accuracy : ±(2% of Setting + 2 counts)
		Range: 0.000~50.00mA
		Resolution: 0.01mA
		Accuracy : ±(2% of Setting + 2 counts)
	AC Current (Real)	Range: 0.000~9.999mA
		Resolution: 0.001mA
		Accuracy : ±(3% of Setting + 50μA)
		Range: 0.000~50.00mA
		Resolution: 0.01mA
		Accuracy : ±(3% of Setting + 50μA)
	DC current	Range: 0.000~999.9μA
		Resolution: 0.01μA
		Accuracy : ±(2% of Setting + 2 counts)
		Range: 0.000~20.000μA
		Resolution: 1μA
		Accuracy : ±(2% of Setting + 2 counts)
Lamp High	> 20mA peak maximum, ON/OFF selectable
Charge LO	Range: 0.000 – 3.500 or auto setting
Output Ripple	<4% (5KV/20mA resistive load)
Discharge Time	≤ 50 ms with no load, ≤ 100 ms with capacitor load
maximum capacitive load	1 μF < 1 kV, 0.75 μF < 2 kV, 0.5 μF < 3 kV 0.08 μF < 4 kV, 0.04 μF < 6 kV
Output Frequency	50Hz/60Hz 0.1%, selectable 400Hz/800Hz (optional)
Output Waveform	Sine wave, crest factor = 1.3 to 1.5
Load fluctuation Output voltage stability	± (1 % of output + 5 V) (complex fluctuation) from no load to maximum load, low line to high line
Exam time	AC 0, 0.4 to 999.9 s (0 = continuous) DC 0, 0.3 to 999.9 s (0 = continuous)
Rise time Fall time	Rising AC 0.1 to 999.9 s Falling AC 0.0 to 999.9 s Rising DC 0.4 to 999.9 s Falling DC 0.0, 1.0 to 999.9 s
SMART GFI function	SMART GFI Trip Current: 0.4 to 5.0 mA Shutdown Time:
Ground Continuity
Output Current	DC 0.1A ± 0.00001A
Resistance measurement	Range: 0.000 ~ 10,000.00Ω
Upper/lower limits	0.00 to 10,000 Ω
Exam time	Range: 0.0,0.3 to 999.9 s (0 = continuous)
Offset Resistor	Range: 0.00 ~ 10.00Ω
Earth Continuity
Output Voltage	Range: 3.00 ~ 8.00V AC
Output Frequency	50Hz/60Hz ± 0.1%, selectable
Output Current	Range: 1.00 ~ 40.00A
	Resolution: 0.01A
	Accuracy : ±(2% of setting + 2 counts)
Output Regulation	± (1% of output + 0.02 A)@maximum load or less
maximum load	1.00~10.00 A@ 0~600 mΩ 10.01~30.00 A@ 0~200 mΩ 30.01~40.00 A@ 0~150 mΩ
Upper/lower limits	range:	0 to 150 mΩ (30.01 to 40.00 A)
		0 to 200 mΩ (10.01 to 30.00 A)
		0 to 600 mΩ (1.00 to 10.00 A)
	resolution:	1mΩ
	Accuracy :	± (2 % of setting + 2 counts)@ 6.00~40 A ± (3 % of setting + 3 counts)@ 1.00~5.99 A
Offset Resistor	Range: 0 ~ 200mΩ
Insulation resistance
Output Voltage	Range: 30 to 1,000V DC
charging current	Max > 20mA peak
Upper/lower limits	Range: 0.05 to 99.99 MΩ
	Resolution: 0.01 MΩ
	Range: 100.0 to 999.9 MΩ
	Resolution: 0.1 MΩ
	Range: 1000 to 50,000 MΩ
	Resolution: 1 MΩ
Charge LO	Range: 0.000 – 3.500 or auto setting
Rise time/Fall time	Rise time: 0.1 to 999.9 s Fall time: 0.0, 1.0 to 999.9 s
Exam time	0, 0.5 to 999.9 s (0 = continuous)
Delay time	0.5 to 999.9 seconds
SMART GFI function	SMART GFI Trip Current: 0.4 to 5.0 mA Shutdown Time:
General specifications
Interface	Standard: USB, RS-232C Option: Ethernet, GPIB
safety features	Built-in SMART GFI function
memory	620L: 50 memories, 30 steps 8500 series: 10,000 steps
AC power supply
AC power supply	Maximum 6kVA (8500 STD series)
composition	AC power configuration varies depending on the application. MedTEST hardware is configured to test products with one side of the mains power at earth potential (UL60601-1). MedTEST hardware is configured for unbalanced 0 to 277V DUT input power. Custom configurations are available. Contact us for more information.

^*1 : When using the Touch Current Test 620L option 0.3-620L (Hipot/Ground Bond Interconnect), the applied voltage for the withstand voltage test is limited to 3.5kV. Specifications are subject to change without notice.

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