ISEQUAI! 

: • • • • ' -T' T ,-^, The Smart Choice. 

•'• " " S(;Qu;ii Technoiogies inc. 

July 26, 2010 

Docket Management Facility 

US Department of Transportation 

1200 New Jersey Avenue, SE 

West Building Ground Floor 

Room W12-140 

Washington, DC 20590 

Re: Petition to Amend SFAR No. 106 on Portable Oxygen Concentrator Devices on Passenger 

Aircraft 

Dear Ms. Deaderick: 

Please accept this letter as a petition to amend the Federal Aviation Administration's (FAA) Special 

Federal Aviation Regulation (SFAR) No. 106 under 14 CFR 121 that allows for the use of certain 

portable oxygen concentrator (POC) devices onboard passenger aircraft. We are specifically 

requesting that the FAA amend the Section 2 and Section 3(a) of SFAR No. 106 by adding SeQual 

Technologies' SAROS Oxygen System as one of the approved POC devices for use on passenger 

aircraft. 

Background 

SeQual Technologies Inc. is a manufacturer of medical, military and industrial oxygen concentrators 

and other air separation equipment. We currently are preparing to market our SAROS Oxygen 

System, which is a small, lightweight, battery powered POC device for patients that require 

supplemental oxygen. It is our goal to provide an oxygen system that will expand a patient's ability to 

travel via aircraft and thus substantially improve their quality of life. The SAROS Oxygen System 

Technical Manual is attached as Exhibit A. 

The SAROS Oxygen System separates oxygen from ambient air through a process called Pressure 

Swing Adsorption (PSA). It provides a solution to address both stationary and portable requirements 

for oxygen patients needing up to 3 liters per minute (LPM) full flow operation and up to 96 milli-liter 

bolus in a pulse flow mode operation. The SAROS Oxygen System achieves its performance through 

SeQual's patented Advanced Technology Fractionator (ATF®) technology and patented variable speed 

compressor and compressor drive, advanced molecular sieve materials and rechargeable batteries. It 

provides USP 93% Medical Grade Oxygen to be delivered to the patient. 

The Food and Drug Administration (FDA) has issued SeQual Technologies a written determination 

that the technology used in the SAROS Oxygen System is substantially equivalent to legally marketed 

predicated devices and thus it can be placed on the market as a portable oxygen concentrator. (See 

Exhibit B.) The SAROS Oxygen System also is functionally similar to SeQual's Eclipse Oxygen 

System and the other portable oxygen concentrators referenced in the FAA's January 6, 201 Final 

Rule. (See 70 Fed. Reg. 40156.) 
I SEQUAL' 

The Smart Choice, 

SeQual Request for PHMSA Letter of Interpretation 

On July 22, 2010 SeQual Technologies submitted a letter to the Pipeline and Hazardous Materials 

Safety Administration (PHMSA) requesting a written interpretation that the SAROS Oxygen System is 

not subject to the U.S. hazardous material regulations (HMR) pursuant to the requirements referenced 

in 49 CFR 173.115(b)(1) for Class 2, Division 2.2 gases and 49 CFR 173.185 for lithium ion batteries. 

The letter is attached as Exhibit C. We expect confirmation from PHMSA by mid-October that our 

product is not subject to the HMR. 

Power Source for SAROS Oxvaen Svstem 

The SAROS Oxygen System is capable of being operated directly from an AC or DC power source or 

from a rechargeable lithium ion battery. It can be recharged and/or powered by a separate AC Power 

Adapter or where standard AC line power is available. The 24 Volt DC Cable and the 12 Volt Cable 

accessories allow power to be provided by a DC auxiliary power outlet, such as in a motor vehicle 

during transportation. User changeable lithium ion batteries are available to provide a range of 

ambulatory operational time. The lithium ion battery used to power the SAROS Oxygen System 

provide approximately 30 to 90 minutes of run time, depending on the flow mode and setting required 

by the patient. 

We are very sensitive to FAA's concerns with regard to passengers placing spare batteries in their 

carry-on baggage. We therefore designed a battery with recessed terminals for use in the SAROS 

Oxygen System to meet the requirements contained in Section 3, provision (b)(6) of SFAR No. 106. 

These types of terminals significantly reduce the possibility of external short circuits from occurring 

when batteries are carried onboard aircraft. Our Technical Manual also will contain detailed 

instrucfions on the Federal regulatory requirements for carrying these batteries onboard aircraft. We 

will instruct our customers to utilize the plastic bag (inner packaging) and strong fiberboard box that 

the battery is shipped in when carrying the battery onboard to prevent the battery from being damaged. 

These instructions and additional information on the safe transport of batteries also will be posted on 

our website. 

Instructions for Passengers Using the SAROS Oxvgen Svstem Onboard Aircraft 

To meet the FAA's requirements noted in SFAR No. 106, our Technical Manual and website will 

contain the following instructions for passengers that intend to use the SAROS Oxygen System 

onboard aircraft: 

1 The user must have a written statement, to be kept in that person's possession, signed by a 

licensed physician statement that states: 

(i) Whether the user of the SAROS Oxygen System has the physical and cognitive ability to 

see, hear, and understand the device's aural and visual cautions and warnings and is able, 

without assistance, to take the appropriate action in response to those cautions and 

warnings; 

(ii) Whether or not oxygen use is medically necessary for all or a portion of the duration of 

the trip; and 

(iii) The maximum oxygen flow rate corresponding to the pressure in the cabin of the aircraft 

under normal operating conditions. 

Page 2 of4 
I SEQUAL' 

The Smart Choice. 

2. The user must inform the aircraft operator and crew that the SAROS Oxygen System may be 

used onboard the aircraft and have the physician's statement available that specifies the 

duration of oxygen use required; 

3. During movement on the surface, takeoff, and landing, the SAROS Oxygen System must: (i) 

Either be stowed under the seat in front of the user, or in another approved stowage location, 

so that it does not block the aisle way or the entryway into the row; 

4. Users of the SAROS Oxygen System are prohibited from sitting in exit rows; 

5. If the user of the SAROS Oxygen System is not capable of hearing the unit's alarms, seeing 

the alarm light indicators, or have the cognitive ability to take the appropriate action in 

response to the various caution and warning alarms and alarm light indicators they must be 

traveling with someone who is capable of performing those funcfions; 

6. The user must ensure the SAROS Oxygen System is free of oil, grease or other petroleum 

products and is in good condition free from damage or other signs of excessive wear or 

abuse; 

7. The user must ensure that all lotions or salves that are oxygen approved may be used by 

persons using the SAROS Oxygen System; 

8. The user, whose physician statement specifies the duration of oxygen use, must obtain from 

the aircraft operator, or by other means, the duration of the planned flight. The user then 

must carry on the flight a sufficient number of batteries to power the SAROS Oxygen System 

for the duration of the oxygen use specified in the user's physician statement, including a 

conservative estimate of any unanticipated delays; 

9. The user must ensure that the SAROS Oxygen System batteries carried onboard the aircraft 

in carry-on baggage are packaged in such a way to prevent short circuits or generating a 

dangerous quantity of heat and protects them from physical damage; and 

10. If the user does not intend to use the SAROS Oxygen System onboard during the flight, the 

battery must be removed and packaged separately to prevent accidental operation. 

CompUance with RTCA/DO-160E 

The SAROS Oxygen System has successfiilly met testing pursuant to the requirements of RTCA /DO160E, Section 21 to show that the device will not interfere with an aircraft's electrical, navigation, or 

communication equipment. Attached are the data from the RTCA testing. 

Summarv 

We trust the information contained in this petition is sufficient for FAA to detennine that the SAROS 

Oxygen System is safe to be carried onboard aircraft. We therefore request that Section 2 and Section 

3(a) of SFAR No. 106 be amended by adding SeQual Technologies' SAROS Oxygen System as an 

approved POC device for use onboard aircraft. 

Should you need additional information or have any questions regarding our product, please do not 

hesitate to call me at the contact information below. 

Page 3 of4 
ISEQUAL* 

The Smart Choice. 

Respectfiilly, 

Pamela J. Jackson 

Senior Director, Government and Military 

SeQual Technologies Inc. 

11436 Sorrento Valley Road 

San Diego, CA 92121 

Phone:858-202-3144 

FAX: 858-558-1915 

Cell: 760-805-9000 

Email: pjackson@sequal.com 

Page 4 of4 
EXHIBIT A 

SAROSTM Oxygen System, Model 3000 

Technical Manual 

1 of 89 
CONTENTS 

GENERAL INFORMATION 4 

SYSTEM SPECIFICATIONS 5 

ELECTROMAGNETIC COMPATIBILITY 8 

HOW THE SYSTEM WORKS 9 

THEORY OF OPERATON 9 

ATF CONCENTRATION MODULE 10 

COMPRESSOR 10 

BRUSHLESS COMPRESSOR MOTOR DRIVER (BCMD) 10 

COOLING FAN 10 

POWER BOARD 10 

SYSTEM BOARD 10 

CONTROL PANEL 11 

CONTINUOUS FLOW MODE 11 

PULSE FLOW MODE WITH AUTOSAT TECHNOLOGY 12 

UTILITY MODE 12 

SERVICE MODE FUNCTIONS 12 

POWER SUPPLIES 12 

AC POWER ADAPTER 12 

24 VOLT DC CABLE 13 

BATTERY 13 

CHARGING ALGORITHM 14 

TRAINING INTRODUCTION 16 

TRAINING CHECKLIST 17 

IMPORTANT SAFETY INSTRUCTIONS 19 

Symbols used 19 

INDICATIONS FOR USE 21 

CONTRAINDICATIONS 21 

SAFETY GUIDELINES 21 

Battery Safety 23 

INTRODUCTION TO YOUR SAROS 24 

UNDERSTANDING THE CONTROLS on the FRONT PANEL 25 

Description of the SAROS 25 

Input/Output Connections 27 

User-Controls and System Status Indicators 28 

Examples of LCD Display 29 

RECOMMENDED OPERATING ENVIRONMENTS 31 

The Proper Location 32 

OPERATING INSTRUCTIONS 32 

Powering ON Your SAROS 33 

Operating Your SAROS 37 

ALERTS, ALARMS AND TROUBLESHOOTING 40 

STANDARD COMPONENTS AND OPTIONAL ACCESSORIES 43 

CLEANING, CARE AND ROUTINE MAINTENANCE 44 

BATTERY CLEANING, CARE AND MAINTENANCE 45 

INTRODUCTION-SERVICE AND REPAIR 46 

2 of 89 
PERIODIC MAINTENANCE LIST 46 

MAITENANCE PROCEDURE 47 

TEST PROCEDURES 51 

RECORD HOURS OF OPERATION AND SOFTWARE VERSION 52 

ELECTRICAL SAFETY TEST 53 

CLEANING THE SAROS 53 

SERVICE AND MAINTENANCE RECORD 54 

SHIPPING AND TRANSPORTING THE SAROS 55 

STORING THE SAROS 55 

DISCARDING 55 

ALARM INDICATIONS AND CODES 56 

SERVICE AND REPAIR PROCEDURES 60 

SYSTEM SCHEMATIC AND DIAGRAMS 61 

MAIN COMPONENTS 62 

REMOVE AND REPLACE THE BATTERY CONNECTOR 63 

POWER CONNECTOR REPLACEMENT 70 

USER PANEL REPLACEMENT 71 

REMOVE AND REPLACE THE ATF ASSEMBLY 74 

MAINTENANCE AND REPLACEMENT PARTS 86 

MAUFACTURED BY 89 

3 of 89 
General Information 

This Technical Manual will familiarize you with information regarding the SAROS Oxygen System, Model 

3000. Instructions in this manual are intended to help ensure that: 

• Users are familiar with the SAROS system components and system principles of operation 

• Users are given proper guidance in the use of the SAROS and its accessories 

• Users are made aware of the care, maintenance, service and repair of the SAROS Oxygen System. 

WARNING 

A 

IMPORTANT SAFETY INFORMATION FOR HAZARDS THAT MIGHT CAUSE 

SERIOUS INJURY. 

CAUTION 

A IMPORTANT INFORMATION FOR PREVENTING DAMAGE TO THE SAROS. 

DQ NOT; INFORMATION NEEDING SPECIAL ATTENTION. 

IMPORTANT! CLARIFYING INFORMATION, SPECIFIC INSTRUCTIONS, OR USER REFERENCE 

INFORMATION. 

4 of 89 
SAROS OXYGEN SYSTEM SPECIFICATIONS 

Oxygen Concentrator 

Dimensions 

- With battery 

- Without battery 

Weight 

- With Battery 

- Without Battery 

Flow Settings 

- Continuous Flow 

- Pulse flow 

Continuous Flow Accuracy 

Oxygen concentration 

Maximum System Pressure 

Oxygen Output Pressure 

Oxygen Concentration Status Indicator 

Nominal Sound Level 

Operating Environment 

- Temperature 

- Humidity 

Storage Environment 

- Temperature 

- Humidity 

Nominal Power 

3 LPM Continuous Flow 

Nominal Battery operating time at 

3 LPM Continuous Flow 

Continuous Flow Indication 

Audible Alarm Indicators 

Back-Up Alarm Power 

Filters 

Device Classification 

26.80" long x 4.375" diameter 

23.25" long x 4.375" diameter 

12.25 pounds 

10.00 pounds 

-1,2 , 3 LPM 

-16,32,48,64,80,96 ml 

+/- 10% or 20Gml/min, whichever is greater 

93% +/- 3% for all flow settings 

15 psig (103.5 kPa) 

4.0 psig (27.6 kPa) nominal 

Green Light = Normal Operation 

Yellow Light Flashing = Warning or Caution, less than 85% 

± 3 % 

Red Light = Abnormal Operation, less than 70% ± 5% 

<59 dB(A) 

32°Fto 109°F(0°to43''C) 

10% to 95%, Non-condensing, 82.4°F (28°C) Maximum 

Dew point 

-4° F to 140° F (-20° to 60°C) 

Up to 95% Non-condensing 

SI 30 Watts 

30 Minutes 

Expressed in liters per minute (LPM) 

• Loss of Power/Hot Battery 

• Low Battery/Warm Battery 

• Low Oxygen Output 

• No breath detection 

• 02 Flow Outside Normal Limits 

• Low 9V battery 

• Unit Malfunction 

9V Internal Battery 

Air Inlet Filter, HEPA and Exhaust Filter 

lEC Class 1. Type B Applied Part, IPX1 

5 of 89 
Pulse Mode Specifications 

Pulse Settings 

autoSAT Technology 

Trigger Sensitivity 

Trigger Criteria 

Minimum time between breaths 

Response to Missing Breaths 

16,32,48,64,80,96 ml 

Servo-control to maintain consistent Fi02 

Adjustable settings of 1 (most sensitive), 2 and 3 

(least sensitive) 

Cannula pressure has dropped below the trigger 

point (typically between 0.15 - 0.45 Cm of H2O of 

negative pressure) 

1.25 seconds (max. 3 consecutive breaths) 

Switch to Continuous Mode if no inspiration has been 

detected for 60 seconds with an audible alarm. 

Bolus Volume and Breath Rates 

Bolus Size ml (± 15%) 

16 

32 

48 

64 

80 

96 

Max Breath Rate 

40 

40 

40 

40 

37 

31 

NOTE: At breath rate above Max Breath Rate, bolus size will be reduced proportionally. 

Power Accessory Specifications 

AC Power Adapter 24 VDC Cable 

Input Voltage 

Input Power 

Output Voltage 

Output Power 

100-240 VAC, 50-6 0 Hz 

245 - 260 VA 

24 VDC 

200 W 

Input Voltage 

Input Current 

21 -2 9 VDC 

10A 

Battery Specifications 

Output Voltage 

Capacity 

Nominal Battery Life 

Battery Recharge Time 

14.8 VDC 

86 W-hours 

80% Capacity after 200 Charge/Discharge cycles 

2.4 hours to achieve 80% capacity from a fully discharged battery 

6 of 89 
Independent Safety Testing 

SAROS System and SAROS Concentrator, Model 3000 

Safety 

Electromagnetic Compatibility 

lEC 60601-1 :1988 + A1 :1991 + A2 :1995 + 

Corrigendum (6/95) EN 60601-1(1990) + A1(1993) + 

A2(1995) + A12(1993) + A13(1996) + Corrigenda 

(7/94) 

FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-

3-2, EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, 

IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, lEC 

60601-1- 2 :2001, RTCA DO 160 Rev F 

AC Power Adapter 

Safety 

Electromagnetic Compatibility 

lEC 60601-1:1988+ A1:1991 +A2:1995 

FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-

3-2, EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, 

IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, 

EN55014-1 

24 VDC Cable 

Safety 

Electromagnetic Compatibility 

Portions of lEC 60601-1:1988 + A1:1991 + A2:1995 

FCC 15B (Sec. 109), EN55011, EN60601-1-2 :2001, IEC61000-4-2, 

IEC61000-4-3, IEC61000-4-4, IEC61000-4-6, lEC 60601-1-2 :2001 

Battery 

Safety 

Electromagnetic Compatibility 

UL2054, UL60950-1, First Edition (UL File MH29443), lEC 60601-

1:1988 + A1:1991 + A2:1995, UN Transportation Tests T1-T8 

EN 61000-6-3 :2001 (EN55022 :1998+A1 :2001+A2 :2003), 

EN61000-6-1 :2001, EN61000-4-2 :1995+A1 :1998, EN61000-4-3 

:2002 

Any CSA-CUS mark for the SAROS system does not encompass operation with the 24 VDC Cable. 

7 of 89 
ELECTROMAGNETIC COMPATIBILITY 

This equipment complies with the limits for medical devices to the IEC60601-1-2 Electromagnetic 

Compatibility Standard. These limits are designed to provide reasonable protection against harmful 

interference in a typical medical installation. The equipment generates, uses and radiates radio 

frequency energy and, if not installed according with the instructions, may cause harmful interference to 

other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular 

installation. If this equipment does cause harmful interference to other devices, which can be determined 

by turning the equipment off and on, the user is encouraged to try to correct the interference by one or 

more of the following measures: 

Reorient or relocate the receiving device. 

Increase the separation distance between the equipment. 

Connect the equipment into an outlet on a circuit different from that which the other device(s) are 

connected. 

Consult with SeQual Technical Support for help. 

Guidance and Manufacturer's declaration - electromagnetic emissions 

The SeQual Technologies SAROS Oxygen System is intended for use in the electromagnetic 

environment specified below. The customer or the user of the SeQual Technologies SAROS Oxygen 

System should assure that it is used in such an environment. 

Emissions Test 

RF emissions 

EN 55011 

RF emissions 

EN 55011 

Harmonic emissions lEC 61000-

3-2 

Voltage fluctuations/ flicker 

emissions lEC 61000-3-3 

Compliance 

Group 1 

Class B 

Class A 

Complies 

Electromagnetic environment 

- guidance 

The SeQual Technologies 

SAROS Oxygen System uses 

RF energy only for its internal 

function. Therefore, its RF 

emissions are very low and are 

not likely to cause any 

interference in nearby electronic 

equipment. 

The SeQual Technologies 

SAROS Oxygen System is 

suitable for use in all 

establishments, including 

domestic establishments and 

those directly connected to the 

public low - voltage power 

supply network that supplies 

buildings used for domestic 

purposes. 

8 of 89 
HOW SAROS WORKS 

INTRODUCTION 

The SAROS Oxygen System, Model 3000 with autoSATTM Technology is a portable medical device used 

to extract oxygen from the atmosphere, concentrate it to greater than 90% and flow it through the oxygen 

outlet port. The device will operate in Continuous flow or Pulse flow modes. In Continuous Flow Mode 

the oxygen is provided at a constant flow rate of 1, 2, or 3 LPM. In Pulse flow Mode, oxygen is supplied 

in a bolus at the beginning of each inspiration, providing a selectable range setting of flow between 16 ml 

and 96 ml, in increments of 16 ml. A setting of 16 ml in Pulse Flow Mode delivers the equivalent amount 

of oxygen as a continuous flow Mode setting of 3 LPM. 

SAROS is BTP (Body, Temperature, and Pressure) compensated. It delivers oxygen by accounting for 

difference between ambient conditions and those found in the patient's lungs (37°C). 

SAROS operates from external power, AC or 24VDC, or from a rechargeable Battery. The system 

includes a "Smart Battery" charger that recharges the Battery whenever the SAROS is connected to 

external power. The system monitors and controls both the power source and the Battery Charger. 

BASIC THEORY OF OPERATION 

SAROS Oxygen System uses a variable speed compressor to provide both positive and negative air 

pressure and is driven by a Brushless DC Motor (BLDC) and drive system. 

The ATF® Concentrator Module accepts positively and negatively pressurized air and extracts oxygen 

from this air using the Pressure Swing Adsorption (PSA) process. The ATF module sub-components 

consist of patented rotary valves, manifold, housing, sieve beds, and a stepper motor / gear drive system. 

The rotary valve system channels the gas in a sequential manner to each of the sieve beds. Each bed is 

pressurized to force the oxygen through the sieve and into the product tank while most of the nitrogen is 

separated and remains in the sieve. Once the process is maximized then the sieve beds are purged of 

the nitrogen. The purged nitrogen is then vented to atmosphere through the exhaust vent. The process is 

continuously repeated in each sieve bed. 

The flow of produced oxygen passes from the product tank to a flow and concentration monitoring and 

control system which utilizes a proprietary ultrasonic flow and concentration sensor. It then continues 

through a flow control valve to accurately control the flow of oxygen in continuous and pulse flow modes. 

The oxygen then passes through a HEPA filter and is delivered to the oxygen outlet port. 

The oxygen flow rate and mode are selected by the user. In continuous flow mode, oxygen is delivered 

continuously at rates of 1, 2, and 3 LPM and, in pulse flow mode; a bolus is delivered at the beginning of 

each inspiration with selectable volume delivery approximately equivalent to rates between 16 and 96 mL. 

The SAROS electronic system, together with embedded operational firmware, provide the means to 

manage power, control oxygen production, monitor safety functions and interface with the user. Power 

management functions include switching between various power inputs, driving the compressor, ATF 

stepper motor, and proportional valve, monitoring battery status and charging when power is available 

from an external source. System management functions include monitoring ail flow, pressures, 

concentrations and safety functions. User Interface components such as buttons, illuminated indicators, 

LCD display and audio transducer are also monitored or controlled. The User Interface informs the user 

of the system status, allows the user to select a continuous flow or pulse mode flow setting and the ability 

to set the desired flow rate. The Utility Button the User Interface also allows the User to obtain 

information about the system - hours of operation, software version and 9V battery status - or make 

selections on various features such as Tactical or Normal Mode, Trigger Sensitivity Adjustments, Buzzer 

loudness and LCD Brightness and Contrast. 

9 of 89 
ATF® CONCENTRATOR MODULE 

The SAROS Oxygen System, Model 3000 with autoSAT Technology uses a passive system to separate 

oxygen from air. Air flows into the SAROS where it is filtered and then enters the compressor. 

Pressurized air flows from the compressor into the ATF Concentrator Module where it is separated into 

oxygen and nitrogen components. The air separation process uses a rotary valve system to force air 

through a series of pressurized sieve beds. Through a process known as "pressure swing adsorption," 

nitrogen molecules are collected on an adsorbent material or zeolite allowing the concentrated oxygen to 

be forced through a sieve bed into the product tank. The nitrogen molecules are then purged from the 

adsorbent material using a vacuum pressure cycle. 

Oxygen flows from the product tank through a sensor that measures flow and concentration and then 

through a HEPA filter. A flow control valve regulates the flow of concentrated oxygen. The process is 

continuously repeated during operation. 

COMPRESSOR 

The SAROS compressor is a two-head variable speed scroll compressor driven by a highly efficient 

Brushless DC (BLDC) motor. When air flows into the compressor, it passes through an air inlet mesh 

filter that filters out impurities. Using one head, the compressor takes in filtered air, compresses it and 

channels the compressed gas to the ATF Module. The second head pulls a vacuum on the ATF module 

and exhausts nitrogen rich gas through an exhaust outlet muffler to suppress the noise and then to the 

exhaust vent at the bottom of the device. 

BRUSHLESS COMPRESSOR MOTOR DRIVER (BCMD) 

The BCMD drives the compressor motor based on the input power from either the battery, the AC Power 

Adapter or the 24 VDC Cable. 

COOLING FAN 

A cooling fan is installed in the SAROS to provide forced air cooling to the various components in the 

system that generate heat. 

POWER BOARD 

The Power Board takes external power that comes into the SAROS from the AC Power Adapter, 24 VDC 

Cable or Battery and monitors and controls power distribution to the rest of the OMNI system. The Power 

Board also drives the cooling fan. 

SYSTEM BOARD 

The System Board is the center of nearly all the SAROS functions. The System Board is a 

microcontroller-based system that monitors system dynamics such as temperatures, pressures, ATF 

stepper motor and proportional valve, product flow and concentration, and the Users' input, indicators and 

buzzer operation and external communications. It measures temperature of the oxygen, compressor 

motor, ambient temperature, and ATF temperature, BCMD, Power Board and the Battery. 

The System Board utilizes a proprietary ultrasonic flow and concentration sensor and a flow control valve 

to accurately control the flow oxygen in the various flow delivery modes. 

10 of 89 
From Product Tank 

Ullrasonic Flow 

Concentration 

Measurement 

miaMmmmii 

To Output Port 

Product Pressure Control System 

CONTROL PANEL 

The Control Panel provides a user interface consisting of a membrane panel keyboards, Liquid Crystal 

Display (LCD), external power present indicator, Battery capacity indicator, alarm status indicators, and a 

buzzer. The user interface informs the user of the system status and allows the user to set the desired 

flow modes and flow rate - continuous or pulse, display mode - tactical or normal, set up system 

parameters and acquire system information. 

CONTINUOUS FLOW MODE 

The user may set the SAROS oxygen flow rate and mode. Continuous Flow Mode delivers a constant 

flow of oxygen to the Oxygen Outlet Port at settings of 1, 2, and 3 LPM. Within the SAROS, concentrated 

oxygen is stored in a product tank at pressures in the range of 5 - 9 psi and is back-pressure 

compensated. This pressure gives Continuous Flow Mode the capability to deliver the indicated flow rate 

to the patient even if extension tubing is used, up to 50 feet long. In addition, the SAROS Continuous 

Flow Mode is fully compatible with humidifier use. 

11 of 89 
PULSE FLOW MODE WITH autoSATTM TECHNOLOGY 

The SAROS Pulse Flow Mode with autoSATTM Technology delivers a high flow of oxygen at the very 

beginning of each inspiratory effort. The approach is based on the manner in which gas is delivered into 

a patient's airway. SAROS user may select pulse volume delivery rates between 16 and 96 ml. Pulse 

durations vary between 100 milliseconds and 500 milliseconds due to dead space considerations. 

The fundamental approach to triggering and controlling the oxygen bolus in Pulse Flow Mode is: 

The user may select pulse trigger sensitivity in settings 1 (most sensitive), 2, or 3 (least sensitive). The 

pulse will be triggered when the system meets all the following criteria: 

The cannula pressure has dropped below the trigger point (typically between 0.15 and 0.45 cmHzO). 

At lest 1.25 seconds has passed since the last pulse began. 

The SAROS autoSATTM Technology consistently maintains the Fi02 by adjusting to the patient's 

respiratory rate. As their rate increases, the autoSATTM feature servo controls the device to automatically 

increase oxygen output to ensure uninterrupted delivery of the set bolus volume. autoSATTM provides the 

patient with unparalleled performance without limiting available oxygen, enabling the system to 

automatically adjust to increased oxygen demands that often occur. 

UTILITY MODE 

A User or Service Technician can access the Utility Mode function by pressing using the Utility Button on 

the control panel. All information is displayed on the LCD. Advance to the next feature in the Utility Mode 

by depressing the Utility Button. The "+" or"-" button is used to toggle when a feature is selected. 

Pressing the Flow Mode button takes you back one step. 

SERVICE MODE FUNCTIONS 

Factory maintenance or service updates may sometimes be required on the SAROS. Factory and 

qualified factory-trained technicians can access service mode software functions by using the Service 

Port located on the top of the unit. . 

POWER SUPPLIES 

SAROS may operate from either an AC Power Adapter, 24 VDC Cable or Battery. When power is 

available from an external supply, the SAROS will draw from the external source rather than depleting the 

Battery. Connection to external power is indicated when the External Power Present Indicator located on 

the Control Panel is illuminated. 

AC POWER ADAPTER 

The AC Power Adapter is a universal input type, capable of accepting 100 - 240 VAC, 50/60 Hz. It is 

capable of delivering up to 200W at 24 VDC output. The input cord requires a grounded receptacle. 

Country specific cords may be used with the AC Power Adapter, as the supply is equipped with a 

universal input receptacle. When used in a medical care facility, international safety standards require 

the use of hospital grade AC power cord with the SAROS. 

12 of 89 
The AC Power Adapter contains protection circuits for output over-current, input over-voltage, and 

internal over-temperature conditions, if any of these conditions exist, output power will be a Loss of 

Power Alarm. Refer to Alert, Alarms and Troubleshooting Table. These three conditions are selfresetting, such that output power will resume when protection circuits fall back into acceptable operating 

ranges. 

24 VDC CABLE 

The 24 VDC Cable is intended for use with 24 volt power sources, such as those found in various 

vehicles. 

BATTERY 

The Battery allows operating the SAROS away from AC or DC power. The Battery used with the SAROS 

contains Lithium Ion battery cells, similar to those used in laptop computers and cell phones. The SAROS 

Battery is approximately 86 W-hours in capacity and provides an output voltage of 12V to 16.8V. The 

Battery connects to the bottom of the SAROS and is secured by a mechanical latching mechanism. The 

Battery can be recharged when the SAROS is connected to the AC Power Adapter or the 24 VDC Cable. 

The Battery Gauge indicator on the SAROS LCD will have a "waterfall" effect when the Battery is 

charging. The fastest way to recharge the Battery is using the AC Power Adapter. 

The Battery has an integral safety circuit that prevents over charge, over discharge or damage due to an 

external short circuit of the pack. An Integral fuel gauge communicates battery voltage, current, charge 

state, and temperature. Based on the voltage supplied by the Battery, the system is configured to 

optimize battery charging by regulating the charging voltage and current as follows: 

13 of 89 
Battery Pack Output Voltage 

(VDC) 

<10.0 

10.0-11.9 

>12.0 

Charging Voltage 

(VDC) 

FAULT 

16.6 

16.6 

Charging Current 

(A) 

FAULT 

0.66 

5.60 

When the SAROS is operating on Battery power, the LCD displays an estimate of the amount of time the 

unit can operate at the current settings, within +/- 5 minutes. When the SAROS is operating on Battery 

and the time on battery falls below 15 minutes, the LCD time on battery characters will flash to indicate a 

low battery condition. 

The capacity of the SAROS Battery is determined by electronics and software. While the SAROS Battery 

allows the concentrator to operate at its full range of capabilities, the primary purpose of the Battery is to 

allow an autonomous system while moving between AC or DC power sources. The SAROS's Battery, like 

all lithium ion batteries, is susceptible to permanent damage from excessive heat. Exposure to excessive 

heat may shorten the Battery's service life. 

The Battery contains multiple temperature sensors to monitor battery cell temperature. The amount of 

heat the Battery can safely endure varies depending on how the Battery is being used. During discharge, 

the SAROS software will alarm when internal battery cell temperature exceeds 60°C, and will shut the 

system down if internal battery cell temperature exceeds 59°C. While the Battery is charging, software will 

interrupt charger operation when the internal battery temperature exceeds 40°C or temperature is less 

than 5°C. In both of these cases, when internal battery cell temperature returns within these limits, the 

SAROS will resume normal operation. Operation near these temperature limits will not damage the 

Battery, but are in place to ensure that the service life of the Battery is preserved. 

Heat in the Battery is generated during discharge, and can also be the result of operating the SAROS in 

high ambient temperatures. The amount of internally generated heat varies with the flow setting - higher 

flows induce greater Battery heating. While high ambient temperatures are typically the result of operation 

on a hot day, running the SAROS with inadequate ventilation can also cause additional heat. Always 

ensure that the SAROS is operated in a well-ventilated space, the air intake filter is clean, and intake and 

exhaust vents are unobstructed. 

CHARGING ALGORITHM 

The charging algorithm is performed by the Power Board software and involves three basic decisions: 

1. When to start charging 

2. How fast to charge 

3. When to stop charging 

Charging begins when Battery voltage falls below 93% relative capacity. The charging current is limited 

by the charger capability and the rated capacity of the Battery. Under certain conditions, the SAROS may 

not have enough external power available to charge the batteries at the full rate. In this case, the charging 

rate will be limited to the available power. As the Battery accumulates charge, the charging current 

required will eventually fall. Battery charging will cease when the Battery voltage is greater than 16V, 

charge current is less than 0.66A, and relative charge is greater than 93%. 

The software will only charge when the Battery temperature is at or below 40°C. The software will always 

run the cooling fan whenever the charger is enabled. The Battery Charger is disabled and the cooling fan 

is set to maximum whenever the Battery temperature exceeds 40°C. The Battery charger is disabled 

when temperature is less than 5°C. 

14 of 89 
All lithium ion batteries self-discharge at very low rates when not in use. SAROS Batteries are shipped 

from SeQual in a partially charged state (nominally 40%). When the Battery is stored in a cool, dry 

location, it is recommended to recharge the Battery every 3 months. SeQual recommends a first in, first 

out rotation of Battery inventory for maximum service life. 

15 of 89 
The following section is intended to assist the Trainer to provide a basic overview of the SAROS Oxygen 

System for Set up, use, routine maintenance, trouble shooting and repair. Setting up and training to use, 

maintain and service the A Check List is provided to assist you in covering various aspects of the system. 

Proper training of the users will result in fewer service calls, improved compliance and utilization of the 

SAROS to its fullest capability. 

Before delivering the device, check and log the status of the following: 

Parts Inventory - Verify that each SAROS is provided with the following items: 

• Technical Manual 

• SAROS Concentrator 

• Cannula 

• AC Power Cord 

• AC Power Adapter 

• 24 Volt DC Cable 

• Battery 

• Spare Filter Set 

Power Sources - Insert and check the following for proper operation: 

• AC Power Adapter with Power Cord 

• 24 VDC Cable 

• Battery 

Electrical System - Use the Control Panel to check and/or adjust the following: 

Feature 

Tactical or Normal Mode 

Alarm Codes 

Pulse Sensitivity Setting 

LCD Contrast 

Tactical Buzzer Volume 

Tactical Mode Brightness 

Normal Mode Brightness 

9V Battery Status 

Hours of Operation 

System Software Part Number and Revision 

Motor Software Part Number and Revision 

Factory Default 

TACT ON 

AC=NONE 

2 

3 

3 

3 

2 

GOOD 

Actual Hours 

Latest Revision 

Latest Revision 

16 of 89 
TRAINING TOPIC 

Pre-Delivery check List 

Indications for Use 

Contraindications 

BASIC CONCEPT TRAINING 

Read the Technical Manual 

Device Specifications 

Safely Guidelines, Warnings/Cautions 

Locating Device 

User Panel Buttons and Indicators 

Alerts and Alarms 

Attaching the AC Power Adapter 

Attaching the 24 VDC Cable 

Attaching and removing the Battery 

Turning the device ON and OFF 

Selecting Flow Mode and Settings 

- Selecting Continuous Flow Mode 

- Selecting Pulse Flow Mode with autoSAT 

Reading the Display 

Accessing the Utility Menu 

- Turn off Tactical Mode 

- Alarm codes 

- Pulse Sensitivity Setting 

- LCD Contrast 

- Tactical Buzzer Volume 

- Tactical Mode Brightness 

- Normal Mode Brightness 

- 9V Battery Status 

- Hours of Operation 

- System Software Part Number and Revision 

- Motor Software Part Number and Revision 

CLEANING, CARE AND MAINTENANCE 

- Device and accessory cleaning 

- Replacing the filters and 9V battery 

TROUBLESHOOTING AND REPAIR 

TRAINED BY: 

INITIALS/DATE 

17 of 89 
SAROS Oxygen System 

Technical Manual - How to use it 

18 of 89 
Important Safety Instructions 

SeQual® Technologies Inc. (SeQual) recommends that this Technical Manual be given to each user 

receiving an SAROS Oxygen System. This manual provides all of the necessary information needed for a 

user, or clinician, to successfully operate the SAROS. 

SYMBOLS USED IN THE TECHNICAL MANUAL AND ON SAROS 

Refer to this section for an explanation of the symbols and the Warnings that accompany them. 

[_JlJ "Read Instructions": Please consult the Technical Manual instructions provided with the product. 

/ [ \ "Attention or Caution": Indicates important information that requires the user to take special 

precautions when certain conditions are present. 

"No Smoking or Open Flames": The use of oxygen requires that special care be taken to 

reduce the risk of fire. Materials that burn in air, and even some materials that will not burn in air, are 

easily ignited and burn more rapidly in high concentrations of oxygen. For safety concerns, all possible 

sources of ignition must be kept away from the SAROS and preferably out of the room in which it is being 

used. Smoking in the proximity of an operating SAROS is dangerous, and can permanently damage the 

device and void the warranty. 

rsc ) "Use No Oils or Grease": Indicates important information about the possibility of spontaneous 

and violent ignition that may occur if oils, grease or other petroleum based substances come into contact 

with oxygen under pressure. 

IPX2 Dripping Rain: The SAROS Battery will provide protection against water ingress according to the 

specifications indicated. Water sprayed at an angle up to 15° on the outside shall have no harmful effects 

(IPX2. per lEC 60529). 

IPX1 Drip Proof Equipmenl-IPXI: The SAROS, the AC Power Adapter and 24 VDC Cable provide 

protection against the harmful effects of the ingress of liquids. (IPX, per lEC 60529). 

lEC Icon for DC Power (Input) 

n ^ "Type B Equipment": Indicates equipment providing a particular degree of protection against 

electric shock, particulariy regarding: 

• Allowable leakage current; 

• Reliability of the protective earth connection (grounding). 

A "Amperes" 

19 of 89 
-'"Nw^ "Alternating Current" 

/ V ) "Audible Alarm": An audible indicator is provided to announce a reduction in oxygen 

concentration or when the power has been interrupted or lost. 

"ON/OFF" (Standby): Powers the device ON or OFF, but does not directly disconnect the mains 

power. 

m m "Increase Flow Setting": Increases the flow setting by 1 LPM and pulse volume by 16 mL 

increments each time the button is pressed. 

"Decrease Flow Setting": Decreases the flow setting by 1 LPM and pulse volume by 16 mL 

increments each time the button is pressed. 

"Flow Mode"; Activates either Continuous Flow Mode or Pulse Flow Mode Operation. 

^^^ H "External Power is Present Indicator": Indicates the presence of external power. 

"Battery Status Gauge": Shows the amount of charge remaining in the Battery. 

O 2 "Oxygen Output": The port from which the oxygen flows and where the tubing or interface 

(standard nasal cannula) is attached. 

r^j—" • Utility: The Button that activates a Utility Menu to access information or to change settings. 

'> .Recycl e Symbol 

^ WEEE Symbol: Do Not Discard, Recycle. Contact the local city or town offices for instructions on 

proper disposal of the Batter, electrical or electronic equipment. 

EC REP I Authorized European Representative 

20 of 89 
Indications for Use 

SAROS OXYGEN SYSTEM IS INDICATED FOR THE ADMINISTRATION OF SUPPLEMENTAL 

OXYGEN. THE DEVICE IS NOT INTENDED FOR LIFE SUPPORT NOR DOES IT PROVIDE ANY 

PATIENT MONITORING CAPABILITIES. 

A PHYSICIAN HAS PRESCRIBED A SPECIFIC OXYGEN FLOW SETTING TO MEET AN INDIVIDUAL'S 

NEEDS. OXYGEN FLOW SETTINGS SHOULD BE ADJUSTED ONL Y UNDER THE DIRECTION OF A 

PHYSICIAN 

WARNING 

FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. 

Contraindications 

WARNING 

IN CERTAIN CIRCUMSTANCES, THE USE OF NON-PRESCRIBED OXYGEN CAN BE HAZARDOUS. 

THIS DEVICE SHOULD ONLY BE USED UNDER THE DIRECTION OF A PHYSICIAN OR QUALIFIED 

CLINICIAN. 

NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS. 

AS WITH ANY ELECTRICALLY POWERED DEVICE.JHE USER MAY EXPERIENCE PERIODS OF 

NON-OPERATION AS A RESULT OF ELECTRICAL POWER INTERRUPUTION, OR THE NEED TO 

HAVE THE SAROS SERVICED BY A QUALIFIED TECHNICIAN. SAROS IS NOT APPROPRIATE 

FOR ANY PATIENT WHO WOULD EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE 

RESULT OF SUCH TEMPORARY INTERRUPTION. 

USE OF AN OXYGEN MASK IS CONTRAINDICATED DUE TO THE POSSIBILITY OF REBREATHING 

EXHALED CARBON DIOXIDE. 

Safety Guidelines 

These are Warnings and Cautions that apply to hazards or unsafe practices that could result in serious 

injury or property damage. 

Keep SAROS and the power cord away from hot surfaces or open flames. 

SAROS should be located in a well-ventilated area to allow for adequate air intake. 

Avoid the intake of airborne pollutants, smoke and fumes. 

ONLY use this device with accessories specified by, or recommended by, SeQual. 

If SAROS has been dropped, damaged or exposed to water please contact a qualified 

technician for inspection or possible repair of the device. 

When using SAROS in any vehicle, be sure it is properly secured, belted or restrained. 

DO NOT use SAROS if it has a damaged power cord or plug. 

21 of 89 
• DO NOT drop or insert any objects into any opening on the device. 

• DO NOT block the air inlet or the exhaust vent of the SAROS when it is on a soft surface, 

such as a litter, bed, chair, carpet, couch or vehicle seat. 

• DO NOT cover the device with a blanket, towel or sheet, etc. 

• DO NOT overfill the optional humidifier. Fill the optional humidifier with water to the level 

shown by the manufacturer of the humidifier. 

WARNING 

DO NOT REMOVE THE COVER. THERE ARE NO USER-SERVICEABLE PARTS INSIDE THE 

DEVICE. ONLY QUALIFIED SERVICE PERSONNEL SHOULD REMOVE THE COVER OF THE 

DEVICE. 

DO NOT OPERATE THE DEVICE, COMPONENTS OR ACCESSORIES ON WET SURFACES OR IN 

STANDING WATER AND DO NOT SUBMERSE IN WATER. 

PROTECT ELECTRICAL POWER CORDS FROM SHARP EDGES. ELECTRICAL SHOCK AND 

SERIOUS PHYSICAL INJURY MAY OCCUR. 

ONLY USE THE SEQUAL SUPPLIED AC POWER ADAPTER AND 24 VDC CABLE WITH YOUR 

SAROS. USE OF ANY OTHER AC POWER ADAPTER OR DC CABLE MAY BE HAZARDOUS, 

CAUSE SERIOUS DAMAGE TO YOUR SAROS AND WILL VOID THE WARRANTY. 

AVAILABILITY OF AN ALTERNATE, OR BACK-UP, SOURCE OF SUPPLEMENTAL OXYGEN IS 

RECOMMENDED IN CASE OF A POWER OUTAGE OR A MECHANICAL FAILURE OF THE DEVICE. 

CAUTION 

LOCATE OXYGEN SUPPLY TUBING AN D ALL POWE R CORD S IN A MANNE R T O PREVENT 

TRIPPING HAZARDS. 

D O NOT PLACE THE SARO S IN A SMALL, ENCLOSED SPACE, SUCH AS A BATHROOM, CLOSET, 

O R BO X WITH THE OXYGE N CANNUL A O R TUBING LEADING OU T OF THE ENCLOSED SPACE. 

D O NOT EXPOSE THE DEVICE T O TEMPERATURES OUTSIDE OF THE SPECIFIED RANG E OF 

OPERATING O R STORAG E TEMPERATURES AS THIS MA Y DAMAG E THE DEVICE. 

22 of 89 
Battery Safety 

WARNING 

DO NOT DISASSEMBLE, PUNCTURE, OR CRUSH THE BATTERY. BATTERY ELECTROLYTES MAY 

BE TOXIC IF SWALLOWED AND CAN BE HARMFUL TO SKIN AND EYES. KEEP THE BATTERY 

AWAY FROM CHILDREN. 

DO NOT SHORT-CIRCUIT THE BATTERY'S METAL CONTACTS WITH METALLIC OBJECTS, SUCH 

AS KEYS OR COINS. THIS MAY CAUSE SPARKS OR EXCESSIVE HEAT TO BE GENERATED. 

USE OF A DAMAGED BATTERY MAY CAUSE PERSONAL INJURY 

THE BATTERY MAY EXPLODE AND CAUSE POTENTIAL INJURY IF EXPOSED TO A FIRE, OR 

DISPOSED OF IN A FIRE. 

EXPOSING THE BATTERY TO WATER OR OTHER LIQUIDS MAY CAUSE PERSONAL INJURY. 

CAUTION 

DO NOT EXPOSE THE BATTERY TO TEMPERATURES ABOVE 140° F (60°C), SUCH AS IN A 

VEHICLE PARKED IN THE SUN ON A HOT DAY. 

IT IS NOT RECOMMENDED THAT THE BATTERY IS CHARGED BELOW 41 F° (5° C) OR ABOVE 

104° F (40° C). 

ONLY USE THE BATTERY FOR ITS INTENDED PURPOSE. 

23 of 89 
INTRODUCTION TO YOUR SAROS OXYGEN SYSTEM 

This Technical Manual will inform you about the use and care of the SAROS, its standard components and 

the optional accessories. Please read thoroughly all of the information in this manual before operating the 

SAROS and receive proper training on the use and care of this device. 

A PHYSICIAN HAS PRESCRIBED SUPPLEMENTAL OXYGEN AS PART OF A 

TREATMENT PLAN TO MEET AN INDIVIDUAL'S CLINCIAL NEEDS. OXYGEN FLOW 

MODES AND SETTINGS SHOULD BE ADJUSTED ONLY UNDER THE ADVICE OF A 

PHYSICIAN OR CLINICIAN. 

A representation of the major features of the SAROS hardware interface are shown below 

• Membrane Panel containing: 

• Five tactile buttons allow control of all user controllable settings 

" Five variable intensity LED indicators provide overall status 

• An 8 character LCD display shows settings 

9V Battery 

Oxygen Outlet Port 

External Power Connector 

Data Communications Connector 

Battery 

Simplified User instructions Label 

Main / Rating Label 

Particulate Mesh/Inlet Filter 

24 of 89 
Understanding the Controls on the Front Panel 

DESCRIPTION OF THE SAROS 

Become familiar with the key features of the SAROS and the user control panel. 

Particulate 

Mesh/Inlet 

Filter 

Cover 

Oxygen 

Outlet Port 

HEPA 

Filter 

Main/Rating 

Label 

(Underneath) 

Battery 

Simplified 

User 

Instructions 

Label (Behind) 

FRONT - CONTROL PANEL BACK - SIMPLIFIED INSTRUCTIONS 

25 of 89 
TOP 

External 

Power 

Connector 

Oxygen 

Outlet Port 

BOTTOM -WITHOUT BATTERY 

Main/Rating 

Label 

SERVICE PORT (USB) BOTTOM-WITH BATTERY 

N Exhaust Vent 

Push Button 

to release 

Battery 

26 of 89 
Input/Output Connections 

Oxygen Outlet Port Oxygen supply tubing or a cannula is attached to this port. 

Particulate Mesh/ Inlet Filter Ambient air is drawn into the device through the air inlet located at the 

top of the device. This air inlet filter prevents dust /debris from entering 

the SAROS and should be cleaned regulariy. 

Service Port This connection allows qualified service personnel to diagnose and 

monitor the SAROS performance. It is not intended for the user. 

External Power Receptacle The SAROS AC Power Adapter or 24 VDC Cable connects to this 

receptacle. 

Exhaust Vent Exhaust air from the SAROS leaves the device from this vent. 

27 of 89 
USER CONTROLS AND SYSTEM STATUS INDICATORS 

The SAROS User Control Panel displays important operating information. This section will help you 

understand this operating information. 

Tactical Mode is provided for operation where noise and light may compromise a situation, In these 

situations, the LED indicators will be off and the audio indicator sound is reduced. The system always 

starts up in Tactical Mode and can be changed to Normal Mode by depressing the Utility Button and then 

the Decrease button to change from TACT=ON to TACT=OFF. Tactical Mode is indicated by a "T" on the 

LCD. 

Normal Mode provides all LED indications with full brightness, full audio indicator sound and LCD 

backlight Normal Mode is indicated by an "N" on the LCD. 

Green, Yellow, and Red Indicators on the front panel indicate the operating condition of the device. For 

additional information on these indicators see the Alerts, Alarms and Troubleshooting Table in this 

manual. 

ON/OFF (Standby) Button -Green Indicator: This button powers the device ON or powers it 

OFF. The Green indicator is illuminated when the device is powered ON and operating in the Normal 

Mode and off when operating in Tactical Mode. 

^jf-U H Increase or Decrease Flow Setting Button: Use these buttons to set the flow or to make 

selections in the Utility Menu. 

Delivery Mode Button and Indicator (Blue): The SAROS contains a button to toggle between 

Continuous Flow and Pulse Flow mode. The Pulse Flow mode activates autoSATTM Technology - as 

breath rate changes, the system adjusts to provide a consistent bolus size. The Pulse Flow Mode allows 

a significant increase in operating time when powered by a Battery. When the Pulse Flow Mode is 

activated, the blue Flow Mode Indicator illuminates and a pulse of oxygen is delivered with each 

inspiratory effort. When the pulse of oxygen is delivered, the flow mode indicator turns off. Changes in 

flow mode should only be made by a clinician. 

o 

/ \ ALERT (Yellow) Indicator - Low and Medium Priority Alerts: 

In Normal Mode, when illuminated, this indicates a low priority awareness condition or Caution. Continue 

to use your system and refer to the Alerts, Alarms, and Troubleshooting Table for the proper response. A 

flashing yellow indicates a medium priority alert. A prompt response is necessary. In Tactical Mode, a 

blinking star "*" indicates an alert. 

A^ ALARM (Red) Indicator- High Priority Alarms: 

In Normal Mode, when illuminated, this indicates a high priority alarm condition. An immediate response 

is necessary. Refer to the Alerts, Alarms, and Troubleshooting Table and contact a qualified service 

technician. In Tactical Mode, a blinking star "*" indicates an alert. 

Buzzer: An audible alarm (or buzzer) is used to alert you to the operating condition of the device, either a 

warning or failure, and to confirm a valid key press by the user. 

28 of 89 
Flow Setting Indicator: This is the main focus on your control panel. A clinician will correctly set 

the prescribed flow for either the CX - Continuous Flow Mode at X LPM (1, 2 or 3) and/or the PXXX -

Pulse Flow Mode XXX ml (16, 32, 48, 64, 80, 96) settings. Each time the device is turned ON, it will 

operate at C3 (3 LPM) continuous flow in the Tactical Display Mode. 

I Battery Status Gauge: 

• ••I I 

This indicator displays the charge remaining in the Battery. When the Battery is fully charged all 5 gray 

bars are illuminated. Each gray bar represents approximately 20% of the total Battery charge. When the 

Battery is being charged, the charge indicator bars will waterfall. If the Battery is not installed, or if it is 

improperiy installed, the Battery Status Gauge will not be illuminated and Time on Battery is not 

displayed. 

External Power is Present Indicator: 

When the SAROS is properly plugged in and is using the AC or 24 VDC Cable, this indicator will 

illuminate on the User Control Panel in Normal Mode. 

Examples of LCD display at Power Up 

Example of LCD Display indicates the following information: 

Continuous Flow at 3 LPM, Tactical Mode, Battery between 81% 

and 100% of capacity, 29 minutes of battery operating time remains. 

Battery symbol is animated with a waterfall effect when charging. 

29 of 89 
Example of LCD display during Continuous Mode 

Example of LCD Display indicates the following information: 

Continuous Flow at 2 LPM, Normal Mode, Battery between 61% and 

80% of capacity, 24 minutes of battery operating time remains. 

Battery symbol is animated with a waterfall effect when charging. 

Example of LCD display during Pulse Mode 

Example of LCD Display indicates the following information: 

Pulse mode at bolus size of 48 mL, Tactical Mode, Battery between 

61% and 80% of capacity, 1.1 hours of battery operating time 

remains. Battery symbol is animated with a waterfall effect when 

charging. 

30 of 89 
Recommended Operating Environments 

The following chart provides important information concerning the recommended operating environments, 

or operating conditions, for proper use of the device. 

Operating Temperature 

Operating Humidity 

Transport/Storage Temperature 

Electrical 

Altitude 

Placement 

Environment 

Operating Time 

0° C to 43° C 

10% - 95% at an 82.4° F (28° C) dew point 

-4° F to 140° F (-20° C to 60° C) 

Humidity; Up to 95% Non-Condensing 

Use no extension cords or electrical outlets controlled by a 

switch. 

0 - 18,000 feet (0 - 5,486 meters) 

DO NOT block the air inlet or the exhaust vent. Place device a 

minimum of 3 inches (7.5 cm) away from walls, draperies, 

furniture, etc.) 

Must be smoke, pollutant, and fume free. 

24-hours per day when connected to an external AC Power 

Adapter or 24 VDC Cable. 

NOTE: When moving the SAROS from an extreme temperature environment, please allow time for your 

device to acclimate to the recommended operating temperature environment. 

WARNING 

OPERATING THE SAROS OUTSIDE OF THE RECOMMENDED OPERATING TEMPERATURE 

ENVIRONMENT MAY NEGATIVELY IMPACT DEVICE PERFORMANCE, MAY CAUSE DAMAGE TO 

THE DEVICE AND WILL VOID THE WARRANTY IF THIS OCCURS. 

OPERATING THE SAROS UNDER HIGH AMBIENT TEMPERATURE CONDITIONS MAY RESULT IN 

HIGH PRODUCT GAS TEMPERATURE. 

31 of 89 
THE PROPER LOCATION 

Select a location for the device that avoids the intake of smoke, fumes and pollutants. Correct placement 

of the device should allow intake of air through the air inlet filter at the top and allow exhaust air to freely 

leave the exhaust vent at the bottom of the device. 

Locate the device such that the alarms can be heard and Position the oxygen supply tubing in such a way 

that it does not kink or occlude. Keep the SAROS at least five (5) feet (1.5 m) away from hot, sparking 

objects or open flames. 

DO NOT locate the device near flammable materials or cleaning agents or in the direct path of any heat 

source, such as a stove, range, heat register or car heater. 

Operating Instructions 

BEFORE OPERATING 

This Technical Manual serves as your reference to help you operate and maintain the device. If you have 

any questions or concerns please qualified representative, or SeQual Technologies Inc. 

WARNING 

PROTECT THE SAROS AND THE AC POWER ADAPTER AND 24 VDC CABLE FROM ALL FLUID 

SPILLS OR FLUID DRIPS TO AVOID POSSIBLE SHOCK HAZARDS. 

CAUTION 

ALWAYS CHECK THAT THE AIR INLET AND THE EXHAUST VENT OF THE DEVICE ARE NOT 

BLOCKED AND THAT THE AIR INLET FILTER IS CLEAN BEFORE USING YOUR DEVICE. 

32 of 89 
POWERING ON YOUR SAROS 

The SAROS comes complete with the concentrator, AC Power Adapter, 24 VDC Cable, Battery and extra 

filters. The SAROS is a lightweight portable and stationary source of supplemental oxygen. The device is 

capable of being operated directly from three different power sources: 

CONCENTRATOR 1 Standard Power Sources 

jy^ ^ 

r f ^ 

^S?*^H^^^ 

AC Power Adapter 

24 VDC Cable 

Battery 

GENERAL CHARGING INFORMATION: 

The SAROS charges the Battery when external power (AC or DC) is present and when the Battery 

temperature is below a safe charging temperature. When external power is disconnected, the device will 

automatically switch over to the Battery, if installed and charged. When external power is restored, by 

plugging into an AC or DC outlet, the device will accept power from the external power source and 

recharge the Battery while operating the device if adequate AC or DC power is available. 

WARNING 

J2aji2 I TOUCH THE POWER CONNECTOR ON THE BOTTOM OF THE UNIT WITH THE BATTERY 

REMOVED AND WHEN THE DEVICE IS CONNECTED TO AN EXTERNAL AC OR DC POWER 

SOURCE. 

(1) AC POWER ADAPTER: The SAROS includes a universal AC Power Adapter for use wherever 

standard AC power is available. To connect to an AC power source, be sure the AC Power Adapter 

device cord is securely inserted into the recessed power receptacle on the top of the device and that the 

AC power cord from the AC Power Adapter is plugged into a grounded AC outlet. When the device is 

plugged in properiy, the External Power is Present Indicator will appear on the user control panel in 

Normal Mode. 

33 of 89 
CAUTION 

THE AC POWER CORDS USED WITH THE SAROS MUST MEET THE ELECTRICAL 

REQUIREMENTS OF THE COUNTRY WHERE THE DEVICE IS USED. 

USE ONLY WITH A GROUNDED, 3-PIN RECEPTACLE. DO NOT REMOVE THE GROUNDING PIN 

FROM THE POWER CORD. USE ONLY WITH SEQUAL SUPPLIED POWER CORDS. 

(2) DC POWER SUPPLY: A 24 VDC Cable allows the system to operate from DC outlets, such as those 

found in vehicles. Start the vehicle. Insert the 24 VDC cable into the power receptacle on the top of the 

device. Next, insert the 24 VDC Cable plug into the DC power outlet in your vehicle. When the device is 

properiy connected and receiving power from the DC power source, a green indicator light on the 

External Power is Present Indicator, on the control panel will illuminate in Normal Mode. 

WARNING 

SECURE THE SAROS AND THE DC POWER SUPPLY IN YOUR VEHICLE AND BE SURE THERE IS 

ADEQUATE AIR FLOW TO THE DEVICE AND THAT THE AIR INLET AND EXHAUST VENTS ARE 

NOT BLOCKED. BLOCKING OF THE AIR INLET OR EXHAUST VENT MAY IMPAIR DEVICE 

PERFORMANCE. 

DO NOT LEAVE THE SAROS OR 24 VDC CABLE PLUGGED INTO THE VEHICLE WITHOUT THE 

ENGINE RUNNING OR ATTEMPT TO START THE VEHICLE WHILE THE DC POWER SUPPLY IS 

CONNECTED TO THE VEHICLE. DOING SO WILL DRAIN THE VEHICLE'S BATTERY. 

IF THE VEHICLE'S DC POWER SOURCE DROPS BELOW 11.5 VOLTS (BROWNOUT CONDITION) 

THE SAROS WILL REVERT TO BATTERY OPERATION IF THE BATTERY IS PRESENT. 

TYPICAL NEW BATTERY OPERATING TIME 

Battery Operating Time: The operating time of the Battery is displayed on the user control panel. A 

variety of factors, such as flow setting, Pulse or Continuous Flow Mode, temperature or age will impact 

the operating time. The following table provides operating time estimates for the SAROS operating on a 

fully charged Battery given certain flow settings and nominal operating conditions. 

CONTINUOUS 

FLOW SETTING 

(LPM) 

1.0 

2.0 

3.0 

CONTINUOUS FLOW H PULSE FLOW 

BATTERY OPERATING • BATTERY OPERATING 

TIME m TIME 

1.1 hours H 1.2 hours 

45 min H 1.1 hours 

30 min H 53 min 

H 47 min 

H 46 min 

H 37 min 

PULSE FLOW MODE 

SETTING (ML) 

16 

32 

48 

64 

80 

96 

NOTE: Battery run time will degrade under high temperature use and as the battery cells age. 

34 of 89 
CAUTION 

STORE THE BATTERY IN A COOL AND DRY LOCATION. THIS WILL HELP TO ASSURE THE 

LONGEVITY OF YOUR BATTERY. 

U.S. DEPARTMENT OF TRANSPORTATION (DOT) AND UNITED NATIONS (UN) REGULATIONS 

REQUIRE THE REMOVAL OF THE BATTERY FROM THE DEVICE FOR ALL INTERNATIONAL 

AIRLINE TRAVEL WHEN THE SAROS IS CHECKED AS LUGGAGE.WHEN SHIPPING THE SAROS, 

THE BATTERY MUST ALSO BE REMOVED FROM THE DEVICE AND PACKAGED PROPERLY. 

QQJiQI ATTEMPT TO OPEN THE BATTERY; THERE ARE NO SERVICEABLE PARTS INSIDE THE 

BATTERY. 

ONLY REPLACE THE SEQUAL BATTERY SUPPLIED WITH THE DEVICE WITH A SEQUAL 

BATTERY. 

RETURN THE BATTERY TO AN AUTHORIZED SERVICE CENTER OR SEQUAL TECHNOLOGIES 

FOR PROPER DISPOSAL. 

DO NOT DISASSEMBLE, INCINERATE, OR HEAT THE BATTERY ABOVE 140° F (60° C). THE 

BATTERY, USED IN THIS DEVICE, MAY PRESENT A RISK OF FIRE OR CHEMICAL BURN IF 

MISTREATED. 

TYPICAL BATTERY RECHARGE TIME 

The typical time to recharge your Battery, in order to achieve 80% capacity, from a fully discharged 

Battery is 2.4 hours. 

If the Battery becomes too warm during discharging, recharging will not begin until the Battery sufficiently 

cools. Removing the Battery and allowing it to cool may expedite this cooling process. 

INITIAL BATTERY CHARGING 

The new Battery supplied with the SAROS is not fully charged when it is shipped from the factory. 

Pushing the Test Button on the Battery will indicate the level of Charge within. Before using the SAROS 

for the first time, fully charge the Battery. 

Attach the Battery by aligning the connector on the battery to the mating part on the bottom of the 

SAROS. The Battery will click into place. 

Power the SAROS ON, with the AC Power Adapter plugged in, and the Battery correctly installed. With 

the device powered ON, allow the Battery to completely charge. The Battery is fully charged when the 

Battery Status Gauge Indicator on the Control Panel is completely illuminated or the device has been 

charging for a minimum of 5 hours. 

NOTE: The SAROS can be used when either discharging or recharging of the Battery is taking place. 

CAUTION 

DO NOT LEAVE THE SAROS, OR BATTERY, IN THE SEATING AREA OF A MOTOR VEHICLE OR IN 

THE TRUNK OF A MOTOR VEHICLE DURING A HOT DAY. 

NOTE: THE STORAGE TEMPERATURE RANGE FOR THE DEVICE IS -4°F (-20°C) TO +140^ 

(+60°C) AND 95% NON-CONDENSING HUMIDITY. 

35 of 89 
In the event of an external power interruption, the SAROS will automatically switch to the Battery 

operation. When external power is restored, the Battery will automatically start recharging. If the 

Battery is not present, or fully discharged, during an external power interruption, the SAROS will shut 

down. 

LOW BATTERY ALERTS 

The table below describes the LCD Display and Alarm for Low Battery Conditions. 

MINIMUM REMAINING TIME ON BATTERY 

Time Remaining (Min) 

Battery Icon 

Alarm 

< 6 Minutes 

Flash 

Flash 

ON 

12 Minutes <X< 15 

Minutes 

Flash 

Solid 

OFF 

> 15 Minutes 

Solid 

Solid 

OFF 

NOTE: Press and hold the Utility Button for and this will silence the Loss of Power alarm for 2 

minutes. Connecting the SAROS to an external AC power supply will also eliminate this alarm. 

When replacing the Battery without the device being externally powered, push the ON/OFF 

(Standby) to restart the SAROS. 

BATTERY INSTALLATION ONTO SAROS 

1. Press the Latching Pin Release Button inward on the bottom of the Battery prior to installing onto the 

SAROS. 

2. Insert the Battery onto the SAROS by aligning the Battery Connector of the Battery into the connector 

opening at the bottom of the unit. Battery is properiy engaged when the latch pin is snapped into 

place. 

Battery 

Connector of 

SAROS 

36 of 89 
OPERATING YOUR SAROS FOR THE FIRST TIME 

step 1: Locating your SAROS. 

Place the SAROS in a well-ventilated area. Be sure the air inlet and exhaust vent are not obstructed. 

Position the SAROS so all audible and visual indicators or alarms can be easily seen and heard. 

Connect the AC Power Adapter to External Power Receptacle located on top of the device and plug the 

device into a grounded AC Power outlet, connect to a DC Power source with the 24 VDC Cable, or be 

sure there is a fully charged Battery installed. 

Step 2: Power ON the Device and allow it to Warm Up 

Oxygen Monitoring - The SAROS has an oxygen concentration status indicator (OCSI) built-in to the 

device. The OCSI continually monitors the oxygen output of the device. 

Press and hold the "ON/OFF" Button to power ON your SAROS. The SAROS will start up in Tactical 

Mode and Continuous Flow of 3 LPM. Allow up to five (5) minutes for the device to reach its 

performance specifications. If the device fails to reach its performance specifications after 5 minutes, the 

unit will alarm according to the mode it is in. 

Step 3: CONNECT THE OXYGEN SUPPLY TUBING TO THE OXYGEN. 

Clean and Replace the cannula and oxygen supply tubing regulariy, as recommended by the 

Manufacturers' Instructions. 

Step 4: SELECT THE FLOW DELIVERY MODE 

Press the Flow Mode button to select the desired flow mode - Continuous or Pulse. Pressing this button 

repeatedly will toggle you back and forth between the flow modes. 

When operating in the Continuous Flow Mode, a continuous supply of oxygen measured in liters per 

minute (LPM) will flow from the Oxygen Outlet Port. 

WARNING 

DO NOT USE SUPPLY TUBING OR CANNULA EXTENSIONS THAT ARE MORE THAN 50' (15.2M) IN 

LENGTH IN THE CONTINUOUS FLOW MODE. 

PULSE FLOW MODE OPERATION: 

When operating in Pulse Flow Mode and there is no inspiratory effort detected by the device after 60 seconds 

total time, the device will switch to the Continuous Flow Mode and will produce at an equivalent minute 

volume. The alert will cease at this time. 

When operating in Pulse Flow Mode, a bolus of oxygen measured in mL will be delivered from the Oxygen 

Outlet Port, each time an inspiratory effort, or negative pressure, is detected. 

37 of 89 
PULSE FLOW MODE FEATURES: 

The SAROS Pulse Flow Mode delivers a high flow oxygen bolus at the beginning of each inspiration. 

Your SAROS Pulse Flow Mode has a feature, called autoSATTM Technology and a Pulse Flow Mode 

Sensitivity Setting to easily trigger the oxygen bolus delivery. 

These features are provided to ensure that patients can easily trigger a delivery of an oxygen bolus and 

that the oxygen bolus maintains consistency over higher breath rates. 

autoSATTM Technology provides a consistent bolus volume of oxygen as a patients' breath rate 

increases. 

Pulse Setting 

Bolus Size 

(+/-15%) 

16 

32 

48 

64 

80 

96 

Maximum Breath Per 

Minute (bpm) 

40 

40 

40 

40 

37 

31 

NOTE: Bolus volume decreases as breath rate exceeds published range. 

The Pulse Flow Sensitivity (P SENS) can be adjusted in the Utility Menu from 1 - 3. A setting of 1 is the 

most sensitive and a setting of 3 is the least. 

WARNING 

PULSE FLOW MODE SETTINGS MUST BE DETERMINED FOR EACH PATIENT INDIVIDUALLY. 

SETTINGS USED IN THE CONTINUOUS FLOW MODE MAY NOT APPLY, OR BE APPROPRIATE, IN 

THE PULSE FLOW MODE AND VICE VERSA. 

AS WITH ALL OXYGEN-CONSERVING TYPE DEVICES, THE SAROS MAY NOT BE ABLE TO 

DETECT ALL INSPIRATORY EFFORTS IN THE PULSE FLOW MODE. 

Step 5: ADJUST THE FLOW SETTING TO THE PRESCRIBED LEVEL 

Using the Flow Setting Buttons, adjust the flow setting to the prescribed setting. 

Step 6: SELECT USER DEFINABLE SETTINGS USING THE UTILITY MENU 

The Utility Menu has the features that can be adjusted by the user or information for the user or Service 

Technician. Below are the features of the Utility Button and the Utility Menu: 

• Pressing the Utility button will turn off the audio alarm for 119 seconds unless this is prevented by 

a malfunction. 

• The Utility Menu mode can be entered whenever the unit has power (Standby or ON) or 9V 

Battery. 

• Each time the Utility Button is pressed, the Utility menu will advance to the next option. 

• The options within the Utility Menu can be changed by using the Increase and Decrease buttons. 

• Pressing the Flow Mode button in the Utility Menu goes back to the previous Utility menu item. 

• The Utility Menu will revert back to the previous display mode after 5 seconds. 

• Pressing and holding the Utility button for at least 10 seconds will reset the SAROS. To restart, 

press and hold ON/OFF (Standby) button. 

• The first menu item to appear is Tactical Mode On / Off. 

38 of 89 
The following sequence of screens shall be displayed on the LCD when the Utility Menu is displayed. 

Tactical Mode On / Off selection: 

Format: TACT=ON Tactical mode is ON 

Format: TACT=OFF Normal mode is ON 

Alarm Codes: 

Format: AC^XXXX 

See Alarm Code Table definitions. When more than one alarm code is present, pressing the Increase 

key will show the next highest priority code and pressing the Decrease key will show the next lowest 

priority code. 

Pulse Sensitivity 

Format: P SENS = X (where X is the value of 1 thru 3) 

LCD Contrast 

Format: LCD CT = X (where X is the value from 1 thru 6) 

Tactical Volume 

Format: T VOL=X (where X is the value from 0 thru 6) 

Tactical Brightness: 

Format T BRT= X (where X is 0 thru 6) 

Selects the LED and LCD backlight Light intensity used in Tactical Mode. 

Normal Mode Brightness: 

Format N BRT = X (where X is 1 thru 6) 

Selects the LED and LCD backlight Light intensity used in Normal Mode. 

9V Battery Status: 

Format: 9V = GOOD Battery is good 

Format: 9V = RPLC Replace 9v battery 

Hours of Operation 

Format: HR= XXXXX 

System Software Part Number and Revision: 

Format: SPPPP Mm (where SPPPP = System Software Part Number, M = Major Version, and m 

minor Version) 

Motor Software Part Number and Revision: 

Format: MPPPP Mm (where MPPPP = Motor Software Part Number, M = Major Version, and m 

minor Version) 

Step 7: BEGIN USING YOUR SAROS 

NOTE: You will achieve longer operating time on the Battery if you operate in the Pulse Flow Mode. 

Step 8: POWER OFF THE DEVICE 

Press and hold the "ON/OFF" Standby Button for two (2) seconds to power OFF your SAROS. 

Store the SAROS in a cool and dry location. 

39 of 89 
Alerts, Alarms, and Troubleshooting Table 

The tables show the possible audible and visual alerts and alarms, their conditions and suggest 

appropriate troubleshooting responses. If you are unsure about any alerts or alarm conditions, or 

responses please contact an authorized service technician or go to www.sequal.com. 

Alarm levels 

Type 

High 

Alarm 

Med 

Alarm 

Low 

Alarm 

Status 

Level 

0 

1 

2 

3 

Green 

LED 

OFF 

OFF 

OFF 

ON 

Yellow 

LED 

OFF 

Blink 

Blink 

OFF 

Red LED 

ON 

OFF 

OFF 

OFF 

Audio Alarm 

ON 

(may shutdown 

electronics after 

10 seconds) 

2 beeps every 

119 sec 

1 beep every 

119s 

OFF 

LCD 

Flashing star 

replaces T or 

N 

Flashing star 

replaces T or 

N 

Flashing star 

replaces T or 

N 

NC 

Description 

Malfunction 

Attention is 

required 

Attention is 

required 

All OK 

NC= No Change 

WARNING 

AVAILABILITY OF A BACK-UP SOURCE OF OXYGEN IS RECOMMENDED IN CASE OF POWER 

OUTAGE OR A DEVICE FAILURE. CONSULT YOUR PROVIDER FOR BACK-UP OXYGEN SYSTEM. 

DO NOT Ignore Alarms. System will attempt to produce oxygen under fault condition but may not be at 

purity or flow. 

40 of 89 
SYSTEM TROUBLESHOOTING GUIDE 

S YMPTOM 

SAROS does not power on 

when 

ON/OFF button is pressed 

No Oxygen 

Low Oxygen Concentration 

Low Oxygen Flow 

No Oxygen delivered in 

Pulse Flow Mode 

PROBABLE CAUSE 

No Battery installed 

Battery is discharged or no external 

power is present 

Other 

Air Inlet or HEPA Filter Blocked 

Humidifier 

SAROS not ON 

Tubing or cannula is not properiy 

connected or is kinked 

Other 

Restriction in tubing or humidifier 

Air Inlet or HEPA Filter restricted 

Inadequate Ventilation 

Other 

Restriction in humidifier or tubing 

Air Inlet or HEPA Filter Blocked 

Other 

Tubing/cannula longer than 

7 feet (2.1m) 

Humidifier attached 

No inspiration detected 

REMEDY 

Install Battery or plug into external 

power 

Plug into external power 

Contact an authorized Service 

Technician 

Clean Air Inlet Filter or replace 

HEPA Filter 

Check humidifier attachment 

and tubing 

Power SAROS ON 

Check tubing, cannula 

and connections 

Contact an authorized Service 

Technician 

Repair or replace tubing or 

humidifier. Place your SAROS so 

there is adequate air flow. 

Clean air inlet filter or replace HEPA 

Filter. Place your SAROS so there is 

adequate air flow. 

Place your SAROS so that there is 

adequate air flow, i.e. not covered 

by a blanket or a poncho. 

Contact an authorized Service 

Technician 

Repair or replace humidifier or 

tubing 

Clean Air Inlet Filter or replace 

HEPA Filter 

Contact an authorized Service 

Technician 

Attach 7 foot (2.1m) tubing/cannula 

Remove humidifier 

Contact an authorized Service 

Technician 

41 of 89 
S YMPTOM 

Battery Status Gauge never 

indicates fully charged 

Heat related failures, i.e. 

Compressor too hot 

Battery will not latch onto 

SAROS 

Oxygen production is limited 

due to power limitations 

PROBABLE CAUSE 

Battery is aging 

Ambient condition is too hot 

Battery Latching Pin Release is 

stuck in the wrong position 

External power source cannot 

supply enough power 

REMEDY 

Contact an authorized Service 

Technician 

to replace Battery 

Place unit in cool environment or out 

of direct sunlight, if possible. 

Press the Latching Pin Release 

Button inward to free the latch 

mechanism and re-install Battery 

Check air inlet filter and check the 

external power source 

42 of 89 
SAROS Optional Accessories 

Visit us at www.sequal.com for more information about optional accessories. There are many different 

types of oxygen tubing, cannula, and humidifiers. The following items are recommended by SeQual 

Technologies for use with your SAROS. 

Salter Labs® Humidifier, Part Number 7600, or equivalent: If an optional humidifier is prescribed, follow 

the manufacturer's instructions for use. Attach the humidifier to the oxygen outlet port of the SAROS. Use 

of optional humidifiers not recommended for the SAROS may impair performance of the device and may 

void the warranty. 

DO NOT use a humidifier in the Pulse Flow Mode. The SAROS will not detect inspiratory effort. The 

device will alarm and default to the Continuous Flow Mode for continuing operation. 

SeQual Technologies Humidifier Adapter - Part Number 3509: If prescribed an optional humidifier is 

prescribed, use the SeQual Humidifier Adapter. Follow the instructions for use. Attach the Humidifier 

Adapter to the oxygen outlet port of the SAROS and then to the humidifier. Attach the cannula, or oxygen 

tubing to the humidifier outlet. 

Salter Labs Oxygen Supply Tubing, Part Number Series 2000, or equivalent: The internal diameter 

should be no less than 3/16" (0.48 cm). Connect the oxygen tubing to the outlet port of the humidifier or 

directly to the oxygen outlet port of the SAROS if you do not use a humidifier. Connect the other end of 

the tube to the nasal cannula, if oxygen supply tubing is not already attached to the cannula. Tubing not 

specified for use with this SAROS may impair the performance of the device. 

WARNING 

THE TUBE FITTING MAY BE TIGHT - DO NOT USE OILS OR GREASE TO LUBRICATE TUBING OR 

OXYGEN OUTLET PORT. 

IF TUBING BECOMES DISCONNECTED DURING OPERATION, THE SAROS DOES NOT ALARM. 

CHECK FLOW AT THE CANNULA TO VERIFY OXYGEN DELIVERY. 

Salter Labs Oxygen Cannula, Part Number 1600 Series, or equivalent: A cannula is typically used to 

deliver oxygen to the patient. In most cases they are already attached to the oxygen tubing. If not, follow 

the instructions included with the cannula to attach it to the oxygen tubing. Use of an oxygen cannula not 

specified for use with this SAROS may impair the performance of the device. 

WARNING 

USE OF AN OXYGEN MASK IS CONTRAINDICATED DUE TO THE POSSIBILITY OF REBREATHING 

EXHALED CARBON DIOXIDE. 

43 of 89 
Cleaning, Care and Routine Maintenance 

ROUTINE MAINTENANCE 

Servicing of the internal components of this device must be conducted by a trained and qualified service 

technician. 

A qualified technician will perform inspections and maintenance of the compressor, alarms, internal 9 volt 

battery, Battery and other parts only as needed. 

WARNING 

DO NOT DISASSEMBLE THE SAROS OR ATTEMPT TO PERFORM ANY MAINTENANCE TASKS 

OTHER THAN THOSE DESCRIBED IN THE USER CARE AND CLEANING OF THE DEVICE SECTION 

BELOW. DISASSEMBLING THE SAROS MAY CREATE AN ELECTRICAL SHOCK HAZARD AND 

WILL VOID YOUR WARRANTY. CONTACT A QUALIFIED TECHNICIAN FOR ANY INSPECTION, 

MAINTENANCE, OR REPAIR REQUIRED. 

USER CARE AND CLEANING OF THE DEVICE 

Cannula Replacement: Clean and Replace your supply tubing and cannula on a regular basis as 

recommended by the manufacturer's instructions. 

Air Inlet Filter: Ambient air is drawn into the device through the air inlet located on the top of the device. 

Cleaning the air inlet filter is the most important maintenance activity to keep your SAROS performing 

properiy. Check this air inlet filter daily and clean it at least once a week using the following procedure: 

1. Remove the four screws on the Cover on the top of the device and remove the air inlet filter. 

2. Wash the filter in warm tap water; 

3. Allow the filter to air dry; 

4. Reinsert the filter in the location it was removed; 

5. Cleanino tip - keep a clean second filter as a replacement for use when one filter is drying. 

CAUTION 

THE AIR INLET FILTER SHOULD BE FREE OF LIQUID WATER AND DRY TO THE TOUCH BEFORE 

REINSTALLATION. EXCESS MOISTURE IN THE FILTER MAY IMPAIR THE PROPER OPERATION OF 

THE SAROS. 

The air inlet filter should be replaced as needed. If the SAROS is used in a dusty environment, the filter 

may need to be replaced more often. 

AC Power Adapter, 24 VDC Cable and Power Cord: Turn OFF the SAROS and disconnect from AC or 

DC power before any cleaning or disinfection activity. Use a damp (not soaking wet) cloth or sponge. 

Spray the cloth or sponge with a mild detergent solution to clean the exterior and power supplies. To 

disinfect the SAROS use Lysol® Brand II disinfectant. Proceed as directed by the manufacturer. 

44 of 89 
WARNING 

UNPLUG POWER CORDS, AC OR DC POWER SUPPLIES BEFORE CLEANING THE EXTERIOR. 

DO NOT USE DENATURED ALCOHOL OR APPLY LIQUID SPRAY OR AEROSOL CLEANERS TO 

THE CORDS OR POWER SUPPLIES. 

Optional Humidifier: If used, clean the humidifier daily to reduce the possibility of contamination. Follow 

the cleaning recommendations by the manufacturer of the humidifier. Replace the humidifier monthly, or 

as recommended by the manufacturer. 

Battery Cleaning, Care and Maintenance 

The Battery in the SAROS requires special care to assure a longer life and the highest level of 

performance. The SeQual Battery is the only approved Battery recommended for use with the SAROS. 

Use a damp (not soaking wet) cloth or sponge. First spray the cloth or sponge with a mild detergent and 

then clean the Battery case and the latch. 

Battery Disposal: Your Battery is rechargeable and can be recycled. Always return it to an authorized 

service center or SeQual Technologies for proper disposal. You can also contact your local city or town 

offices for instructions on proper disposal of the Battery. 

Battery Storage: Your Battery should be stored in a cool and dry location. 

45 of 89 
INTRODUCTION - SERVICE AND REPAIR 

Maintaining the SAROS will insure longer life and higher performance. Periodic maintenance is 

recommended. 

CAUTION 

A 

The SAROS contains electrostatic sensitive components. Do 

Not open or handle except at a static free workstation. Do not 

remove cover without ESD protection. 

PERIODIC MAINTENANCE LIST 

Perform the following maintenance procedures, as needed. The frequency of the periodic maintenance 

should be based on the environment in which the SAROS is used within. 

Check and clean the air inlet screen. Replace as needed 

Check Battery visually and functionally when received. Replace as needed. 

Inspect AC Power Adapter, 24 VDC Cable and cords for damage. Replace as needed. 

Verify that the AC Power Adapter and 24 VDC Cable operates with the SAROS. 

Check 9V battery. Replace if needed. 

Check HEPA Filter. Replace if needed. 

Read and record hour meter. 

Check flow rate, purity. Pulse Mode and alarm functions. 

46 of 89 
MAINTENANCE PROCEDURES 

The following section lists procedures that are necessary to maintain the SAROS. Service should only be 

performed by a qualified technician. To perform periodic maintenance, the only tools that should be 

necessary are: 

#1 or #2 Phillips Screwdriver 

Wire-cutting Pliers 

Small cable ties 

3/8" open end wrench 

ESD Mat or approved ESD system 

REMOVING THE AIR INLET COVER 

1. Disconnect power supplies and remove the battery if connected. 

2. Using a Phillips screwdriver, loosen the four captive screws shown in figure 1. 

3. Remove cover. 

Figure 1 

47 of 89 
REMOVING AND CLEANING/REPLACING THE AIR INLET FILTER 

1. Gently remove the filter shown in figures 2 and 3. 

2. If the filter is damaged, replace. 

3. For cleaning, gently wash with warm soapy water. Allow filter to completely dry before reinstalling. 

4. Re-install Air Inlet Filter. 

5. Using a Phillips screwdriver, re-attach the Cover. 

6. Initial and date the Service and Maintenance Record. 

CAUTION 

A 

Operating the SAROS with a clogged air inlet filter may reduce 

performance and lead to system damage or premature failure. 

Figure 2 

Figure 3 

48 of 89 
REPLACING THE 9V BATTERY 

1. Disconnect power supplies and remove external battery if connected. 

2. Using a Phillips screwdriver, loosen the four captive screws shown in figure #1. 

3. Remove cover. 

4. Remove 9V battery from where shown in figure 4. 

5. Disconnect and replace battery as shown in figure 5. 

6. Using a Phillips screwdriver, replace the Air Inlet Cover. 

7. Initial and date the Service and Maintenance Record. 

Figure 5 

49 of 89 
REPLACING THE HEPA FILTER 

1. Disconnect all power supplies including external Battery if connected. 

2. Using a 3/8" open end wrench, remove the O2 Fitting/HEPA Filter shown in figures 6 & 7. 

3. Unscrew the HEPA Filter from the O2 Fitting as shown in figure 8. 

4. Replace with new HEPA Filter. Do not over tighten. NOTE: Insure that the 0-Rings shown in figure 

9 are positioned correctly before re-installation. 

5. Re-install the 02 Fitting/HEPA Filter. Do not over tighten. 

6. Initial and date the Service and Maintenance Record. 

Figure 6 Figure 7 

Figure 8 

50 of 89 
TEST PROCEDURES 

SAROS PURITY AND FLOW RATE TEST PROCEDURE - PREFERRED METHOD 

It is recommended that the SAROS be tested for oxygen concentration and flow performance. SeQual 

recommended test setup is shown on the following diagram. Oxygen monitors may or may not have an 

internal pump to draw samples of oxygen to be measured. Placement of the oxygen monitor in the test 

setup depends whether they have an internal pump. Only one oxygen monitor is needed though. An 

oxygen monitor such as Salter Labs' PRO2 Check Elite or equivalent may be used. 

• Connect the circuit per the diagram shown below. 

• Turn the concentrator on and set the target flow on the SAROS to 3 LPM continuous flow. 

• Allow the SAROS to stabilize, (a minimum of 5 minutes) 

• Verify the O2 concentration and O2 flow rates are within specification. 

SAROS 

Unit 

Flow Meter 

O2 Monitor with Pump 

(Alternate location) 

O2 Monitor with Pump 

(preferred location) 

• Vent to 

Atmosphere 

Figure 9: SeQual Recommended Test Setup to verify performance of Oxygen Concentrator 

The SAROS oxygen concentration and flow sensor cannot be 

calibrated in the field. If you suspect that the SAROS flow and 

oxygen purity measurement is out of calibration, please return it to 

SeQual for service. 

PURITY AND FLOW RATE PROCEDURE - ALTERNATE METHOD 

Attach a calibrated oxygen monitor to the oxygen outlet port in accordance with oxygen monitor 

manufacturer's recommendations. 

NOTE: 

Some sensing equipment may restrict the actual flow rate below what 

the SAROS can provide and provide inaccurate concentration 

readings. If testing is performed with the oxygen monitor in the 

alternate location pictured above, ensure that the oxygen monitor does 

not significantly restrict oxygen flow. 

51 of 89 
RECORD HOURS OF OPERATION AND SOFTWARE VERSION 

To help maintain the SAROS, you may obtain the Total Hours of Operation and software version numbers 

for the Control Board. 

To obtain system information, follow 

these steps: 

Press the "Utility" Button on the 

control panel and advance to the 

following display mode for each time 

the icon is depressed: 

Tactical Mode 

Alarm Code 

Pulse Sensitivity 

LCD Contrast 

Tactical Volume 

Tactical Brightness 

Normal Brightness 

9-volt Battery Status 

Hour of Operation 

System Software Version 

Motor Software Version 

Figure 9: Data Output Form 

Alarm Code 

Pulse 

Sensitivity 

LCD Contrast 

Tactical Volume 

Tactical 

Brightness 

Normal 

Brightness 

9-Volt Battery 

Status 

Hour Meter 

System 

Software 

Version 

Motor Software 

Version 

--/ '• -

'1- ^ ~~ 

-

• 

Log the Results 

52 of 89 
ELECTRICAL SAFETY TEST 

To test the basic electrical safety of the SAROS AC Power Adapter, SeQual recommends using an LKG601 Electrical Safety Analyzer (NeTech Corporation, Hicksville, NY) or equivalent to verify that the current 

leakage to ground is within appropriate limits. This is required for the SAROS Oxygen System that 

utilizes the Hospital Grade Power Cord. 

1. 

2. 

3. 

4. 

5. 

Plug the AC Power Adapter into the electrical safety analyzer. Disconnect the AC Power Adapter 

from the SAROS unit. 

Plug the safety analyzer into a wall outlet. 

Follow the analyzer manufacturer's instructions for measuring both the forward and reverse earth 

leakage current only. Verify that the fonft^ard and reverse-current leakage to ground is </= 250ua 

(100/115VAC applications) and </= 500 us (200/240VAC applications). 

Disconnect the AC Power Adapter from the electrical safety analyzer. 

If the AC Power Adapter measures leakage current greater than the criteria in step 3, please 

return it to SeQual for service. 

CLEANING THE SAROS 

Use mild detergent solution to clean the sleeve, control panel and power supplies. Turn OFF the SAROS 

and disconnect from AC or DC power before any cleaning or disinfection activity. DO NOT spray the 

sleeve, control panel or power supplies. Use a damp (not soaking wet) cloth or sponge. Spray the cloth 

or sponge with mild detergent solution to clean the sleeve, control panel or power supplies. To disinfect 

the SAROS, use Lysol Brand II disinfectant. Proceed as directed by the manufacturer. 

WARNING: 

Unplug Power Cords, AC or DC Power Supplies before 

cleaning the exterior cabinet. DO NOT use denatured alcohol 

or apply liquid spray or aerosol cleaners. 

53 of 89 
SERVICE AND MAINTENANCE RECORD 

Whenever maintenance or service is performed on an SAROS unit, an entry should be made in the 

service log for that concentrator or recorded in accordance with your company's standard procedure. 

Whenever the sleeve of the SAROS is removed, the flow rate, purity, and alarm status should be verified 

per the Test Procedures in this manual. 

SAROS Serial Number 

Date 

Hour meter 

Reading Initials Service Performed Purity Flow Alarms Comments 

Sample SAROS Maintenance Record 

54 of 89 
SHIPPING AND TRANSPORTING THE SAROS 

When shipping the SAROS use original packaging if possible. Always remove the Battery from the 

SAROS before shipping. 

If original packaging material is available, repack the SAROS, Battery and power supplies in the 

designated packaging area. 

If original packaging material or other SeQual authorized shipping container is not available, contact 

SeQual for replacement shipping container. 

WARNING: 

A 

DO NOT expose the SAROS to water. The SAROS enclosure 

does not provide protection against the harmful effects of liquid 

ingress. Electrical shock or damage to the unit may result. 

STORING THE SAROS 

Heat and humidity may degrade the performance or severely damage the SAROS. Store the device in a 

cool, dry protected area away from high temperatures, moisture and humidity. Remove the Battery when 

storing the device. 

DISCARDING 

BATTERY: Contact the local city, town or country offices for instructions on proper disposal of the 

Battery. Alternately, SeQual may be contacted for the Battery disposal. 

SAROS: Local environmental laws may prohibit disposal of electrical and/or electronic equipment such 

as the SAROS and AC Power Adapter. Contact the local city, town or country offices for instructions on 

proper disposal of electrical or electronic equipment. Alternately, SeQual may be contacted for disposal 

information. 

55 of 89 
Alarm Indications and Codes 

This table is arranged accordingly to alarm priority. 

Description 

External 

voltage too 

high 

Loss of Power 

Missing Power 

Product Too 

Hot 

Compressor 

Too Hot 

Power Board 

Too Hot 

Motor Driver 

Board Too Hot 

IPC Failure 

%02 < 70% 

Ultrasonic 

Failure 

Compressor 

Stall 

Compressor 

Temperature 

Sensor Failure 

ATF 

Temperature 

Sensor Failure 

Compressor 

and ATF 

Level 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Audio 

indicator 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

Ext. 

Power 

LED 

(Is/Is) 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Battery 

Icon 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Alarm 

Code 

ACOO 

4000 

4010 

A410 

9100 

9200 

9300 

AOOO 

0400 

A300 

9194 

9110 

8900 

9110 

8900 

Description 

This alarm shall activate when the external 

voltage is greater than 30V. 02 Production 

and battery charging shall not begin and the 

electronics shall shut down after 10 seconds. 

This alarm shall activate during production 

when the system determines that valid power 

has been lost. 02 Production and battery 

charging shall stop, and the electronics shall 

shut down after 10 seconds. 

This alarm shall activate if the user attempts to 

start the unit while there is no usable power 

source connected. 02 Production and battery 

charging shall not begin and the electronics 

shall shut down after 10 seconds. 

This alarm shall activate when the product 

temperature exceeds 60°C. 02 production 

shall stop or cannot be started. 

02 production shall stop or cannot be started. 

02 production and battery charging shall stop 

or cannot be started. The electronics shall shut 

down after 10 seconds when on battery power. 

The display shall be blanked after 10 seconds 

when on external power. 

0 2 production and battery charging shall stop 

or cannot be started. 

02 production and battery charging shall stop 

or cannot be started. The electronics shall shut 

down after 10 seconds when on battery power. 

The display shall be blanked after 10 seconds 

when on external power. 

The alarm shall activate only when 

concentration has been less than 70% for 

more than 60 seconds. It shall clear 

immediately if the concentration goes above 

70%.The unit shall continue production. 

02 production shall stop or cannot be started. 

02 production shall stop or cannot be started. 

02 production shall continue. 

0 2 production shall continue. 

02 production shall stop or not be started 

depending on 

56 of 89 
Description 

Temperature 

Sensor Failure 

Product 

Pressure 

Sensor Failure 

Ambient 

Pressure 

Sensor Failure 

Product 

Temperature 

Sensor Failure 

Ambient 

Temperature 

Sensor Failure 

Product and 

Ambient 

Temperature 

Sensor Failure 

Unable to 

Achieve or 

Maintain 

Product Tank 

Pressure 

Purity 

Calibration 

Data Failure 

Flow 

Calibration 

Data Failure 

Watchdog 

Timeout 

Invalid Reset 

I/O Port Failure 

RAM Failure 

Level 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Audio 

indicator 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

ON 

Ext. 

Power 

LED 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Battery 

icon 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Alarm 

Code 

A100 

ABOO 

A410 

AB10 

A410 

AB10 

A500 

A600 

A700 

9000 

8000 

8100 

8200 

Description 

Compressor Temperature Sensor and ATF 

Temperature Sensor condition. 

0 2 production shall stop. 

02 production shall continue. 

0 2 production shall continue. 

0 2 production shall continue. 

02 production shall stop or not be started 

depending on Product Temperature Sensor 

and Ambient Temperature Sensor condition. 

0 2 production shall stop. 

The unit shall produce using default data. 

The unit shall produce using default data. 

02 production and battery charging shall stop 

or cannot be started. The electronics shall shut 

down within 15 seconds when on battery 

power. The display shall be blanked within 15 

seconds when on external power. 

02 production and battery charging shall not 

start. The electronics shall shut down within 15 

seconds when on battery power. The display 

shall be blanked within 15 seconds when on 

external power. 

0 2 production and battery charging shall not 

start. The electronics shall shut down within 15 

seconds when on battery power. The display 

shall be blanked within 15 seconds when on 

external power. 

0 2 Production and battery charging shall stop. 

The electronics shall shut down within 15 

seconds when on battery power. The display 

shall be blanked within 15 seconds when on 

external power. 

57 of 89 
Description 

Program 

Memory Failure 

Battery Too 

Hot 

SSI Requested 

Alarm High 

Flow Limited by 

Available 

Power 

Pulse Mode 

Disabled 

Battery 

Communication 

Error 

Warm Battery 

Battery Too 

Cold to Use 

Battery Too 

Cold to Charge 

Flow Rate 

Error 

Cannot Charge 

Battery 

Low Battery 

Low 9 volt 

battery 

70%< 0 2 

<85% 

Key Stuck On 

Level 

0 

0 

0 

Audio 

indicator 

ON 

ON 

ON 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

Ext. 

Power 

LED 

NC 

NC 

NC 

NC 

NC 

(Is/Is) 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Battery 

Icon 

NC 

(Is/Is) 

NC 

NC 

NC 

(1s/1s) 

(Is/Is) 

(Is/Is) 

(Is/Is) 

NC 

(1s/1s) 

(Is/Is) 

NC 

NC 

NC 

Alar m 

Cod e 

8310 

9510 

FOOO 

2010 

A200 

9500 

9530 

95C0 

95CC 

2000 

952C 

9540 

1000 

0800 

8110 

Descriptio n 

0 2 Production and battery charging shall stop. 

The electronics shall shut down within 15 

seconds on when on battery power. The 

display shall be blanked within 15 seconds 

when on external power. 

Battery shall not be charged or discharged. 

This is an alarm test and shall not affect 

operation. 

This alarm shall activate when flow is limited 

by the available power. 

This alarm shall activate when a breath sensor 

malfunction is detected. The system shall not 

enter pulse mode. 

Battery shall not be charged or discharged. 

The battery shall not be charged. 

The battery shall not be charged or 

discharged. 

The battery shall not be charged. 

The alarm shall activate when the difference 

between the desired flow rate and the 

measured flow rate exceeds 10% for a 

minimum duration of 60 seconds. 

This alarm shall activate if system is attempting 

to charge the battery, but can't do so. 

The alarm shall activate when the time 

remaining on battery is s 6 minutes. The alarm 

shall cease when the time remaining is > 12 

minutes. 

The alarm shall activate when the measured 

voltage is less than 6.5V, and shall remain 

active until battery voltage improves 

significantly (non-volatile). 

The alarm shall activate only when 

concentration has been less than 85% for 

more than 60 seconds. It shall clear 

mmediately if the concentration goes above 

85%. 

This alarm shall activate when a key is active 

for greater than 7 seconds. 

58 of 89 
Description 

Run Log 

Storage Failure 

Breath 

Pressure 

Sensor Failure 

Power Board 

Thermistor 

Failure 

Motor Driver 

Board 

Thermistor 

Failure 

Battery 

Thermistor 

failure 

Battery Chip 

Thermistor 

failure 

EEPROM Data 

Write Failure 

Event Log 

Storage Failure 

SSI Requested 

Alarm Medium 

All OK 

Initialization 

Level 

3 

3 

Audio 

indicator 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

2 beeps of 

0.5s every 

119s 

OFF 

OFF 

Ext. 

Power 

LED 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

NC 

Battery 

Icon 

NC 

NC 

NC 

NC 

(Is/Is) 

(Is/Is) 

NC 

NC 

NC 

NC 

NC 

Alarm 

Code 

8300 

A210 

9210 

9310 

9550 

6560 

8400 

8320 

F100 

None 

None 

Description 

Production shall continue. Battery charging if 

required shall continue. 

The alarm shall activate when a breath 

pressure sensor failure. 

Production shall continue. Battery charging if 

required shall continue. 

Production shall continue. Battery charging if 

required shall continue. 

The system shall not use the battery if the 

reported independent battery thermistor value 

is > 433K or < 222K. 

The system shall not use the battery if the 

reported battery chip thermistor value is > 

433K or < 250K. 

Production shall continue. Battery charging if 

required shall continue. 

Production shall continue. Battery charging if 

required shall continue. 

This is an alarm test and shall not affect 

operation. 

This indication shall exist when no alarms are 

detected. 

Purity alarms shall be inhibited during the 

initialization period. 

DO NOT Ignore Alarms, 

purity or flow. 

System will attempt to produce oxygen under fault condition but may not be at 

59 of 89 
SERVICE AND REPAIR PROCEDURES 

CAUTION 

A 

The SAROS contains electrostatic sensitive components. Do 

Not open or handle except at a static free workstation. Do not 

remove cover without ESD protection. 

WARNING 

A When performing Service and Repair procedures: 

• DO NOT touch exposed circuits during the maintenance. 

• DO NOT touch moving parts. 

60 of 89 
Svstem Schematics and Diagrams 

Mf M.t,i-im* J 

i 

f 

"-|-7l-V"- { Ok—f! ^— -ik^—r« 

ih. 

i -- •] 

•^iW; l# 

I 

J 3 | 

; (si) I— i 

TC: \ rj£iSUr: 

...Hlr 

'-!-] 

^—[^ ^ 

Figure 10: SAROS Oxygen System Block Diagram 

fo OM-V61 of 89 
Inlet Cap 

Assembly 

Compressor/Product Tank 

Assembly 

Battery Connector/Cable 

Assembly 

PCB Assembly ATF 

Assembly 

Figure 11: Main Components 

62 of 89 
ELECTRICAL CIRCUIT 

REMOVE AND REPLACE THE BATTERY CONNECTOR 

1. Remove the three screws shown below and remove the Battery Interface Plate. 

Figure 12: Removal of the three BIP Screws 

2. Detach the Battery Interface Assembly from the Rain Guard by removing the two screws shown 

below. 

Figure 13: Removal of Battery Interface Assembly Screws. 

63 of 89 
3. Remove Sleeve, Sleeve Gasket and Sleeve Alignment Ring to expose wiring. 

Figure 14 Figure 15 

4. Cut and remove the green ties shown below. Caution must be used to avoid damaging wiring. 

GREEN TIES= O 

Figure 16: Green Tie removal 

64 of 89 
5. Loosen the four screws shown below and remove the Air Inlet Cover and the Air Inlet Filter. 

Figure 17: Air Inlet Cover and Screen Removal 

6. Remove and disconnect the 9V Battery and the Filter.. 

Filter 

9V Battery 

Figure 18: 9V Removal. 

65 of 89 
7. Remove the three Inlet Cap Mounting screws shown below. 

Inlet Cap Mounting 

Screws 

Figure 19: Inlet Cap Screw Removal 

8. Cut green cable tie and disconnect the Oxygen Outlet Tube shown below. 

Figure 20: Oxygen Outlet Tube Disconnect. 

66 of 89 
9. Remove tape from Front Panel Flex Cable and all tape securing the Sleeve Alignment Ring to the 

Mounting Rails. Disconnect the Front Panel Flex cable. 

^jWi:-;5a.-,' -:• 

Securing Tape 

Figure 20a: Front Panel Flex Cable Disconnect. 

10. Disconnect the Thermistor Connector and 9V Battery Connector. 

Thermistor 

Connector 

9V Battery 

Connector 

Figure 20b: Thermistor Connector and 9V Battery Connector 

67 of 89 
11. Loosen the screws shown below and remove the wires for the Inlet Cap Power Connector. 

Disconnect the Tube shown and remove the Inlet Cap. 

Figure 21: Inlet Cap Power Figure 21a: Tube Disconnect 

12. Remove the two bulkhead wiring grommets shown in the two figures below. 

Bulkhead Grommets 

Figure 22 Figure 23 

68 of 89 
13. Loosen the screws shown below and disconnect the Battery Interface main power wires. 

Figure 24: Main Power Wires for Battery Interface. 

14. Disconnect where shown below. 

Figure 25: Secondary Connector for Battery Interface 

15. Remove Battery Interface cable. 

16. Route wires for new Battery Interface Cable. 

17. Connect Secondary Connector. 

18. Attach Main Power Wires for Battery Interface. 

19. Position wires and re-apply bulkhead wire grommets. 

20. Attach Inlet Cap Power Connector wires. 

21. Connect Oxygen Outlet Tube. 

22. Attach Inlet Cap using three screws. Use Loctite 222 and do not over tighten the screws. 

23. Attach and install 9V Battery and attach Front Panel Flex Cable. 

24. Install Inlet Filter Screen and Inlet Filter Cover. 

25. Apply Cable Ties to properiy re-secure the wiring removed in previous steps. 

26. Replace Sleeve using 2 Sleeve Gaskets and 2 Sleeve Alignment Rings. 

27. Attach Battery Interface to the Rain Guard. Use Loctite 222 and do not over tighten the screws. 

69 of 89 
28. Attach the rain Guard to the Sleeve and secure with the Battery Interface Plate. Use three 

screws with Loctite 222. Do not over tighten Screws. 

29. Perform product test. 

Power Connector Replacement 

1. Perform steps 1-3 and 5-11 from the previous section titled "Remove and Replace the Battery 

Connector". 

2. Remove the four screws shown below and remove the Power Connector. 

Power Connector 

Screws 

Figure 26: Power Connector Removal 

3. Install new Power Connector. Use Loctite 222 on the four mounting screws. Replace 0-Ring if 

necessary. 

4. Perform steps 20-29 from the previous section titled "Remove and Replace the Battery 

Connector". 

70 of 89 
User Panel Replacement 

1. Perform steps 1-3 and 5-11 from the previous section titled "Remove and Replace the Battery 

Connector". 

2. Peel off the User Panel as shown in the figure below. 

Figure 28: User Panel Removal 

71 of 89 
3. Clean the surface shown in the figure below before re-applying the new User Panel. 

Clean Surface 

Figure 29: Surface Prep for application of User Panel 

4. Remove the PSA protective cover from the new User Panel. Insert the Flex Cable as shown in 

the figure below. 

Figure 31: Insert Flex Cable 

72 of 89 
7. Position and apply the new User Panel as shown in the figures below. Press firmly on the entire 

surface of the new User Panel to insure that it is bonded correctly. 

Figure 32 Figure 33 

5. Reconnect the small tube. 

6. Perform steps 20-29 from the previous section titled "Remove and Replace the Battery 

Connector". 

73 of 89 
OXYGEN CIRCUIT 

Remove and Replace the ATF Assembly. 

NOTE: 

There arc no setviceabie parts inside the ATF Module. L"^o noi 

attempt to disassemble or modify the ATF Module. 

1. Perform steps 1-11 from the previous section titled "Remove and Replace the Battery Connector" 

2. Cut and remove the green ties shown below. Caution must be used to avoid damaging wiring. 

GREEN TIES 

Figure 34: Green Tie removal 

3. Remove the three mounting rail screws shown below. Set aside the rail. 

Figure 35: Rail Screw Removal 

74 of 89 
4. Cut and remove the two green ties shown below. Caution must be used to avoid damaging the tubing. 

Remove Ties 

Figure 36: Green Tie Removal 

5. Remove the clamps shown below. Disconnect the tube. 

Figure 37: Clamp Removal 

75 of 89 
6. Remove three screws from each of the mounting rails shown in the two figures below. Remove 

securing tape and rails. 

Figure 38 

Figure 39 

76 of 89 
7. Disconnect the ATF Motor Connector from the PCB where shown in the figure below. 

Figure 40: ATF Motor Power Disconnect. 

8. Disconnect the ATF Thermistor Connector from the PCB where shown in the figure below. 

77 of 89 
Figure 41: ATF Thermistor Disconnect 

9. Remove the ATF Bulkhead and set aside. 

ATF Bulkhead 

Figure 42 

10. Separate the ATF Module from the Compressor/Tank Module as shown in the figure below. Do 

not damage the hoses during separation. 

Figure 43: ATF Module Separation 

78 of 89 
11. Remove the caps from the ATF Ports on the replacement unit. Position the new ATF Unit as 

shown in figure 43 above and reattach the two hoses. Secure joints with clamps or cable ties. Do not 

use oil or grease if the tubing is difficult to install. 

Once the hoses are disconnected from the ATF Module the ATF 

Module is exposed to the atmosphere. Cap the ATF Module 

ports immediately in order to minimize exposure to debris and 

humidity which may result in ATF Module damage. 

DO NOT uses any petroleum based or other lubricants. A 

spontaneous and violent ignition may occur if oil, grease or other 

petroleum substances come into contact vx'ith oxygen under 

pressure. Keep these substances away from the oxygen system, 

tubing and connections and any other oxygen source. 

Remove caps on ATF ports ONLY before connecting the tubes. 

DO NOT leave the ports open unless ready to install the tubes. 

Also place the removed caps from the new ATF and place on the 

ports of the replaced ATF. 

12. Reattach ATF Bulkhead. 

13. Reattach the two side rails. Use Loctite 222 on the six screws. 

14. Reconnect the ATF Thermistor and ATF Motor Connectors to the PCB. 

15. Reattach tube from the Product Tank to the ATF. Secure with a green tie. 

16. Reattach top rail using three screws. Apply Loctite 222 to the screws. 

79 of 89 
17. Perform steps 20-29 from the previous section titled "Remove and Replace the Battery 

Connector". 

Remove and Replace the Compressor/Product Tank/Bulkheads Assembly. 

1. Perform steps 1-10 from the previous section titled "Remove and Replace the Battery Connector" 

2. Perform steps 2-9 from the previous section titled "Remove and Replace the ATF Assembly". 

3. Disconnect the Compressor Thermistor Connector shown in the figure below. 

Figure 44: ATF Thermistor Connector 

4. Disconnect the Compressor Hall Sensor Connector shown in the figure below. 

Figure 45: Compressor Hall Sensor Connector 

80 of 89 
5. Disconnect the Compressor Power cables as shown in the figure below. 

Figure 46: Compressor Power Wires 

6. Remove the Bulkhead Grommet shown in the figure below. 

Figure 47 

81 of 89 
7. Disconnect the Fan Connector shown in the figure below. 

Figure 48: Fan Connector 

8. Cut and remove the green tie shown in the figure below. Disconnect product tube. 

Figure 49 

82 of 89 
9. Remove the two screws shown below. Remove rail. 

Figure 50 

10. Remove the two screws shown below. Remove rail. 

Figure 51 

83 of 89 
11. Remove the Compressor/Product Tank/Bulkhead Assembly as shown below. Insure that no wires 

catch on edges while removing the assembly. 

Figure 52 

12. Cut and remove the two green ties shown in the figure below. Set aside removed components for 

reassembly. 

Figure 53 

NOTE: 

There are no serviceable parts inside the Compressor/Product 

Tank/Bulkhead Assembly. Do not attempt to disassemble or 

modify the Compressor/Product Tank/Bulkhead Assembly. 

84 of 89 
13. Attach components removed from step 12 to the new Compressor/Product Tank/Bulkhead Assembly. 

Secure with cable ties. 

14. Reattach rail removed in step 10. Use Loctite 222 on all screws. 

15. Reattach rail removed in step 9. Use Loctite 222 on all screws. 

16. Reattach product tube. Secure with a cable tie. 

17. Route all wires as shown in previous steps. 

18. Reconnect all connectors and wires to PCB. 

19. Perform steps 20-29 from the section titled "Remove and Replace the Battery Connector" 

85 of 89 
PREVENTATIVE MAINTENANCE AND REPLACEMENT PARTS 

Preventative Maintenance Parts 

Description 

Air Inlet Filter 

9V Battery 

0 2 Fitting 

HEPA Filter 

Large HEPA Filter 0-Ring 

Small HEPA Filter 0-Ring 

SeQual Part Number 

9798 

9257 

9764 

9765 

9250 

9251 

Replacement Parts List 

"#"''^^^^^^^^^^^^^MQa:*''4T'fTlV--''''^>"-""i-" ^ 

Loctite 222MS 

Kapton Tape 

Tubing 

Tubing 

Cable Tie 

Tubing 

PCB Wire Harness Assembly 

Down Pipe 

Filter, Exhaust 

Exhaust Tube 

Tube, Filter to Cap 

Tube, Silicone 

Compressor Module Assembly 

0-Ring 

0-Ring 

Barb 

Inlet Cover Assembly 

Foam 

Battery, 9V Lithium 

Tube 

Tube 

Fiberglass Sleeve 

Screw 

Guard, Rain 

Muffler Tube 

Muffler Assembly 

Sleeve , Alignment Ring 

Ambient ThermisterThermistor 

ATF Wire Harness 

ThermisterThermistor Assembly 

Pipe, ATF - Product Tank 

Battery Ribbon 

ii^S^uaSplNurriBer? ' '•-

1405 

2696 

SP3255 

4056 

6968 

6981 

9201 

9218 

9221 

9226 

9227 

SP9234 

SP9240 

9250 

9251 

9254 

SP9255 

9256 

9257 

SP9268 

SP9273 

9280 

9291 

9292 

SP9311 

SP9314 

9315 

9321 

9322 

9324 

9342 

SP9348 

86 of 89 
^^^^^^^^^^^^^^^^^^^^^^^^^^^H 

Double Sided Tape 

Tube, Muffler to Rain Guard 

Wire Sleeve 

PCBA ASSY 

EXTERNAL BATTERY ASSEMBLY 

DC Cable, 24VDC, Omni II 

ATF MODULE ASSEMBLY, OMNI II 

Membrane Panel 

Tube 

Grommeting 

CYLINDER SLEEVE, COMPOSITE 

Inlet Cap Assembly 

Inlet Cap Assembly 

Foam 

ELECTRONICS BRACKET 

Fitting, Barb 

Filter 

External Wire Harness 

Fan 

FAN ASSY 

Fan Bulkhead 

MUFFLER EXHAUST 

STRUT, TOP 

STRUT, LEFT 

STRUT, RIGHT 

RAIN GUARD 

COMPRESSOR BULKHEAD 

VIBRATION MOUNT BUSHING 

VIBRATION MOUNT RIGHT 

COMPRESSOR HOSE 

EXHAUST FITTING 

COMPRESSOR INLET FITTING 

BATTERY CAP 

Product Tube, ATF to Product 

Inlet Screen 

ATF MOUNT 

Silicone Rubber Tubing 1/8" ID, 1/4" OD, 1/16" Wall, White 

Alum Tubing 1/4" OD,.18" ID, .035" Thick, 6* L 

ATF BULKHEAD 

Isolation Grommet 

SLEEVE GASKET 

ATF BULKHEAD 

Push Pin 

Battery Interface RecpticalReceptacle Assembly 

Wire Harness, Backup Battery 

Product Tank Assemblyy 

Grommet 

Screw 

Hi^^H^it^urriMftli 

9370 

9390 

SP9638 

SP9710 

SP9723 

9727 

SP9729 

9731 

9732 

SP9739 

9752 

SP9756 

9757 

9758 

9761 

9764 

9765 

9766 

9767 

SP9770 

9772 

9776 

9778 

9779 

9780 

9786 

9787 

9788 

9789 

9790 

9791 

9793 

9794 

9797 

9798 

9799 

9907 

9908 

9922 

9927 

9928 

9929 

9936 

SP9939 

9941 

SP9945 

9959 

9203-2 

87 of 89 
Alum Tubing 3/8" OD,.1875" ID, Blue 

'^^^^^^^^msmmM&murrib m 

9908-1 

SHCSM3x 4 9910-1 

Socket Head Cap Screw M3x 8mm 9910-4 

100 Peg Flat Head Phillips Screw 300SS, 4-40, 3/16" L, 9912-1 

Pan Head Phillips Machine Screw 4-40 Thread, 1-1/4" 9913-10 

4-40 Screw 9913-3 

Pan Head Phillips Screw 6-32 Thread, 1/2" Length 9914-6 

0-Ring 9916-3 

0-Ring 9916-4 

8-32 Ph Head Screw 9926-2 

#2-56 X 1/4" LPH 

Screw 

9960-3 

9960-4 

88 of 89 
Manufactured by: 

SeQual Technologies Inc. 

11436 Sorrento Valley Road 

San Diego, CA 92121 USA 

Toil-Free: 1-800-826-4610 in the U.S., 

or 1-858-202-3100 

Toll-Free Fax: 877-786-9943 

Worldwide: www.sequal.com 

SeQual®, SAROSTM and autoSat TM are trademarks of SeQual Technologies Inc., San Diego, CA 92121 

Salter Labs® is a registered mark of Salter Labs, Arvin, CA 92303 

Lysol® is a registered trademark of Reckitt Benckiser, UK. 

P/N 9705 Rev: A DRAFT 

89 of 89 
EXHIBITS Co\^l t3 

510(k) Summary 

OCT 20 2009 

Submitter Information: 

Submitter: 

Contact: 

Phone: 

FAX: 

Date of Summary: 

Device Name: 

Proprietary Name: 

Common Name: 

Classification of Device: 

Product Code: 

SeQual Technologies, Inc. 

11436 Sorrento Valley Road 

San Diego, CA 92121 

Brian Jarrell, Director of Quality and Regulatory 

(858)202-3157 

(858)558-1915 

June 11,2009 

OMNI 2 Oxygen System 

Oxygen Concentrator 

Generator, Oxygen, Portable as per 21 CFR 868.5440 

CAW 

Predicate Device Equivalence: 

SeQual Technologies is claiming substantial equivalence to tlie following legally 

marketed predicate device: 

KOI 3931 - OMNI Oxygen System, Model 1000 (aka: Eclipse Oxygen System) 

Description of Device: 

The OMNI 2 Oxygen System is an oxygen concentrator that provides up to 3 LPM 

continuous flow or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter). The 

OMNI 2 Oxygen System is based on pressure swing adsorption (PSA) principles. The 

OMNI 2 Oxygen System operates from AC power, DC power, or rechargeable batteries. 

This device delivers supplemental oxygen for patients through the molecular sieve beds 

and is designed to conserve the use of oxygen while operating in pulse flow mode. 

During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve 

when the start if inhalation is detected. 

Page 5-2 
The OMNI 2 Oxygen System consists of pneumatic and electrical components, AC 

power supplies, DC cables and lithium ion batteries. The system has inlet filtration, air 

compressors, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet 

filtration, electronic flow control and audible / visual alarms. 

Intended Use: 

The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. 

The device is not intended for life support nor does it provide any patient monitoring 

capabilities. The OMNI 2 Oxygen System is prescription legend required. 

Technological Characteristics; 

The OMNI 2 Eclipse Oxygen System operates comparably to the listed predicate device. 

Tlie PSA technology employed to generate the oxygen is well established, and therefore, 

raise no new questions of safety and effectiveness. 

Performance Data: 

The OMNI 2 Oxygen System has a comprehensive test platform that covers system 

performance, environmental conditions, electromagnetic compatibility (EMC), and 

software validation. The test platform confirms compliance with ISO 8359 standard for 

Oxygen Concentrator devices. 

Outside agencies provide independent analysis related to compliance with EMC and lEC 

60601-1 (Medical Electrical Equipment—Part 1: General Requirements). 

The test platform ensures compliance to recognized consensus standards and therefore 

raises no new questions of safety and effectiveness. 

Conclusion; 

Based on intended use, technology characteristics, design and performance data the 

OMNI 2 Oxygen System is substantially equivalent to the currently marketed devices. 

Page 5-3 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Food and Drug Administration 

10903 New Hampshire Avenue 

Document Control Room W-O66-0609 

Silver Spring, MD 20993-0002 

Mr. Brian Jarrell 

Director of Quality and Regulatory Affairs 

Sequal Technologies, Incorporated 

11436 Sorrento Valley Road 

San Diego, California 92121-1306 

OCT 2 0 2009 

Re: K083163 

Trade/Device Name: OMNI 2 Oxygen System 

Regulation Number: 21 CFR 868.5440 

Regulation Name: Portable Oxygen Generator 

Regulatory Class: II 

Product Code: CAW 

Dated: June 11,2009 

Received: September 18, 2009 

Dear Mr. Jarrell: 

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined tlie device is substantially equivalent (for the 

indications for use stated in the enclosure) to legally marketed predicate devices marketed in 

interstate commerce prior to May 28, 1976, the enactment date of the Medical Device 

Amendments, or to devices that have been reclassified in accordance with the provisions of 

the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket 

approval application (PMA). You may, therefore, market the device, subject to the general 

controls provisions of the Act, The general controls provisions of the Act include 

requirements for armual registration, listing of devices, good manufacturing practice, 

labeling, and prohibitions against misbranding and adulteration. 

If your device is classified (see above) into either class II (Special Controls) or class 111 

(PMA), it may be subject to additional controls. Existing major regulations affecting your 

device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In 

addition, FDA may publish further amiouncements concerning your device in the Federal 

Register. 
Page 2- Mr. Jarrell 

Please be advised that FDA's issuance of a substantial equivalence determination does not 

mean that FDA has made a determination that your device complies with other requirements 

of the Act or any Federal statutes and regulations administered by other Federal agencies. 

You must comply with all the Act's requirements, including, but not limited to: registration 

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing 

practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 

and if applicable, the electronic product radiation control provisions (Sections 531 -542 of 

the Act); 21 CFR 1000-1050. 

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 

please go to 

http://www.fda.gov/AboutFDA/CentersOfficcs/CDRHyCDRHOFfices/ucmll5809.hcm for 

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, 

please note the regulation entitled, "Misbranding by reference to premarket notification" 

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the 

MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the 

CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 

You may obtain oUier general information on your responsibilities under the Act from the 

Division of Small Manufacturers, International and Consumer Assistance at its toll-free 

number (800) 638-2041 or (240) 276-3150 or at its Internet address 

http://www.fda.gov/cdrh/industry/support/index.html. 

Sincerely yours. 

•for 

Susan Runner, D.D.S,, M.A. 

Acting Division Director 

Division of Anesthesiology, General Hospital 

Infection Control and Dental Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

Enclosure 
SeQual Technologies Inc. 

11436 Sorrento Valley Road. San Diego CA 92121 USA 

Indications for Use Statement 

Ver/ 3 - 4/24/96 

Applicant: SeQual Technologies Inc. 

510(k) Number (if known): K © 'S'3 / ^ 3 

Device Name: OMNI 2 Oxygen System 

indications For Use: 

The OMNI 2 Oxygen System is intended for the administration of 

supplemental oxygen. The device is not intended for life support nor 

does it provide any patient monitoring capabilities. 

Prescription Use X 

(Part 21 CFR 801 Subpart D) 

AND/OR Over-The-Counter Use _ 

(21 CFR 807 Subpart C) 

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF 

NEEDED) 

Concurrence of CDRH, Office of Device Evaluation (ODE) 

(Per 21 CFR 801.109) 

(Optiona^omTat^^6|i^ 

r 

IntStOk/induse 

.pAM^ 

(Division Sign-Off) 

Division of Anesthesiology, General Hospital 

infection Contioi, Dental Devices 

510(k) Number:, ^o^^f^ J 

Page 4 - 2 

X. 
Exhibit C 

ISEQSJAL' 

The Smart Choice. 

SeQual Technologies inc. 

1 i4:irt Sorrontfi Vni'-y iv.i.;o 

San Dle;;o. C-\ -i^'i.'' 

Phoni; 85c).;-'02.:ili:i: 

'^•i^x 8;:,'H,h;-i8.nr:i 

vV-,VW.peQu;:i tX'-V 

July 22, 2010 

Office of Hazardous Materials Standards 

Pipeline and Hazardous Materials Safety Administration 

U.S. Department of Transportation 

1200 New Jersey Avenue, SE 

Washington, D.C. 20590 

Re: Classification of SeQual Technologies' Lithium ion Battery and SAROS'^'^ Oxygen Svstem 

To Whom It May Concern: 

I am writing to request written confirmation from the Pipeline and Hazardous Materials Safety 

Administration (PHMSA) that the lithium ion battery used in our new SAROS^^^ Oxygen System is 

not subject to the U.S. hazardous materials regulations (HMR) pursuant to Special Provision 188 and 

may be carried onboard passenger aircraft pursuant to 49 CFR § 175.10(a)(17). 

Background 

The SeQual SAROS Oxygen System is a device that separates oxygen from ambient air through a 

process called Pressure Swing Adsorpdon (PSA). The product was developed in cooperation with the 

US Army Medical Materiel Command to support the oxygen needs of the patients on the battlefield. 

The SAROS provides a solution to address both stationary and portable requirements for oxygen 

patients needing up to 3 LPM fiall flow operadon and up to 96 ml flow in a pulse mode operation. It 

consists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for 

condnuous flow or pulse delivery and is capable of being operated directly from an AC or DC power 

source or from rechargeable lithium ion batteries. It can be recharged and/or powered by a separate 

AC Power Adapter or where standard AC line power is available. A 24 Volt DC Cable or the 12 Volt 

DC cable accessories allow power to be provided by a DC auxiliary power ouflet, such as in a motor 

vehicle during transportation. Changeable and rechargeable battery packs are available to provide a 

range of ambulatory operational time. 

The SAROS Oxygen System achieves its performance through SeQual's patented Advanced 

Technology Fractionator (ATF®) technology and patented variable speed compressor and compressor 

drive, advanced molecular sieve materials and rechargeable batteries. This system will expand an 

oxygen patient's ability to travel via aircraft and improve the patient's quality of life. 
ISEQUAL' 

The Smart Choice. 

Class 2, Division 2.2 Gas - 49 CFR 173.115 

The maximum pressure of the oxygen exerted within the SAROS Oxygen System packaging currently 

is 23.7 psia during normal operation at 20° C. This is substandally less than the 40.6 psia at 20° C 

referenced in 49 CFR 173.115(b)(1) for defining a Division 2.2 gas. Therefore, it is our opinion that 

the oxygen exerted within the SAROS Oxygen System is not a Division 2.2 gas and thus is not subject 

to the U.S. HMR. 

Lithium ion Batteries used in SAROS Oxygen System 

The SAROS Oxygen System is powered by a lithium ion battery pack that consists of 16, 1.5 amperehour lithium ion cells. Therefore, the battery contains an aggregate equivalent lithium content of 7.20 

grams (or 86 Watt-hours). The cells and battery have been tested pursuant to the requirements of the 

UN Manual of Tests and Criteria. 

It is our opinion that the lithium ion battery is not subject to the HMR pursuant to Special Provision 

188 because the cells contain not more than 1.5 grams of equivalent lithium content, the battery 

contains not more than 8 grams of equivalent lithium content, the cells and battery have been tested in 

accordance with the UN Manual of Tests and Criteria and the battery and SAROS Oxygen System will 

be packed pursuant to the requirements of Special Provision 188 when offered for transport. The 

battery also meets the excepdon found in 49 CFR 175.10(a) (17) for passengers and crew members. 

This provision is generally consistent with one found in the ICAO Technical Instructions that 

authorizes consumer electronic devices containing lithium ion batteries with up to 100 Watt-hours to 

be carried onboard passenger aircraft. 

I trust the information contained herein is sufficient for PHMSA to provide a written determination 

that the SAROS''"'^ Oxygen System and lithium ion battery used to power it are not subject to the U.S. 

HMR pursuant to Special Provision 188 and they meet the excepdon found in 49 CFR 175.10(a)(17) 

for passengers and crew members. Should you need additional information or have any questions 

regarding our product, please do not hesitate to call me at the contact infonnation below. 

Respectfully, 

\•'/^.|lhL(^LQvJ|i.t 

Pamela J. Jackson 

Senior Director, Government and Military 

SeQual Technologies Inc. 

11436 Sorrento Valley Road 

San Diego, CA 92121 

Phone:858-202-3144 

Cell: 760-805-9000 

Email: piackson(a),sequal.com 

Page 2 of 2 
® Nemko 

Nemko USA, Inc. 

11696 Sorrento Valley Rd., Suite F 

San Diego, CA 92121-1024 

Phone (858) 755-5525 Fax (858) 452-1810 

TEST REPORT 

PER 

RCTAINC.DO-160F 

FOR THE 

Oxygen Concentrator 

Model: 3000 

PREPARED FOR 

SEQUAL TECHNOLOGIES, INC. 

11436 SORRENTO VALLEY RD. 

SAN DIEGO, CA 92121 

PREPARED on April 15,2010 

REPORT NUMBER: 2010 04147534 DO160 

REVISION NONE 

PROJECT NUMBER: 42884-1 

NEx Number: 147534 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone(858) 755-5525 Fax(858)452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT# 

2010 04147534 DOI60 

PAGE 

2 of 32 

DOCUMENT HISTORY 

REVISION 

. 

_ 

DATE 

April 15,2010 

April 15.2010 

COMMENTS 

Prepared By: 

Released By: 

Rodel Resolme 

Alan Laudani 

NOTE: Nemko USA, Inc. hereby makes the following statements so as to confomi to the Requirements of EN 17025 

"General Criteria For the Operation Of Test Laboratories": 

o The unit described in this report was received at Nemko USA, Inc.'s facilities onApril 05, 2010. 

o Testing was performed on the unit described in this report onApril 05, 2010.. 

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 shall not be reproduced, except in full, without prior written 

approval of Nemko USA, Inc. However, all ownership rights are hereby returned unconditionally to Sequal 

Technologies, Inc., and approval is hereby granted to Sequal Technologies, Inc. and its employees and agents to 

reproduce all or part of this report for any legitimate business purpose without further reference to Nemko USA, Inc 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT# 

2010 04147534 DO160 

PAGE 

3 of 32 

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 laboratory. Testing was performed Per test methods described in RTCA, Inc. DOI60F. 

1 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. 

4&-'^y^^^ " 

Alan Laudani, EMC/RF Test Engineer 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENTS 

2010 04147534 DOI60 

PAGE 

4 of 32 

TABLE O F CONTENTS 

DOCUMENT HISTORY 2 

CERTIFICATION 3 

1 ADMINISTRATIVE DATA AND TEST SUMMARY 6 

1.1 Administrative Data 6 

1.2 Test Specifications 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 and 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 Frequency 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 19 

4.2.4 Test Equipment List 28 

APPENDICES 

APPENDIX A: Logsheet Al 

APPENDIX B. Nemko USA, Inc. Test Equipment & Facilities Calibration Program Bl 

APPENDIX C: NVLAP Accreditation CI 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone(858)755-5525 Fax(858)452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT# 

2010 04147534 DOI60 

PAGE 

5 of 32 

LIST OF FIGURES 

FIGURE 2.4-1 UUT TEST SETUP 

FIGURE 2.4-2 GENERAL TEST SET-UP 

FIGURE 2.4-2 SAROS OXYGEN SYSTEM TEST CONFIGURATION 

FIGURE 4.2-1 RADIATED EMISSIONS ANTENNA CONFIGURATIONS 

FIGURE 4.2-2 AMBIENT SCAN HORIZONTAL 

FIGURE 4.2-3 AMBIENT SCAN VERTICAL 

FIGURE 4.2-4 HORIZONTAL 120VAC 60Hz DATA HORIZONTAL 

FIGURE 4.2-5 HORIZONTAL 120VAC 60Hz DATA VERTICAL 

FIGURE 4.2-6 HORIZONTAL BATTERY ONLY DATA HORIZONTAL 

FIGURE 4.2-7 HORIZONTAL BATTERY ONLY DATA VERTICAL 

FIGURE 4.2-8 HORIZONTAL 24VDC DATA HORIZONTAL 

FIGURE 4.2-9 HORIZONTAL 24VDC DATA VERTICAL 

FIGURE 4.2-10 100 MHz TO 200 MHz RANGE 120VAC 60Hz 

FIGURE 4.2-11 200 TO 1 GH Z RANGE 120VAC 60Hz 

FIGURE 4.2-12 1 TO 6 GH Z RANGE 120VAC 60Hz 

FIGURE 4.2-13 100 MHz TO 200 MHz RANGE BATTERY ONLY 

FIGURE 4.2-14 200 TO 1 GHz RANGE BATTERY ONLY 

FIGURE 4.2-15 1 TO 6 GHz RANGE BATTERY ONLY 

FIGURE 4.2-16 100 MHz TO 200 MHz RANGE 24VDC 

FIGURE 4.2-17 200 TO 1 GHz RANGE 24VDC 

FIGURE 4.2-18 1 TO 6 GHz RANGE 24VDC 

9 

9 

14 

15 

15 

16 

16 

17 

17 

18 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

LIST OF TABLES 

Table 1 Emission Tests 6 

Table 2 Other tests 6 

Table 3 Emissions Test Summary 7 

Table 4 Other Test Summary 7 

Table 5 Bonding Test Results 12 

Table 6 Bonding Equipment List 12 

Table 7 Equipment List 28 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

6 of 32 

1 ADMINISTRATIVE DATA AND TEST SUMMARY 

LI Administrative Data 

CLIENT: 

CONTACT: 

E-MAIL: 

Sequal Technologies, Inc. 

11436 Sorrento Valley Rd. 

San Diego, CA 92121 

(858)202-3164 

LoAn Mayer 

imayer(gsequal.com 

DATE (S) OF TEST: April 05,2010 

UNIT UNDER TEST (UUT): 

PART NUMBER: 

SERIAL NUMBER: 

CONDITION UPON RECEIPT 

Oxygen Concentrator 

3000 

3 

Suitable for Test 

1.2 Test Specifications 

Radio Frequency Emissions and Electromagnetic Immunity tests in accordance with the requirements of RCTA, Inc. 

DO-160F. 

Table 1 Emission Tests 

Test 

Method 

Section 21 

Requirement 

RCTA, Inc. DO-160F 

Description 

Emission of RF Energy 

Radiated 

Frequency Range 

100 MHz to 6 GHz 

Limit 

Category M 

Table 2 Other tests 

Test Metliod 

Bonding Test 

Requirement 

<2.5mfi 

Description 

Measurement of ground 

plane resistance 

Frequency Range 

N/A 

Limit 

2.5mQ 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

7 of 32 

L3 Test Summary 

Section 21, Emission of RF Energy Test, radiated emissions on 3 different modes: 120VAC 60Hz, 

battery, and 24VDC. 

L3.1 Emissions Test Summary 

Table 3 Emissions Test Summary 

Specification 

RCTA, Inc. DO-I60F, Section 21 radiated 

Frequency Range 

Cat. M 100MHzto6GHz 

Compliance Status 

Passed 

L3.2 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 

EUT - Oxygen Concentrator 

EUT - Power Supply Unit 

MANUFACTURER 

MODEL # 

SERIAL* 

Sequal Technologies, Inc. 

Model: 3000 

Serial #: 3 

SL Power Electronics Corp. 

Model: MENTI220A2400F04 

Serial #: Sample 12 

POWER CABLE 

Powered by external AC 

power supply 

2m, 18 AWG, 3 wire. 

Medical lEC connectors 

2.2 Device Interconnection and I/O Cables 

Connection 

N/A 

I/O Cable 1 

N/A 1 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

8 of 32 

2.3 Description and Metliod of Exercising the UUT. 

The Model 3000 is anOxygen Concentrator. Its function is to extract oxygen from the atmosphere, 

concentrate it to greater than 90 % and flow it through the oxygen output port. The EUT was exercised in 

the following three (3) operational configurations: AC operation and charging, DC operation and charging 

and Battery pack (external attached) operation. The EUT mode of operation in all cases was Continuous flow 

at 3 LPM in Tactical Mode. If testing induces a mode change or the EUT stops operation or charging; this 

may be considered a failure. 

The EUT's performance during test was evaluated against the performance criterion specified by applicable test 

standards. Performance results are detailed 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 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENTS 

2010 04147534 DO 160 

PAGE 

9 of 32 

Figure 2.4-2 General Test Set-Up 

•'.•:\(.t:-iv^<L'C'. •'<.; C .li I 

t_«i 

NLli.^^.•••^;u;!l•.e M.inocM rVf^Yl. 

y 

.A^ . 

7 p' -

-iZ^ 

'••^y. 

/ 

/ / 

Figure 2.4-2 SAROS Oxygen System Test Configuration 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENTS 

2010 04147534 DOI60 

PAGE 

10of32 

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 Association of Radio and Telecommunication 

Engineers (NARTE) personnel. 

3.1 Ground Plane 

The emissions and susceptibility portions of the testing was performed on a ground plane. The ground plane consisted 

of a 8' X 3' X 1/8" thick copper plate mounted on a wooden 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 2.5mQ. 

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

3.2 Anechoic Chamber 

The radiated and conducted emissions tests were conducted inside a semi anechoic chamber which measures 20' x 12' x 

10'. Carbon-loaded cones provide RF dissipation. 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 lOOVDC, 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 consists of a spectrum analyzer controlled by a computer. 

Preamplifiers used where necessary and where they are used an appropriate notation is made in the relevant section of 

the report. Commercially available EMI measurement software Total Integrated Laboratory Environment (TILE) was 

used in the performance of these measurements. 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. 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

Aprin5,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT* 

2010 04147534 DOl 60 

PAGE 

11 of32 

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 Z540-1. Specifically, all of NEMKO XMA'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, impulse 

generators, signal generators and pulse/fianction 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 laboratory by another accreditation body (such as A2LA) 

that is mutually recognized by NIST; or, 

• A manufacturer of Measurement and Test Equipment (M&TE), if the manufacturer uses NIST-traceable standards 

and is ISO Standard 17025-accredited as calibration laboratory 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, NEMKO USA conducts an annual audit of the manufacturer 

or metrology laboratory for the purposes of proving traceability to NIST, ensuring that adequate and repeatable 

calibration procedures are being applied, and verifying conformity with the other requirements of ISO Standard 

17025). 

In ail 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 advises a shorter interval or if US 

Government directives or client requirements demand a shorter 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 calibrated 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 antenna 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. 
Nemko SD USA, Inc . 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

12 of 32 

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 were measured and verified to be less than 2,5 milliohms. 

4.1.2 Bonding Data Sheets 

Customer 

Job order 

Test Engineer 

Date 

Standard 

Remarks 

Sequal Technologies, Inc. 

42884-1 

Rodel Resolme 

April 5, 2010 

RTCADO160F 

3000 

Table 5 Bonding Test Results 

From 

Location 

Wall 

Table 

Table 

To 

Location 

Table 

LISN Positive 

LISN Negative 

Measured 

mO 

1.8 

0.09 

0.08 

Limit 

mfl 

2.5 

i 

1 

Pass 

Pass 

Pass 

Pass 

Remarl<s 

4.1.3 Test Equipment List 

Table 6 Bonding Equipment List 

Asset No. 

824 

904 

Description 

USN, Set 

Micro-ohmmeter 

Part Number Number 

Corn-Power LI-400 

Keithley 580 

Serial Number 

25063 

402336 

Last Cal. 

4-14-09 

7-13-09 

Cal due 

4-14-10 

7-13-10 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

13 of 32 

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 emissions 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, 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT# 

2010 04147534 DO160 

PAGE 

14 of 32 

Figure 4.2-1 Radiated Emissions Antenna Configurations 

Test Setup 

Boundary 

Ground 

Plane 

Bonding 

Strap 

ROD 

Counterpoise 

Floor 

Test Setup 

Boundary 

Ground 

Plane 

BICONICAL 

Test Setup 

Boundary 

Ground 

Plane 

DOUBLE 

RIDGE HORN 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENTS 

2010 04147534 DOI60 

PAGE 

15 of 32 

4.2.2 Radiated Emissions Test Data 

Figure 4.2-2 AMBIENT SCAN Horizontal 

Nemko USA 

MIL-STD.461D To.t Method RE102 

Horizontal Polarization Radiated Emissions Ambient Scans 

Sequal Technoiogies, Inc. 

SAROS Oxygen System, Model 3000 

42884-1/147S34 

11:S1:35AM, Thursday, April 15,2010 

Figure 4.2-3 AMBIENT SCAN Vertical 

Nemko USA 

MIL-STD-461F Test Method RE102 

Vertical Polarization Radiated Emissions Ambient Scan 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

42684-1/147534 

•t !• t t ) 

11:46:11 AM, Thursday, April 15, 2010 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

16 of 32 

Figure 4.2-4 Horizontal 120VAC 60Hz Data Horizontal 

Nemko USA 

MIL-STD-461D Test Method RE102 

Horizontal Polarization Radiated Emissions 120VAC 60Hz 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

426S4-1/147S34 120VAC COHz 

20.0-J10.0 

-10.0: r 

•20.0 -. 7 

*JM«MJ»*IM*<** 

-30.0' 

11:27:11 AM, Monday, April 05, 2010 

LOG 

Frequency 

Figure 4.2-5 Horizontal 120VAC 60Hz Data Vertical 

Nemko USA 

MIL-STD-461F Test Method RE102 

Vertical Polarization Radiated Emissions 120Hz 60Hz 

100.0 • ^ 

90.o•i• 

80.0 

70.0 

60.0-t 

50.0 

5 40.0-t 

m 30.0:1-

T3 

20.0-J10.0 

0 

•lO.O-t 

-20.0: r 

Sequal Technoiogies, inc. 

SAROS Oxygen System, Model 3000 

428B4-1/147534 120VAC 60Hz 

wU<-* ^ 

LOG 

Frequency 

11:25:56 AM, Monday, April 05, 2010 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

17of32 

Figure 4.2-6 Horizontal Battery Only Data Horizontal 

Nemko USA 

MIL-STD-461D Test Method RE102 

Horizontal Polarization Radiated Emissions Battery Powered 

100.0 T 

90.0: r 

•0.0 : r 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

42684-1/147534 Battery Powered 

-10.0 

•20.0-f 

-30.0' 

S^^fNfmf^"^ 

LOG 

Frequency 

12:36:15 PM, Monday, April 05, 2010 

Figure 4.2-7 Horizontal Battery Only Data Vertical 

Nemko USA 

MIL-STD-461F Test Method RE102 

Vertical Polarization Radiated Emissions Battery Powered 

100.0-q 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

42684-1/147534 Battery Powered 

E t 

O 30.0' 

20.0 

10.0 

0 : • 

•10.0-f-

•20.0 

-30.0 

JiMiiiiiii at Al i \k\\ik\ 

-'^mwNnwr^ni^iiii 

J^M^JUm^ 

LOG 

Frequency 

12:32:47 PM, Monday, April 05, 2010 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT# 

2010 04147534 DOI60 

PAGE 

18or32 

Figure 4.2-8 Horizontal 24VDC Data Horizontal 

Nemko USA 

MIL-STD-461D Test Method RE102 

Horizontal Polarization Radiated Emissions 28VDC 

100.0 

90.0-^ 

80.0 

70.0 

60.0 

50.0 

J 40.0 

m 30.0-^ 

20.0 

10.0-t 

-lO.O-i r 

-20.0: r 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

42884-1/147534 28VDC 

-30.0 

iWM<%.**-J^ 

LOG 

Frequency 

02:09:21 PM, Monday, April 05, 2010 

Figure 4.2-9 Horizontal 24VDC Data Vertical 

Nemko USA 

MIL-STO-461F Test Method RE102 

Vertical Polarization Radiated Emissions 26VDC 

100.0-3 

so.o80.0-

70.0-

80.0-

50.0-

5 40.0-

m 30.0-

20.0-

10.0-

0-

-10.0-

-20.0-

r 

r 

r 

r 

: 

" • - ' ~ 

rL——' 

a 

\M4 I Ik I I 

*''^\*.jji«W» ^ 

l%¥^^ V 

-

-

"YoO OM 

02:06:37 PM, Monday. April 05, 2010 

Sequal Technologies, Inc. 

SAROS Oxygen System, Model 3000 

42S84-1/147S34 28VDC 

tr^ 1 

- - . I*" * 

j j 1 1 V ^ 

Amf/M^*" ^ L^^ s 

Frequency 

""" 

.. 1.. ji.1. 

^^M^lKHldl^BP^^^^^^ ^ 

10.DG 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOl 60F Test Report 

DOCUMENTS 

2010 04147534 DO160 

PAGE 

19of32 

4.2.3 Radiated Emissions Photographs 

Figure 4.2-10 100 MHz to 200 MHz range 120VAC 60Hz 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

II696Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DOI60F Test Report 

DOCUMENT* 

2010 04147534 DO160 

PAGE 

20 of 32 

Figure 4.2-11 200 to 1 GHz range 120VAC 60Hz 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT* 

2010 04147534 DO 160 

PAGE 

21 or32 

Figure 4.2-12 1 to 6 GHz range 120VAC 60Hz 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT # 

2010 04147534 DO 160 

PAGE 

22 of 32 

Figure 4.2-13 100 MHz to 200 MHz range Battery Only 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858)755-5525 Fax (858)452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

23 of 32 

Figure 4.2-14 200 to 1 GHz range Battery Only 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT* 

2010 04147534 DO160 

PAGE 

24 of 32 

Figure 4.2-15 1 to 6 GHz range Battery Only 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

Aprin5,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT* 

2010 04147534 DO160 

PAGE 

25 of 32 

Figure 4.2-16 100 MHz to 200 MHz range 24VDC 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160r Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

26 of 32 

Figure 4.2-17 200 to 1 GHz range 24VDC 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

27 of 32 

Figure 4.2-18 1 to 6 GHz range 24VDC 
Nemko SD USA, Inc . 

REVISION 

-

DATE 

April 15, 2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. Model: 3000 

DO160F Test Report 

DOCUMENT * 

2010 04147534 DO160 

PAGE 

28 of 32 

4.2.4 Test Equipment List 

Table 7 Equipment List 

Asset No. 

117 

317 

825 

824 

350 

752 

911 

901 

Description 

Antenna, Eicon 

Pre-amp, HP 

LISN Set, Corn-Power 

LISN Set, Corn-Power 

Antenna, Dual Ridge 

Antenna, DRG Horn 

Spectrum Analyzer, Agilent 

Pre-amp, Sonoma 

Part Number Number 

BIA-25 

8449A 

Ll-400 

LI-400 

RGA30 

3115 

E4440A 

310N 

Serial Number 

2611 

2749A 

25064 

25063 

2225 

4943 

US41421266 

130607 

Last Cal. 

5/18/09 

4/16/09 

6/18/09 

4/14/09 

4/9/09 

11/12/08 

12/17/09 

3/27/09 

Cal due 

5/18/11 

4/16/10 

6/18/10 

4/14/10 

4/9/11 

11/12/10 

12/17/10 

3/27/10 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone(858)755-5525 Fax(858)452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. 

3000 

DO160F Test Report 

DOCUMENT* 

2010 04147534 DO160 

PAGE 

Bl of 32 

APPENDIX B. Nemko USA, Inc. Test Equipment & Facilities Calibration Program 

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 Policy Guide PG-1-

1988, ANSI/NCSL Z540-1-1994, ISO 10012: 2003, ISO/IEC 17025:1999, and lSO-9000: 2000. Nemko USA, Inc.'s 

calibrations program therefore meets or exceeds the US national commercial and military requirements [N.B. 

ANSI/NCSL Z540-1-1994 replaces M1L-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, impulse generators, 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 calibration 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 purposes of proving traceability to NIST, ensuring that 

adequate and repeatable calibration procedures are being applied, and verifying conformity with the other 

requirements of ISO Guide 25). 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. 

3000 

DOI60F Test Report 

DOCUMENT* 

2010 04147534 DO160 

PAGE 

B2of32 

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 advises a shorter interval or if US 

Government directives or client requirements demand a shorter 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 antenna'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 antenna's OEM if the OEM is NIST or 

A2LA ISO Standard 17025-accredited as an antenna calibration laboratory 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 antennas 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. 
Nemko SD USA, Inc. 

REVISION 

-

DATE 

April 15,2010 

11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 

Phone (858) 755-5525 Fax (858) 452-1810 

DOCUMENT NAME 

Sequal Technologies, Inc. 

3000 

DOl 60F Test Report 

DOCUMENT # 

2010 04147534 DO160 

PAGE 

CI of 32 

APPENDIX C: NVLAP Accreditation 

United States Department of Commerce 

National Institute of Stanciards and Technology 

Certificate of Accreditation to ISO/IEC 17025:2005 

NVI.API.AHCODE: 200116-0 

Ncniko USA, Inc. - San Dicgo EMC Division 

San Diego, CA 

IS eccroOited by She Nalional Volwtlary Lafcoralo/y Acoredilation Progrnm for spocitic sorvicos, 

listed on the Scope of Accrediialion, tor: 

ELECTROMAGNETIC COMPATIBILITY AND TELECOMMUNICATIONS 

This laboratory is accrediled in accordanco with the recot/rnzcd IntomalioiKil Standard ISO/IEC 170252005 

This accreditation demonstrates technical competence lor a defined scope and tfie operation of a laboiatoty Quality 

managemoni system (refer to joint ISO-lLAC-tAF Communique dated January 200S). 

/.•*:"" !°V 

2I)1I)-01-01 lliroiii;li 20111-12-11 

Effective dates JfittOfUtI fnaUiitti of Stunc'iHils and Tect'noit: 

hfV/LAP-01ClRE\.' 70C'9-0\-2S)