Oxygen System

OPERATOR MANUALMODEL 4000

CAIRE Inc.
2200 Airport Industrial Dr., Ste 500
Ball Ground, GA 30107
www.caireinc.com
Copyright © 2022 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its products, or change theprices, materials, equipment, quality, descriptions, specifications and/or processes to its products at
any time without prior notice and with no further obligation or consequence. All rights not expressly
stated herein are reserved by us, as applicable.
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WARNING: DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE
UNABLE TO UNDERSTAND THE WARNINGS AND INSTRUCTIONS, CONTACT YOUR EQUIPMENT PROVIDER BEFORE ATTEMPTINGTO USE THIS EQUIPMENT; OTHERWISE, INJURY OR DAMAGE MAY RESULT.

DEFINITION OF SYMBOLS PAGE / WARNING PAGEWARNING: INDICATES A HAZARDOUS SITUATION THAT, IF NOT AVOIDED, COULD RESULT IN DEATH OR SERIOUS INJURY.

CAUTION: Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

NOTE: Indicates information considered important, but not hazard-related (e.g. messages relating to property damage).
SYMBOLS USED IN THE OPERATION OF SAROS
Symbols are frequently used on equipment in preference to words with the intention of reducing any possibility of misunderstanding causedby language differences. Symbols can also permit easier comprehension of a concept within a restricted space.

ISO 7000; GRAPHICAL SYMBOLS FOR USE ON
EQUIPMENT—INDEX AND SYNOPSIS
Portable operating temperature is -10C to 40C.
Base operating temperature range is 10C-40C.
Reg. # 0632

ISO 7010: GRAPHICAL SYMBOLS—SAFETY COLORS AND SAFETYSIGNS—REGISTERED SAFETY SIGNS

Portable humidity range is 15 to 90%. Basehumidity range is 30 to 75%. Reg. #2620

Keep away from open flame, fire, sparks. Open ignition source and smoking prohibited. Reg. # P003

Atmospheric pressure limitation. Reg. # 2621

Do not smoke near unit or while operating unit.
Reg. # P002

Keep away from rain, keep dry. Reg. # 0626

Type BF applied part (degree of protection againstelectric shock). Reg. # 5333

Name and address of manufacturer. Reg. # 3082

Date of Manufacture. Reg. #2497
Caution, consult accompanying documents.
Reg. # 0434A
Catalog Number. Reg. # 2493
Serial Number. Reg. # 2498
This way up. Reg. # 0623
Fragile, handle with care. Reg. # 0621

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Stacking height. Reg #2403

Warning. Reg. # W001
The instruction manual must be read. Reg. #M002
IEC 60417: GRAPHICAL SYMBOLS FOR USE
ON EQUIPMENT
IEC Icon for DC Power (Input) Indicates equipment providing a particular degree of protection
against electric shock, particularly regarding:
Allowable leakage current; Reliability of a proper
ground connection. Reg. #5031
Alternating Current (AC). Reg # 5032

Operator Manual
COUNCIL DIRECTIVE 93/42/EEC; CONCERNING
MEDICAL DEVICES
If the product unique device identifier (UDI)
label has the CE#### symbol on it, the device
complies with the requirements of Directive
93/42/EEC concerning medical devices. The
CE#### symbol indicates notified body number.
INTERNAL SYMBOLS
Keep away from flammable materials, oil andgrease.

O2

Oxygen Output; The port from which the Oxygen
flows and where the tubing or interface(standard
nasal cannula) is connected.
Amperes (Current)

Alert (Yellow) Indicator*: When illuminated, thisindicates an awareness condition or Caution.

ON/OFF (Standby); Powers the device ON or
OFF, but does not directly disconnect the main
power.

21 CFR 801.15: CODE OF FEDERAL REGULATIONS TITLE 21
Federal law restricts this device to sale by or on
the order of a physician.
COUNCIL DIRECTIVE 2012/19/EU: WASTE ELECTRICAL AND
ELECTRONIC EQUIPMENT (WEEE)
WEEE
IEC 60601-1: MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCEClassification; Class II Equipment, double
insulated.
Protected from tools and wires greater than 2.5
millimeters, Protected from water spray less than
60 degrees from vertical.
*Alarms for the SAROS are considered information-only signals.
This product may be covered by one or more patents, US and international. Please visit our website below for the listing of applicablepatents. Pat.: www.caireinc.com/corporate/patents/.

Increase Flow Setting; Increases the flow settingby 1.0 LPM increments or by 1 pulse setting
each time the button is pressed.
Decrease Flow Setting; Decreases the flow
setting by 1.0 LPM increments or by 1 pulse
setting each time the button is pressed.
Activates either Continuous Flow Mode or Pulse
Flow Mode Operation.

Utility; The Button that activates a utility menu
to access information or to change settings.

External Power is Present Indicator; Indicates thepresence of external power.

Battery Status Indicator; Shows the amount ofcharge remaining in the battery. When charging,battery displays as a “Waterfall” Effect.
“Alarm Off” indicator displayed during TacticalMode.

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TABLE OF CONTENTS
DEFINITION OF SYMBOLS PAGE / WARNING PAGE............................................................................................................................................. 2
ILLUSTRATIONS........................................................................................................................................................................................................ 5
TABLES...................................................................................................................................................................................................................... 5
INDICATIONS FOR USE............................................................................................................................................................................................ 6
INDICATIONS............................................................................................................................................................................................................. 6
CONTRAINDICATIONS.............................................................................................................................................................................................. 7
SAFETY GUIDELINES......................................................................................................................................................................................7
BATTERY SAFETY............................................................................................................................................................................................8
1.0 INTRODUCTION................................................................................................................................................................................................... 9
1.1 GENERAL INFORMATION..........................................................................................................................................................................9
1.2 SAROS OXYGEN SYSTEM SPECIFICATIONS........................................................................................................................................10
2.0 INTRODUCTION TO YOUR SAROS OXYGEN SYSTEM ................................................................................................................................. 13
2.1 DESCRIPTION OF THE SAROS ASSEMBLY—SHIPPABLE ..................................................................................................................13
2.2 USER CONTROLS AND SYSTEM STATUS INDICATORS......................................................................................................................15
2.3 RECOMMENDED OPERATING ENVIRONMENTS..................................................................................................................................18
3.0 PREPARATION FOR USE AND INSTALLATION.............................................................................................................................................. 19
3.1 BATTERY INSTALLATION ONTO SAROS................................................................................................................................................19
3.2 LOCATING THE SAROS...........................................................................................................................................................................19
4.0 OPERATING INSTRUCTIONS........................................................................................................................................................................... 20
4.1 OPERATING THE SAROS FOR THE FIRST TIME...................................................................................................................................23
5.0 OPERATOR MAINTENANCE & SERVICE......................................................................................................................................................... 26
5.1 CLEANING THE SAROS ..........................................................................................................................................................................26
5.2 ROUTINE MAINTENANCE .......................................................................................................................................................................26
5.3 CLEANING OR REPLACING AIR INLET FILTER.....................................................................................................................................27
5.4 REPLACING THE HEPA FILTER...............................................................................................................................................................28
5.5 RUN DEVICE AND FULLY DRAIN SAROS BATTERY..............................................................................................................................29
5.6 REPLACING THE 9V BATTERY...............................................................................................................................................................29
6.0 ALERTS, ALARMS, AND TROUBLESHOOTING TABLE................................................................................................................................. 29
6.1 SYSTEM TROUBLESHOOTING GUIDE...................................................................................................................................................30
6.2 ALARM INDICATIONS AND CODES.........................................................................................................................................................31
7.0 REPROGRAMMING/CALIBRATION.................................................................................................................................................................. 33
8.0 SHIPPING AND TRANSPORTING THE SAROS............................................................................................................................................... 33
9.0 STORING AND DISCARDING THE SAROS...................................................................................................................................................... 33
10.0 EMC TESTING.................................................................................................................................................................................................. 34

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ILLUSTRATIONSFIGURE 2-1. SAROS COMPONENTS............................................................................................................................................................13
FIGURE 2-2. SAROS COMPONENTS............................................................................................................................................................14
FIGURE 3-1. BATTERY INSTALLATION.........................................................................................................................................................19
FIGURE 5-1. BATTERY INSTALLATION.........................................................................................................................................................22
FIGURE 4-2. CANNULA INSTALLATION........................................................................................................................................................23
FIGURE 5-1. SAROS COMPONENTS............................................................................................................................................................27
FIGURE 5-2. REMOVE COVER......................................................................................................................................................................27
FIGURE 5-3. FILTER.......................................................................................................................................................................................28
FIGURE 5-4. REINSTALL O2 FITTING/HEPA FILTER....................................................................................................................................28
FIGURE 5-5. REPLACING 9V BATTERY........................................................................................................................................................29

TABLESTABLE 1-1. SAROS SPECIFICATIONS......................................................................................................................................................... 10
TABLE 1-2. PULSE MODE SPECIFICATIONS...............................................................................................................................................11
TABLE 1-3. BOLUS VOLUME AND BREATH RATES.....................................................................................................................................11
TABLE 1-4. POWER ACCESSORY SPECIFICATIONS..................................................................................................................................11
TABLE 1-5. BATTERY SPECIFICATIONS.......................................................................................................................................................11
TABLE 1-6. SAROS ....................................................................................................................................................................................... 12
TABLE 2-1. USER CONTROLS AND INDICATORS...................................................................................................................................... 15
TABLE 2-2. RECOMMENDED OPERATING ENVIRONMENTS.................................................................................................................... 18
TABLE 4-1. TYPICAL NEW BATTERY OPERATING TIME............................................................................................................................ 21
TABLE 4-2. MINIMUM REMAINING TIME ON BATTERY ............................................................................................................................. 22
TABLE 4-3. PULSE SETTINGS...................................................................................................................................................................... 24
TABLE 4-4. UTILITY MENU SCREENS......................................................................................................................................................... 25
TABLE 5-1. ROUTINE MAINTENANCE ........................................................................................................................................................ 26
TABLE 6-1. ALARM LEVELS.......................................................................................................................................................................... 29
TABLE 6-2. SYSTEM TROUBLESHOOTING GUIDE.................................................................................................................................... 30
TABLE 6-3. ALARM INDICATIONS AND CODES.......................................................................................................................................... 32

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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. The SAROS can be used in the Military Medical Service that is operationally used for medical
assemblages, such as the Expeditionary Medical Support (EMEDS) and En-Route Patient Staging System (ERPSS), in deployed scenarios,
including wartime operations, deterrence and humanitarian and contingency operations.
The SAROS is used by patients suffering from discomfort due to ailments which affect the efficiency of one’s lungs to transfer the oxygenin air to their bloodstream. The device will be operated by a trained medical technician or clinician with a working knowledge of oxygen
concentrators. A physician has prescribed a specific oxygen flow setting to meet an individual’s needs. Oxygen flow should be adjusted only
under the direction of a physician.
The SAROS uses a vacuum pressure adsorbent process to separate oxygen from the air and deliver oxygen rich gas to a patient through anasal cannula.
WARNING: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

INDICATIONSWARNING: 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, THE USER MAY EXPERIENCE PERIODS OF NON-OPERATION AS A RESULT OF
ELECTRICAL POWER INTERRUPTION, OR THE NEED TO HAVE THE SAROS SERVICED BY A QUALIFIED TECHNICIAN. SAROSIS 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.
WARNING: EXHAUST GAS MAY REACH HIGH TEMPERATURES DURING NORMAL OPERATIONS. USE CAUTION TO AVOID TOUCHING THE EXHAUST PORT OF THE SAROS WHILE IN USE.

WARNING: THERE IS A RISK OF FIRE ASSOCIATED WITH OXYGEN THERAPY. DO NOT USE CONCENTRATOR OR ACCESSORIESNEAR SPARKS OR OPEN FLAMES.

WARNING: SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN SERIOUS INJURY OR DEATH OF
THE PATIENT AND OTHERS FROM FIRE.

WARNING: OPEN FLAMES DURING OXYGEN THERAPY ARE DANGEROUS AND IS LIKELY TO RESULT IN FIRE OR DEATH. DO NOTALLOW OPEN FLAMES WITHIN 2 METERS OF THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES.

WARNING: SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO
NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OF ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE THE
CANNULA AND LEAVE THE ROOM WHERE EITHER THE CANNULA OR MASK OR THE OXYGEN CONCENTRATOR IS LOCATED. IF
UNABLE TO LEAVE THE ROOM, YOU MUST WAIT 10 MINUTES AFTER YOU HAVE TURNED THE OXYGEN CONCENTRATOR OFF
BEFORE SMOKING.
NOTE: Auditory alarms may not be heard in noisy environments and/or in tactical mode. Care providers must rely on visual indications to determine if
there are any alarms or other system malfunctions. Care providers should monitor the SAROS for any alarm conditions.

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CONTRAINDICATIONSSAFETY GUIDELINES
These are Warnings and Cautions that apply to hazards or unsafe practices that could result in serious injury or property damage.
WARNING: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

WARNING: DO NOT USE SAROS IF IT HAS A DAMAGED POWER CORD OR PLUG.

WARNING: DO NOT DROP OR INSERT ANY OBJECTS INTO ANY OPENING ON THE DEVICE.

WARNING: 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.
WARNING: DO NOT COVER THE DEVICE WITH A BLANKET, TOWEL OR SHEET, ETC.

WARNING: DO NOT STORE THE SAROS WITH THE BATTERY INSTALLED IN THE UNIT.

WARNING: DO NOT REMOVE THE COVER. THERE ARE NO USER-SERVICEABLE PARTS INSIDE THE DEVICE. ONLY QUALIFIEDSERVICE PERSONNEL SHOULD REMOVE THE COVER OF THE DEVICE.
WARNING: DO NOT MODIFY THIS EQUIPMENT WITHOUT AUTHORIZATION OF THE MANUFACTURER.

WARNING: DO NOT OPERATE THE DEVICE, COMPONENTS OR ACCESSORIES ON WET SURFACES OR IN STANDING WATER AND
DO NOT SUBMERSE IN WATER.

WARNING: GERIATRIC, PAEDIATRIC OR ANY OTHER PATIENT UNABLE TO COMMUNICATE DISCOMFORT CAN REQUIRE ADDITIONAL MONITORING AND OR A DISTRIBUTED ALARM SYSTEM TO CONVEY THE INFORMATION ABOUT THE DISCOMFORT AND
OR THE MEDICAL URGENCY TO THE RESPONSIBLE CARE GIVER TO AVOID HARM.
WARNING: OXYGEN MAKES IT EASIER FOR A FIRE TO START AND SPREAD. DO NOT LEAVE THE NASAL CANNULA OR MASKON BED COVERINGS OR CHAIR CUSHIONS, IF THE OXYGEN CONCENTRATOR IS TURNED ON, BUT NOT IN USE; THE OXYGENWILL MAKE THE MATERIALS FLAMMABLE. TURN THE OXYGEN CONCENTRATOR OFF WHEN NOT IN USE TO PREVENT OXYGENENRICHMENT.
WARNING: IF YOU FEEL DISCOMFORT OR ARE EXPERIENCING A MEDICAL EMERGENCY WHILE UNDERGOING OXYGENTHERAPY, SEEK MEDICAL ASSISTANCE IMMEDIATELY TO AVOID HARM.
WARNING: WIND OR STRONG DRAUGHTS, INCLUDING AN OPEN WINDOW OR FAN, CAN ADVERSELY AFFECT ACCURATE
DELIVERY OF OXYGEN THERAPY.

WARNING: THE SETTINGS OF OTHER MODELS OR BRANDS OF OXYGEN THERAPY EQUIPMENT DO NOT CORRESPOND WITH
THE SETTINGS OF THE SAROS MODEL 4000.

WARNING: IN THE EVENT THERE IS A SERIOUS INCIDENT OCCURRING WITH THIS DEVICE, THE USER SHOULD IMMEDIATELYREPORT THE INCIDENT TO THE PROVIDER AND/OR THE MANUFACTURER. A SERIOUS INCIDENT IS DEFINED AS AN INJURY,DEATH, OR POTENTIAL TO CAUSE INJURY/DEATH SHOULD THERE BE A REOCCURRENCE OF THE INCIDENT. THE USER CAN
ALSO REPORT THE INCIDENT TO THE COMPETENT AUTHORITY IN THE COUNTRY WHERE THE INCIDENT OCCURRED.
WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING NICKEL, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER. FOR MORE INFORMATION, GO TO WWW.P65WARNINGS.CA.GOV.

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CAUTION: INDICATES A HAZARDOUS SITUATION THAT, IF NOT AVOIDED, COULD RESULT IN MINOR OR MODERATE INJURY.

CAUTION: KEEP SAROS AND THE POWER CORD AWAY FROM HOT SURFACES OR OPEN FLAMES.

CAUTION: SAROS SHOULD BE LOCATED IN A WELL-VENTILATED AREA TO ALLOW FOR ADEQUATE AIR INTAKE.

CAUTION: AVOID THE INTAKE OF AIRBORNE POLLUTANTS, SMOKE AND FUMES.

CAUTION: ONLY USE THIS DEVICE WITH ACCESSORIES SPECIFIED BY, OR RECOMMENDED BY CAIRE INC.

CAUTION: IF SAROS HAS BEEN DROPPED, DAMAGED OR EXPOSED TO WATER, PLEASE CONTACT A QUALIFIED TECHNICIANFOR INSPECTION OR POSSIBLE REPAIR OF THE DEVICE.
CAUTION: WHEN USING SAROS IN ANY VEHICLE, BE SURE IT IS PROPERLY SECURED, BELTED OR RESTRAINED.

CAUTION: LOCATE OXYGEN SUPPLY TUBING AND ALL POWER CORDS IN A MANNER TO PREVENT TRIPPINGHAZARDS.
CAUTION: DO NOT PLACE THE SAROS IN A SMALL, ENCLOSED SPACE, SUCH AS A BATHROOM, CLOSET, BAG OR BOX WITH
THE OXYGEN CANNULA OR TUBING LEADING OUT OF THE ENCLOSED SPACE.
CAUTION: DO NOT EXPOSE THE DEVICE TO TEMPERATURES OUTSIDE OF THE SPECIFIED RANGE OF OPERATING OR STORAGE
TEMPERATURES AS THIS MAY DAMAGE THE DEVICE.

NOTE: THIS DEVICE MUST COOL FROM THE MAXIMUM STORAGE TEMPERATURE BETWEEN USES UNTIL IT IS READY FOR TEMPERATURESFOR INTENDED USE.
NOTE: SAROS UNIT MUST BE CONSTRAINED OR MOUNTED TO PREVENT DAMAGE TO UNIT OR INJURY TO USER WHILE IN USE.
NOTE: THIS DEVICE DOES EXHAUST NITROGEN GAS. HOWEVER, THIS EXHAUST IS NOT SUFFICIENT TO DISPLACE OXYGEN IN THE OPERATING ENVIRONMENT. NO ADDITIONAL SAFETY PRECAUTIONS NEED TO BE TAKEN TO ACCOUNT FOR THE NITROGEN EXHAUST.
NOTE: PROTECT ELECTRICAL POWER CORDS FROM SHARP EDGES OR ELECTRICAL SHOCK AND SERIOUS PHYSICAL INJURY MAY
OCCUR.
NOTE: ONLY USE THE CAIRE INC. SUPPLIED AC POWER ADAPTER AND 24 VDC CABLE WITH THE SAROS. USE OF ANY OTHER AC POWER
ADAPTER OR DC CABLE MAY BE HAZARDOUS, CAUSE SERIOUS DAMAGE TO THE SAROS AND WILL VOID THE WARRANTY.
NOTE: 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.
BATTERY SAFETYWARNING: 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.
WARNING: 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.
WARNING: USE OF A DAMAGED BATTERY MAY CAUSE PERSONAL INJURY.

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WARNING: THE BATTERY MAY EXPLODE AND CAUSE POTENTIAL INJURY IF EXPOSED TO A FIRE, OR DISPOSED OF IN A FIRE.

WARNING: 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.
CAUTION: IT IS NOT RECOMMENDED THAT THE BATTERY IS CHARGED BELOW 41° F (5° C) OR ABOVE 104° F (40° C).

CAUTION: ONLY USE THE BATTERY FOR ITS INTENDED PURPOSE.

CAUTION: PUSH LOCKING/UNLOCKING BUTTON BEFORE BATTERY INSTALLATION.

1.0 INTRODUCTION
1.1 GENERAL INFORMATIONThis manual will familiarize you with information regarding the SAROS Oxygen System, Model 4000.
INTRODUCTION
The SAROS Oxygen System, Model 4000 with autoSAT® Technology (hereafter referred to as SAROS) 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 inContinuous 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.
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 AC power, 24VDC or from a rechargeable Battery. The system includes a “Smart Battery” charger thatrecharges the Battery whenever the SAROS is connected to external power. The system monitors and controls both the power source and theBattery Charger.
SAROS has a recommended five minute warm up/stabilization period.
INTENDED USE
The CAIRE SAROS 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.

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1.2 SAROS OXYGEN SYSTEM SPECIFICATIONS
Dimensions• With Battery /• Without Battery

26.80” long x 4.375” diameter (68.1 cm long x 11.1 cm diameter) /diameter (59.1 cm long x 11.1 cm diameter)• Without Battery

12.25 pounds (5.56 kg)

23.25” long x 4.375”

Weight• With Battery //10.00 pounds (4.54 kg)

Flow Settings• Continuous Flow /• Pulse flow

1, 2, 3 LPM/

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

Continuous Flow Accuracy

1LPM: +/- 0.2 LPM

Oxygen concentration

93% +/- 3% for all flow settings/

2LPM: +/- 10%

Maximum System Pressure

15 psig (103.4 kPa)

Oxygen Output Pressure

4.0 psig (27.5 kPa) nominal

Nominal Sound Level<59 dB(A) at 3LPM

Operating Environment• Temperature• Humidity

32º F to 104º F (0° to 40° C)
10% to 90%, Non-condensing, 82.4°F (28°C) Maximum Dew point

Storage Environment• Temperature / • Humidity-4º F to 140º F (-20° to 60° C)

Transient Environmental Operating Conditions• Temperature / • Humidity

32º F to 104º F (0° to 40° C)

Ambient Pressure Range(620 hPa to 1060 hPa) or (-1253 ft [-381m] to 12971 ft [3953m])///

3LPM: +/- 10%

Up to 90% Non-condensing
Up to 90% Non-condensing

Nominal Power
3 LPM Continuous Flow

≤130 Watts

Nominal Battery operating time at 3 LPM Continuous Flow
30 Minutes
Battery Life

80% Nominal Capacity after 200 Charge/Discharge cycles

Continuous Flow Indication

Expressed in liters per minute (LPM)

Audible Alarm Indicators• Loss of Power/Hot Battery• Low Battery/Warm Battery• Low Oxygen Concentration

Audible Signal Characteristics

Alarms Signal - 200 msec Beep
Info Signal - 100 msec Beep (Occurs as power-up confirmation, button push confirmation).
Volume of all signals is fixed and are both the same volume.

Visual Alarm Indicators

Yellow LED: Constant ON during alarm state

Back-Up Alarm Power

9V Internal Battery

Filters

Air Inlet Filter, HEPA and Exhaust Filter

Device Classification

IEC Class II, Type BF Applied Part, IP33
Table 1-1. SAROS Specifications

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Pulse Settings

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

autoSAT Technology

Servo-control to maintain consistent FiO2

Trigger Sensitivity

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

Trigger Criteria

Cannula pressure has dropped below the trigger point (typically between 0.15 – 0.45 cm of H2O ofnegative pressure with a MAX trigger point of .50 cm H2O)

Minimum time between breaths

1.25 seconds (max 3 consecutive breaths)

Response to Missing Breaths

Switch to Continuous Mode if no inspiration has been detected for 60 seconds with an audible alarm.

Table 1-2. Pulse Mode Specifications

Bolus Size ml (± 15%)

Max Breath Rate with Full
Bolus Size

Max Breath Rate with Full Bolus Size within delivered
oxygen capture time per ISO 80601-2-67:2014

16

40

40

32

40

40

48

40

35

64

40

30

80

37

25

96

31

20

NOTE: At breath rate above Max Breath Rate, bolus size will be reduced proportionally.
Table 1-3. Bolus Volume and Breath Rates

Input Voltage

AC Power Supply

24 VDC Cable

100- 240 VAC, 50 – 60 Hz

20 – 28 VDC; 24VDC (Nominal)

115V at 400Hz
Input Current

2.5- 1.3A

10 A

Output Voltage

24 VDC-

Output Power

200 W

-

Table 1-4. Power Accessory Specifications

Output Voltage

14.4 VDC

Capacity

84.2 W-Hr

Battery Life

80% Nominal Capacity after 200 Charge/Discharge cycles

Battery Recharge Time

1.5 hours typical (3 hours max) to achieve 80% capacity from a fully discharged battery
while operating at 3 lpm
Table 1-5. Battery Specifications

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List of Items Furnished
Concentrator

Standard Power Sources
AC Power Adapter(9726-1-SEQ)

AC Power Adapter Cord
(North America)(4997-SEQ)

AC Power Adapter Cord (EU)(4998-SEQ)

24 VDC Cable(9727-SEQ)

Battery(9723-SEQ;
reorder PN 20952897)

Table 1-6. SAROS
Also includes: Nasal Cannulas (2), Operator Manual, a spare HEPA and air intake filter.
No additional parts required for standard operation.

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2.0 INTRODUCTION TO YOUR SAROS OXYGEN SYSTEM
This operator manual will inform you about the use and care of the SAROS and its standard components. Please read thoroughly all of theinformation 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
CLINICAL NEEDS. OXYGEN FLOW MODES AND SETTINGS SHOULD BE ADJUSTED ONLY UNDER THE ADVICE OF A PHYSICIAN OR CLINICIAN. THESE SHOULD BE PERIODICALLY REASSESSED FOR THE EFFECTIVENESS OF THE THERAPY.
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
		- Four variable intensity LED indicators provide overall status		- An 8-character LCD display shows settings• 9V Battery• Oxygen Outlet Port
• External Power Connector• Battery• Simplified User Instructions Label• Main / Rating Label• Air Inlet Filter• HEPA Filter
2.1 DESCRIPTION OF THE SAROS ASSEMBLY—SHIPPABLE
Become familiar with the key features of the SAROS and the user control panel.
ADDITIONAL PARTS
24 VDC Cable: 9727-SEQ
AC Power Supply 9726-1-SEQ and Power Cord 4997-SEQ (North America) or 4998-SEQ (EU)
Carry Strap 21495456

External
Power
Connector

Air Inlet Filter(9798-SEQ)
9V Battery(9257-SEQ)

Membrane
Panel

Inlet Cover(9758-SEQ)

SAROS Shell

Main/Rating
Label(underneath)

Simplified User
Instructions
Label (behind)

HEPA
Filter(4770-SEQ)

OxygenOutlet Port
(9764-SEQ)

Battery

Figure 2-1. SAROS Components

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FRONT – CONTROL PANELBACK – SIMPLIFIED INSTRUCTIONSAir InletTOP

BOTTOM – WITHOUT BATTERYOxygenOutletPort
Main/Rating
Label

External
Power
Connector

Battery
Connector

BOTTOM WITH BATTERY

Exhaust Vent

Push Button to
Release Battery

Figure 2-2. SAROS Components
Input/Output Connections
Oxygen Outlet Port: Oxygen supply tubing or a cannula is attached to this port.
Air 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 regularly.
External Power Connector: 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.
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2.2 USER CONTROLS AND SYSTEM STATUS INDICATORSThe SAROS User Control Panel displays important operating information. This section will help you understand this operating information.
The SAROS has two modes: Normal and Tactical. To switch between these modes, depress Utility Button, and then the Decrease Button toswitch between TACT=ON and TACT=OFF.
Normal Mode provides all LED indications with full brightness, full audio indicator sound and LCD backlight. The system always starts up
in Normal Mode. Normal Mode is indicated by TACT=OFF.
Tactical Mode is provided for operation where noise and light may compromise a situation. In these situations, the LED indicators will beoff. Tactical Mode is indicated by TACT=ON.
Green and Yellow 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) and Power Indicator (Green): This button powers the device ON or powers it OFF. The Power Indicator
is illuminated when the device is powered ON and operating in the Normal Mode and off when operating in Tactical Mode.
If Power Indicator is blinking, there may be an issue with the power source. Check Alarm Section for more details.

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 autoSAT 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 witheach inspiratory effort. When the pulse of oxygen is delivered, the flow mode indicator turns off.
ALERT (Yellow) Indicator: 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.

N/A

Buzzer: An audible alarm (or buzzer) is used to alert you to the operating condition of the device, including Alarm and Infosignals.
Flow Setting Indicator: This is the main focus on your control panel. A clinician will correctly set the prescribed flow for
either the CY - Continuous Flow Mode at Y 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 Normal Display
Mode.
Battery Status Gauge: 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 improperly installed, theBattery Status Gauge will not be illuminated and Time on Battery is not displayed.
External Power is Present Indicator (green): 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.

“Alarm Off” indicator displayed during Tactical Mode.

Table 2-1. User Controls and Indicators

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Definition of LCD display screen.

Mode

Battery Status

Alarm Signal

Mode

Battery Status
Normal mode, Pulse Dose. P indicates Normal mode.
XX is the Pulse Dose value 16 to 96.
Tactical mode, Pulse dose. Symbol indicates Tacticalmode. XX is the Pulse Dose value 16 to 96.
Normal mode, Continuous Flow. C indicatesContinuous Flow. Y is flow level 1 to 3.
Tactical mode, Continuous Flow. Symbol indicates
Tactical mode. Y is flow level 1 to 3.

Alarm Signal
Blank fields indicate no alarm conditions present.

ZZ indicates an alarm condition is present. See Alarm
Table for alarm definitions.

Blank fields indicate no battery attached.

Symbol indicates battery. TT is time remaining on
battery.
Battery icon indicates battery is present anddischarging and current battery charge level. TT is timeremaining at the current battery consumption level.
Battery icon indicates battery is present anddischarging and current battery charge level. T
indicates hour of remaining battery at current setting,and .t indicates the tens of minutes, with 1=10 minutes,
2=20 minutes, through 5=50 minutes.
Animated (waterfall) battery icon with any charge leveland no time displayed indicates battery charging.
Animation will pause on one charge level, whichindicates current battery charge level.
Blinking battery icon indicates a battery error condition
or a battery charge level of less than 15 minutes
remaining at the current setting.
Battery at full charge.

Battery at 80% charge.

Battery at 60% charge.

Battery at 40% charge.

Battery at 20% charge.

Battery at 0% charge.

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Examples of LCD display during Normal Mode with Continuous Flow

Example of LCD Display indicates the following information: Normal mode, Continuous
Flow at 1 LPM, no alarm, battery installed, estimated time remaining 28 minutes.

Example of LCD display during Normal Mode with Pulse Flow

Example of LCD Display indicates the following information: Normal mode in pulse
flow setting, 96 is Pulse Dose 96 mL, BL indicates low battery alarm, battery installed,
time remaining.

Example of LCD display during Tactical Mode with Continuous Flow

Example of LCD Display indicates the following information: Tactical mode, continuous
flow is 3 LPM, no alarm, no battery installed.

Example of LCD display during Tactical Mode with Pulse Flow

Example of LCD Display indicates the following information: Tactical mode, 96 is Pulse
Dose 96mL, no alarm, no battery installed.

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2.3 RECOMMENDED OPERATING ENVIRONMENTS
The following chart provides important information concerning the recommended operating environments, or operating conditions, for
optimum use of the device.
Operating Temperature

See Table 1-1

Operating Humidity

See Table 1-1

Transport/Storage Temperature

See Table 1-1

Electrical

Use no extension cords or electrical outlets controlled by a switch.

Altitude0 - 13,000 feet (0 - 3,962 meters)

Placement

DO NOT block the air inlet or the exhaust vent. Place device a minimum of 3 inches (7.5 cm) awayfrom walls, draperies, furniture, other equipment, etc.

Environment

Must be smoke, pollutant, and fume free. Pollution Protection Degree 3 for EMS Environments.

Operating Time24-hours per day when connected to an external AC Power Adapter or 24 VDC Cable.
Table 2-2. Recommended Operating Environments

WARNING: OPERATING THE SAROS OUTSIDE OF THE RECOMMENDED OPERATING ENVIRONMENT MAY NEGATIVELY IMPACT
DEVICE PERFORMANCE, MAY CAUSE DAMAGE TO THE DEVICE AND WILL VOID THE WARRANTY IF THIS OCCURS.

WARNING: OPERATING THE SAROS UNDER HIGH AMBIENT TEMPERATURE CONDITIONS MAY RESULT IN HIGH PRODUCT GASTEMPERATURE.

WARNING: USE OF THIS EQUIPMENT ADJACENT TO OR STACKED WITH OTHER EQUIPMENT SHOULD BE AVOIDED BECAUSE
IT COULD RESULT IN IMPROPER OPERATION. IF SUCH USE IS NECESSARY, THIS EQUIPMENT AND THE OTHER EQUIPMENTSHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERATING NORMALLY.

NOTE: When moving the SAROS from an extreme temperature environment, please allow time for your device to acclimate to the recommended
operating temperature environment.
OPERATION CHARACTERISTICS AT EXTREME TEMPERATURESSAROS has been designed to optimally operate at temperatures between 0º C – 40º C. When operating the system in environments outsidethese temperatures, the system performance is characterized as follows:
The conditions below are not part of IEC60601-1 Compliance Testing.
While operating in temperatures between 0º C to 40º C, SAROS is capable of maintaining flow and purity in continuous and pulse flowmodes, while operating on all power sources with the exception of Battery charging.
While operating in temperatures above 40ºC the purity of the oxygen may fall below 90% and the operating time on the battery may be
reduced. If SAROS is operating on external power at this temperature, the system may not transition to battery operation due to the safety
circuit in the Battery being too hot. During discharge, the SAROS software 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.
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, heatregister or vehicle heater.

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3.0 PREPARATION FOR USE AND INSTALLATION
Pre-Delivery Check List
Before delivering the device, check and log the status of the following:
Parts Inventory – Verify that each SAROS is provided with the following items:• SAROS Concentrator• AC Power Cord
• AC Power Adapter• 24 VDC Cable• Battery• Nasal Cannulas (2)• Operator Manual• Spare Filter Set
3.1 BATTERY INSTALLATION ONTO SAROS
1. Remove connector and pin caps.
2. Press the Latching Pin Release Button inward on the bottom of the Battery prior to installing onto the SAROS.
NOTE: It is important to depress the latching pin release button prior to installation.
3. 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 properly engaged when the latch pin is snapped into place.
Battery
Connector

Battery
Test Button
Latching Pin
Release
ButtonBattery Connector of
SAROS
Figure 3-1. Battery Installation
3.2 LOCATING THE 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.

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4.0 OPERATING INSTRUCTIONSBEFORE OPERATING
This Operator & Service Manual serves as your reference to help you operate and maintain the device. If you have any questions or concerns
please contact a qualified representative, or CAIRE 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.

WARNING: USE OF ACCESSORIES, TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED OR PROVIDED BY THE
MANUFACTURER OF THIS EQUIPMENT COULD RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS OR DECREASED ELECTROMAGNETIC IMMUNITY OF THIS EQUIPMENT AND RESULT IN IMPROPER OPERATION.
WARNING: DO NOT LUBRICATE FITTINGS, CONNECTIONS, TUBING, OR OTHER ACCESSORIES OF THE OXYGEN CONCENTRATOR TO AVOID THE RISK OF FIRE AND BURNS.

CAUTION: Always check that the air inlet and the exhaust vent of the device are not blocked and the air inlet filter is clean before
using your device.

POWERING ON YOUR SAROSThe SAROS comes complete with the concentrator, AC Power Adapter, power cord, 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: AC power adapter, DC power supply, and battery. To power the SAROS on, connect a source of power and press and hold the
ON/OFF button for 2–3 seconds.
GENERAL CHARGING INFORMATIONThe 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: DO NOT 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.

AC POWER ADAPTERThe SAROS includes a universal AC Power Adapter for use wherever standard AC power is available. To connect to an AC power source, besure 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 an AC outlet. When the device is plugged in properly, the External Power is Present Indicator will appear on the user control panel in Normal Mode.
CAUTION: The AC power cords used with the SAROS must meet the electrical requirements of the country where the device is used.

CAUTION: Use only with CAIRE Inc. supplied power cords.

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 thedevice is properly 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.
WARNING: 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 CABLE IS CONNECTED TO THE VEHICLE. DOING SO WILL DRAIN THE VEHICLE’S
BATTERY.
WARNING: IF THE VEHICLE’S DC POWER SOURCE DROPS BELOW 20.0 VOLTS (BROWNOUT CONDITION) THE SAROS WILL
REVERT TO BATTERY OPERATION IF THE BATTERY IS PRESENT.
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TYPICAL NEW BATTERY OPERATING TIME
Battery Operating Time: The remaining operating time of the Battery is displayed on the user control panel when in Battery mode. A variety
of factors, such as flow setting, Pulse or Continuous Flow Mode, temperature or age will impact the operating time. The following tableprovides operating time estimates for the SAROS operating on a fully charged Battery given certain flow settings and nominal operating
conditions.
CONTINUOUS FLOWSETTING (LPM)

CONTINUOUS FLOWBATTERY OPERATING TIME

PULSE FLOW BATTERYOPERATING TIME

PULSE FLOW MODE SETTING
(ML)

1.0

1.1 hours

1.2 hours

16

2.0

45 min1.1 hours

32

3.0

30 min53 min48

47 min64

46 min80

37 min96

Table 4-1. Typical New Battery Operating Time
NOTE: Battery run time will degrade under high temperature use and as the battery cells age.
CAUTION: Store the battery in a cool and dry location. This will help to assure the longevity of the battery.

CAUTION: U.S. Department of Transportation (DOT) and United Nations (U.N.) regulations require the removal of the battery from thedevice 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.
CAUTION: Only replace the CAIRE Inc. battery supplied with the device with a CAIRE Inc. battery.

WARNING: DO NOT ATTEMPT TO OPEN THE BATTERY; THERE ARE NO SERVICEABLE PARTS INSIDE THE BATTERY.

WARNING: DO NOT STORE THE SAROS WITH THE BATTERY INSTALLED IN THE UNIT. RETURN THE BATTERY TO AN AUTHORIZEDSERVICE CENTER OR CAIRE INC. FOR PROPER DISPOSAL.

WARNING: 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 1.5 hours, while operating at 3
LPM continuous flow.
If the Battery becomes too warm during discharging, recharging will not begin until the Battery sufficiently cools. Removing the Battery andallowing it to cool may expedite this cooling process.
INITIAL BATTERY CHARGINGThe 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.
Depress latching pin button prior to connecting battery.
Power the SAROS ON, with the AC Power Adapter plugged in, and the Battery correctly installed. With the device powered ON, allow theBattery 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.
WARNING: If out of operating specifications, allow SAROS and SAROS accessories to return to normal operating range specifications prior to use.

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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 hotday.

NOTE: The SAROS can be used when either discharging or recharging of the Battery is taking place.
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 BATTERYTime Remaining (Min)< 6 Minutes

7 Minutes < X < 15 Minutes> 15 Minutes

Flash

Flash

Solid

Battery Icon

Flash

Solid

Solid

Alarm

ON

OFF

OFF

Table 4-2. Minimum Remaining Time on Battery
When replacing the Battery without the device being externally powered, push the ON/OFF (Standby) to restart the SAROS.
BATTERY INSTALLATION ONTO SAROS
1. Remove connector and pin caps.
2. Press the Latching Pin Release Button inward on the bottom of the Battery prior to installing onto the SAROS.
NOTE: It is important to depress the latching pin release button prior to installation.
3. 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 properly engaged when the latch pin is snapped into place.

Battery
Connector

Latching Pin
Release
ButtonBattery Connector of
SAROS
Figure 5-1. Battery Installation

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4.1 OPERATING THE SAROS FOR THE FIRST TIME
Step 1: Locating the 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. SAROS is operable in both vertical andhorizontal orientations. Although capable of operating in a vertical orientation, the device is more stable operating in the horizontal orientation when freestanding. The user or technician must secure the device firmly to the either the patient stretcher (horizontal orientation), or toan appropriate permanent mount in a vehicle that prevents the device from moving or coming loose during all driving conditions. CAIRE canalso offer a carrying strap P/N 21495456 to allow secure carrying of the SAROS while outside the vehicle.
Connect the AC Power Adapter to External Power Receptacle located on top of the device and plug the device into an 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 Normal Mode and Continuous Flow of 3 LPM.
Allow five (5) minutes minimum for the device to reach its performance specifications. The five (5) minutewarm-up time is a stabilization period during which no alerts or codes are to be expected. If the device fails to reach its performance specifications after five (5) minutes, the unit will alarm according to the mode it is in.
Step 3: Connect the oxygen supply tubing to the SAROS

Figure 4-2. Cannula Installation
Clean and Replace the cannula and oxygen supply tubing regularly, as recommended by the cannula manufacturer’s 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 andforth 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. IN PULSE MODE, USE ONLY THE CANNULA WITHOUT EXTENSIONS.

WARNING: USE ONLY WATER-BASED LOTIONS OR SALVES THAT ARE OXYGEN-COMPATIBLE PRIOR TO AND DURING OXYGENTHERAPY. NEVER USE PETROLEUM OR OIL-BASED LOTIONS OR SALVES TO AVOID THE RISK OF FIRE AND BURNS.

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 willswitch to the Continuous Flow Mode and will produce at the last equivalent setting. 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.

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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 afeature, called autoSAT 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.
autoSAT Technology provides a consistent bolus volume of oxygen as a patients’ breath rate increases or decreases.
Pulse Setting
Bolus Size (+/- 15%)

Maximum Breath Per Minute
(bpm)

16

40

32

40

48

40

64

40

80

37

96

31
Table 4-3. Pulse Settings

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 isthe 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.

WARNING: AS WITH ALL OXYGEN-CONSERVING TYPE DEVICES, THE SAROS MAY NOT BE ABLE TO DETECT ALL INSPIRATORYEFFORTS 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 MENUThe 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:• 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.
The following sequence of screens shall be displayed on the LCD when the Utility Menu is displayed.

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Format: AC=XXXX
Alarm Codes

See Alarm Code Table definitions. When more than one alarm code is present, pressing the Increase key will show thenext 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)

Normal Mode
Brightness

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

Tactical Mode
Brightness

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

Tactical Buzzer Volume

Tactical Mode On / Off
selection

9V Battery Status

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

Selects the LED and LCD backlight Light intensity used in Tactical Mode.
Format: TVOL=ON
Format: TVOL=OFF
Format: TACT=ON
Format: TACT=OFF
Format: 9V = GOOD
Format: 9V = RPLC

Hours of Operation

Format: HR= XXXXX

System Software Part
Number and Revision

Format: FW-1 x.y(x = Major Version, and y = minor Version)

Motor Software Part
Number and Revision

Format: FW-2 x.y(x = Major Version, and y = minor Version)
Table 4-4. Utility Menu Screens

Step 7: Begin using the SAROSNOTE: 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 the SAROS.

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5.0 OPERATOR MAINTENANCE & SERVICE
5.1 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 only Lysol Brand II disinfectant (or equivalent). Proceed as directed by the manufacturer.
WARNING: USE ONLY SPARE PARTS RECOMMENDED BY THE MANUFACTURER TO ENSURE PROPER FUNCTION AND TO AVOIDTHE RISK OF FIRE AND BURNS.

Cleaning the SAROS Battery
The Battery in the SAROS requires special care to assure a longer life and the highest level of performance. The CAIRE Inc. 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 thelatch.
Cannula Replacement
Replace your supply tubing and cannula on a regular basis as recommended by the cannula manufacturer’s instructions.
5.2 ROUTINE MAINTENANCE
Maintenance StepFrequency

Performed By

Clean Air Inlet Filter

weekly (If in use, not required if in storage.)User

Run device and fully drain SAROS battery

3 months*

User, Distributor, or Authorized Service Center

Replace 9-volt battery

as needed

User, Distributor, or Authorized Service Center

Air Inlet Filter Replacement

6 months, or as needed

User, Distributor, or Authorized Service Center

HEPA Filter

6 months, or as needed

User, Distributor, or Authorized Service Center

Performance Verification Check**

6 months, or when a problem is suspected

Distributor or Authorized Service Center

Table 5-1. Routine Maintenance*Three month recommendation is based on a climate-controlled storage environment.
** Contact Distributor to scheduleTools Required
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 Phillips Screwdriver• 3/8” open end wrench• Oxygen Analyzer that includes the capability to measure both flow rate (LPM and mL) and Oxygen concentration/purity %.
• Tubing to connect the SAROS to the Oxygen Analyzer for testing.

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Air Inlet Filter(9798-SEQ)

Inlet Cover Screws
x4 (9291-SEQ)

9V Battery(9257-SEQ)
Inlet Cover(9758-SEQ)
OxygenOutlet Port
(9764-SEQ)

Simplified User
Instructions
Label (behind)

HEPA
Filter(4770-SEQ)

Battery

Figure 5-1. SAROS Components

5.3 CLEANING OR REPLACING AIR INLET FILTER
5.3.1 Removing the air inlet cover.
5.3.2 Disconnect power supplies and remove the battery if connected.
5.3.3 Using a Phillips #1 screwdriver, loosen the four captive screws.
5.3.4 Remove cover.

Figure 5-2. Remove Cover5.3.5 REMOVING AND CLEANING/REPLACING THE AIR INLET FILTER
5.3.6 Gently remove the filter shown in figure 6-3.
5.3.7 If the filter is damaged, replace.
5.3.8 For cleaning, gently wash with warm soapy water. Allow filter to completely dry before re-installing.
5.3.9 Re-install Air Inlet Filter.

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5.3.10 Using a Phillips #1 screwdriver, re-attach the Cover with screws.
5.3.11 Initial and date the Service and Maintenance Record.

Figure 5-3. Filter
CAUTION: Operating the SAROS with a clogged air inlet filter may reduce performance and lead to system damage or premature
failure.

5.4 REPLACING THE HEPA FILTER
5.4.1 Disconnect all power supplies including external Battery if connected.
5.4.2 Using a 3/8” open end wrench, remove the O2 Fitting/HEPA Filter shown in figures 6-4.
5.4.3 Unscrew the HEPA Filter from the O2 Fitting as shown in figure 6-4.
5.4.4 Replace with new HEPA Filter. Do not over tighten.
NOTE: Ensure that the O-Rings shown in figure 6-4 are positioned correctly before re-installation.
5.4.5 Re-install the O2 Fitting/HEPA Filter. Do not over tighten.
5.4.6 Initial and date the Service and Maintenance Record.

HEPA filter

o-rings

Figure 5-4. Reinstall O2 Fitting/HEPA Filter

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5.5 RUN DEVICE AND FULLY DRAIN SAROS BATTERY
Operate the device once every 3 months by running the device on battery power until drained. This is required if the device is in storage
and unused. If the device is not run regularly per this recommendation there is a risk it will not perform to specification when removed fromstorage.
1) Turn on the SAROS and run at any continuous flow setting until the battery is completely drained and the SAROS powers off.
2) Once the SAROS powers off, immediately connect to AC external power to begin re-charging the battery. You may either continue to run the SAROS
or leave it powered off during re-charge.
3) Once the battery is fully charged, disconnect the battery, power off the unit if still running, and return the SAROS to proper storage conditions.

5.6 REPLACING THE 9V BATTERY
5.6.1 Disconnect power supplies and remove external battery if connected.
5.6.2 Using a Phillips #1 screwdriver, loosen the four captive screws shown in figure 5-2.
5.6.3 Remove cover.
5.6.4 Remove 9V battery from where shown in figure 5-5.
5.6.5 Disconnect and replace battery as shown in figure 5-5.
5.6.6 Using a Phillips #1 screwdriver, replace the Air Inlet Cover.
5.6.7 Initial and date the Service and Maintenance Record.

Figure 5-5. Replacing 9V battery

6.0 ALERTS, ALARMS, AND TROUBLESHOOTING TABLE
The tables show the possible audible and visual alerts and alarms, their conditions and suggest appropriate troubleshooting responses. The
SAROS runs functional verification on alarm system as part of its operation. If you are unsure about any alerts or alarm conditions, or
responses please contact an authorized service technician or go to www.caireinc.com.
Alarm levels
Type

Level

Yellow LED

Audio Alarm

LCD

Description

Displays Alarm Signal

Attention isrequiredNC (No Change)

All OK

Alarm

1

ON

1 beep 200ms only or repeats every
20 seconds

Status0

OFF

OFF
Table 6-1. Alarm Levels

WARNING: AVAILABILITY OF A BACK-UP SOURCE OF OXYGEN IS RECOMMENDED IN CASE OF POWER OUTAGE OR A DEVICEFAILURE. CONSULT YOUR PROVIDER FOR BACK-UP OXYGEN SYSTEM.

WARNING: DO NOT Ignore Alarms. System will attempt to produce oxygen under fault condition but may not be at purity or flow.

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Operator Manual
6.1 SYSTEM TROUBLESHOOTING GUIDESYMPTOMPROBABLE CAUSEREMEDYNo Battery installed

Install Battery or plug into external power

Battery is discharged or no external power
is present

Plug into external power

Other

Contact an authorized Service Technician

Air Inlet or HEPA Filter Blocked

Clean Air Inlet Filter or replace HEPA Filter

SAROS not ON

Power SAROS ON

Tubing or cannula is not properly connected
or is kinked

Check tubing, cannula and connections

Other

Contact an authorized Service Technician

Restriction in tubing

Repair or replace tubing.

Air Inlet or HEPA Filter restricted

Clean air inlet filter or replace HEPA Filter. Place your
SAROS so there is adequate air flow.

Inadequate Ventilation

Place your SAROS so that there is adequate air flow,
i.e. not covered by a blanket or a poncho.

Hot environment

Allow SAROS to cool

Other

Contact an authorized Service Technician

Restriction tubing

Repair or replace tubing.

Air Inlet or HEPA Filter Blocked

Clean Air Inlet Filter or replace HEPA Filter

Other

Contact an authorized Service Technician

Tubing/cannula longer than 7 feet (2.1m)

Attach 7 foot (2.1m) tubing/cannula

No inspiration detected

Contact an authorized Service Technician

Battery is aging

Contact an authorized Service Technician to replace
Battery

Ambient condition is too hot

Place unit in cool environment or out of direct
sunlight, if possible.

Battery will not latch onto SAROS

Battery Latching Pin Release is stuck in thewrong position

Press the Latching Pin Release Button inward to freethe latch mechanism and re-install Battery

Oxygen production is limited due topower limitations

External power source cannot supply enoughpower

Check air inlet filter and check the external powersourceSAROS does not power onwhen ON/OFF button is pressed(constant tone)

No Oxygen

Low Oxygen Concentration

Low Oxygen FlowNo Oxygen delivered in
Pulse Flow Mode
Battery Status Gauge never indicatesfully charged
Heat related failures, i.e.
Compressor too hot

Table 6-2. System Troubleshooting Guide

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6.2 ALARM INDICATIONS AND CODES
Priority #Alarm Signal

Alarm Type

Alarm Code

Alarm Description

Buzzer

1

PN

Power None

4000

Loss of Power

1 beep only

2

HU

Hot Unit

9510

Battery Too Hot

1 beep every 20 seconds for 120 seconds;
LCD Battery Icon blinking

3

HB

Hot Battery

9300

Motor Driver Board Too Hot

1 beep every 20 seconds for 120 seconds

4

HU

Hot Unit

9200

Power Board Too Hot

1 beep every 20 seconds for 120 seconds

5

HU

Hot Unit

9100

Compressor Too Hot

1 beep every 20 seconds for 120 seconds

6

HU

Hot Unit

9110

Compressor Temperature Sensor
Failure1 beep only

7

SM

Shutdown
Mechanical

A500

Unable to Achieve or Maintain
Product Tank Pressure

1 beep every 20 seconds for 120 seconds

8SE

Shutdown
Electrical

AC00

External Voltage Too High

1 beep every 20 seconds for 120 seconds;
Power LED blinking

9SE

Shutdown
Electrical

8000

Invalid Reset

1 beep every 20 seconds for 120 seconds

10SM

Shutdown
Mechanical

9194

Compressor Stall

1 beep every 20 seconds for 120 seconds

11

SE

Shutdown
Electrical

9195

Compressor Driver Fault

1 beep every 20 seconds for 120 seconds

12SE

Shutdown
Electrical

A300

Ultrasonic Sensor Failure

1 beep every 20 seconds for 120 seconds

13

SE

Shutdown
Electrical

A000

IPC Failure

1 beep every 20 seconds for 120 seconds

14

SE

Shutdown
Electrical

A010

Board Communication Failure

1 beep every 20 seconds for 120 seconds

15

SE

Shutdown
Electrical

9000

Watchdog Time out

1 beep every 20 seconds for 120 seconds

16

PN

Power None

4010

Missing Power POST

1 beep only

17

SE

Shutdown
Electrical

FD00

Motor Controller Fault

1 beep every 20 seconds for 120 seconds

18

TN

Trigger None

B000

No Breath Detected for 15-59
seconds

1 beep every 20 seconds for 120 seconds

19

TN

Trigger None

B010

No Breath Detected for 60
seconds

1 beep only; Automatically switches tocontinuous mode

20

BL

Battery Low

9540

Low Battery ≤ 6 minutes

1 beep every 20 seconds for 120 seconds;
LCD Battery Icon blinking

21

OL

Oxygen Low

0800

Oxygen Concentration Low(< 85% nominal)

1 beep every 20 seconds for 120 seconds

22

XF

Malfunction
Flow

2000

Flow Rate Error

1 beep every 20 seconds for 120 seconds

23

XB

Malfunction
Battery

9500

Battery Communication Error

1 beep every 20 seconds until condition
clears24

XK

Malfunction
Keypad8110

Key Stuck On

1 beep every 20 seconds until condition
clears

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Operator Manual
Priority #Alarm Signal

Alarm Type

Alarm Code

Alarm Description

Buzzer25

TN

Trigger None

A200

Pulse Mode Disabled due to
Sensor Failure

1 beep every 20 seconds until condition
clears26

XB

Malfunction
Battery

952C

Cannot Charge Battery

1 beep every 20 seconds until condition
clears27

9L

9V Low

1020

Low 9 Volt Battery POST

1 beep only

28

9L

9V Low

1000

Low 9 Volt Battery

1 beep only

29

XB

Malfunction
Battery

1030

Battery Too Hot to Charge

1 beep every 20 seconds until condition
clears30

XB

Malfunction
Battery

95C0

Battery Too Cold to Use

1 beep every 20 seconds until condition
clears31

XB

Malfunction
Battery

95CCBattery Too Cold to Charge

1 beep every 20 seconds until condition
clears32

XB

Malfunction
Battery

9550

Battery Thermistor Failure

1 beep every 20 seconds until condition
clears; LCD Battery Icon blinking

33

XB

Malfunction
Battery

9560

Battery Chip Thermistor Failure

1 beep every 20 seconds until condition
clears; LCD Battery Icon blinking

34

BL

Battery Low

1040

Low Battery ≤ 15 Minutes

1 beep only

35

XP

Malfunction
Pressure

A210

Breath Pressure Sensor Failure

1 beep only

36

XE

Malfunction
Electrical

A600

Purity Calibration Data Failure

1 beep only

37

XE

Malfunction
Electrical

A700

Flow Calibration Data Failure

1 beep only

38

XP

Malfunction
Pressure

AB00

Ambient Pressure Sensor Failure

1 beep only

39

XT

Malfunction
Temperature

AB10

Ambient Temperature Sensor
Failure1 beep only

40

XE

Malfunction
Electrical

8300

Run Log Storage Failure

1 beep only

41

XE

Malfunction
Electrical

8320

Event Log Storage Failure

1 beep only

42

XE

Malfunction
Electrical

8400

EEPROM Data Write Failure

1 beep only

43

XT

Malfunction
Temperature

8900

ATF Temperature Sensor Failure

1 beep only

44

XT

Malfunction
Temperature

9210

Power Board Temperature Sensor
Failure1 beep only

45

XT

Malfunction
Temperature

9310

Motor Driver Board Temperature
Sensor Failure

1 beep only

46

XP

Malfunction
Pressure

A400

Ambient Pressure Error

1 beep only

Table 6-3. Alarm Indications and Codes

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7.0 REPROGRAMMING/CALIBRATIONAll reprogramming of the circuit boards shall be performed by CAIRE, Inc or by a factory authorized service center. Flow calibration isrequired whenever replacing an ATF, control board, compressor, or proportional valve. Flow calibration can be done at a CAIRE authorized
service center or in the field using item T-10560. See manual MN053 for details on performing flow calibration and firmware updates in thefield using item T-10560.
8.0 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 CAIRE Inc. authorized shipping container is not available, contact CAIRE Inc. for replacement shipping container.
9.0 STORING AND DISCARDING THE SAROSWARNING: Do not expose the SAROS to water. The SAROS enclosure does not provide protection against the harmful effects ofliquid 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 fromhigh temperatures, moisture and humidity. Remove the Battery when storing the device.
Ensure that all recommended maintenance procedures in section 5.0 are performed while the device is in storage. It is especially importantthat the 3-month requirement to run the device and fully drain the SAROS battery be performed while the unit is in storage to ensure proper
operation.
Discarding the SAROS
Battery Disposal: Your Battery is rechargeable and can be recycled. Always return it to an authorized service center or CAIRE Inc. for proper
disposal. You can also contact your local city or town offices for instructions on proper disposal of
the Battery.
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,
CAIRE Inc. may be contacted for disposal information at 1-800-482-2473.

MN255-1 D | 33

Operator Manual
10.0 EMC TESTING
Guidance and Manufacturer’s Declaration­—Electromagnetic Emissions
The SAROS is intended for use in the electromagnetic environment specified below. The customer or the user of the SAROS should assure that it is usedin such an environment.
Emissions Test

ComplianceElectromagnetic Environment - Guidance

RF emissions CISPR 11

Group 1The SAROS 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.

RF emissions CISPR 11

Class B

Harmonic emissions
IEC 61000-3-2Class A

Voltage fluctuations/ flicker
emissions IEC 61000-3-3Complies

The SAROS 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.

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The SAROS is intended for use in the electromagnetic environment specified below. The customer or the user of the SAROS should assure that it is usedin such an environment.
Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidanceElectromagnetic environment – guidance±8 kV contact±8 kV contact±15 kV air discharge±15 kV air discharge

Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.

±2 kV for power supply lines±2 kV for power supply lines±1 kV for input/output lines

N/A

IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4

Mains power quality should be that of a typicalprofessional healthcare facility and home healthcare
environments.

±1 kV line(s) to line(s)Surge±2kV common mode on AClines

IEC 61000-4-5±1kV differential on AC lines±1 kV line(s) to line(s)±2kV common mode on outdoor
I/O lines

Voltage dips, shortinterruptions and voltage
variations on power supply
input lines IEC 61000-4-11

Power frequency (50/60
Hz) magnetic field IEC
61000-4-8

0% UT for 0.5 cycle (0°, 45°,90°, 135°, 180°, 225°, 270°,315°)

0% UT for 0.5 cycle (0°, 45°,90°, 135°, 180°, 225°, 270°,315°)

0% UT for 1 cycle (00)

0% UT for 1 cycle (00)

70% UT (30% dip in UT) for 25/30 70% UT (30% dip in UT) for
cycles (00)
25/30 cycles (00)
0% UT for 250/300 cycles (00)

0% UT for 250/300 cycles (00)

3A/m

3A/m

Mains power quality should be that of a typicalprofessional healthcare facility and home healthcare
environments.

Mains power quality should be that of a typicalprofessional healthcare facility and home healthcare
environments. If the user of the SAROS requires
continued operation during power mains interruptions,
it is recommended that the SAROS is powered froman uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels
characteristic of a typical location in a professional
healthcare facility and home healthcare environments.

NOTE UT is the A.C. mains voltage prior to application of the test level.
NOTE In some cases, the SAROS may reset after a significant Electrostatic Discharge, and may require a Full Power Cycle to resume normal operation.
See Troubleshooting section for more details.

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Guidance and Manufacturer’s Declaration–Electromagnetic Immunity
The SAROS is intended for use in the electromagnetic environment specified below. The customer or the user of the SAROS should assure that it is usedin such an environment.
Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF

10 Vrms

10 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer
to any part of the SAROS, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.

Radiated RF

10 V/mIEC 61000-4-3

80 MHz to 2700 MHz

10 V/mRecommended separation distanced  1.2 P

d  1.2 P

d  1.2 P

d  1.2 P
d  1.2 P = 80 MHz to 800 MHz
d  1.2 P = 800 MHz to 2700 MHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distancein metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey,a should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following
symbol:NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects andpeople.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SAROS is used exceeds the applicable RF compliance level above, the SAROS should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the SAROS.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

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Operator Manual
Recommended separation distances between portable and mobile RF communications equipment and the SAROSThe SAROS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
SAROS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and the SAROS as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter

Separation distance according to frequency of transmitterm
150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHzd  1.2 P

d  1.2 P

d  1.2 P

0,01

0.12

0.12

0.23

0,1

0.38

0.38

0.73

W

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to thetransmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects andpeople.

Classification
Type of protection against electric shock:Class II
Protection from electric shock is achieved bydouble			
insulation.
Degree of protection against electric shock:Type BF
Equipment providing a particular degree of		 protection against electric shock regarding		 1) allowable leakage current;		 2) reliability of protective earth connection (if present).
		 Not intended for direct cardiac application.
Independent testing for Medical Electrical Equipment Standard:
Tested to be in compliance with
• IEC 60601-1 edition 3.1: Medical Electrical equipment Part 1 General Requirements for safety.

Protection against potential electromagnetic or other interference
between the equipment and other devices.
• Tested to be in compliance with EN 60601-1-2/IEC
		 60601-1-2: 4th Edition.
• Tested to be in compliance with RTCA/DO160
Section 21 Category M.
• CISPR 11 / EN 55011 Class B Group 1, “Industrial,
Scientific, and Medical (ISM) Equipment”• FCC Part 15, Subpart B – Class B Unintentional Radiators
IP33 – Protection against ingress of tools, thick wires, etc. >
2.5mm. Water falling as a spray at any angle up to 60° from thevertical shall have no harmful effect.
Method of cleaning and infection control allowed: Please refer tocleaning section of this SAROS manual.
Degree of safety of application in the presence of flammable anesthetic gases: Equipment not suited for such application.
Mode of operation: Continuous duty.

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NOTES

MN255-1 D | 37

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NOTES

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NOTES

MN255-1 D | 39

www. cai rei nc. com

CAIRE Inc.
2200 Airport Industrial Dr., Ste. 500
Ball Ground, GA 30107 U.S.A.
Medical Product Service GmbH
Borngasse 20
35619 Braunfels, Germany
Tel: +49 (0) 6442-962073
Email: info@mps-gmbh.eu
CAIRE and CAIRE Inc. are registered trademarks of CAIRE Inc. Please visit
our website below for a full listing of trademarks. Trademarks: www.caireinc.
com/corporate/trademarks/.
Salter Labs® is a registered mark of Salter Labs, Arvin, CA 92303.
Lysol® is a registered trademark of Reckitt Benckiser, UK.
© Copyright 2022 CAIRE Inc. All Rights Reserved. CAIRE Inc. reserves
the right to discontinue its products, or change the prices, materials,
equipment, quality, descriptions, specifications and/or processes to its
products at any time without prior notice and with no further obligation orconsequence. All rights not expressly stated herein are reserved by us, asapplicable.

|MN255-1-DO~

27 Apr 2022

MN255-1 D