test report iec 60601-1-2 medical electrical equipment ... · test report issued under the...

Test Report issued under the responsibility of:

TEST REPORT

IEC 60601-1-2

Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance

Collateral Standard: Electromagnetic Compatibility

Report Reference No. .................... : 10985723

Date of issue ................................... : February 23, 2016

Total number of pages .................... 21

CB Testing Laboratory................... : UL NBK

Address ........................................... : 333 Pfingsten Rd. Northbrook, IL 60062

Applicant’s name ............................ : Matrix IT Medical Tracking System Inc.

Address ........................................... : 200 S Executive Dr, Suite 101 Brookfield, WI 53005

Test specification:

Standard .......................................... : IEC 60601-1-2: 2007 (Third Edition)

Test procedure ............................... : Informative

Non-standard test method……...…..:

N/A

Test Report Form No...................... : IEC60601_1_2CEMC

Test Report Form(s) Originator .... : UL(US)

Master TRF ...................................... : Dated 2013-04

Copyright © 2013 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved.

This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context.

If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB Scheme procedure shall be removed.

This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.

Test item description ..................... : The Tractus scanner is a high speed specialty scanner

Trade Mark ...................................... :

Manufacturer ................................... : Matrix IT Medical Tracking System Inc.

Model/Type reference .................... : Tractus

Ratings ............................................ : Battery Operated 24V

of 21 Report No. Error! Reference source not found.

TRF No. IEC60601_1_2CEMC

1.0 Testing Program Details

Testing procedure and testing location:

CB Testing Laboratory: UL NBK

Testing location/ address ..................... : 333 Pfingsten Rd. Northbrook, IL 60062

Associated CB Test Laboratory:

Testing location/ address ..................... :

Tested by (name + signature) ...... Michael E. Rayunas

Approved by (name + signature) : Bartlomiej Mucha

Testing procedure: TMP

Tested by (name + signature) ..... :

Approved by (name + signature) :

Testing location/ address ..................... :

Testing procedure: WMT


Witnessed by (name + signature) ....................................................... :


Testing location/ address ................... :

Testing procedure: SMT



Supervised by (name+ signature) ....................................................... :


Testing procedure: RMT


Approved by (+ signature) .......... :

Supervised by (+ signature) ........ :




List of Attachments (including a total number of pages in each attachment): None

Summary of testing:

Tests performed (name of test and test clause):

6.1.1 Radiated Emissions

6.2.2 Electrostatic Discharge (ESD)

6.2.3 Radiated RF Electromagnetic Fields

6.2.8 Magnetic Fields

Testing location:

UL NBK

333 Pfingsten Rd. Northbrook, IL 60062

Summary of compliance with National Differences

List of countries addressed: US

The product fulfils the requirements of IEC 60601-1-2: 2007 (Third Edition).

Copy of marking plate



Test item description ................................ : The Tractus scanner is a high speed specialty scanner

Trade Mark ................................................. :

Manufacturer .............................................. : Matrix IT Medical Tracking System Inc.

Model/Type reference ............................... : Tractus

Ratings ....................................................... : Battery Operated

Possible test case verdicts:

- test case does not apply to the test object ........................................................................ :

N/A

- test object does meet the requirement ... : P (Pass)

- test object does not meet the requirement ........................................................................ :

F (Fail)

Testing ........................................................... :

Date of receipt of test item .......................... : January 29, 2016

Date (s) of performance of tests ................ : February 15, 2016

General remarks:

The test results presented in this report relate only to the object tested.

The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report.

This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory.

"(see Enclosure #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report.

Throughout this report point is used as decimal separator.

General product information:

The TRACTUS scanner is a high speed specialty scanner that sits in the sterile field and is Bluetooth and battery powered. The TRACTUS platform, comprised of the TRACTUS scanner and software is used to document medical implants and device that are used during a surgery.



Report Index:

Item Description

1.0 Testing Program Details 6

1.1 Equipment Description 6

1.1.1 Equipment Marking Plate 6

1.1.2 Equipment Used During Test 6

1.1.3 Input/Output Ports 7

1.1.4 EUT Internal Operating Frequencies 7

1.1.5 Power Interface 7

1.2 EUT Operation Modes 8

1.3 EUT Configuration Modes 8

1.4 Immunity Performance Criteria 8

1.5 Compliance Summary 8

1.6 Result Summary 9

1.7 Test Conditions and Results - Radiated Emissions 10

1.8 Test Conditions and Results - Immunity to electrostatic discharges 14

1.9 Test Conditions and Results - Immunity to RF electromagnetic fields 17

1.10 Test Conditions and Results – Power Frequency Magnetic Immunity 20



1.1 Equipment Description

The TRACTUS scanner is a high speed specialty scanner that sits in the sterile field and is Bluetooth and battery powered. The TRACTUS platform, comprised of the TRACTUS scanner and software is used to document medical implants and device that are used during a surgery.

1.1.1 Equipment Marking Plate

1.1.2 Supporting Equipment Used During Test:

Use* Product Type Manufacturer Model Comments

EUT High Speed Scanner

Matrix IT Medical Tracking System Inc.

Tractus None

SIM Bar code - - Needed to use for scanner to scan

SIM Computer Lenovo Think pad None

Note: * Use

EUT - Equipment Under Test

AE - Auxiliary/Associated Equipment

SIM - Simulator (Not Subjected to Test) *Note: Use abbreviations:



1.1.3 Input/Output Ports:

Port

No.

Name Type* Cable

Max. >3m

Cable

Shielded

Comments

0 Enclosure N/E — — None

1 Mains DC - - Battery operated

*Note: AC = AC Power Port DC = DC Power Port N/E = Non-Electrical

I/O = Signal Input or Output Port (Not Involved in Process Control)

TP = Telecommunication Ports

1.1.4 EUT Internal Operating Frequencies:

Frequency (MHz) Description

< 108 Operating frequencies

1.1.5 Power Interface

Mode No.

Voltage (V)

Current (A)

Power (W)

Frequency (DC/AC-Hz)

Phases (No.)

Comments

1 24 - - DC Battery



1.2 EUT Operation Modes:

Mode # Description

1 Standby

2 EUT is powered up. The sensor gets triggered which turns on the camera which scans the bar codes that sends the character by Bluetooth to a computer.

1.3 EUT Configuration Modes

Mode # Description

1 The EUT is configured to scan medical parts and by Bluetooth send the character to a computer.

1.4 Immunity Performance Criteria

Medical Equipment Performance Criteria - unacceptable operating conditions / responses are:

- 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, including unintended or uncontrolled motion, even if

accompanied by an alarm; - error of a displayed numerical value sufficiently large to affect diagnosis or treatment; - noise on a waveform in which the noise is indistinguishable from physiologically-produced

signals or the noise interferes with interpretation of physiologically-produced signals; - artefact or distortion in an image in which the artefact is indistinguishable from

physiologically-produced signals or the distortion interferes with interpretation of physiologically-produced signals;

- failure of automatic diagnosis or treatment EQUIPMENT and SYSTEMS to diagnose or treat, even if accompanied by an alarm.

Medical Specific Compliance Criteria for the Voltage Dips and Interruptions Test:

Clause 6.2.7.1 b) - the equipment is allowed a deviation from the requirements of 6.2.1.10 at the immunity levels specified in Table 11 (<5% / >95% / 5s), provided the equipment remains safe, experiences no component failures and is restorable to the pre-test state with operator intervention.

1.5 Compliance Summary

The Applicant did not request the labeling and documentation evaluation/inspection/test required by IEC 60601-1-2: 2007, Section 5. It is the manufacturers responsibility to ensure that proper labeling is utilized on the product. Also, it is the responsibility of the manufacturer to ensure the accompanying documentation provided is in accordance to IEC 60601-1-2: 2007, 5.2.



1.6 Result Summary

Clause Requirement – Test Result/Comments Verdict

6.1 Emissions

6.1.1.1 Classification —

Class A or B ........................................................ : Class A —

Group 1 or 2 ........................................................ : 2 —

CISPR 11, 22, 14-1, or 15 ................................... : CISPR 11 —

6.1.1.2 Limits of mains terminal disturbance voltage :

Limits for radiated disturbance ........................ : See data in results P

Limits for disturbance power (if applicable) .. : NA NA

6.1.3.1 Harmonic Current Emissions per IEC61000-3-2..:

NA NA

6.1.3.2 Voltage Fluctuations and Flicker per IEC61000-3-3

NA NA

6.2 Immunity

6.2.2 Electrostatic Discharges (ESD) ........................ : See data in results P

6.2.3 Radiated RF electromagnetic Fields……………..:

See data in results P

6.2.4 Electrical Fast Transients and bursts .............. : NA NA

6.2.5 Surges ................................................................. : NA NA

6.2.6 Conducted Disturbances, induced by RF fields ............................................................................. :

NA NA

6.2.7 Voltage Dips, Interruptions, and variations .... : NA NA

6.2.8 Power-frequency Magnetic Fields .................... : See data in results P



1.7 Test Conditions and Results – Radiated Emissions

CISPR 11 TEST: Limits for radiated disturbance 30 MHz –1 GHz Verdict

Method: Measurements were made in a 10-meter semi-anechoic chamber or Open Area Test Site that complies to CISPR 16. Preliminary (peak) measurements were performed at an antenna to EUT separation distance of 10 meter. The EUT was rotated 360° about its azimuth with the receive antenna located at various heights in horizontal and vertical polarities. Final measurements (quasi-peak) were then performed by rotating the EUT 360° and adjusting the receive antenna height from 1 to 4 m. All frequencies were investigated in both horizontal and vertical antenna polarity, where applicable.

P

Laboratory Parameters: Required prior to the test During the test

Ambient Temperature 10 to 40 °C 20.3°C

Relative Humidity 10 to 90 % 29.8%

Fully configured sample scanned over the following frequency range

Frequency range on each side of line

Measurement Point

30MHz – 1GHz 10 m measurement

distance

Equipment mode

Power interface mode 1

EUT configurations mode 1

Operation mode 1

Limits – Group 1 Class A

Frequency (MHz)

Limit dB (µV/m)

Quasi-Peak Results

30 to 230 40 P

230 to 1000 47 P

Supplementary information: None

Description Manufacturer Model Identifier Cal Date Due Date

EMI Test Receiver Rohde & Schwarz ESCI EMC4328 11/16/2015 11/16/2016

Bicon Antenna Chase VBA6106A EMC4078 12/28/2015 12/28/2016

Log-P Antenna Chase UPA6109 EMC4258 4/27/2015 4/27/2016



Photo of test setup for Radiated Disturbance



Graphical representation of Radiated Disturbance Measurement



Tabulated Results for Radiated Disturbance

Matrix IT Medical

Tractus

On and Idle

Battery

Red=Horizontal Green=Vertical

Trace Markers

Test Meter Transducer Gain/Loss Corrected Limit:1 2 3 4 5 6

No. Frequency Reading Factor Factor Reading dB(uVolts/meter)

(MHz) (dB) (dB)

====================================================================================================

Range 3: LogP Horizontal 200 - 1000MHz ---------------------------------------

1 250 43.32dBuV Pk 11.7 -28.7 26.32 47 - - - - -

Azimuth:0-360 Height:299 Horz Margin (dB) -20.68 - - - - -

2 300 42.15dBuV Pk 13 -28.3 26.85 47 - - - - -


3 400 42.29dBuV Pk 15.5 -27.6 30.19 47 - - - - -


4 450 41.87dBuV Pk 16.9 -27.4 31.37 47 - - - - -


5 500 40.99dBuV Pk 17.2 -27.1 31.09 47 - - - - -


Range 4: LogP Vertical 200 - 1000MHz -----------------------------------------

6 250 36.14dBuV Pk 11.7 -28.7 19.14 47 - - - - -

Azimuth:0-360 Height:399 Vert Margin (dB) -27.86 - - - - -

7 300 39.75dBuV Pk 13 -28.3 24.45 47 - - - - -


8 400 39.77dBuV Pk 15.5 -27.6 27.67 47 - - - - -


9 450 38.02dBuV Pk 16.9 -27.4 27.52 47 - - - - -


10 500 39.18dBuV Pk 17.2 -27.1 29.28 47 - - - - -


LIMIT 1: CISPR Class A 10 m

Pk - Peak detector



1.8 Test Conditions and Results – Immunity to Electrostatic Discharges

61000-4-2 TEST: Electrostatic discharges (IEC 61000-4-2: - 2008) Verdict

Method: The test is intended to demonstrate the immunity of equipment subjected to static electricity discharges from operators directly and to adjacent objects. The tabletop equipment under test is placed on a wooden table, 0.8 m high, standing on the ground reference plane. A horizontal coupling plane (HCP), 1.6 x 0.8 m, is placed on the table. The EUT and the cables are isolated from the coupling plane by an insulating support 0.5 mm thick. The floor standing equipment is isolated from the ground reference plane by an insulating support about 0.1 m thick. The vertical coupling plane (VCP) of dimensions 0.5 m x 0.5 m is placed parallel to, and positioned at a distance of 0.1 m from, the EUT.

P




Equipment mode Power interface mode 1


Operation mode 2

Test Levels

Discharge type

Discharge Level (kV) Number of discharges per location (each polarity)

Positive Negative

Air – Direct 2, 4, 8 2, 4, 8 10

Contact – Direct 2, 4, 6 2, 4, 6 10

Contact – Indirect 2, 4, 6 2, 4, 6 10

Discharge location See photo documentation of the test set-up

All external locations accessible by hand, Horizontal plate (HCP) Vertical coupling plate (VCP)

Supplementary information: EUT powered at one of the Nominal input voltages and frequencies

Description Manufacturer Model Identifier Cal. Date Cal. Due

ESD Gun HV Technologies ESD3000 EMC4248 5/12/2015 5/12/2016

ESD Module EMC Partner ESD3000DM1 EMC4249 5/12/2015 5/12/2016

Temp / Humidity Meter Extech SD700 EMC4367

2/27/2015 2/27/2016



Photo of test setup for Immunity to Electrostatic Discharges

ESD Waveform Verification

Positive 6000V Amplitude Negative 6000V Amplitude



Tabulated Results for Electrostatic Discharges

Nominal Voltage (V) ................. : Battery

Nominal Frequency (Hz) ......... : DC

Direct discharges: Air and Contact

Discharge location Air discharge voltage (kV)

Polarity Remark

EUT Seams 2, 4, 8 +/- 1

Power Bank Seams 2, 4, 8 +/- 1

Ethernet Port Cover Seams 2, 4, 8 +/- 1

Discharge location Contact

discharge voltage (kV)

Polarity Remark

Power Button 2, 4, 6 +/- 1

Accessible Underneath Screws 2, 4, 6 +/- 1

Indirect discharges

Discharge location Contact

discharge voltage (kV)

Polarity Remark

HCP - Front 2, 4, 6 +/- 2

HCP - Left 2, 4, 6 +/- 2

HCP - Right 2, 4, 6 +/- 2

HCP - Rear 2, 4, 6 +/- 2

VCP - Front 2, 4, 6 +/- 2

VCP - Left 2, 4, 6 +/- 2

VCP - Right 2, 4, 6 +/- 2

VCP - Rear 2, 4, 6 +/- 2

1 – No discharge observed, no observed response from the EUT. 2 – Discharge observed, no observed response from the EUT.



1.9 Test Conditions and Results - Immunity to Radio Frequency Electromagnetic Fields

61000-4-3 TEST: RF electromagnetic fields (IEC 61000-4-3: - 2010) Verdict

Method: The test allows estimating of the radiated immunity of electrical and electronic equipment to electromagnetic disturbances coming from intended radio-frequency (RF) transmitters in the frequency range 80 MHz to 2500 MHz. The interference is applied on the enclosure of the equipment by using transmitting antennas.

p




Equipment mode Power interface mode 1


Operation mode 2

Test specifications

Calibration Requirements Uniform field area

(UFA)

1.5 m x 1.5 m, 16 points with a minimum UFA size 0.5 m x 0.5 m

75 % of calibration points within specifications if UFA is larger than 0.5 m x 0.5 m. 100 % (all 4

points) in the specifications for 0.5 x 0.5 m UFA

Frequency bandwidth 80 MHz to 2500 MHz

Level

Non-Life Supporting Equipment

3 V/m

Amplitude modulation

80 % / 1 KHz sine wave

Frequency step 1%

1 kHz Modulation

1 sec minimum


Description Manufacturer Model Identifier Cal. Date Cal. Due

Amplifier Amplifier Research 500W1000M5 NA NA

Amplifier Milmega AS0827 EMC4359 NA NA

Switch Driver Hewlett-Packard HP11713A EMC4134 NA NA

Power Meter Rhode & Schwarz NRVD EMC4074 01/04/2016 01/31/2017

Power Sensor Rhode & Schwarz NRV-Z51 EMC4079 01/07/2016 01/31/2017

Power Sensor Rhode & Schwarz NRV-Z51 EMC4295 01/07/2016 01/31/2017

Field Probe Holiday HI-4422 EMC4208 01/08/2016 01/31/2017

Bilog Antenna Schaffner CBL6144 NA NA

Temperature /Humidity Pressure probe

EXTECH SD700 EMC4367 2/27/2015 2/27/2016



Photo of test setup for Radio Frequency Electromagnetic Fields



Tabulated Results for RF Electromagnetic Field 80 MHz to 2500 MHz

Nominal Voltage (V) ................. : Battery

Nominal Frequency (Hz) .......... : DC

Side of the equipment under

test

Frequency (MHz)

Antenna polarization (V/H)

Dwell Time (second)

Remark

Front 80 - 2500 V 3 1

80 – 2500 H 3 1

Back 80 – 2500 V 3 1

80 – 2500 H 3 1

Left 80 – 2500 V 3 1

80 – 2500 H 3 1

Right 80 – 2500 V 3 1

80 - 2500 H 3 1

Results Descriptions:

X - Not performed nor required. 1 – Compliant - No observed response from EUT.



1.10 Test Conditions and Results – Power- Frequency Magnetic Fields

61000-4-8 TEST: Power-frequency magnetic field – (IEC61000-4-8: - 2009) Verdict

Method: Measurements were made on a ground plane that extends 1-meter minimum beyond sides of the system under test. Tabletop EUT is located 80cm above the reference ground plane and floor-standing EUT is located 10cm above the reference ground plane. The indicated field was pre-calibrated prior to placement of the EUT under test.

P




Equipment mode

Power interface mode 1


Operation mode 2

Fully configured sample tested at the power line frequency (See Note 1)

Frequency Application Point

50Hz and 60 Hz 1 Enclosure

Frequency (Hz) Test Level (A/m)

50 3

60 3

Tested at 50Hz and 60Hz powered at any one of its NOMINAL RATED input voltages.


Description Manufacturer Model Identifier

Ammeter Fluke 336 EMC4291 1/4/2016 1/31/2017

Loop UL UL-LOOP

EMC4277 NA NA



Photo of test setup for Power- Frequency Magnetic Fields

Tabulated Results for Power Frequency Magnetic Field

Nominal Rated Voltage (V) ...... DC

Point of application Results

50 Hz 60 Hz

X-Axis 1 1

Y-Axis 1 1

Z-Axis 1 1

Supplementary information:

X - Not performed or not required.

1 – Compliant - No observed response from EUT.

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