Nemko USA, Inc. 11696 Sorrento Valley Rd., Suite F San Diego, CA 92121-1024 Phone (858) 755-5525 Fax (858) 452-1810



# T EST 

# R EPORT

PER 

# RCTA I NC



# . DO-160F

F OR 

# T HE 

# Oxygen Concentrator Model: 4000

P REPARED FOR



### C HART 

### S E 

### Q UAL 

### T ECHNOLOGIES 

### , I NC



### . 11436 S ORRENTO 

### V ALLEY 

### R D



### . S AN 

### D IEGO 

### , CA

P REPARED 

### on May19, 2011

R EPORT 

### N UMBER 

### : 2011 05173008 DO160
R EVISION N ONE



### P ROJECT 

### N UMBER 

### : 1028020-1

NEx Number : 

### 173008

### Nemko SD USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810
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## DOCUMENT HISTORY

REVISION DATE COMMENTS

- May19, 2011 Prepared By: Rodel Resolme

- May19, 2011 Released By: Alan Laudani

NOTE: Nemko USA, Inc. hereby makes the following statements so as to conform to the Requirements of EN 17025
"General Criteria For the Oper ation Of Test Laboratories":

o The unit described in this report was received at Nemko USA, Inc.'s f acilities on April 27, 2011.

o Testing was performed on the unit described in this report onApril 27, 2011 to May 4, 2011.

o The Test Results reported herein apply only to the Unit actually tested, and to substantially identical Units.

This Report is the property of Nemko USA, Inc., and sha ll not be reproduced, except in full, without prior written
approval of Nemko USA, Inc. Howeve r, all ownership rights are hereby returned unconditionally to Chart SeQual
Technologies, Inc., and approval is hereby granted to Chart SeQual Technologies, Inc. and its employees and agents to
reproduce all or part of this report for any legitimate bus iness purpose without further re ference to Nemko USA, Inc

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## CERTIFICATION

The compatibility testing and this report have been prepared by Nemko USA, Inc., an independent electromagnetic

compatibility consulting and test laboratory.

The compatibility testing and this report have been prepared by Nemko USA, Inc., an independent electromagnetic

compatibility consulting and test laborat ory. Testing was performed Per test methods described in RTCA, Inc. DO160F.

I certify the data evaluation and equipment configuration herein to be a true and accurate representation of the sample's

immunity and emission characteristics, as of the test date(s), and for the design of the test sample utilized to compile

this report.

Alan Laudani, EMC/RF Test Engineer

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# T ABLE 

# O F 

# C ONTENTS

DOCUMENT HISTORY .............................................................................................................. ................................ 2

CERTIFICATION ................................................................................................................. ........................................ 3

1 ADMINISTRATIVE DATA AND TEST SUMMARY .......................................................................................... 6 1.1 Administrativ e Data ........................................................................................................... ............................ 6 1.2 Test Specifi cations ........................................................................................................... .............................. 6 1.3 Test Summary .................................................................................................................. .............................. 7 1.3.1 Emissions Test Summary 7 1.3.2 Other Tests Summary 7

2 SYSTEM CONFIGURATION .......................................................................................................... ...................... 7 2.1 System Components a nd Power Cables ............................................................................................ ............ 7 2.2 Device Interconnection and I/O Cables ......................................................................................... ................ 7 2.3 Description and Method of Exercising the UUT. ................................................................................. ......... 8 2.4 Figure and Picture of actual test Set-up ...................................................................................... ................... 8

3 TEST SITE INFORMATION

.............................................................................................................................. .. 10 3.1 Ground Plane .................................................................................................................. ............................. 10 3.2 Anechoic Chamber .............................................................................................................. ........................ 10 3.3 Detection System .............................................................................................................. ........................... 10 3.4 Test Equipment ................................................................................................................ ............................ 11

4 DO-160F Tests ................................................................................................................. ...................................... 12 4.1 Bonding Test .................................................................................................................. ............................. 12 4.1.1 Bonding Test Method 12 4.1.2 Bonding Data Sheets 12 4.1.3 Test Equipment List 12 4.2 Emission of Radio Fre quency Energy Test ....................................................................................... .......... 13 4.2.1 Section 21 Emission of Radio Frequency Energy Test Method 13 4.2.2 Radiated Emissions Test Data 15 4.2.3 Radiated Emissions Photographs 17 4.2.4 Test Equipment List 20

APPENDICES APPENDIX A. Nemko USA, Inc. Test Equi pment & Facilities Calib ration Program ......................................... A1 APPENDIX B: NVLAP Accreditation ............................................................................................... ................... B1

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### LIST OF FIGURES

F IGURE 2.4-1 UUT T EST S ETUP 8 F IGURE 2.4-2 G ENERAL T EST S ET -U P 9 F IGURE 4.2-1 R ADIATED E MISSIONS A NTENNA C ONFIGURATIONS 14 F IGURE 4.2-2 AMBIENT SCAN H ORIZONTAL 15 F IGURE 4.2-3 AMBIENT SCAN V ERTICAL 15 F IGURE 4.2-4 H ORIZONTAL B ATTERY O NLY D ATA H ORIZONTAL 16 F IGURE 4.2-5 H ORIZONTAL B ATTERY O NLY D ATA V ERTICAL 16 F IGURE 4.2-6 100 MH Z TO 200 MH Z RANGE B ATTERY O NLY 17 F IGURE 4.2-7 200 TO 1 GH Z RANGE B ATTERY O NLY 18 F IGURE 4.2-8 1 TO 6 GH Z RANGE B ATTERY O NLY 19



### LIST OF TABLES

Table 1 Emi ssion Tests ........................................................................................................ .......................................... 6
Table 2 Othe r tests ........................................................................................................... .............................................. 6
Table 3 Emissions Test Summary ................................................................................................ ................................. 7
Table 4 Other Te st Summary .................................................................................................... .................................... 7 Table 5 Bonding Te st Results .................................................................................................. ................................... 12 Table 6 Bonding E quipment List ................................................................................................ ................................ 12 Table 7 Equipm ent Li st ........................................................................................................ ....................................... 20

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## 1 ADMINISTRATIVE DATA AND TEST SUMMARY

1.1 Administrative Data

CLIENT: Chart SeQual Technologies, Inc. 11436 Sorrento Valley Rd. San Diego, CA 858-202-3164

CONTACT: LoAn Mayer E-MAIL: Loan.Mayer@CHART-IND.com

DATE (S) OF TEST: April 27, 2011 to May 4, 2011

UNIT UNDER TEST (UUT): Oxygen Concentrator PART NUMBER: 4000 SERIAL NUMBER: n/a CONDITION UPON RECEIPT Suitable for Test



### 1.2 Test Specifications

Radio Frequency Emissions and Electroma gnetic Immunity tests in accordance w ith the requirements of RCTA, Inc. DO-160F.

Table 1 Emission Tests

Test Method Requirement Description Frequency Range Limit

Section 21 RCTA, Inc. DO-160F Emission of RF Energy Radiated 100 MHz to 6 GHz Category M

Table 2 Other tests

Test Method Requirement Description Frequency Range Limit Bonding Test < 2.5 m Ω Measurement of ground plane resistance N/A 2.5m Ω

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### 1.3 Test Summary Section 21, Emission of RF Energy Test, radiated emissions on 3 different modes: 120VAC 60Hz, battery, and 24VDC.

1.3.1 Emissions Test Summary

Table 3 Emissions Test Summary



### Specification Frequency Range Compliance Status RCTA, Inc. DO-160F, Section 21 radiated Cat. M 100MHz to 6GHz Passed



### 1.3.2 Other Tests Summary
Table 4 Other Test Summary 

### Specification Test Requirements Compliance Status Bonding Test < 2.5 mOhm Passed

Refer to the test results section for further details.



## 2 SYSTEM CONFIGURATION

2.1 System Components and Power Cables

DEVICE MANUFACTURER MODEL # SERIAL # POWER CABLE

EUT - Oxygen Concentrator Chart SeQual Technologies, Inc. Model: 4000 Serial #: n/a 2m, 18 AWG, 2 wire, DIN
connector

EUT – AC to DC Power Adapter Megmeet Model: MANGO150-28 Serial # n/a 1.6m, 18 AWG, 2 wire, IEC
connector



### 2.2 Device Interconnection and I/O Cables

Connection I/O Cable

N/A

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### 2.3 Description and Method of Exercising the UUT.

The Eclipse 4000 is an Oxygen Concentrator system which is portable used to extract oxygen from the atmosphere, concentrate it to greater than 90% and present it to the patient. The device will operate in Continuous Flow or Pulse Dose Modes. In Continuous Fl ow Mode the oxygen is provi ded at a constant flow rate between 0.5 and 3.0 LPM. In Pulse Dose Mode, oxy gen is supplied in a bolus at the beginning of each inspiration, providing a selectable range setting of 16mLto 192mL.

The Eclipse 4000 operates from either external power or from an internal recharg eable battery. The system includes a “Smart Battery” charger that recharges the internal battery wh enever the Eclipse is connected to external power. The system monitors and contro ls the power source and the battery charger.

The Eclipse 4000 separates oxygen from ambient air. The ai r is filtered and then separated into oxygen and nitrogen, the nitrogen is then purged. This cycle concentrates the oxygen.

The EUT was exercised by settings to operate in Conti nuous Flow at a rate of 3.0LPM. If testing induces a mode change or the EUT indicates reduced flow rate or stops it may be considered a failure.

The EUT’s performance during test was evaluated agains t the performance criterion specified by applicable test standards. Performance results are detaile d in the test results section of this report.



### 2.4 Figure and Picture of actual test Set-up



## Figure 2.4-1 UUT Test Setup

(Ambient scan configuration shown)

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## Figure 2.4-2 General Test Set-Up

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## 3 TEST SITE INFORMATION

The test site is located at: NEMKO USA, Inc. 11696 Sorrento Valley Road, Suite F San Diego, CA 92121

NEMKO USA is NVLAP certified. The NVLAP Certification is included in Appendix C of this document. The site is physically located 18 miles northwest of downtown San Diego. The general area is a valley 1.5 miles east of the Pacific Ocean. The EMI testing was under the guidance of National Associa tion of Radio and Telecommunication Engineers (NARTE) personnel.



### 3.1 Ground Plane
The emissions and susceptibility portions of the testing wa s performed on a ground plane. The ground plane consisted of a 8’ x 3’ x 1/8” thick copper plate mounted on a woode n bench and is connected to the ground rod via a copper bus bar 2’ wide and 0.25" thick. The DC bonding resistance between the ground plane and ground was less than 2.5m Ω

. The Unit Under Test (UUT) and Line Isolation Stabiliza tion Network (LISN) were bonded to the ground plane.



### 3.2 Anechoic Chamber

The radiated and conducted emissions tests were conducted in side a semi anechoic chamber which measures 20' x 12' x 10'. Carbon-loaded cones provide RF di ssipation. Radiated susceptibility tests were conducted inside a semi anechoic chamber which measures 20' x 12' x 10’. Power capability of the chamber includes 50 amps at 100VDC, 30 amps per phase of 120 VAC at 400 Hz, and 50 amps of up to 250 VAC at up to 60 Hz.



### 3.3 Detection System
The automated detection system used in emission testing c onsists of a spectrum analyzer controlled by a computer. Preamplifiers used where necessary and wh ere they are used an appropriate notation is made in the relevant section of the report. Commercially available EM I measurement software Total Integrated Laboratory Environment (TILE) was used in the performance of these measur ements. In this software package, the bandwidths and measurement times are user-selectable, and the bandwidths and sweep times were per the requirements RTCA, Inc. DO-160F.

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### 3.4 Test Equipment

NEMKO USA, Inc. operates a comprehensive Periodic Calibration Program in order to ensure the validity of all test data. NEMKO USA’s Periodic Calibration Program is fully compliant to the requirements of NVLAP ISO Standard 17025. NEMKO USA, Inc.’s calibration program therefore meets or exceeds the US national commercial and military requirements [N.B. ANSI/NCSL Z 540-1-1994 which replaced MIL-STD-45662A ].. Specifically, all of NEMKO

USA’s primary reference standard devices (e.g. vector voltmeters, multimeters, attenuators and terminations, RF power meters and their detector heads, oscilloscope mainframes and plug-ins, spectrum analyzers, RF preselectors, quasi-peak adapters, interference analyzers, impul se generators, signal generators and pulse/function generators, field-strength meters and their detector heads, etc.) and certain secondary standard devices are periodically recalibrated by:

• A NEMKO USA-approved independent (third party) metrology laboratory that uses NIST-traceable standards and that is ISO Standard 17025-accredited as a calibration laboratories by NIST; or,

• A NEMKO USA-approved independent (third party) metrology laboratory that uses NIST-traceable standards and that is ISO Standard 17025-accredited as a calibration la boratory by another accredita tion body (such as A2LA) that is mutually recognized by NIST; or,

• A manufacturer of Measurement and Te st Equipment (M&TE), if the manufact urer uses NIST-traceable standards and is ISO Standard 17025-accredited as calibration laborat ory either by NIST or by another accreditation body (such as A2LA) that is mutually recognized by NIST; or

• A manufacturer of M&TE (or by a NEMKO USA-approved independent third party metrology laboratory) that is not ISO Standard 17025-accredited. (In these cases, NEM KO USA conducts an annual audit of the manufacturer or metrology laboratory for the purposes of proving traceab ility to NIST, ensuring that adequate and repeatable calibration procedures are being applied, and verifying c onformity with the other requirements of ISO Standard 17025).

In all cases, the entity performing the Calibration is required to furnish NEMKO USA with a calibration test report and/or certificate of calibration, and a “calibration sticker” on each item of M& TE that is successfully calibrated.

Calibration intervals are normally one year, except when the manufacture advi ses a shorter interval or if US Government directives or client requirements demand a shor ter interval. Items of instrumentation/related equipment which fail during routine use, or which suffer visible mechanical damage (during use or while in transit), are sidelined pending repair and recalibration. (Repairs are carried out either in-house [if minor] or by a NEMKO USA-approved independent [third party] metrology laboratory, or by the manufacturer of the item of M&TE).

Each antenna used for radiated emissions testing is calib rated annually by either a NIST (or A2LA) ISO Standard 17025-Accredited third-party Antenna Calibration Laboratory or by the antenna’s OEM if the OEM is NIST or A2LA
ISO Standard 17025-accredited as an an tenna calibration laboratory.

Note: The reason NCR (no cal required) equipment is used in a test set up and still supports the test is that other calibrated equipment is used in a calibration test set up before running the official test.

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## 4 DO-160F Tests

4.1 Bonding Test

4.1.1 Bonding Test Method
Per DO160F, the bonding between the LISN’s and ground plane we re measured and verified to be less than 2.5 milliohms.



### 4.1.2 Bonding Data Sheets

Customer Chart SeQual Technologies, Inc. Job order 173008 Test Engineer Rodel Resolme Date May 5, 2011 Standard RTCA DO160F Remarks 4000

Table 5 Bonding Test Results

From Location To Location Measured

m Ω Limit

m Ω Pass Remarks

Wall Table 1.8 2.5 Pass

Table LISN Positive 0.89 ↓ Pass
Table LISN Negative 1.08 ↓ Pass



### 4.1.3 Test Equipment List
Table 6 Bonding Equipment List

Asset No. Description Part Number Number Serial Number Last Cal. Cal due 825 LISN, Set Com

‐ Power LI

‐ 400 25064 6/16/10 6/16/11 904 Micro-ohmmeter Keithley 580 402336 7/28/10 7/28/11

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### 4.2 Emission of Radio Frequency Energy Test

4.2.1 Section 21 Emission of Radio Frequency Energy Test Method

These tests determine that the equipment does not emit undesired RF noise in excess of the levels specified below. The
notches specified in the radiated emi ssions limits are included to protect aircraft RF sensors operating at those
frequencies.

Radiated Emissions shall meet the Category M limits as specified in DO-160F Section 21.4 and Figure 21-5. The

radiated emission will be measured from 100 MHz to 6 GHz.

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## Figure 4.2-1 Radiated Emissions Antenna Configurations

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### 4.2.2 Radiated Emissions Test Data



## Figure 4.2-2 AMBIENT SCAN Horizontal

Nemko USA
RTCA/DO-160F Test Method 21.4 Cat. M Horizontal Polarization Radiated Emissions

100.0M 1.0G 10.0G Frequency -20.0 -10.0 0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0Amplitude dBuV/m

04:58:21 PM, Thursday, May 05, 2011 Sequal Technologies Inc. Oxygen Concentrator 4000 (Eclipse 4) 1028020/173008



## Figure 4.2-3 AMBIENT SCAN Vertical

Nemko USA
RTCA/DO-160F Test Method 21.4 Cat. M Vertical Polarization Radiated Emissions Ambient Scan

100.0M 1.0G 10.0G Frequency -20.0 -10.0 0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0Amplitude dBuV/m

05:02:52 PM, Thursday, May 05, 2011 Sequal Technologies Inc. Oxygen Concentrator 4000 (Eclipse 4) 1028020/173008

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## Figure 4.2-4 Horizontal Battery Only Data Horizontal

Nemko USA
RTCA/DO-160F Test Method 21.4 Cat. M Horizontal Polarization Radiated Emissions

100.0M 1.0G 10.0G Frequency -20.0 -10.0 0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0Amplitude dBuV/m

05:12:49 PM, Thursday, May 05, 2011 Sequal Technologies Inc. Oxygen Concentrator 4000 (Eclipse 4) 1028020/173008



## Figure 4.2-5 Horizontal Battery Only Data Vertical

Nemko USA
RTCA/DO-160F Test Method 21.4 Cat. M Vertical Polarization Radiated Emissions Battery Mode

100.0M 1.0G 10.0G Frequency -20.0 -10.0 0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0Amplitude dBuV/m

05:07:33 PM, Thursday, May 05, 2011 Sequal Technologies Inc. Oxygen Concentrator 4000 (Eclipse 4) 1028020/173008

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### 4.2.3 Radiated Emissions Photographs



## Figure 4.2-6 100 MHz to 200 MHz range Battery Only

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## Figure 4.2-7 200 to 1 GHz range Battery Only

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## Figure 4.2-8 1 to 6 GHz range Battery Only

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### 4.2.4 Test Equipment List
Table 7 Equipment List

Asset No. Description Part Number Number Serial Number Last Cal. Cal due 117 Antenna, Bicon BIA-25 2611 5/18/09 5/18/11 317 Pre-amp, HP 8449A 2749A 5/7/2010 5/7/2011 824 LISN, Set Com-Power LI-400 25063 5/15/2010 825 LISN, Set Com-Power LI-400 25064 6/16/2010 350 Antenna, Dual Ridge RGA 30 2225 4/21/2011 4/21/2013 752 Antenna, DRG Horn 3115 4943 12/2/2010 12/2/2012 911 Spectrum Analyzer, Agilent E4440A US41421266 12/17/09 12/17/10 901 Pre-amp, Sonoma 310N 130607 10/26/2010 10/26/2011

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### APPENDIX A. Nemko USA, Inc. Test Equi pment & Facilities Calibration Program

Nemko USA, Inc. operates a comprehensive Periodic Calibration Pr ogram in order to ensure the validity of all test data. Nemko USA’s Periodic Calibration Program is fully compliant to the requirements of NVLAP Policy Guide PG-1- 1988, ANSI/NCSL Z540.3: 2006, ISO 10012:2003, ISO/IEC 17025:2005, and ISO-9000: 2000. Nemko USA, Inc.’s calibrations program therefore meet s or exceeds the US national commerc ial and military requirements [N.B. ANSI/NCSL Z540-1-1994 replaced MIL-STD-45662A].

Specifically, all of Nemko USA’s primary reference standard devices (e.g. vector voltmeters, multimeters, attenuators and terminations, RF power meters and their detector heads, oscilloscope mainframes and plug-ins, spectrum analyzers, RF preselectors, quasi-peak adapters, in terference analyzers, impulse generato rs, signal generators and pulse/function generators, field-strength meters and their detector heads, etc.) and certain secondary standard devices (e.g. RF Preamplifiers used in CISPR 11/22 and FCC Part 15/18 tests) are periodically recalibrated by:

o A Nemko USA-approved independent (third party) metrology laboratory that uses NIST-traceable standards and that is ISO Guide 25-accredited as a calibration laboratories by NIST; or,

o A Nemko USA-approved independent (third party) metrology laboratory that uses NIST-traceable standards and that is ISO Guide 25-accredited as a calibration laboratory by another accreditation body (such as A2LA) that is mutually recognized by NIST; or,

o A manufacturer of Measurement and Test Equipment (M&TE), if the manufacturer uses NIST-traceable standards and is ISO Guide 25-accredited as calibra tion laboratory either by NIST or by another accreditation body (such as A2LA) that is mutually recognized by NIST; or

o A manufacturer of M&TE (or by a Nemko USA-approved independent third party metrology laboratory) that is not ISO Guide 25-accredited. (In these cases, Nemko USA conducts an annual audit of the manufacturer or metrology laboratory for the purpos es of proving traceability to NIST, ensuring that adequate and repeatable calibration procedures are bei ng applied, and verifying conformity with the other requirements of ISO Guide 25).

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In all cases, the entity performing the Calibration is required to furnish Nemko USA with a calibration test report and/or certificate of calibration, and a “calibration sticker” on each item of M&TE that is successfully calibrated.

Calibration intervals are normally one year, except when the manufacture advi ses a shorter interval or if US Government directives or client requirements demand a shor ter interval. Items of instrumentation/related equipment which fail during routine use, or which suffer visible mechanical damage (during use or while in transit), are sidelined pending repair and recalibration. (Repairs are carried out either in-house [if minor] or by a Nemko USA-approved independent [third party] metrology laboratory, or by the manufacturer of the item of M&TE).

Each antenna used for CISPR 11 and CISPR 22 and FCC Part 15 and Part 18 radiated emissions testing (and for testing to the equivalent European Norms) is calibrated annually by either a NIST (or A2LA) ISO Standard 17025-Accredited third-party Antenna Calibration Laboratory or by the ante nna’s OEM if the OEM is NIST or A2LA ISO Standard 17025-accredited as an antenna calibration laboratory. The antenna calibrations are performed using the methods specified in Annex G.5 of CISPR 16-1(2003) or ANSI C63.5-2004, including the “Three-Antenna Method”. Certain other kinds of antennas (e.g. magnetic-shielded loop antennas) are calibrated annually by either a NIST (or A2LA) ISO Standard 17025-accredited third-party antenna calibration laboratory, or by the an tenna’s OEM if the OEM is NIST or A2LA ISO Standard 17025-accredited as an antenna calibration la boratory using the procedures specified in the latest version of SAE ARP-958.

In accordance with FCC and other regulations, Nemko USA recalibrates its suite of an tennas used for radiated emissions tests on an annual basis. These calibrations are performed as a precursor to the FCC-required annual revalidation of the Normalized Site Attenuation properties of Nemko USA’s Open Area Test Site. Nemko USA, Inc. uses the procedures given in both Sub clause 16.6 and Annex G.2 of CISPR 16-1 (2003), and, ANSI C63.4-2003 when performing the normalized site attenuation measurements.

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## APPENDIX B: NVLAP Accreditation