DOC #: AC200035

Print Date: 16-Apr-13

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AC200035 AGENCY DOCUMENTS, ESY15M/ESY19M Series

REVISION HISTORY Rev Description Author. Approved by Date

A Initial release per ECO-13-0159 Daniel Livingston

Daniel Livingston

April 16, 2013

AGENCY DOCUMENTS: ESY15M/ESY19M Series

DOC #: AC200035

Print Date: 16-Apr-13

REV: A

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FOR THE LATEST VERSION OF THIS DOCUMENT GO TO ELO TOUCH SOLUTIONS’

WEBSITE: www.elotouch.com

Contents

1. Elo combined Declaration of Conformity 2. CB Certificate - ITE 3. CB Certificate - Medical 4. UL Report Cover Sheet and Technical Considerations - 15MX/19MX- ITE 5. UL Report Cover Sheet and Technical Considerations - 15M - Medical 6. UL Report Cover Sheet and Technical Considerations - 19M - Medical 7. EMC certificate for EU – 15M – ITE 8. EMC certificate for EU – 15M – Medical 9. EMC certificate for EU – 19M – ITE 10. EMC certificate for EU – 19M – Medical 11. EMC certificate for FCC, ICES – 15M 12. EMC certificate for FCC, ICES – 19M 13. VCCI Certification - 15M 14. VCCI Certification - 19M 15. RFID EN 300 328, EN 301 893 - 15M 16. RFID EN 302 291 - 15M 17. RFID EN 63211 - 15M 18. RFID EN 300 328, EN 301 893 - 19M 19. RFID EN 302 291 - 19M 20. RFID EN 63211 - 19M 21. RFID - FCC - Grant of Authorization - 15M 22. RFID - FCC - Grant of Authorization - 19M 23. RFID - IC - Certificate - 15M 24. RFID - IC - Certificate - 19M 25. RFID - India Certification - 15M1 26. RFID - India Certification - 15M2 27. RFID - India Certification - 19M1 28. RFID - India Certification - 19M2 29. RFID - Japan ARIB STD T82 - 15M 30. RFID - Japan ARIB STD T82 - 19M 31. WiFi - India Certification 2.4 GHZ - 15M1 32. WiFi - India Certification 5 GHZ - 15M1 33. WiFi - India Certification 2.4 GHZ - 15M2 34. WiFi - India Certification 5 GHZ - 15M2 35. WiFi - India Certification 2.4 GHZ - 19M1 36. WiFi - India Certification 5 GHZ - 19M1 37. WiFi - India Certification 2.4 GHZ - 19M2 38. WiFi - India Certification 5 GHZ - 19M2

Issue Date: 2012-11-14 Page 1 of 10 Report Reference #

Copyright © 2012

UL TEST REPORT AND PROCEDURE Standard: UL 60950-1, 2nd Edition, 2011-12-19 (Information Technology

Equipment - Safety - Part 1: General Requirements) CSA C22.2 No. 60950-1-07, 2nd Edition, 2011-12 (Information Technology Equipment - Safety - Part 1: General Requirements)

Certification Type: Listing CCN: NWGQ, NWGQ7 (Information Technology Equipment Including

Electrical Business Equipment)

Product: LCD Monitor Model: ESY15MX, ESY19MX (X can be 0-9, A-Z, "-" or blank) Rating: Input: 12 Vdc, 6 A

(rating marking is optionally provided)

Applicant Name and Address:

This is to certify that representative samples of the products covered by this Test Report have been investigated in accordance with the above referenced Standards. The products have been found to comply with the requirements covering the category and the products are judged to be eligible for Follow-Up Service under the indicated Test Procedure. The manufacturer is authorized to use the UL Mark on such products which comply with this Test Report and any other applicable requirements of UL LLC ('UL') in accordance with the Follow-Up Service Agreement. Only those products which properly bear the UL Mark are considered as being covered by UL's Follow-Up Service under the indicated Test Procedure. The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety. Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL. Prepared by: Steven Huang Reviewed by: Alex Lin

Issue Date: 2012-11-14 Page 2 of 10 Report Reference #

Supporting Documentation The following documents located at the beginning of this Procedure supplement the requirements of this Test Report: A. Authorization - The Authorization page may include additional Factory Identification Code markings. B. Generic Inspection Instructions - i. Part AC details important information which may be applicable to products covered by this Procedure.

Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of this Test Report.

ii. Part AE details any requirements which may be applicable to all products covered by this Procedure. Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of each Test Report.

iii. Part AF details the requirements for the UL Certification Mark which is not controlled by the technical standard used to investigate these products. Products are permitted to bear only the Certification Mark(s) corresponding to the countries for which it is certified, as indicated in each Test Report.

Product Description The unit is a wall mounted, touch screen LCD monitor which is supplied by external power supply. Consists of LCD panel with LED backlight, CPU board, Main board accompanied with USB, RJ-45, Audio ports, one optional HDD, one optional RFID module, one optional Barcode reader, one optional Magnetic Stripe Reader (MSR) and enclosed by metal/plastic enclosure.

Model Differences Model ESY15MX is similar to Model ESY19MX except for panel size, enclosure size and handle size.

Technical Considerations Equipment mobility : movable

Connection to the mains : No direct connection

Operating condition : continuous

Access location : operator accessible

Over voltage category (OVC) : OVC I

Mains supply tolerance (%) or absolute mains supply values : No direct connection

Tested for IT power systems : No

IT testing, phase-phase voltage (V) : N/A

Class of equipment : Class III (supplied by SELV)

Considered current rating of protective device as part of the building installation (A) : N/A

Issue Date: 2012-11-14 Page 3 of 10 Report Reference #

Pollution degree (PD) : PD 2

IP protection class : IP X1

Altitude of operation (m) : up to 3000 m

Altitude of test laboratory (m) : less than 2000 m

Mass of equipment (kg) : ESY15MX: 5.92 kg; ESY19MX: 7.1 kg; Headset bracket: 1.1 kg; Base: 2.91 kg

The product was submitted and evaluated for use at the maximum ambient temperature (Tma) permitted by the manufacturer’s specification of: 40 degree C

The following circuit locations (with circuit/schematic designation) were investigated as a limited power source (LPS): USB 2.0, RJ-45, Audio and front I/O ports.

The following are available from the Applicant upon request: Installation (Safety) Instructions / Manual

The power supply in this equipment was: UL 60950-1, 2nd edition, 2007. , As part of the investigation of this product, the power supply and its test report were reviewed and found to comply with UL/IEC 60950-1 latest effective edition/revision.

LEDs provided in the product are considered low power devices: Yes

Additional Information N/A Additional Standards The product fulfills the requirements of: N/A

Markings and instructions Clause Title Marking or Instruction Details Inter-connecting cables - External detachable

Listee's Name and Part number (Marking or Instruction)

Power rating - Company identification

Listee's or Recognized company's name, Trade Name, Trademark or File Number

Power rating - Model

Model Number

UL TEST REPORT AND PROCEDURE Standard: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10)(Medical Electrical

Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)

Certification Type: Classification CCN: MDAF, MDAF7 (Medical Equipment - General Medical Equipment) Product: Touch Computer Model: ESY15MX (X=0-9, A-Z, “-” or blank ) Rating: Monitor:

Ratings: 12Vdc, 6A, Class I Adapter : Manufacture: XP POWER L L C/ model:AHM85PS12 Power supply input: 100-240Vac, 50/60Hz,1.0A Output : 12Vdc, 7.08A Adapter : Manufacture: FSP Group Inc / model: FSP100-RAAM Power supply input: 100-240Vac, 50-60Hz, 1.6-0.8A Output : 12Vdc, 9.17A

Applicant Name and Address:

This is to certify that representative samples of the products covered by this Test Report have been investigated in accordance with the above referenced Standards. The products have been found to comply with the requirements covering the category and the products are judged to be eligible for Follow-Up Service under the indicated Test Procedure. The manufacturer is authorized to use the UL Mark on such products which comply with this Test Report and any other applicable requirements of UL LLC ('UL') in accordance with the Follow-Up Service Agreement. Only those products which properly bear the UL Mark are considered as being covered by UL's Follow-Up Service under the indicated Test Procedure. The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety. Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL. Prepared by: Marcell Lin & Christine Wang Reviewed by: Conga Chen

Supporting Documentation The following documents located at the beginning of this Procedure supplement the requirements of this Test Report: A. Authorization - The Authorization page may include additional Factory Identification Code markings. B. Generic Inspection Instructions - i. Part AC details important information which may be applicable to products covered by this Procedure.

Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of this Test Report.

ii. Part AE details any requirements which may be applicable to all products covered by this Procedure. Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of each Test Report.

iii. Part AF details the requirements for the UL Certification Mark which is not controlled by the technical standard used to investigate these products. Products are permitted to bear only the Certification Mark(s) corresponding to the countries for which it is certified, as indicated in each Test Report.

Product Description The unit is touch computer and is consisted with 15.6 inch TFT-LED design and all components were soldered on PWB and enclosed in metal chassis and plastic enclosure. The unit provided option for use with VESA wall mounting means for installation. The product is only used with UL R/C, QQHM2 power supply, Manufacture: XP POWER L L C/ model:AHM85PS12 Power supply and Manufacture: FSP Group Inc / model: FSP100-RAAM. Model Differences N/A Technical Considerations

Classification of installation and use : Portable, Fixed (when mounting means used)

Device type (component/sub-assembly/ equipment/ system) : ME Equipment

Intended use (Including type of patient, application location) : General use (no applied parts)

Mode of operation : Continuous

Supply connection : Appliance coupler

Accessories and detachable parts included : None

Other options include : None

The product was investigated to the following additional standards:: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes Deviations for United States), CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)

The product was not investigated to the following standards or clauses:: Electromagnetic

Compatibility (IEC 60601-1-2), Clause 14, Programmable Electronic Systems, Biocompatibility (ISO 10993-1), Usability (IEC 60601-1-6),

The degree of protection against harmful ingress of water is:: IP21 (not evaluated by UL)

The following accessories were investigated for use with the product:: N/A

The mode of operation is:: Continuous

The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide:: No

Clause 14: Software (PEMS) is relied upon for meeting Basic Safety and Essential Performance: No

The product is suitable for use in an Oxygen Rich Environment: No

Manufacturer’s Recommended Ambient: 40 °C

USB Handset Bracket cannot support equipment as a stand base.

The connector between base and touch computer is fixed and cannot be rotated at any angle.

Additional Information 1. Risk Management report and file, according to ISO/IEC 14971: 2007, were provided by client. The document were reviewed to meet the requirements of ISO/IEC 14971:2000, and also the requirements of IEC60601-1 Third Edition, ANSI/AAMI ES60601-1 First Edition, and CAN/CSA-C22.2 No. 60601-1:08 Second Edition. 2. IP21 (according to IEC 60529, not evaluated by UL) Additional Standards The product fulfills the requirements of: CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)

Markings and instructions Clause Title Marking or Instruction Details Company identification Classified or Recognized company's name, Trade name, Trademark or File Model Model number Supply Connection Voltage range, ac/dc, phases if more than single phase Direct current

Power Input Amps, VA, or Watts IP Rating IP21

UL TEST REPORT AND PROCEDURE Standard: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10)(Medical Electrical

Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)

Certification Type: Classification CCN: MDAF, MDAF7 (Medical Equipment - General Medical Equipment) Product: Touch Computer Model: ESY19MX (X=0-9, A-Z, “-” or blank ) Rating: Monitor:

Ratings: 12Vdc, 6A, Class I Adapter : Manufacture: XP POWER L L C/ model:AHM85PS12 Power supply input: 100-240Vac, 50/60Hz,1.0A Output : 12Vdc, 7.08A Adapter : Manufacture: FSP Group Inc / model: FSP100-RAAM Power supply input: 100-240Vac, 50-60Hz, 1.6-0.8A Output : 12Vdc, 9.17A

Applicant Name and Address:

This is to certify that representative samples of the products covered by this Test Report have been investigated in accordance with the above referenced Standards. The products have been found to comply with the requirements covering the category and the products are judged to be eligible for Follow-Up Service under the indicated Test Procedure. The manufacturer is authorized to use the UL Mark on such products which comply with this Test Report and any other applicable requirements of UL LLC ('UL') in accordance with the Follow-Up Service Agreement. Only those products which properly bear the UL Mark are considered as being covered by UL's Follow-Up Service under the indicated Test Procedure. The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety. Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL. Prepared by: Marcell Lin & Christine Wang Reviewed by: Conga Chen

Supporting Documentation The following documents located at the beginning of this Procedure supplement the requirements of this Test Report: A. Authorization - The Authorization page may include additional Factory Identification Code markings. B. Generic Inspection Instructions - i. Part AC details important information which may be applicable to products covered by this Procedure.

Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of this Test Report.

ii. Part AE details any requirements which may be applicable to all products covered by this Procedure. Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of each Test Report.

iii. Part AF details the requirements for the UL Certification Mark which is not controlled by the technical standard used to investigate these products. Products are permitted to bear only the Certification Mark(s) corresponding to the countries for which it is certified, as indicated in each Test Report.

Product Description The unit is touch computer and is consisted with 18.5 inch TFT-LED design and all components were soldered on PWB and enclosed in metal chassis and plastic enclosure. The unit provided option for use with VESA wall mounting means for installation. The product is only used with UL R/C, QQHM2 power supply, Manufacture: XP POWER L L C/ model:AHM85PS12 Power supply and Manufacture: FSP Group Inc / model: FSP100-RAAM. Model Differences N/A Technical Considerations

Classification of installation and use : Portable, Fixed (when mounting means used)

Device type (component/sub-assembly/ equipment/ system) : ME Equipment

Intended use (Including type of patient, application location) : General use (no applied parts)

Mode of operation : Continuous

Supply connection : Appliance coupler

Accessories and detachable parts included : None

Other options include : None

The product was investigated to the following additional standards:: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes Deviations for United States), CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)

The product was not investigated to the following standards or clauses:: Electromagnetic

Compatibility (IEC 60601-1-2), Clause 14, Programmable Electronic Systems, Biocompatibility (ISO 10993-1), Usability (IEC 60601-1-6),

The degree of protection against harmful ingress of water is:: IP21 (not evaluated by UL)

The following accessories were investigated for use with the product:: N/A

The mode of operation is:: Continuous

The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide:: No

Clause 14: Software (PEMS) is relied upon for meeting Basic Safety and Essential Performance: No

The product is suitable for use in an Oxygen Rich Environment: No

Manufacturer’s Recommended Ambient: 40 °C

USB Handset Bracket cannot support equipment as a stand base.

The connector between base and touch computer is fixed and cannot be rotated at any angle.

Additional Information 1. Risk Management report and file, according to ISO/IEC 14971: 2007, were provided by client. The document were reviewed to meet the requirements of ISO/IEC 14971:2000, and also the requirements of IEC60601-1 Third Edition, ANSI/AAMI ES60601-1 First Edition, and CAN/CSA-C22.2 No. 60601-1:08 Second Edition. 2. IP21 (according to IEC 60529, not evaluated by UL) Additional Standards The product fulfills the requirements of: CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)

Markings and instructions Clause Title Marking or Instruction Details Company identification Classified or Recognized company's name, Trade name, Trademark or File Model Model number Supply Connection Voltage range, ac/dc, phases if more than single phase Direct current

Power Input Amps, VA, or Watts IP Rating IP21