EMC − T E S T R E P O R T

Type / Model Name : Aquarius GE-F097-00

Product Description : Hemofiltration system

Applicant : NIKKISO Europe GmbH

Address : Desbrocksriede 1

30855 Langenhagen

Manufacturer : NIKKISO Europe GmbH

Address : Desbrocksriede 1

30855 Langenhagen

Test Result according to the standards

listed in clause 1 test standards: POSITIVE

09. March 2017

Test Report No. : E41867-00-00VK ______________________________________________________________________________________________

Date of issue

The test report merely corresponds to the test sample.

It is not permitted to copy extracts of these test results
without the written permission of the test laboratory.

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 Contents
1 TEST ST AND ARDS 3

2 SUMM ARY 6
2.1 GENERAL REMARKS 6
2.2 SUMMARY FOR ALL EMC TESTS 6
2.3 FINAL ASSESSMENT 7

3 EQUIPMENT UNDER TEST 8

3.1 PHOTO DOCUMENTATION OF THE EUT 8
3.2 POWER SUPPLY SYSTEM UTILISED 9
3.3 HIGHEST INTERNAL FREQUENCY 9
3.4 SHORT DESCRIPTION OF THE EQUIPMENT UNDER TEST (EUT) 9
3.5 ESSENTIAL PERFORMANCE OF THE EUT BASED ON CUSTOMER DEFINITION 9
3.6 EUT OPERATION MODE 9
3.7 EUT MONITORING 10
3.8 EUT CONFIGURATION 10
3.9 COMPLIANCE CRITERIA 11
3.10 PERFORMANCE LEVEL 13

4 TEST ENVIRONMENT 14
4.1 ADDRESS OF THE TEST LABORATORY 14
4.2 STATEMENT REGARDING THE USAGE OF LOGOS IN TEST REPORTS 14
4.3 REPRESENTATIVE OF THE APPLICANT DURING MEASUREMENTS 14
4.4 ENVIRONMENTAL CONDITIONS 14
4.5 STATEMENT OF THE MEASUREMENT UNCERTAINTY 14

5 TEST CONDITIONS AND RESULTS 15

5.1 CONDUCTED EMISSION 15
5.2 RADIATED EMISSION < 1GHZ (ELECTRIC FIELD) 20
5.3 HARMONIC CURRENT EMISSION 23
5.4 VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER 26
5.5 ELECTROSTATIC DISCHARGE 29
5.6 RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD 34
5.7 ELECTRICAL FAST TRANSIENTS / BURST 36
5.8 SURGE 38
5.9 CONDUCTED DISTURBANCES INDUCED BY RADIO-FREQUENCY FIELDS 40
5.10 POWER FREQUENCY MAGNETIC FIELD 43
5.11 VOLTAGE DIPS 45
5.12 SHORT INTERRUPTIONS 47

6 USED TEST EQUIPMENT AND ACCESSORIES 48

7 ID, M ARKING AND DOCUMENTS EN60601-1-2:2007 50

8 ID, M ARKING AND DOCUMENTS EN60601-1-2:2015 51

9 CONSTRUCTIONAL DAT A FORM 52

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1 TEST STANDARDS

The tests were performed according to following standards:

Emission:

This standard is not part of the DAkkS accreditation scope.

EN 60601-2-16 : 2015
IEC 60601-2-16 : 2012
Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment

(The standard above refers to following standard:)

EN 60601-1-2 : 2007 + AC: 2010 Chapter: 6

IEC 60601-1-2 : 2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

(The standard above refers to following standards:)

EN 55011 : 2009 + A1: 2010 Class A Class B

CISPR 11 (modified) : 2009 + A1: 2010 Group 1 Group 2
Industrial scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics –
Limits and methods of measurement
EN 61000-3-2 : 2014
IEC 61000-3-2 : 2014
Harmonic current emissions
EN 61000-3-3 : 2013
IEC 61000-3-3 : 2013
Voltage changes, voltage fluctuations and flicker

EN 60601-1-2 : 2015 Chapter: 7

IEC 60601-1-2 : 2014
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

(The standard above refers to following standards:)

EN 55011 : 2009 + A1: 2010 Class A Class B

CISPR 11 (modified) : 2009 + A1: 2010 Group 1 Group 2
Industrial scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics –
Limits and methods of measurement
EN 61000-3-2 : 2005 + A1: 2009 + A2: 2009
IEC 61000-3-2 : 2005 + A1: 2008 + A2: 2009
Harmonic current emissions
EN 61000-3-3 : 2013
IEC 61000-3-3 : 2013
Voltage changes, voltage fluctuations and flicker

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Immunity:

This standard is not part of the DAkkS accreditation scope.

EN 60601-2-16 : 2015
IEC 60601-2-16 : 2012
Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment

(The standard above refers to following standard:)

EN 60601-1-2 : 2007 + AC: 2010 Chapter: 6

IEC 60601-1-2 : 2007
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

(The standard above refers to following basic standards:)

EN 61000-4-2 : 2009
IEC 61000-4-2 : 2008
Electrostatic discharge immunity test (ESD) “I2”
EN 61000-4-3 : 2006 + A2: 2010
IEC 61000-4-3 : 2006 + A2: 2010
Radiated, radio-frequency, electromagnetic field immunity test “I3”
EN 61000-4-4 : 2012
IEC 61000-4-4 : 2012
Electrical fast transient / burst immunity test (BURST) “I4”
EN 61000-4-5 : 2014
IEC 61000-4-5 : 2014
Surge immunity test (Surge) “I5”
EN 61000-4-6 : 2014 + AC: 2015
IEC 61000-4-6 : 2013 + Cor: 2015
Immunity to conducted disturbances, induced by radio-frequency fields “I6”
EN 61000-4-8 : 2010
IEC 61000-4-8 : 2009
Power frequency magnetic field immunity test “I8”
EN 61000-4-11 : 2004
IEC 61000-4-11 : 2004
Voltage dips, short interruptions and voltage variations immunity test “I11”

EN 60601-1-2 : 2015 Chapter: 8

IEC 60601-1-2 : 2014
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests

(The standard above refers to following basic standards:)

EN 61000-4-2 : 2009
IEC 61000-4-2 : 2008
Electrostatic discharge immunity test (ESD) “I2”
EN 61000-4-3 : 2006 + A1: 2008 + A2: 2010
IEC 61000-4-3 : 2006 + A1: 2007 + A2: 2010
Radiated, radio-frequency, electromagnetic field immunity test “I3”
EN 61000-4-4 : 2012
IEC 61000-4-4 : 2012
Electrical fast transient / burst immunity test (BURST) “I4”
EN 61000-4-5 : 2006
IEC 61000-4-5 : 2005
Surge immunity test (Surge) “I5”

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 EN 61000-4-6 : 2014
IEC 61000-4-6 : 2013
Immunity to conducted disturbances, induced by radio-frequency fields “I6”
EN 61000-4-8 : 2010
IEC 61000-4-8 : 2009
Power frequency magnetic field immunity test “I8”
EN 61000-4-11 : 2004
IEC 61000-4-11 : 2004
Voltage dips, short interruptions and voltage variations immunity test “I11”

Description of the deviations from the requirements:

None

Justification for the deviations from the requirements:

None

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2 SUMMARY

2.1 General remarks

The Aquarius GE-F095-00 is the highest stage of expansion of the Aquarius collection. Equipped with RCA
(Regional citrate anticoagulation ) option, the GE-F097-00 has been used for the test procedure described here
because in that stage it is equivalent to the GE-F095-00, but can also be operated at 115 V as well as 230 V. In
comparison to the devices GE-F096-00 and GE-F097-00, the GE-F095-00 device differs only with additional non
EMC- relevant components. All electrical components contained in GE-F096-00 and GE-F097-00 are also included
in GE-F095-00.

2.2 Summary for all EMC tests

Type of test Test result

Emission:
A4 Conducted emission (AC mains power / DC power) Fulfilled
A5 Radiated emission Fulfilled
SER3 Radiated emission (>1 GHz) Fulfilled
H&FL Harmonic current emission Fulfilled
H&FL Voltage changes, voltage fluctuations and flicker Fulfilled
achieved
Test result Performance
Immunity: criteria
I2 Electrostatic discharge (ESD) Fulfilled See section 3.9
I3 Radiated, radio frequency electromagnetic field Fulfilled See section 3.9
I4 Electrical fast transients (BURST) Fulfilled See section 3.9
I5 Surge Fulfilled See section 3.9
I6 Conducted disturbances induced by radio-frequency fields Fulfilled See section 3.9
I8 Power frequency magnetic field Fulfilled See section 3.9
I11 Voltage dips Fulfilled See section 3.9
I11 Short interruptions Fulfilled See section 3.9
Identification, marking and documents: Fulfilled

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2.3 Final assessment
The equipment under test fulfills the EMC requirements cited in clause 1 test standards.

Date of receipt of test sample : 28. November 2016

Testing commenced on : 28. November 2016

Testing concluded on : 02. December 2016

Checked by: Tested by:

Seamus Murray Vera Kammermeier
I confirm the integrity and I am the author of
correctness of this
the document
document
2017.03.10 08:02:31 2017.03.09 16:18:17
+01'00' +01'00'

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3 EQUIPMENT UNDER TEST
3.1 Photo documentation of the EuT

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3.2 Power supply system utilised
Power supply voltage : 115 / 230 V, 50 / 60 Hz, 1

All tests were carried out with a supply voltage of 230 V, 50 Hz unless otherwise stated.
Exceptions are described in the detailed test conditions.

3.3 Highest internal frequency

Highest internal frequency : 800 MHz

3.4 Short description of the Equipment under Test (EuT)

The Aquarius system with RCA controls and monitors the extracorporeal blood circuit and the fluid balance circuit.
The fluid balance circuit is defined as a filtrate/ substitution system in hemofiltration, a filtrate/ dialysate system in
hemodialysis, a filtrate/ dialysate- substitution system in hemodiafiltration, a plasma/ substitution system in
therapeutic plasma exchange, and a filtrate system only in slow continuous ultrafiltration. The fluid balance circuit is
inactive in hemoperfusion. The fluid balance is controlled by pumps and scales.
Toxins are removed from the blood and the blood composition is corrected by means of filters and solutions, using
filtration and/or absorption in the extracorporeal circuit. The blood is then returned to the patient.

Number of tested samples: 1

Serial number: 5521

3.5 Essential Performance of the EuT based on customer definition

(see definition from IEC 60601-1: 2005)

The essential performance is the control and monitoring of the extracorporeal blood circuit and the fluid balance

circuit as well as providing a comprehensive alarm system at occurring critical situations.

For more details please see chapter 3.9

3.6 EuT operation mode

The equipment under test was operated during the measurement under the following conditions:

- Continuous Veno Veno Hemofiltration Post-dilution with RCA

This treatment has been chosen because in this case the highest number of components are in operation.

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3.7 EuT monitoring
The equipment under test was monitored during the measurement by following method:

The EuT was monitored visually with the software 6.02.10 (normal application device software).

Deviations from the parameters were shown in red error messages and were accompanied with an alarm.

3.8 EuT configuration

(The CDF filled by the applicant can be viewed at the test laboratory.)

The following peripheral devices and interface cables were connected during the measurements:

- Tube set - Common salt and Accusul35 solution

Port Cable Screening Transmission Status Length

1 AC power line unshielded analogue active 4m
2 PEC unshielded analogue passive 1.5 m
3 Tubes unshielded analogue active 2m

Modifications during the EMC test: None

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3.9 Compliance Criteria

according to EN 60601-1-2: 2007 + AC: 2010

Under the test conditions specified in 6.2, the EQUIPMENT or SYSTEM shall be able to provide the BASIC SAFETY
and ESSENTIAL PERFORMANCE. The following DEGRADATIONS, if associated with BASIC SAFETY and ESSENTIAL
PERFORMANCE, shall not be allowed:

- component failures;
- changes in programmable parameters;
- reset to factory defaults (manufacturer’s presets);
- change of operating mode;
- false alarms;
- cessation or interruption of any intended operation, even if accompanied by an alarm;
- initiation of any unintended operation, included unintended or uncontrolled motion, even if accompanied
by an alarm;
- error of displayed numerical value sufficiently large to affect diagnosis or treatment;
- noise on a waveform in which the noise would interfere with diagnosis, treatment or monitoring;
- artefact or distortion in an image in which the artefact would interfere with diagnosis, treatment or
monitoring;
- failure of automatic diagnosis or treatment EQUIPMENT and SYSTEMS to diagnose or treat, even if
accompanied by an alarm.

For EQUIPMENT and SYSTEMS with multiple FUNCTIONS, the criteria apply to each FUNCTION, parameter and
channel.

The EQUIPMENT or SYSTEM may exhibit DEGRADATION of performance (e.g. deviation from MANUFACTURER’S
specifications) that does not affect BASIC SAFETY and ESSENTIAL PERFORMANCE.

according to EN 60601-1-2: 2015

The EQUIPMENT or SYSTEM shall be able to provide the BASIC SAFETY and ESSENTIAL PERFORMANCE.

The EQUIPMENT or SYSTEM may exhibit DEGRADATION of performance (e.g. deviation from MANUFACTURER’S
specifications) that does not affect BASIC SAFETY and ESSENTIAL PERFORMANCE.

EuT specific compliance criteria:

Freedom from unacceptable risk directly caused by physical hazards.

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Blood Pump:

Input range Regular: 30 ml/min – 450 ml/min (10 ml/min steps)

Low flow: 10 ml/min – 200 ml/min (2 ml/min steps)
TPE: 30 ml/min – 250 ml/min (10 ml/min steps)
Citrate anticoagulation: 30 ml/min – 300 ml/min (10 ml/min steps)
Flow rate accuracy: ± 5ml at 30 ml/min – 100 ml/min
± 5% at 101 ml/min – and above
Low flow: ±6ml at 10 ml/min – 60 ml/min
± 10% at 61 ml/min – 200 ml/min

Dialysate Pump:

Input range: 0 or 100 – 10 000 ml/h

Low blood flow: 0 or 100 – 10 000 ml/h (CVVHD)
0 or 100 – 6 000 ml/h (CVVHDF)
Increment: 100 ml/h / 10 ml/h (low blood flow)

The total flow rate resulting from the flow rates of pre-dilution and post-dilution pump must not exceed
10 000 ml/h.

Net Fluid Removal:

Input Range RCA: 0 – 2 000 ml/h

Low flow: 0 or 100 – 1 000 ml/h
Accuracy: ± 10%

Substitution Fluid Flow (Post-dilution):

Input range: 0 or 100 – 10 000 ml/h

Citrate Anticoagulation: 0 or 500 – 6 000 ml/h
Low blood flow: 0 or 100 – 4 000 ml/h
Increment: 100 ml/h / 10 ml/h (low blood flow)

The total flow rate resulting from the flow rates of pre-dilution and post-dilution pump must not exceed
10 000 ml/h.

Substitution Fluid Flow (Pre-dilution):

Input range: 0 or 100 – 10 000 ml/h

Low blood flow: 0 or 100 – 6 000 ml/h
Increment: 100 ml/h / 10 ml/h (low blood flow)

The total flow rate resulting from the flow rates of pre-dilution and post-dilution pump must not exceed
10 000 ml/h.

Dialysis time: 72 h extendable in steps of one hour up to 80 h

Dialysis Fluid composition: N/A
Dialysis Fluid Temperature: 35 °C to 39 °C in 0.5 °C steps
Substitution Fluid Temperature: 35 °C to 39 °C in 0.5 °C steps

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Performance level

The test results shall be classified in terms of the loss of function or degradation of performance of the Equipment
under Test, relative to a performance level defined by its manufacturer or the requestor of the test, or agreed between
the manufacturer and the purchaser of the product.

Definition related to the performance level:

based on the used product standard
based on the declaration of the manufacturer, requestor or purchaser

Please see chapter 3.9 for compliance criteria and chapter 3.5 for the essential performance.

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4 TEST ENVIRONMENT

4.1 Address of the test laboratory

CSA Group Bayern GmbH

Ohmstrasse 1-4
94342 STRASSKIRCHEN
GERMANY

4.2 Statement regarding the usage of logos in test reports

The accreditation and notification body logos displayed in this test report are only valid for standards listed in the
accreditation or notification scope of CSA Group Bayern GmbH.

4.3 Representative of the applicant during measurements

Mr. Preine was present at all times during the EMC assessment testing. He also participated in the performance
assessment of the device with regard to the ESSENTIAL PERFORMANCE.

4.4 Environmental conditions

During the measurement the environmental conditions were within the listed ranges:

Temperature: 15-35 °C

Humidity: 30-60 %

Atmospheric pressure: 860-1060 hPa

4.5 Statement of the measurement uncertainty

The data and results referenced in this document are true and accurate. It is noted that the expanded measurement
uncertainty corresponds to the measurement results from the standard measurement uncertainty multiplied by the
coverage factor k = 2. The true value is located in the corresponding interval with a probability of 95 % The
measurement uncertainty was calculated for all measurements listed in this test report acc. to CISPR 16-4-2 / 2011
+ A1 / 2014 „Uncertainties, statistics and limit modelling – Uncertainty in EMC measurements“ and is documented
in the quality system acc. to DIN EN ISO/IEC 17025. For all measurements shown in this report, the measurement
uncertainty of the test laboratory, CSA Group Bayern GmbH, is below the measurement uncertainty as defined by
CISPR. Therefore, no special measures must be taken into consideration with regard to the limits according to
CISPR. Furthermore, component and process variability of devices similar to that tested may result in additional
deviation. The manufacturer has the sole responsibility of continued compliance of the device.

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TEST CONDITIONS AND RESULTS
5.1 Conducted emission
For test instruments and accessories used see section 6 Part A 4.
Legend for tables:
QP … QuasiPeak reading including correction factor
AV … Average reading including correction factor
Margin… Measured value to limit delta
5.1.1 Description of the test location

Test location: Shielded Room S2

5.1.2 Photo documentation of the test setup

5.1.3 Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

Frequency range: 0.15 MHz - 30 MHz

Min. limit margin by 23.19 dB at 0.1815 MHz

The requirements are FULFILLED.

Remarks: For detailed results, please see the following page(s).

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5.1.4 Test protocol
File No.: E41867-00-00VK_med Result passed
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA
Tested by: Vera Kammermeier
Location: S2 Date: 30.11.2016
Remarks: 115 V / 60 HZ, Phase 1
CISPR 11/CISPR 11 A - Average/
CISPR 11/CISPR 11 A - QPeak/
Meas.Peak (Phase 1)
Meas.Avg (Phase 1)
QuasiPeak (Finals) (Phase 1)
Average (Finals) (Phase 1)

120
dBµV 110

100

90

80

70

60

50

40

30

20

10

-10

-20
150kHz 1M 10M 30MHz
Frequency Line: Phase 1

CISPR 11/CISPR 11A

freq SR QP margin limit AV margin limit line corr

MHz dB(µV) dB dB dB(µV) dB dB dB
0.1815 1 44.70 34.30 79.00 22.40 43.60 66.00 Phase 1 9.82
0.1995 1 43.11 35.89 79.00 37.39 28.61 66.00 Phase 1 9.82
0.2175 1 38.44 40.56 79.00 14.55 51.45 66.00 Phase 1 9.81
0.24 1 35.53 43.47 79.00 20.40 45.60 66.00 Phase 1 9.81
0.3 2 30.28 48.72 79.00 10.79 55.21 66.00 Phase 1 9.80
0.336 2 27.52 51.48 79.00 15.79 50.21 66.00 Phase 1 9.80
0.5115 2 25.27 47.73 73.00 25.05 34.95 60.00 Phase 1 9.80
0.6 3 14.14 58.86 73.00 11.58 48.42 60.00 Phase 1 9.80
0.7305 3 12.53 60.47 73.00 11.06 48.94 60.00 Phase 1 9.79
0.8655 3 12.73 60.27 73.00 10.38 49.62 60.00 Phase 1 9.80
1.272 4 12.05 60.95 73.00 11.00 49.00 60.00 Phase 1 9.78
2.0055 4 11.52 61.48 73.00 9.06 50.94 60.00 Phase 1 9.80
3.273 5 14.80 58.20 73.00 7.46 52.54 60.00 Phase 1 9.80
3.345 5 18.28 54.72 73.00 14.97 45.03 60.00 Phase 1 9.81
4.362 5 27.09 45.91 73.00 17.05 42.95 60.00 Phase 1 9.81
4.371 5 24.37 48.63 73.00 11.44 48.56 60.00 Phase 1 9.81
4.8855 6 23.67 49.33 73.00 17.03 42.97 60.00 Phase 1 9.82
8.931 6 10.81 62.19 73.00 3.87 56.13 60.00 Phase 1 9.88
9.4215 6 27.09 45.91 73.00 23.98 36.02 60.00 Phase 1 9.89
9.699 7 23.02 49.98 73.00 20.38 39.62 60.00 Phase 1 9.90
16.116 7 21.40 51.60 73.00 13.45 46.55 60.00 Phase 1 10.16
17.7315 7 21.43 51.57 73.00 14.03 45.97 60.00 Phase 1 10.23
23.376 8 24.05 48.95 73.00 17.42 42.58 60.00 Phase 1 10.35
24.0015 8 27.37 45.63 73.00 22.55 37.45 60.00 Phase 1 10.35
24.006 8 25.86 47.14 73.00 21.01 38.99 60.00 Phase 1 10.35

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 File No.: E41867-00-00VK_med Result passed
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA
Tested by: Vera Kammermeier
Location: S2 Date: 30.11.2016
Remarks: 115 V / 60 HZ, Neutral
CISPR 11/CISPR 11 A - Average/
CISPR 11/CISPR 11 A - QPeak/
Meas.Peak (Neutral)
Meas.Avg (Neutral)
QuasiPeak (Finals) (Neutral)
Average (Finals) (Neutral)

120
dBµV 110

100

90

80

70

60

50

40

30

20

10

-10

-20
150kHz 1M 10M 30MHz
Frequency Line: Neutral

CISPR 11/CISPR 11A

freq SR QP margin limit AV margin limit line corr

MHz dB(µV) dB dB dB(µV) dB dB dB
0.1545 9 49.69 29.31 79.00 27.78 38.22 66.00 Neutral 9.83
0.1995 9 40.10 38.90 79.00 36.30 29.70 66.00 Neutral 9.84
0.222 9 35.76 43.24 79.00 13.19 52.81 66.00 Neutral 9.83
0.24 9 34.80 44.20 79.00 21.14 44.86 66.00 Neutral 9.82
0.3045 10 29.80 49.20 79.00 13.02 52.98 66.00 Neutral 9.80
0.336 10 27.24 51.76 79.00 17.84 48.16 66.00 Neutral 9.80
0.4305 10 20.72 58.28 79.00 1.15 64.85 66.00 Neutral 9.80
0.5115 10 24.95 48.05 73.00 24.46 35.54 60.00 Neutral 9.80
0.609 11 11.45 61.55 73.00 4.63 55.37 60.00 Neutral 9.80
0.7395 11 9.93 63.07 73.00 6.48 53.52 60.00 Neutral 9.79
1.005 11 11.06 61.94 73.00 9.12 50.88 60.00 Neutral 9.80
1.14 11 11.27 61.73 73.00 10.26 49.74 60.00 Neutral 9.79
1.2675 12 1.80 71.20 73.00 -0.81 60.81 60.00 Neutral 9.78
2.0055 12 11.50 61.50 73.00 8.13 51.87 60.00 Neutral 9.80
2.2845 12 10.79 62.21 73.00 7.34 52.66 60.00 Neutral 9.79
3.3495 13 15.99 57.01 73.00 9.24 50.76 60.00 Neutral 9.80
4.344 13 24.45 48.55 73.00 14.14 45.86 60.00 Neutral 9.80
4.3485 13 26.91 46.09 73.00 9.28 50.72 60.00 Neutral 9.80
4.899 14 22.79 50.21 73.00 12.17 47.83 60.00 Neutral 9.81
8.4765 14 23.80 49.20 73.00 13.72 46.28 60.00 Neutral 9.82
8.6475 14 20.32 52.68 73.00 11.32 48.68 60.00 Neutral 9.82
10.0455 15 24.81 48.19 73.00 17.42 42.58 60.00 Neutral 9.83
13.0515 15 20.65 52.35 73.00 13.07 46.93 60.00 Neutral 9.89
13.9875 15 24.88 48.12 73.00 17.50 42.50 60.00 Neutral 9.91
14.1225 15 23.64 49.36 73.00 16.35 43.65 60.00 Neutral 9.91
20.514 16 21.90 51.10 73.00 15.00 45.00 60.00 Neutral 10.11
20.595 16 21.51 51.49 73.00 14.46 45.54 60.00 Neutral 10.11
24.258 16 19.35 53.65 73.00 13.10 46.90 60.00 Neutral 9.96
26.004 16 22.79 50.21 73.00 18.16 41.84 60.00 Neutral 9.89

CSA Group Bayern GmbH File No. E41867-00-00VK, page 17 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
 File No.: E41867-00-00VK_med Result passed
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA
Tested by: Vera Kammermeier
Location: S2 Date: 30.11.2016
Remarks: 230 V / 50 HZ, Phase 1

CISPR 11/CISPR 11 A - Average/

CISPR 11/CISPR 11 A - QPeak/
Meas.Peak (Phase 1)
Meas.Avg (Phase 1)
QuasiPeak (Finals) (Phase 1)
Average (Finals) (Phase 1)

120
dBµV 110

100

90

80

70

60

50

40

30

20

10

-10

-20
150kHz 1M 10M 30MHz
Frequency Line: Phase 1

CISPR 11/CISPR 11A

freq SR QP margin limit AV margin limit line corr

MHz dB(µV) dB dB dB(µV) dB dB dB
0.1815 1 55.75 23.25 79.00 31.64 34.36 66.00 Phase 1 9.82
0.1995 1 49.69 29.31 79.00 36.89 29.11 66.00 Phase 1 9.82
0.2175 1 41.33 37.67 79.00 21.21 44.79 66.00 Phase 1 9.81
0.3 2 25.78 53.22 79.00 8.99 57.01 66.00 Phase 1 9.80
0.336 2 23.70 55.30 79.00 13.44 52.56 66.00 Phase 1 9.80
0.5115 2 25.54 47.46 73.00 25.32 34.68 60.00 Phase 1 9.80
0.6045 3 14.08 58.92 73.00 13.08 46.92 60.00 Phase 1 9.80
1.0095 3 13.65 59.35 73.00 13.02 46.98 60.00 Phase 1 9.80
1.05 3 0.07 72.93 73.00 -3.20 63.20 60.00 Phase 1 9.80
1.281 4 4.44 68.56 73.00 -0.25 60.25 60.00 Phase 1 9.78
2.154 4 11.32 61.68 73.00 8.29 51.71 60.00 Phase 1 9.80
3.3 5 19.07 53.93 73.00 15.76 44.24 60.00 Phase 1 9.81
4.3755 5 29.40 43.60 73.00 23.84 36.16 60.00 Phase 1 9.81
4.9035 6 17.95 55.05 73.00 7.47 52.53 60.00 Phase 1 9.82
4.908 6 23.25 49.75 73.00 16.60 43.40 60.00 Phase 1 9.82
8.5665 6 20.12 52.88 73.00 12.44 47.56 60.00 Phase 1 9.87
8.6295 6 19.84 53.16 73.00 13.41 46.59 60.00 Phase 1 9.87
11.8545 7 25.41 47.59 73.00 21.38 38.62 60.00 Phase 1 9.97
16.341 7 23.11 49.89 73.00 16.01 43.99 60.00 Phase 1 10.18
16.422 7 22.78 50.22 73.00 16.22 43.78 60.00 Phase 1 10.18
22.0035 8 25.79 47.21 73.00 19.89 40.11 60.00 Phase 1 10.34
24.0015 8 27.55 45.45 73.00 22.44 37.56 60.00 Phase 1 10.35
24.006 8 25.67 47.33 73.00 20.62 39.38 60.00 Phase 1 10.35
26.004 8 25.31 47.69 73.00 20.72 39.28 60.00 Phase 1 10.35

CSA Group Bayern GmbH File No. E41867-00-00VK, page 18 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
 File No.: E41867-00-00VK_med Result passed
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA
Tested by: Vera Kammermeier
Location: S2 Date: 30.11.2016
Remarks: 230 V / 50 HZ, Neutral
CISPR 11/CISPR 11 A - Average/
CISPR 11/CISPR 11 A - QPeak/
Meas.Peak (Neutral)
Meas.Avg (Neutral)
QuasiPeak (Finals) (Neutral)
Average (Finals) (Neutral)

120
dBµV 110

100

90

80

70

60

50

40

30

20

10

-10

-20
150kHz 1M 10M 30MHz
Frequency Line: Neutral

CISPR 11/CISPR 11A

freq SR QP margin limit AV margin limit line corr

MHz dB(µV) dB dB dB(µV) dB dB dB
0.1815 9 55.81 23.19 79.00 31.39 34.61 66.00 Neutral 9.83
0.1995 9 49.32 29.68 79.00 35.06 30.94 66.00 Neutral 9.84
0.2175 9 40.73 38.27 79.00 20.84 45.16 66.00 Neutral 9.83
0.336 10 24.39 54.61 79.00 17.07 48.93 66.00 Neutral 9.80
0.5115 10 25.03 47.97 73.00 25.22 34.78 60.00 Neutral 9.80
0.588 10 9.21 63.79 73.00 -3.33 63.33 60.00 Neutral 9.80
0.609 11 10.01 62.99 73.00 6.39 53.61 60.00 Neutral 9.80
0.744 11 5.76 67.24 73.00 -0.63 60.63 60.00 Neutral 9.79
1.014 11 11.26 61.74 73.00 10.18 49.82 60.00 Neutral 9.80
1.149 11 11.35 61.65 73.00 10.18 49.82 60.00 Neutral 9.79
1.2855 12 10.59 62.41 73.00 9.00 51.00 60.00 Neutral 9.78
2.1495 12 3.58 69.42 73.00 -1.40 61.40 60.00 Neutral 9.79
3.309 13 19.79 53.21 73.00 16.84 43.16 60.00 Neutral 9.80
3.3135 13 20.15 52.85 73.00 15.62 44.38 60.00 Neutral 9.80
4.389 13 28.69 44.31 73.00 25.49 34.51 60.00 Neutral 9.80
4.9215 14 22.54 50.46 73.00 15.87 44.13 60.00 Neutral 9.81
4.926 14 12.27 60.73 73.00 5.70 54.30 60.00 Neutral 9.81
8.562 14 21.82 51.18 73.00 14.39 45.61 60.00 Neutral 9.82
8.6655 14 21.01 51.99 73.00 14.73 45.27 60.00 Neutral 9.82
11.8545 15 22.08 50.92 73.00 16.73 43.27 60.00 Neutral 9.86
13.92 15 22.92 50.08 73.00 15.86 44.14 60.00 Neutral 9.91
22.8225 16 22.12 50.88 73.00 15.71 44.29 60.00 Neutral 10.01
23.0025 16 21.91 51.09 73.00 15.51 44.49 60.00 Neutral 10.01
25.554 16 18.41 54.59 73.00 11.51 48.49 60.00 Neutral 9.91
26.004 16 23.07 49.93 73.00 18.46 41.54 60.00 Neutral 9.89
CSA Group Bayern GmbH File No. E41867-00-00VK, page 19 of 61
Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
5.2 Radiated emission < 1GHz (electric field)
For test instruments and accessories used see section 6 Part A 5.
Legend for tables:
Level vert. QuasiPeak reading including correction factor for vertically polarized antenna
Level hor. QuasiPeak reading including correction factor for horizontally polarized antenna
Limit Limit referred to the appropriate standard
DLimit… Delta between limit and result (margin)

5.2.1 Description of the test location

Test location: OATS 1

Test distance: 10 metres

5.2.2 Photo documentation of the test setup

5.5.3 Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

Frequency range: 30 MHz - 1000 MHz

Min. limit margin by 2.4 dB at 36 MHz

The requirements are FULFILLED.

Remarks: For detailed results, please see the following page(s).

CSA Group Bayern GmbH File No. E41867-00-00VK, page 20 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
5.2.3 Test protocol

Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA Result: passed
Remarks: 115 V / 60 Hz
Date: 18.11.2016
Tested by: Vera Kammermeier

Reading Reading Correct. Correct. Level Level

Frequency Limit Dlimit
Vert. Hor. Vert. Hor. Vert. Hor.
(MHz) (dBµV/m) (dB)
(dBµV) (dBµV) (dB/m) (dB/m) (dBµV/m) (dBµV/m)
30.00 18.5 14.2 32.7 40.0 -7.3
32.00 20.8 14.1 34.9 40.0 -5.1
34.00 22.0 14.0 36.0 40.0 -4.0
36.00 23.5 6.3 14.1 13.7 37.6 20.0 40.0 -2.4
37.60 19.7 14.3 34.0 40.0 -6.0
38.00 21.2 14.4 35.6 40.0 -4.4
40.00 19.9 14.7 34.6 40.0 -5.4
42.00 17.0 14.9 31.9 40.0 -8.1
44.00 14.5 15.2 29.7 40.0 -10.3
46.00 15.6 15.3 30.9 40.0 -9.1
48.00 15.6 15.3 30.9 40.0 -9.1
54.00 12.1 15.0 27.1 40.0 -12.9
56.00 12.1 14.9 27.0 40.0 -13.0
72.00 16.0 8.5 13.1 13.0 29.1 21.5 40.0 -10.9
175.40 10.9 14.6 25.5 40.0 -14.5
187.93 15.4 13.1 28.5 40.0 -11.5
511.52 4.6 23.1 27.7 47.0 -19.3

dBµV/m Limit line (Frequency range: 30 - 1000 MHz)

80
Level Vert. dBµV/m
Level Hor. dBµV/m
70

60

50
EN 55011 Class A

40

30

20

10

0
0 200 400 600 800 1000
f [MHz]

CSA Group Bayern GmbH File No. E41867-00-00VK, page 21 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with RCA Result: passed
Remarks: 230 V / 50 Hz
Date: 18.11.2016
Tested by: Vera Kammermeier

Reading Reading Correct. Correct. Level Level

Frequency Limit Dlimit
Vert. Hor. Vert. Hor. Vert. Hor.
(MHz) (dBµV/m) (dB)
(dBµV) (dBµV) (dB/m) (dB/m) (dBµV/m) (dBµV/m)
30.00 18.4 14.2 32.6 40.0 -7.4
32.00 21.0 14.1 35.1 40.0 -4.9
34.00 22.1 14.0 36.1 40.0 -3.9
36.00 23.3 6.5 14.1 13.7 37.4 20.2 40.0 -2.6
37.60 19.8 14.3 34.1 40.0 -5.9
38.00 21.1 14.4 35.5 40.0 -4.5
40.00 19.5 14.7 34.2 40.0 -5.8
42.00 17.6 14.9 32.5 40.0 -7.5
44.00 14.0 15.2 29.2 40.0 -10.8
46.00 15.3 15.3 30.6 40.0 -9.4
48.00 15.6 15.3 30.9 40.0 -9.1
54.00 12.2 15.0 27.2 40.0 -12.8
56.00 12.5 14.9 27.4 40.0 -12.6
72.00 16.0 8.7 13.1 13.0 29.1 21.7 40.0 -10.9
175.40 10.6 14.6 25.2 40.0 -14.8
187.93 15.0 13.1 28.1 40.0 -11.9
511.52 9.6 23.1 32.7 47.0 -14.3

dBµV/m Limit line (Frequency range: 30 - 1000 MHz)

80
Level Vert. dBµV/m
Level Hor. dBµV/m

70

60

50 EN 55011 Class A

40

30

20

10

0
0 200 400 600 800 1000
f [MHz]

CSA Group Bayern GmbH File No. E41867-00-00VK, page 22 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
5.3 Harmonic current emission
For test instruments and accessories used see section 6 Part H & Fl.
5.3.1 Description of the test location

Test location: AREA 1

5.3.2 Photo documentation of the test setup

5.3.3 Test result

The requirements are FULFILLED.

Remarks: For detailed results, please see the following page(s).

Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

CSA Group Bayern GmbH File No. E41867-00-00VK, page 23 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
5.3.4 Test protocol

Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with Result: passed
RCA
Remarks: 230 V / 50 Hz
Date: 30.11.2016
Tested by: Vera Kammermeier

Voltage: 230.81 Vrms THD=0.01 % THV=0.015 V POHV=0.006 V PWHD=0.02 %

Current: 0.499 Arms -0.712 Apk THD=10.66 % THC=0.053 A POHC=0.007 A PWHD=10.51 %
Power: 82.2 W P1=82.2 W 115.2 VA
Power factor: 0.714 CosPhi1: 0.718
Test conditions: EN 61000-3-2:2014, f=50 Hz, Phase=L1, Rang e=4.00 A
Time window=10/12 (200ms), Grouping (>2nd harm.)=on
No Ztest selected
harmonic currents < 0.6 % of I or < 5 mA are disregard for calc. of THD, THC, POHC, PWHD
HARMONIC ANALYSIS: Test PASS in Timewindow 1 of 750
Ha Value Percent Ang le EN61000-3-2 Margin PASS FAIL
Class A
DC -0.0031 A -0.62 % - - - . - Deg -.- --- -- -.- X
1 0.4961 A 100.00 % 44.1 Deg -.- --- -- -.- X
2 0.0027 A 0.54 % 163.5 Deg 1.0800 A -99.8 % X
3 0.0160 A 3.23 % -77.6 Deg 2.3000 A -99.3 % X
4 0.0026 A 0.52 % -93.6 Deg 0.4300 A -99.4 % X
5 0.0427 A 8.61 % 1.3 Deg 1.1400 A -96.3 % X
6 0.0026 A 0.52 % -101.2 Deg 0.3000 A -99.1 % X
7 0.0198 A 3.98 % -5.4 Deg 0.7700 A -97.4 % X
8 0.0025 A 0.51 % 127.8 Deg 0.2300 A -98.9 % X
9 0.0118 A 2.38 % -7.5 Deg 0.4000 A -97.0 % X
10 0.0025 A 0.50 % 118.6 Deg 0.1840 A -98.7 % X
11 0.0055 A 1.11 % -17.8 Deg 0.3300 A -98.3 % X
12 0.0024 A 0.48 % 170.3 Deg 0.1533 A -98.4 % X
13 0.0024 A 0.48 % -48.6 Deg 0.2100 A -98.9 % X
14 0.0023 A 0.47 % 108.4 Deg 0.1314 A -98.2 % X
15 0.0018 A 0.36 % -60.0 Deg 0.1500 A -98.8 % X
16 0.0023 A 0.46 % 134.6 Deg 0.1150 A -98.0 % X
17 0.0023 A 0.46 % 7.7 Deg 0.1324 A -98.3 % X
18 0.0022 A 0.45 % 132.9 Deg 0.1022 A -97.8 % X
19 0.0034 A 0.69 % 13.0 Deg 0.1184 A -97.1 % X
20 0.0021 A 0.42 % 149.3 Deg 0.0920 A -97.8 % X
21 0.0032 A 0.65 % 4.6 Deg 0.1071 A -97.0 % X
22 0.0018 A 0.37 % 127.1 Deg 0.0836 A -97.8 % X
23 0.0020 A 0.41 % -20.2 Deg 0.0978 A -97.9 % X
24 0.0017 A 0.34 % 77.0 Deg 0.0767 A -97.8 % X
25 0.0015 A 0.29 % -44.5 Deg 0.0900 A -98.4 % X
26 0.0017 A 0.35 % 64.1 Deg 0.0708 A -97.6 % X
27 0.0016 A 0.31 % -17.6 Deg 0.0833 A -98.1 % X
28 0.0016 A 0.32 % 79.1 Deg 0.0657 A -97.6 % X
29 0.0023 A 0.47 % 3.5 Deg 0.0776 A -97.0 % X
30 0.0015 A 0.30 % 93.0 Deg 0.0613 A -97.5 % X
31 0.0030 A 0.61 % 10.8 Deg 0.0726 A -95.8 % X
32 0.0013 A 0.26 % 115.6 Deg 0.0575 A -97.8 % X
33 0.0028 A 0.57 % 5.2 Deg 0.0682 A -95.9 % X
34 0.0010 A 0.20 % 76.2 Deg 0.0541 A -98.1 % X
35 0.0021 A 0.42 % -12.9 Deg 0.0643 A -96.8 % X
36 0.0011 A 0.21 % -18.0 Deg 0.0511 A -97.9 % X
37 0.0016 A 0.32 % -49.4 Deg 0.0608 A -97.4 % X
38 0.0010 A 0.20 % 19.8 Deg 0.0484 A -98.0 % X
39 0.0016 A 0.31 % -56.8 Deg 0.0577 A -97.3 % X
40 0.0009 A 0.18 % 62.9 Deg 0.0460 A -98.1 % X
value < 0.6 % of I or < 5 mA

Tested with S PS EMC 4.1.1 / None by Spi tzenberger & Spi es GmbH & Co. KG, Schmi dstr. 32-34, 94234 Vi echtach, Germany, 30.11.2016

CSA Group Bayern GmbH File No. E41867-00-00VK, page 24 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
Tel.:+49(0)9424-94810  Fax:+49(0)9424-9481440 Rev. No. 7.0 2015-04-15
Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with Result: passed
RCA
Remarks: 230 V / 60 Hz
Date: 30.11.2016
Tested by: Vera Kammermeier

Maximum RMS current and corresponding values in timewindow 706:

Voltage: 230.80 Vrms THD=0.01 % THV=0.013 V POHV=0.006 V PWHD=0.02 %
Current: 1.042 Arms THD=5.75 % THC=0.059 A POHC=0.009 A PWHD=6.54 %
Power: 211.6 W P1=224.1 W 240.5 VA
Power factor: 0.880 CosPhi1: 0.950
Test conditions: EN 61000-3-2:2014, f=60 Hz, Phase=L1, Range=4.00 A
Time window=10/12 (200ms), Grouping (>2nd harm.)=on
No Ztest selected
harmonic currents < 0.6 % of I or < 5 mA are disregard for calc. of THD, THC, POHC, PWHD
HARMONIC ANALYSIS: Test PASS
Tobs = entire measurement; POHC: avg=0.00 A, limits=0.25 A
Iavg =0.720 Arms
Entire measurement (2.5 min = 750 time windows) Worst 2.5 min Average P F
A A
Ha Maximum Window EN61000-3-2 Margin 100 to 150 to Ex- 100 to Ex- Value Ex- S I
Class A in MaxWin 150% 200% ceeded 150% ceeded ceeded S L
DC 0.0318 A 87 -.- - - - -- -.- 0 0 0 n.e. n.e. 0.0045 A 0 X
1 1.0216 A 706 -.- - - - -- -.- 0 0 0 n.e. n.e. 0.7035 A 0 X
2 0.0153 A 140 1.0800 A -98.6 % 0 0 0 n.e. n.e. 0.0079 A 0 X
3 0.0235 A 131 2.3000 A -99.0 % 0 0 0 n.e. n.e. 0.0194 A 0 X
4 0.0097 A 603 0.4300 A -97.7 % 0 0 0 n.e. n.e. 0.0055 A 0 X
5 0.0442 A 39 1.1400 A -96.1 % 0 0 0 n.e. n.e. 0.0431 A 0 X
6 0.0067 A 603 0.3000 A -97.8 % 0 0 0 n.e. n.e. 0.0040 A 0 X
7 0.0222 A 39 0.7700 A -97.1 % 0 0 0 n.e. n.e. 0.0212 A 0 X
8 0.0051 A 115 0.2300 A -97.8 % 0 0 0 n.e. n.e. 0.0035 A 0 X
9 0.0138 A 14 0.4000 A -96.6 % 0 0 0 n.e. n.e. 0.0128 A 0 X
10 0.0043 A 140 0.1840 A -97.7 % 0 0 0 n.e. n.e. 0.0030 A 0 X
11 0.0072 A 254 0.3300 A -97.8 % 0 0 0 n.e. n.e. 0.0064 A 0 X
12 0.0040 A 603 0.1533 A -97.4 % 0 0 0 n.e. n.e. 0.0027 A 0 X
13 0.0039 A 140 0.2100 A -98.1 % 0 0 0 n.e. n.e. 0.0031 A 0 X
14 0.0036 A 603 0.1314 A -97.3 % 0 0 0 n.e. n.e. 0.0025 A 0 X
15 0.0033 A 603 0.1500 A -97.8 % 0 0 0 n.e. n.e. 0.0025 A 0 X
16 0.0031 A 115 0.1150 A -97.3 % 0 0 0 n.e. n.e. 0.0024 A 0 X
17 0.0036 A 256 0.1324 A -97.3 % 0 0 0 n.e. n.e. 0.0031 A 0 X
18 0.0030 A 603 0.1022 A -97.1 % 0 0 0 n.e. n.e. 0.0022 A 0 X
19 0.0046 A 122 0.1184 A -96.1 % 0 0 0 n.e. n.e. 0.0041 A 0 X
20 0.0030 A 603 0.0920 A -96.8 % 0 0 0 n.e. n.e. 0.0021 A 0 X
21 0.0044 A 14 0.1071 A -95.9 % 0 0 0 n.e. n.e. 0.0039 A 0 X
22 0.0026 A 603 0.0836 A -96.9 % 0 0 0 n.e. n.e. 0.0020 A 0 X
23 0.0034 A 14 0.0978 A -96.5 % 0 0 0 n.e. n.e. 0.0028 A 0 X
24 0.0025 A 140 0.0767 A -96.8 % 0 0 0 n.e. n.e. 0.0019 A 0 X
25 0.0026 A 140 0.0900 A -97.2 % 0 0 0 n.e. n.e. 0.0021 A 0 X
26 0.0024 A 603 0.0708 A -96.6 % 0 0 0 n.e. n.e. 0.0018 A 0 X
27 0.0025 A 603 0.0833 A -97.0 % 0 0 0 n.e. n.e. 0.0021 A 0 X
28 0.0023 A 603 0.0657 A -96.5 % 0 0 0 n.e. n.e. 0.0017 A 0 X
29 0.0031 A 678 0.0776 A -96.0 % 0 0 0 n.e. n.e. 0.0027 A 0 X
30 0.0021 A 140 0.0613 A -96.7 % 0 0 0 n.e. n.e. 0.0016 A 0 X
31 0.0037 A 603 0.0726 A -94.9 % 0 0 0 n.e. n.e. 0.0034 A 0 X
32 0.0019 A 140 0.0575 A -96.6 % 0 0 0 n.e. n.e. 0.0015 A 0 X
33 0.0037 A 5 0.0682 A -94.6 % 0 0 0 n.e. n.e. 0.0032 A 0 X
34 0.0019 A 603 0.0541 A -96.5 % 0 0 0 n.e. n.e. 0.0014 A 0 X
35 0.0031 A 3 0.0643 A -95.1 % 0 0 0 n.e. n.e. 0.0024 A 0 X
36 0.0018 A 603 0.0511 A -96.4 % 0 0 0 n.e. n.e. 0.0014 A 0 X
37 0.0022 A 140 0.0608 A -96.5 % 0 0 0 n.e. n.e. 0.0017 A 0 X
38 0.0017 A 702 0.0484 A -96.4 % 0 0 0 n.e. n.e. 0.0013 A 0 X
39 0.0020 A 140 0.0577 A -96.5 % 0 0 0 n.e. n.e. 0.0016 A 0 X
40 0.0017 A 494 0.0460 A -96.3 % 0 0 0 n.e. n.e. 0.0012 A 0 X
averag e value < 0.6 % of Iavg or < 5 mA n.e. = not evaluated
Tested with S PS EMC 4.1.1 / None by Spi tzenberger & Spi es GmbH & Co. KG, Schmi dstr. 32-34, 94234 Vi echtach, Germany, 30.11.2016

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5.4 Voltage changes, voltage fluctuations and flicker
For test instruments and accessories used see section 6 Part H & Fl.
5.4.1 Description of the test location

Test location: AREA 1

5.4.2 Photo documentation of the test setup

5.4.3 Test result

The requirements are FULFILLED.

Remarks: For detailed results, please see the following page(s).

Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

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5.4.4 Test protocol

Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with Result: passed
RCA
Remarks: 230 V / 50 Hz, 24 x 1 min.
Date: 30.11.2016
Tested by: Vera Kammermeier

Test conditions: EN 61000-3-3:2013 / 230 V / 50 Hz / Phase L1

EN 61000-4-15:2011 / Obs 24 x 1 min / Ztest (0.400+j0.250) Ohm
Ra+jXa (0.2400+j0.1500) Ohm / Rn+jXn (0.1600+j0.1000) Ohm
FLICKER: Test PASS!
Time Pmax Pst Sliding Plt d(t)>3.30% [s] |dmax| [%] |dc| [%] PASS FAIL
09:34:34 0.136 0.1660 -.- --- 0.000 0.090 0.030 X
09:35:34 0.149 0.1700 -.- --- 0.000 0.110 0.030 X
09:36:34 0.135 0.1790 -.- --- 0.000 0.120 0.070 X
09:37:34 0.267 0.1930 -.- --- 0.000 0.260 0.070 X
09:38:34 0.136 0.1900 -.- --- 0.000 0.110 0.070 X
09:39:34 0.167 0.1910 0.1821 0.000 0.110 0.070 X
09:40:34 0.209 0.2020 0.1881 0.000 0.110 0.120 X
09:41:34 0.134 0.1920 0.1914 0.000 0.130 0.120 X
09:42:34 0.134 0.1870 0.1926 0.000 0.110 0.130 X
09:43:34 0.135 0.1890 0.1920 0.000 0.080 0.110 X
09:44:34 0.158 0.2030 0.1942 0.000 0.120 0.070 X
09:45:34 0.187 0.1940 0.1947 0.000 0.130 0.120 X
09:46:34 0.138 0.1960 0.1936 0.000 0.070 0.080 X
09:47:34 0.239 0.2000 0.1950 0.000 0.170 0.120 X
09:48:34 0.248 0.1990 0.1969 0.000 0.130 0.110 X
09:49:34 0.140 0.1820 0.1959 0.000 0.110 0.130 X
09:50:34 0.172 0.1960 0.1947 0.000 0.110 0.130 X
09:51:34 0.284 0.1970 0.1952 0.000 0.150 0.110 X
09:52:34 0.149 0.1960 0.1952 0.000 0.110 0.090 X
09:53:34 0.187 0.1940 0.1942 0.000 0.120 0.130 X
09:54:34 0.266 0.2030 0.1949 0.000 0.140 0.120 X
09:55:34 0.220 0.2020 0.1981 0.000 0.120 0.080 X
09:56:34 0.171 0.1940 0.1977 0.000 0.110 0.130 X
09:57:34 0.136 0.1940 0.1972 0.000 0.110 0.130 X
Limits: 1.000 0.650 0.500 4.000 3.300
Plt: 0.192489
Evaluated: dc, d(t), dmax averag e (0.118 %)

FLICKER: Source test PASS!

Time Pmax Pst Sliding Plt d(t)>3.30% [s] |dmax| [%] |dc| [%] PASS FAIL
09:34:34 0.000 0.0070 -.- --- 0.000 0.000 -.- -- X
09:35:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:36:34 0.000 0.0070 -.- --- 0.000 0.000 -.- -- X
09:37:34 0.000 0.0100 -.- --- 0.000 0.000 -.- -- X
09:38:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:39:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:40:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:41:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:42:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:43:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:44:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:45:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:46:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:47:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:48:34 0.001 0.0250 -.- --- 0.000 0.000 -.- -- X
09:49:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:50:34 0.000 0.0120 -.- --- 0.000 0.000 -.- -- X
09:51:34 0.001 0.0170 -.- --- 0.000 0.000 -.- -- X
09:52:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:53:34 0.000 0.0120 -.- --- 0.000 0.000 -.- -- X
09:54:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:55:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
09:56:34 0.000 0.0130 -.- --- 0.000 0.000 -.- -- X
09:57:34 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
Plt: 0.011454
Evaluated: PST <= 0.4 dmax < 20 % dmax1

Tested wi th S PS EMC 4.1.1 / None by Spi tzenberger & S pi es GmbH & Co. KG, Schmidstr. 32-34, 94234 V iechtach, Germany, 30.11.2016

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Operation mode: Continuous Veno Veno Hemofiltration Post-dilution with Result: passed
RCA
Remarks: 230 V / 50 Hz, Obs 1 x 10 min.
Date: 30.11.2016
Tested by: Vera Kammermeier

Test conditions: EN 61000-3-3:2013 / 230 V / 50 Hz / Phase L1

EN 61000-4-15:2011 / Obs 1 x 10 min / Ztest (0.400+j0.250) Ohm
Ra+jXa (0.2400+j0.1500) Ohm / Rn+jXn (0.1600+j0.1000) Ohm
FLICKER: Test PASS!
Time Pmax Pst Sliding Plt d(t)>3.30% [s] |dmax| [%] |dc| [%] PASS FAIL
09:15:56 0.132 0.2080 -.- --- 0.000 0.000 -.- -- X
Limits: 1.000 0.650 0.500 4.000 3.300
Plt: 0.208000 X
Evaluated: PST, PLT, Sliding PLT, dc, dmax, d(t)

FLICKER: Source test PASS!

Time Pmax Pst Sliding Plt d(t)>3.30% [s] |dmax| [%] |dc| [%] PASS FAIL
09:15:56 0.000 0.0080 -.- --- 0.000 0.000 -.- -- X
Plt: 0.008000
Evaluated: PST <= 0.4 dmax < 20 % dmax1

Tested wi th S PS EMC 4.1.1 / None by Spi tzenberger & S pi es GmbH & Co. KG, Schmidstr. 32-34, 94234 V iechtach, Germany, 30.11.2016

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5.5 Electrostatic discharge
For test instruments and accessories used see section 6 Part I 2.
5.5.1 Description of the test location

Test location: Shielded Room S3

5.5.2 Photo documentation of the test setup

C A

Legend C: Contact discharge A: Air discharge

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 C A

Legend C: Contact discharge A: Air discharge

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 C A

Legend C: Contact discharge A: Air discharge

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 C A

Legend C: Contact discharge A: Air discharge

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5.5.3 Test specification according to EN60601-1-2:2007

Contact discharge voltage: 2 kV / 4 kV / 6 kV

Air discharge voltage: 2 kV / 4 kV / 8 kV

Discharge impedance: 330  / 150 pF

Discharge factor:  1 sec.

Number of discharges:  10

Type of discharge: direct discharge: - air discharge

- contact discharge
indirect discharge: - contact discharge

Polarity: - negative - positive

Discharge location: - horizontal coupling plane (HCP)

- vertical coupling plane (VCP)
- all external locations accessible by hand
- see photo documentation of the test set-up

5.6.4 Test specification according to EN60601-1-2:2015

Contact discharge voltage: 2 kV / 4 kV / 8 kV

Air discharge voltage: 2 kV / 4 kV / 8 kV / 15 kV

Discharge impedance: 330  / 150 pF

Discharge factor:  1 sec.

Number of discharges:  10

Type of discharge: direct discharge: - air discharge

- contact discharge
indirect discharge: - contact discharge

Polarity: - negative - positive

Discharge location: - horizontal coupling plane (HCP)

- vertical coupling plane (VCP)
- all external locations accessible by hand
- see photo documentation of the test set-up

5.5.4 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.6 Radiated, radio-frequency, electromagnetic field
For test instruments and accessories used see section 6 Part I 3.
5.6.1 Description of the test location

Test location: Anechoic Chamber A1

5.6.2 Photo documentation of the test setup

5.6.3 Test specification according to EN60601-1-2:2007

Frequency range: 80 MHz to 2500 MHz

Field strength: 3 V/m

EuT - antenna distance: 3m

Modulation: AM: 80 % / sinusoidal: 1000 Hz

Frequency step: 1 % with 12 s dwell time

Antenna polarisation: - horizontal - vertical

5.6.4 Test specification according to EN60601-1-2:2015

Frequency range: 80 MHz to 2700 MHz and EN 60601-1-2:2015 Table 9 frequencies

Field strength: 3 V/m and EN 60601-1-2:2015 Table 9 requirements

EuT - antenna distance: 3 m (2.0 m for levels above 10 V/m)

Modulation: AM: 80 % / sinusoidal: 1000 Hz and EN 60601-1-2:2015 Table 9

requirements

Frequency step: 1 % with 12 s dwell time and EN 60601-1-2:2015 Table 9 Test

frequency

Antenna polarisation: - horizontal - vertical

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EN 60601-1-2:2015, chapter 8.10, Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
Test Band a) Service a) Modulation b) Maximum Immunity
frequency power test level
(MHz) (MHz) (W) (V/m)
Pulse modulation b)
385 380 - 390 TETRA 400 1.8 27
18 Hz
FM c)
450 430 - 470 GMRS 460, FRS 460 ±5 kHz deviation 2 28
1 kHz sine
710
Pulse modulation b)
745 704 - 787 LTE Band 13, 17 0.2 9
217 Hz
780
810
GSM 800/900, Pulse modulation b)
870 800 - 960 TETRA 800, iDEN 820, 2 28
CDMA 850, LTE Band 5 18 Hz
930
1720
GSM 1800, CDMA 1900, Pulse modulation b)
1845 1700 - 1990 GSM 1900, DECT, UMTS 2 28
LTE Band 1, 3, 4, 25 217 Hz
1970
Bluetooth, WLAN,
802.11 b/g/n, Pulse modulation b)
2450 2400 – 2570 2 28
RFID 2450, 217 Hz
LTE Band 7
5240
Pulse modulation b)
5500 5100 - 5800 WLAN 802.11 a/n 0.2 9
217 Hz
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the
ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.

b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation

5.6.5 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.7 Electrical fast transients / Burst
For test instruments and accessories used see section 6 Part I 4.
5.7.1 Description of the test location

Test location: Shielded Room S3

5.7.2 Photo documentation of the test setup

5.7.3 Test specification according to EN60601-1-2:2007

Coupling network: 0.5 kV / 1 kV / 2 kV

Coupling clamp: --

Burst frequency: 5.0 kHz

Coupling duration:  60 sec.

Polarity: - positive - negative

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5.7.4 Test specification according to EN60601-1-2:2015

Coupling network: 0.5 kV / 1 kV / 2 kV

Coupling clamp: --

Burst frequency: 100 kHz

Coupling duration:  60 sec.

Polarity: - positive - negative

5.7.5 Coupling points

Cable description: AC power line

Screening: unshielded
Status: active
Signal transmission: analogue
Length: 2m

5.7.6 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.8 Surge
For test instruments and accessories used see section 6 Part I 5.
5.8.1 Description of the test location

Test location: AREA 2

5.8.2 Photo documentation of the test setup

5.8.3 Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

Pulse amplitude-Power line sym.: 0.5 kV / 1 kV

Source impedance: 2  + 18 µF

Pulse amplitude-Power line unsym.: 0.5 kV / 1 kV / 2 kV

Source impedance: 12  + 9 µF

Pulse amplitude-Telecommunication line: --

Source impedance: 2  + 18 µF

Pulse amplitude-Telecommunication line: --

Source impedance: 42  + 0.5 µF

Number of surges: 5 Surges / Phase angle

Phase angle: 0° / 90 ° / 180 ° / 270 °

Repetition rate: ≥60 sec.

Polarity: - positive - negative

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5.8.4 Coupling points

Cable description: AC power line

Screening: unshielded
Status: active
Signal transmission: analogue
Length: 2m

5.8.5 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.9 Conducted disturbances induced by radio-frequency fields
For test instruments and accessories used see section 6 Part I 6.
5.9.1 Description of the test location

Test location: Shielded Room S3

5.9.2 Photo documentation of the test setup

5.9.3 Test specification according to EN60601-1-2:2007

Frequency range: 0.15 MHz to 80 MHz

Test voltage: 3V

Modulation: AM: 80 % / sinusoidal: 1000 Hz

Frequency step: 1 % with 12 s dwell time

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5.9.4 Test specification according to EN60601-1-2:2015

Frequency range: 0.15 MHz to 80 MHz and ISM frequencies

Test voltage: 3 V and 6 V at ISM frequencies

Modulation: AM: 80 % / sinusoidal: 1000 Hz

Frequency step: 1 % with 12 s dwell time

EN 60601-1-2:2015, chapter 8.9, Table 5 to 8 – Test specifications for ENCLOSURE PORT IMMUNITY to RF
wireless communications equipment

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. The amateur radio bands
between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3
MHz; 10.1 MHz to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to 18.17 MHz; 21 MHz to 21.4 MHz; 24.89 MHz to
24.99 MHz; 28 MHz to 29.7 MHz and 50 MHz to 54 MHz.

5.9.5 Coupling points

Cable description (Port1): AC power line

Screening: unshielded
Status: active
Signal transmission: analogue
Length: 0.3 m

Cable description (Port2): PEC

Screening: unshielded
Status: passive
Signal transmission: analogue
Length: 0.3 m

Cable description (Port3): Tube

Screening: unshielded
Status: active
Signal transmission: analogue
Length: 2m

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The following devices were connected during the test at the ports:
The tested port at the matrix is written in bold characters.

Tested Model / Type of CDN at port

Port 1 2 3 4 5 6
1 M3 005 M1 002
2 M3 005 M1 002
3 M3 005 M1 002 CLAMP 26

5.9.6 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.10 Power frequency magnetic field
For test instruments and accessories used see section 6 Part I 8.
5.10.1 Description of the test location

Test location: AREA 1

5.10.2 Photo documentation of the test setup

5.10.3 Test specification according to EN60601-1-2:2007

Test frequency: 50 Hz / 60 Hz

Continuous field: 3 A/m

Duration (Continuous field): 60 sec. each axis

Short duration (1-3 s): --

Axis: x-axis y-axis z-axis

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5.10.4 Test specification according to EN60601-1-2:2015

Test frequency: 50 Hz / 60 Hz

Continuous field: 30 A/m

Duration (Continuous field): 60 sec. each axis

Short duration (1-3 s): --

Axis: x-axis y-axis z-axis

5.10.5 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.11 Voltage dips
For test instruments and accessories used see section 6 Part I 11.
5.11.1 Description of the test location

Test location: AREA 1

5.11.2 Photo documentation of the test setup

5.11.3 Test specification according to EN60601-1-2:2007

minimal Nominal Mains Voltage (VN): 115 V / 50 Hz / 1

maximal Nominal Mains Voltage (VN): 230 V / 50 Hz / 1

Number of voltage fluctuations: 3

Level of reduction (dip) / duration: 100% / 10 ms at 0° and 180°

60% / 100 ms at 0° and 180°
30 % / 500 ms at 0° and 180°

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5.11.4 Test specification according to EN60601-1-2:2015

minimal Nominal Mains Voltage (VN): 115 V / 50 Hz / 1

maximal Nominal Mains Voltage (VN): 230 V / 50 Hz / 1

Number of voltage fluctuations: 3

Level of reduction (dip) / duration: 100% / 10 ms at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
30% / 500 ms at 0° and 180°
100 % / 20 ms at 0° and 180°

5.11.5 Test result

The requirements are FULFILLED.

Remarks: During the test no deviation was detected to the selected operation mode(s).

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5.12 Short interruptions
For test instruments and accessories used see section 6 Part I 11.
5.12.1 Description of the test location

Test location: AREA 1

5.12.2 Photo documentation of the test setup

5.12.3 Test specification according to EN60601-1-2:2007 and EN60601-1-2:2015

minimal Nominal Mains Voltage (VN): 115 V / 50 Hz / 1

maximal Nominal Mains Voltage (VN): 230 V / 50 Hz / 1

Number of Interruptions: 3

Duration of the Interruption: 5000 ms

5.12.4 Test result

The requirements are FULFILLED.

Remarks: During the test a short deviation was detected to the selected operation mode(s).

On the display appeared a message “blood pump off”. After the operator verifies this message,

the filtration device system resumed normal mode.

Essential performance and basic safety requirements were met.

CSA Group Bayern GmbH File No. E41867-00-00VK, page 47 of 61

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6 USED TEST EQUIPMENT AND ACCESSORIES
All test instruments used, in addition to the test accessories, are calibrated and verified regularly.

Test ID Model / Type Kind of Equipment Manufacturer Equipment No.

A4 ESCI EMI Test Receiver Rohde & Schwarz München 02-02/03-05-004

ESH 2 - Z 5 LISN Rohde & Schwarz München 02-02/20-05-004
N-4000-BNC RF Cable mikes-testingpartners gmbh 02-02/50-05-138
N-1500-N RF Cable mikes-testingpartners gmbh 02-02/50-05-140
ESH 3 - Z 2 Pulse Limiter Rohde & Schwarz München 02-02/50-05-155

A5 ESVS 30 EMI Test Receiver Rohde & Schwarz München 02-02/03-05-003

VULB 9168 Trilog Broadband Antenna Schwarzbeck Mess-Elektronik 02-02/24-05-005
NW-2000-NB RF Cable Huber + Suhner 02-02/50-05-113
KK-EF393/U-16N-21N20 m RF Cable 20m Huber + Suhner 02-02/50-12-018
KK-SD_7/8-2X21N-33,0M RF Cable 33 m Huber + Suhner AG 02-02/50-15-028

H & Fl. EMV D 30000/PAS Testsystem Spitzenberger + Spies 02-02/30-05-006

ARS 16/3 Analyser Reference System Spitzenberger + Spies 02-02/30-05-007

I 11 TDS2014 Oscilloscope Keithley Instruments GmbH 02-02/13-05-004

EMV D 30000/PAS Testsystem Spitzenberger + Spies 02-02/30-05-006

I2 NSG 435 ESD Generator Schaffner Elektrotest GmbH 02-02/09-05-002

THL-313 Thermo-Hygro-Meter PTL Dr. Grabenhorst GmbH 02-02/15-05-001

I3 SME 03 Signal Generator Rohde & Schwarz München 02-02/05-05-010

SMB 100A Signal Generator Rohde & Schwarz München 02-02/05-13-001
NRVD Dual Channel Power Meter Rohde & Schwarz München 02-02/07-05-019
URV 5 - Z 2 RF Probe 10 V Rohde & Schwarz München 02-02/07-05-021
URV 5 - Z 2 RF Probe 10 V Rohde & Schwarz München 02-02/07-05-022
NRP-Z91 Power Sensor 6 GHz Rohde & Schwarz München 02-02/07-13-001
1000W1000C RF Amplifier Amplifier Research 02-02/17-05-011
100S1G4 RF Amplifier Amplifier Research 02-02/17-05-018
STLP 9128 D special STLP 9128 D special Schwarzbeck Mess-Elektronik 02-02/24-12-001
BBHA 9120 E DoubleBroadb. Horn Anten Schwarzbeck Mess-Elektronik 02-02/24-13-005
CTR-1001A RadiSense/E-Field Sensor DARE 02-02/50-05-034
DC6280AM1 Coupler Amplifier Research 02-02/50-05-101
10 dB / 50 Ohm Attenuator Huber + Suhner 02-02/50-05-106
DC7144A Coupler Amplifier Research 02-02/50-05-158
N-2000-N RF Cable mikes-testingpartners gmbh 02-02/50-06-045
N-2000-N RF Cable mikes-testingpartners gmbh 02-02/50-06-046
NW-5000-NW RF Cable mikes-testingpartners gmbh 02-02/50-07-024
NW-2000-NW RF Cable mikes-testingpartners gmbh 02-02/50-07-025
NW-3500-NW RF Cable mikes-testingpartners gmbh 02-02/50-07-026
10 dB / 50 Ohm / 18 GHz Attenuator Huber + Suhner 02-02/50-07-066
UFB311A-1-7/16-7/16-650 c RF Cable Rosenberger HF-Technik 02-02/50-08-019
7/16-2000-7/16 RF Cable Cellflex HCF mikes-testingpartners gmbh 02-02/50-09-028
N-2000-N 1 - 18 GHz RF Cable Huber + Suhner 02-02/50-10-006
SF104/11N/11N/1500MM RF Cable 1.5 m Huber + Suhner 02-02/50-13-015

I4 NSG 2025 Burst Generator Schaffner Elektrotest GmbH 02-02/09-05-003

I5 NSG 2050 Surge Generator Schaffner Elektrotest GmbH 02-02/09-05-004

PNW 2050 Pulse Network Schaffner Elektrotest GmbH 02-02/09-05-007
CDN 133 Coupling Network Schaffner Elektrotest GmbH 02-02/22-05-019
PSURGE 8000 HV-Testsystem Haefely Test AG 02-02/30-07-001

CSA Group Bayern GmbH File No. E41867-00-00VK, page 48 of 61

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 Test ID Model / Type Kind of Equipment Manufacturer Equipment No.

I6 F-120-9 RF Clamp FCC Fischer Custom Comm. 01-02/22-05-026

SML 01 Signal Generator Rohde & Schwarz München 02-02/05-05-001
URV 5 - Z 4 RF Probe 100 V Rohde & Schwarz München 02-02/07-05-002
NRVS Single Channel Power Mete Rohde & Schwarz München 02-02/07-05-007
75A250 RF Amplifier Amplifier Research 02-02/17-05-008
CDN M116 Coupling Network Schaffner Elektrotest GmbH 02-02/22-05-002
CDN M316 Coupling Network Schaffner Elektrotest GmbH 02-02/22-05-005
10 dB / 50 Ohm / 18 GHz Attenuator Huber + Suhner 02-02/50-05-037
JFW 50FH-006-100-2 RF Attenuator 6 dB / 100 jfw 02-02/50-05-056
N-500-N RF Cable mikes-testingpartners gmbh 02-02/50-05-059
N-3000-N RF Cable mikes-testingpartners gmbh 02-02/50-05-226
N-140-BNC RF Cable mikes-testingpartners gmbh 02-02/50-06-035

I8 TDS2014 Oscilloscope Keithley Instruments GmbH 02-02/13-05-004

INA 102 Magnetic field antenna Natural Audio Lautsprecher 02-02/24-13-004
EMV D 30000/PAS Testsystem Spitzenberger + Spies 02-02/30-05-006
LEM~flex RR3020 AC Current Probe Logi Metrics 02-03/07-07-002

CSA Group Bayern GmbH File No. E41867-00-00VK, page 49 of 61

Ohmstrasse 1-4  94342 STRASSKIRCHEN  GERMANY
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7 ID, marking and documents EN60601-1-2:2007
Used document: DO-F328-
7.1.1 Requirement 00_IFU_Aquarius_RCA_SW6.03_Rev. Results
5.0_en
Section Short description ok n.ok n/a
5.1.1 Marking on the outside – RF transmitters   
_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.1.2 Marking on the outside – Connector testing exemption   

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ______________________________________

5.1.3 Marking on the outside – use only in a shielded location   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.1 a) Instruction for use – Statement: Precautions regarding EMC   

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _

5.2.1.1 b) Instruction for use – Statement: Portable and mobile RF   

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________

5.2.1.2 a) Instruction for use – Reproduction of the ESD warning symbol   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.1.2 b) Instruction for use – Warning for Pins   

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________ __________________________________________________________________________________

5.2.1.2 c) Instruction for use – ESD precautionary procedures   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.2 d) Instruction for use – Recommendation to all involved staff   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.2 e) Instruction for use – ESD precautionary procedures training   

_______________________________________________________________________________________________________________________________________________________________________________________________________________ __________________________________________________________________________________________________

5.2.1.3 a) Instruction for use – Minimum amplitude of value of signal   

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ____________________

5.2.1.3 b) Instruction for use – Warning of operation below amplitude of value   

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________

5.2.1.4 Instruction for use – Warning: Professional Equipment   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.1 a) Technical description – List of all cables   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.1 b) Technical description – Warning: Use of other materials   

______________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________________________________

5.2.2.1 c) Technical description – Table 1   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.1 d) Technical description – Warning: Not used adjacent or stacked   

____________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ________________________

5.2.2.1 e) Technical description – Justification for lower COMPLIANCE LEVEL   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________

5.2.2.1 f) Technical description – Table 2   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.1 g) Technical description – Essential Performance   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.2 Technical description – Table 3 and 5 or 4 and 6   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.3 a) Technical description – Warning: Use only in shielded locations   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.3 b) Technical description – Table 1 additional text for shielded locations   

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________

5.2.2.3 c) Technical description – Specification for other Equipment   

_________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ___

5.2.2.3 d) Technical description – Table 7 or 8 additional text for shielded locations   

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________

5.2.2.4 Technical description – Guidelines for RF energy used devices   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.5 a) Technical description – Information: RF receivers – frequency details   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________

5.2.2.5 b) Technical description – Warning: Interference of other equipment   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.6 Technical description – RF Transmitters: frequency details   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.7 a) Technical description – List of all EQUIPMENT and SYSTEMS   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________

5.2.2.7 b) Technical description – Warning: Use of other ACCESSORY   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.8 a) Technical description – Information: use of exemption   

________________________________________________________________________________________________________________________________________________________________________________________________________________ _________________________________________________________________________________________________

5.2.2.8 b) Technical description – Warning: RF IMMUNITY selected frequencies   

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ __________________________

5.2.2.8 c) Technical description – List of transmitters or equipment used   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________

5.2.2.9 a) Technical description – Statement: No IMMUNITY test   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.9 b) Technical description – Information for 5.2.2.1 through 5.2.2.8:   

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ____________________________________________________

5.2.2.10 Technical description – Justification: Professional Equipment   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

CSA Group Bayern GmbH File No. E41867-00-00VK, page 50 of 61

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8 ID, marking and documents EN60601-1-2:2015

Used document: Aquarius-riskanalysis-

8.1.1 Requirement 001-2.9
Results
Section Short description ok n.ok n/a

4.1 Risk management file: entries corresponding to EMC are present   

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ____________________________________________

4.2 Non-ME Equipment / Basic Safety, Essential Performance   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

4.3.1 Configurations, unacceptable risk   

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _________________________________________________________________________

8.1 Pass/Fail Criteria, EUT Monitoring   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8.5 Sub-system testing permitted   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8.7 Operation modes, unacceptable risk   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

8.8 Non-ME Equipment 7 Basic Safety, Essential Performance   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

8.9 Justiifcation for special environments   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

Tables 4-8 Modulation Frequency   

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ______________________________________

Used document: DO-F328-

8.1.2 Requirement 00_IFU_Aquarius_RCA_SW6.03_Rev.5 Results
.0_en
Section Short description ok n.ok n/a
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.1 Shielded location special environment marking   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.1.1 a) Instruction for use – Statement: suitable environments, exclusions   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________

5.2.1.1 b) Instruction for use – Statement: Essential performance und consequences   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.1 c) Instruction for use – Warning: Not used adjacent or stacked   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.1 d) Instruction for use – List of all cables and max length, transducer & access   
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.1.1 e) Instruction for use – Warning: Use of other materials   

________________________________________________________________________________________________________________________________________________________________________________________________________________ _________________________________________________________________________________________________

5.2.1.1 f) Instruction for use – Warning: Use of portable RF equipment, 30 cm   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.1.2 Instruction for use – Note: CISPR 11 class A   

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________

5.2.2.1 a) Technical description – Emission class, group, immunity test levels   

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________

5.2.2.1 b) Technical description – Deviations and allowances used   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.1 c) Technical description – Instructions for BS und EP   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.2 a) Technical description – Warning: Failure to use shielded room   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ________________________________________________________

5.2.2.2 b) Technical description – Shielded room specifications   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.2 c) Technical description – Recommended test methods for RF shielding   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.2 d) Technical description – notice at entrance of shielded location   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5.2.2.3 Technical description – RF Receivers: frequency details   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________

5.2.2.4 Technical description – RF Transmitters: frequency details & ERP   

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _________________________________________________________________________

5.2.2.5 a) Technical description – Large permanently installed equipment exemption   

______________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______________

5.2.2.5 b) Technical description – Warnung RF immunity “improper operation”   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.5 c) Technical description – RF immunity test frequency list   

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________

5.2.2.6 Technical description – Compatibility with HF surgical equipment   

_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

CSA Group Bayern GmbH File No. E41867-00-00VK, page 51 of 61

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9 Constructional Data Form

GE-F097-00 with RCA option

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CSA Group Bayern GmbH File No. E41867-00-00VK, page 54 of 61
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CSA Group Bayern GmbH File No. E41867-00-00VK, page 55 of 61
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 72 h extendable in steps of one hour up to 80 h

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CSA Group Bayern GmbH File No. E41867-00-00VK, page 60 of 61
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CSA Group Bayern GmbH File No. E41867-00-00VK, page 61 of 61
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