HELiOSTM Reservoirs

User Manual (English)

HELiOSUser Controls & System Status Indicators
ISO 7000; Graphical symbols for use on equipment—Index and synopsis
Storage or operating temperature
range. Reg. # 0632
Storage humidity range Reg. # 2620
Keep away from rain, keep dry. Reg.
# 0626
Name and address of manufacturer.
Reg. # 3082
Caution, consult accompanying documents. Reg. # 0434A

This device complies with the requirements of Directive 2010/35/EU
concerning medical devices. It bears
the pi marking as shown.
ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
Non-toxic gas.
Hazard Oxidizing substances: fire
intensifying risk.
Refrigerated Liquid, USP; Produced
by Air Liquefaction
Internal Symbols

Catalog Number. Reg. # 2493

Keep unit well ventilated at all times

Serial Number. Reg. # 2498

Keep away from flammable materials,
oil and grease.

This way up. Reg. # 0623
Fragile, handle with care. Reg. #0621
ISO 7010: Graphical symbols—Safety colors andsafety signs—Registered safety signs
Frostbite may occur on contact withcold liquid or gaseous oxygen, or
frosted parts. Warning low temperature. To warn of low temperature or
freezing conditions. Reg. # W010
The instruction manual must be read.
Reg. # M002
Keep away from open flame, fire,
sparks. Open ignition source andsmoking prohibited. Reg. # P003
Do not smoke near unit or while
operating unit. Reg. # P002
Type BF applied part (degree ofprotection against electric shock).
Reg. # 5333
Warning. Reg. # W001
Council Directive 93/42/EEC; concerning medical
devices
Authorized representative in theEuropean Community
If the product unique device identifier(UDI) label has the CE#### symbolon it, the device complies with therequirements of Directive 93/42/EEC
concerning medical devices. The
CE#### symbol indicates notified
body number.
2 - ENG PN 21157307 C | User Manual

Wipe connector with clean dry cloth
before filling.
IEC 60417: Graphical Symbols for use on equipment
Do not cover unit. These units normally vent oxygen. No. 5641
21 CFR 801.15: Code of Federal Regulations Title 21
Federal law restricts this device tosale by or on the order of a physician.
Council Directive 2012/19/EU: waste electrical andelectronic equipment (WEEE)
WEEE
IEC 60601-1: Medical electrical equipment Part 1
General requirements for basic safety and essential
performance
Drip Proof
This product may be covered by one or more patents, US and international. Please visit our website
below for the listing of applicable patents. Pat.:www.caireinc.com/corporate/patents/.

HELiOSSpecifications• Mode of Operation: Continuous Flow
• Type of Protection Against Electrical Shock: Internally Powered Equipment• Degree of Protection Against Electrical Shock: Type BF Applied Part
• IPX1 Classification According to the Degree of Protection Against Ingress of Water: Drip Proof• Equipment not suitable for use in the presence of flammable mixtures
Product Specifications
LOX capacity
Gaseous equivalentcapacity
Weight, filled
Weight, empty
HeightDiameter
Typical use time at 2
LPM demand mode
Operating pressure
Normal evaporation
rateStandard flow control
range
Flow Rate Accuracy

HELiOS U36
85 lb(38,6 kg)
29,069 L

HELiOS U46
110 lb(49,9 kg)
37,916 L

HELiOS 36
85 lb(38,6 kg)
29,069 L

HELiOS 46

110 lb (49,9 kg)
37,916 L

138 lb (62,6 kg)
170 lb (77,1 kg)
138 lb (62,6 kg)
170 lb (77,1 kg)
53 lb (24 kg)
60 lb (27,2 kg)
53 lb (24 kg)
60 lb (27,2 kg)
33.5 in. (851 mm)
37.5 in. (952 mm)
33.5 in. (851 mm)
37.5 in. (952 mm)
15.4 in. (391 mm)
15.4 in. (391 mm)
15.4 in. (391 mm)
15.4 in. (391 mm)
10 days
13 days
10 days
13 days
21 hrs
21 hrs
21 hrs
21 hrs22 psi (152 kPa)
22 psi (152 kPa)
22 psi (152 kPa)
22 psi (152 kPa)
1.2 lb/ day (0,54 kg/ 1.2 lb/ day (0,54 kg/ 1.2 lb/ day (0,54
1.2 lb/ day (0,54
day)
day)
kg/day)kg/day)Maximum flow 10
Maximum flow 10
Maximum flow 10
Maximum flow 10
LPM
LPM
LPM
LPM
Please see Flow Table in the HELiOS Technical Service Manual, PN 14883289

PN 21157307 C | User Manual 3 - ENG

HELiOS

Warning Information
Important: Read this manual thoroughly before
operating the HELiOS.
RX Only.
WARNING: THIS DEVICE IS NOT INTENDED FOR LIFE SUSTAINING USE.
WARNING: IF YOU FEEL THE EQUIPMENT IS NOTOPERATING PROPERLY, CALL YOUR HEALTH
CARE PROVIDER. DO NOT ATTEMPT TO REPAIR
OR ADJUST THE UNIT YOURSELF.
WARNING: DO NOT MODIFY THIS EQUIPMENTWITHOUT AUTHORIZATION FROM THE MANUFACTURER.
WARNING: IF CONTINUITY OF OXYGEN SUPPLY IS
REQUIRED, ENSURE THAT AN ADEQUATE SUPPLYOF OXYGEN AND/OR A SECONDARY OXYGENSUPPLY IS AVAILABLE AT ALL TIMES DURING
THERAPY.
WARNING: PATIENT OR OTHERS MAY BE ENTANGLED IN CANNULA OR OTHER TUBING CAUSINGASPHYXIATION.
WARNING: DO NOT ALLOW SMOKING, CANDLES,OR OPEN FLAMES WITHIN 10 FEET (3 METERS) OF
THE DEVICE, OR CLOSER THAN 8 INCHES (20 CM)
FROM ANY SOURCE OF IGNITION.
WARNING: KEEP YOUR UNIT IN A WELL-VENTILATED AREA.
WARNING: DO NOT STORE LIQUIDOXYGEN EQUIPMENT IN A CLOSET, CAR
TRUNK, OR OTHER CONFINED AREA. DO
NOT PLACE BLANKETS, DRAPERIES, OR
OTHER FABRICS OVER EQUIPMENT.
WARNING: THIS PRODUCT CAN EXPOSE YOU
TO CHEMICALS INCLUDING NICKEL, WHICH IS
KNOWN TO THE STATE OF CALIFORNIA TO CAUSECANCER. FOR MORE INFORMATION, GO TO WWW.
P65WARNINGS.CA.GOV.
WARNING: IN THE EVENT THERE IS A SERIOUS
INCIDENT OCCURRING WITH THIS DEVICE, THE
USER SHOULD IMMEDIATELY REPORT 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 ALSOREPORT THE INCIDENT TO THE COMPETENT AUTHORITY IN THE COUNTRY WHERE THE INCIDENTOCCURRED.
Caution: Use the HELiOS Reservoir only as
directed by your doctor.

4 - ENG PN 21157307 C | User Manual

Caution: The unit contains liquid oxygen which isextremely cold, almost 300°F (-184°C). Exposure tosuch a low temperature can cause severe frostbite.
Caution: Liquid and gaseous oxygen, though nonflammable, cause other materials to burn faster thannormal. This hazard, along with the low temperatureof liquid oxygen, warrants certain safety precautions.
Caution: Keep flammable materials away from thisequipment. Aerosol sprays, oils and grease, including facial creams and petroleum jelly, ignite easily
and may burn rapidly in the presence of oxygen.
Caution: Smoking while wearing an oxygen cannula
can cause facial burns and possibly result in death.
Removing the cannula and placing it on clothing,bedding, sofas, or other cushion material will causea flash fire when exposed to a cigarette, heat source,
spark or flame.
If you smoke please: (1) turn off the portable, (2) takeoff the cannula, and (3) leave the room where thedevice is located.
Caution: In the event of an accidental tip-over, immediately but cautiously return the unit into an uprightposition if possible. If any liquid oxygen is escaping,leave the area immediately and call your healthcare
provider. Do not attempt to move the unit or stop theliquid oxygen from escaping.
Note: Do not touch frosted parts of any unit.
Note: Do not store or operate the portable coupled to
the HELiOS Reservoir.
Note: Do not allow untrained personnel to handle oroperate this device.
Note: Use of this device is prohibited on commercial
passenger and cargo air flights by the Federal Aviation
Administration.

Intended Use

The CAIRE HELiOS Reservoir is intended for theadministration of supplemental oxygen. The device
is not intended for life support nor does it provide
any patient monitoring capabilities.

Introduction

HELiOS
tor. HELiOS Standard reservoirs can only fill the
HELiOS H300 Plus and H850 Marathon portable
units (see Standard and Universal Reservoirs section for model identification).
The HELiOS reservoir is also designed for stationary use. Continuous oxygen flow from 0-10 LPM
can be taken directly from the reservoir with theattachment of an external flow control valve.

HELiOS Universal Reservoir shown.
Universal & Standard reservoirs are available
in 36 and 46 liter models.

Another method of stationary use is to connect
a HELiOS H300 or H850 portable unit to the
HELiOS reservoir using an oxygen supply line.
When the portable is connected to the reservoir inthis manner, the reservoir supplies gas oxygen to
the portable and allows you to breathe from theportable as a conserving (demand) device without
filling it.

A liquid oxygen system is designed to provide supplementary oxygen as prescribed by a physician.
Your liquid oxygen system includes a HELiOS
reservoir. This user manual contains the instructions for using the HELiOS reservoir.

Controls

The Helios reservoir is intended for the administration of supplemental oxygen to the patient in theend user’s home and can also be used in institutions
such as nursing homes or sub-acute care facilities.
The device is not intended for life support nor doesit provide any patient monitoring capabilities. It
is recommended to have an alternate source of
supplemental oxygen in the event of mechanicalfailure.

3. Battery Housing

The device is used by COPD patients or thosewith diminished breathing capacity. The device isprescribed to the patient. The device is sold to a
provider that is trained to operate and service the
Helios reservoir. The provider trains the user.”Your liquid oxygen system may also contain aportable unit to provide an ambulatory source ofoxygen for an extended period of time. Refer to theuser manual supplied with your portable unit for
information on its operation.

1. Portable Fill Connector
2. Vent Valve
4. Contents Indicator

6. Pressure Gauge
7. DISS Connection(Breathing Oxygen
Supply)8. Moisture Container

5. Portable Release
Button
1

2
5

3
4

6
7
8

The HELiOS reservoir is filled with liquid oxygenby your health care provider. It is designed to store
the liquid oxygen for the purposes of filling a portable unit, and breathing directly from the reservoir
for stationary use.
The HELiOS reservoir stores liquid oxygen thatcan be used to fill a portable liquid oxygen tank.
HELiOS Universal reservoirs can fill any CAIRE
top fill (TF) portable with a compatible fill connecPN 21157307 C | User Manual 5 - ENG

HELiOSStandard & Universal
Reservoirs

Operating Instructions –Level Verification

HELiOS Reservoirs are available in both Standard(H36, H46) and Universal (U36, U46) models. The
easiest way to identify which reservoir you have is
by looking at the fill connector. Universal reservoirs
have a higher fill connector whose pop-off assembly is curved upward. Reference the below figure to
identify the model of your reservoir.

1. Press the blue button on the contents indicator.

HELiOS Standard reservoirs will only fill the
HELiOS H300 and H850 portable units.
HELiOS Universal reservoirs will fill any CAIRE
top-fill (TF) portable unit that has a compatible
female fill connector. A compatible female fill connector is shown on this page.

2. Read the LED lights to indicate the liquid contents level.
• If you get a green contents level light, there issufficient oxygen in the reservoir to fill yourportable unit.
• If the yellow low contents light appears, thereservoir is empty or nearing empty. Contact
your heath care provider immediately.
• If the yellow low battery light appears, informyour healthcare provider the next time yourHELiOS reservoir is filled.
NOTE: The HELiOS reservoir will continue to fill anddeliver oxygen when the low battery light is on as longas there is oxygen in the tank.
Green Contents Level LEDs

Universal
reservoir

Standard
reservoir

PB-Style portablefill connector

Yellow Low Contents LED

Yellow Low Battery LED

Push Button

HELiOS contents indicator

WARNING: REMOVE THE BATTERY FROM
THE HELIOS RESERVOIR IF THE RESERVOIR IS NOT LIKELY TO BE USED FOR
SOME TIME.

6 - ENG PN 21157307 C | User Manual

Operating Instructions –Filling a Portable
1. Verify the level of liquid oxygen in the unit (seeOperating Instructions — Level Verification).
2. Clean and dry the fill connectors on both theHELiOS reservoir and the portable unit. Wipe
gently using a clean, dry, lint-free cloth.
WARNING: THE FILL CONNECTORS MUST
BE CLEAN AND DRY WITH A LINT-FREE
CLOTH ON BOTH THE STATIONARY AND
PORTABLE UNITS TO PREVENT FREEZING
AND POSSIBLE EQUIPMENT FAILURE.
WARNING: SHOULD LEAKAGE BE EXCESSIVE TO THE POINT THAT A STREAM OF
LIQUID IS PRESENT, LEAVE THE AREA
AND CALL YOUR HEALTH CARE PROVIDER IMMEDIATELY.
WARNING: DO NOT DEPRESS OR DISTURB THE METAL POPPET ON THE FILL
CONNECTOR WHEN DRYING IT. THIS CANCAUSE LEAKAGE OF LIQUID OXYGEN.

HELiOSFLOW
SETTING
(LPM)
1-6
8
10

MAXIMUM (RECOMMENDED)TUBING LENGTH*
22-psig
100 Ft. (30.5 m)
100 Ft. (30.5 m)
50 Ft. (15.2 m)*Length is oxygen tubing only. Does not include a 7 Ft. cannula.

3. Attach an external flow control valve (FCV) to
the DISS connection of the reservoir. Make sureto tighten the nut until no hissing sound is heard.

External
Flow Control

Tubing Adaptor

Nasal Cannula

Attachment of external flow control valve

Caution: Should there be any liquid leakage
from the HELiOS reservoir after separating
the units, set the portable aside, ensuring
it remains vertical, leave the room and callyour health care provider immediately.

4. If a humidifier bottle will not be used:• Attach a tubing adaptor to the bottom of theexternal flow control valve.
• Attach your nasal cannula or oxygen tubing
to the tubing adaptor.

3. Turn the flow control knob on the portable unit tothe off (0) position.

    If a humidifier bottle will be used:• Attach a humidifier bottle to the bottom on
the external flow control valve.
• Fill the humidifier bottle with distilledwater to the proper level as indicated by thehumidifier’s instructions.
• Attach your nasal cannula or oxygen tubing
to the connector on the humidifier bottle.
Caution: To ensure proper flow rates, verify
that all fittings are tight and leak free.

4. Follow the filling instructions provided for yourportable unit.

Operating Instructions – Breathing
Directly from the Reservoir
Note: Use the duration charts available at www.cairemedical.com as a guideline to determine the length oftime your HELiOS reservoir will operate continuously
at a given flow rate.

External
Flow Control Valve

1. Verify the level of liquid oxygen in the unit (seeOperating Instructions — Level Verification).

Humidifier
Bottle2. Use the following chart as a guideline to therecommended tubing length.

Nasal Cannula

Attachment of a humidifier bottle to the external flow control valve.

5. Turn the knob on the external flow control valve
until your prescribed continuous flow rate (numeric in LPM) is displayed in the window and apositive detent is felt.
PN 21157307 C | User Manual 7 - ENG

HELiOSNOTE: The knob should not be set higher than the
maximum flow rate prescribed by a physician.
NOTE: Out-of-specification oxygen flow will result if theflow control knob is set between flow rates.
6. Properly position your nasal cannula and adjust
it for comfort.
NOTE: Ensure the cannula is fully inserted and secure.
During inhalation, you should hear or feel oxygen
flow to the prongs of the nasal cannula. The proper
placement and positioning of the prongs of the nasal
cannula in your nose is critical to the amount of oxygen
delivered to the respiratory system of the end user.
7. You should be receiving oxygen now. Checkto make sure you feel oxygen flow into yournose and that there are bubbles in the humidifier
bottle (if used).
8. Turn the flow control knob to the off (0) position
when the reservoir is not in use.
9. Under certain environmental conditions with
continuous use, the HELiOS reservoir may
develop an excessive amount of ice on the coils
visible under the shroud. You should defrost theunit between uses to minimize this ice buildup.
To de-frost the unit:• Fill a portable unit so that you can continue toreceive oxygen while the HELiOS reservoir
defrosts• Set the knob on the external flow control
valve to the off (0) position and allow theunit to warm to room temperature, as indicated by the melting of all ice from under the
shroud.
• Check the moisture container frequently during defrosting and empty as required.
• The container should be emptied whenever
the water reaches the (1/1) line visible on theoutside of the container. If the water is not
emptied, moisture may spill onto your floor.
• To empty the moisture container, pull out on
the container and pour the water into a sinkfor disposal.

MoistureContainer
Emptying the Moisture Container

8 - ENG PN 21157307 C | User Manual

Operating Instructions –Using the HELiOS Supply Line
1. Thread the oxygen supply line nut onto the DISS
connection of your HELiOS reservoir. Make
sure to tighten the nut until no hissing sound isheard.
Oxygen Outlet
Connection

Oxygen Supply
Line

Attaching the oxygen supply line to the reservoir

2. Connect the opposite end of the oxygen supply
line to an H300 Plus or H850 Marathon bypushing the supply line into the connector on theleft-hand side of the unit.
Release Button

Oxygen Supply
Connector

Oxygen Supply
Line

Attaching the oxygen supply line to the H300 or H850 portable

3. Breathe from your portable as normal, following
the operating instructions provided with the
H300 or H850 unit. Use only in the demandmode only for the H850.
NOTE: For H300’s and H850’s that have the CPC connector installed, Retrofit Kit P/N 20748595 is available.

HELiOS

Maintenance
Clean the fill connectors on both the stationary
and portable units with a clean, dry, lint-free cloth
between each fill to prevent freezing and possible
equipment failure.

Your service provider is responsible for any maintenance that my be required per the technical manualof this device. Call your service provider for any
maintenance requirements.

There are no user-serviceable parts in the Helios.

The expected service life is a minimum of five
years.

User Troubleshooting
The following information is intended to help you troubleshoot and solve simple operational problems thatyou may experience when using your HELIOS Reservoir.
Issue

Solution

The Reservoir makes ahissing sound.

• Hissing can occur to maintain the correct operating pressure within the Reservoir.
It is most likely to hiss after filling or when the position of the Reservoir ischanged. Hissing can last for 30-60 minutes after filling. Furthermore, improper
filling or lower than normal operating pressure in the Reservoir will contribute to
the unit not being able to fill portables and improper flows

The Reservoir flow stops
during use.

• Ensure that the cannula is firmly attached to the Oxygen Outlet.
• Ensure that the cannula is not kinked.
• Ensure that there is oxygen in the Reservoir.

The Portable does not fill.

• Verify that there is oxygen in the Reservoir.
• Ensure that the Portable and Reservoir fill connectors are fully engaged throughout the filling process.

The Portable vent valve
does not close properly at the end of the filling
process.

• If the vent valve fails to close and the hissing sound and oxygen vapor cloudcontinue, carefully remove the Portable by depressing the release button on the
Reservoir. Venting from the bottom of the Portable will stop in a few minutes. Allow the unit to warm until you can close the vent valve. The Portable may requireas long as 60 minutes to restore adequate pressure for accurate oxygen flow. If
needed, use an alternate source of oxygen such as a flow control valve attachedto the Reservoir.

The Portable does notdisengage easily from theReservoir after filling.

• The Portable and Reservoir fill connectors may have become frozen.

Liquid is spraying from the
top of the reservoir.

• Contact Oxygen Provider• DO NOT USE FORCE OR USE WATER. Allow a few minutes for the frozen parts
to warm, then disengage the Portable when the ice has melted. To prevent theunits from freezing together, always wipe the male fill connector on the Reservoir
and the female fill connector on the Portable with a clean, dry cloth before filling.
• Open doors and windows.
• Leave the area immediately.

Frost and ice buildup andor condensation.

• Some frost and condensation is normal on the warming coils• Condensate collector is full; empty the tray.
• Ensure the Flow Control Knob is closed if not in use.

PN 21157307 C | User Manual 9 - ENG

HELiOS

Cleaning Standard
WARNING: CLEAN ONLY AFTER THE UNIT
IS EMPTY.
• Clean using a solution of mild dish washingdetergent and water.
• Apply cleaning solution directly to a lint-free
cloth. Approved cleaners include HydroPure
and HydroKlean. Do not spray cleaners
directly on the HELiOS Reservoir.
• Wipe the outside surface with the lint-free
cloth until the outside surface is clean.
Caution: Do not use high temperature andhigh pressure washing equipment to clean
these units.
• Do not get cleaner on any internal components or valves.
• Allow the unit to dry thoroughly before using.
Note: Note to health care provider – for reprocessing
procedures, see applicable service manual.

DisposalAlways return HELiOS Reservoir, including allcomponents, to your homecare provider for proper
disposal. You can also contact your local city or
town offices for instructions on proper disposal of
the battery.

WEEE and RoHS

This symbol is to remind the equipment
owners to return it to a recycling facility atthe end of its life, per Waste Electrical andElectronic Equipment (WEEE) Directive.
Our products will comply with the restriction ofHazardous Substances (RoHS) directive. They will
not contain more than trace amounts of lead orother hazardous material content.

Transport and Storage
The device should be stored in the upright position,and be well ventilated. Do not allow the device tolie on its side. Humidity up to 95% noncondensing.
Temperatures range from -40°F to 158°F (-40°C to70°C).
Operating temperature ranges from 14°F to 104°F(10°C to 40°C). Relative humidity range from 30%
to 75% noncondensing.
Note: The atmospheric pressure range is 700 hPa to1060 hPa (elevation of 10,000 Ft. to -1,000 Ft.).

10 - ENG PN 21157307 C | User Manual

Accessories
15 in (38.1 cm) Roller Base for
HELiOS Reservoirs, available forall models.
NOTE: Only use roller base on flat
surfaces.
0-10 LPM External Flow Control
Valve
Allows you to breath continuously
from it between 0-10 LPM. If prescribed, your health care provider
will provide it.
50 ft (15.24 m) HELiOS Oxygen
Supply Line
Used to connect an H300 or H850
portable unit to your reservoir toallow the portable to be used as aconserving device.
Note: When using the HELIOS oxygen supply line with the H850, theportable must be in demand mode.
Note: To Equipment Provider: The following oxygen
administration accessories are recommended for use
with the HELiOS:• Nasal Cannula: CAIRE Part Number 6-778057-00• Firebreak: CAIRE Part Number 21126636
A firebreak is recommended for use with any cannula.
• CAIRE offers a firebreak intended to be used inconjunction with the oxygen reservoir. The firebreak is
a thermal fuse to stop the flow of gas in the event thatthe downstream cannula or oxygen tubing is ignited
and burns to the firebreak. It is placed in-line with thenasal cannula or oxygen tubing between the patient
and the oxygen outlet of the HELiOS. For proper useof the firebreak, always refer to the manufacturer’s
instructions (included with each firebreak kit).
• Additional recommended accessories information isavailable online at www.caireinc.com.

SafetyHELiOSWARNING: PORTABLE RF COMMUNICATIONS EQUIPMENT (INCLUDING PERIPHERALS SUCH
AS ANTENNA CABLES AND EXTERNAL ANTENNAS) SHOULD BE USED NO CLOSER THAN 30
CM (12 INCHES) TO ANY PART OF THE LIBERATOR, INCLUDING CABLES SPECIFIED BY THE
MANUFACTURER. OTHERWISE, DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT
COULD RESULT.

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: 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, THISEQUIPMENT AND THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERATING NORMALLY.
Caution: Medical Electrical Equipment needs special precautions regarding Electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided
in this manual.
Caution: Portable and mobile radio frequency (RF) communications equipment can affect Medical
Electrical Equipment.
Table 1

Guidance and Manufacturer’s declaration—electromagnetic emissions
The HELiOS Reservoir is intended for use in the electromagnetic environment specified below. The
customer or the user of the HELiOS Reservoir should assure that it is used in such an environment.
Emissions test
Compliance Electromagnetic environment—guidance
RF emissions
Group 1The HELiOS uses RF energy only for internal function.
CISPR 11		
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 		
The HELiOS is suitable for use in all establishments, including
IEC 61000-3-2
Not applicable domestic establishments and those directly connected to theVoltage fluctuations/		
public low-voltage power supply network that supplies
flicker emissions
Not applicable buildings used for domestic purposes.
IEC 61000-3-3

PN 21157307 C | User Manual 11 - ENG

HELiOS
Table 2*

Recommended separation distances between portable and mobile
RF communications equipment and the HELiOS Reservoir
The HELiOS Reservoir is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the HELiOS Reservoir can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HELiOS Reservoir as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmittermW
150 kHz to 80 MHz
80 MHz and 800 MHz
800 MHz to 2,5 GHz		
d=1.2√P
d=1.2 √P
d=2.3 √P
0,01
0.12 m0.12 m
0.23 m0,10.38 m0.38 m0.73 m
1
1.2 m
1.2 m
2.3 m
10
3.8 m
3.8 m
7.3 m
100
12 m
12 m
23 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter 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 byabsorption and reflection from structures, objects and people.
* This table is included as a standard requirement for equipment which has been tested to specific testlevels and over specific frequency ranges and been found compliant with regulations.
Table 3

Guidance and manufacturers declaration—electromagnetic immunity
The HELiOS Reservoir is intended for use in the electromagnetic environment specified below. The
customer or the user of the HELiOS Reservoir should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fasttransient/burst
IEC 610004-4
		Surge
IEC 61000-4-5

IEC 60601 test level
Compliance level
Electromagnetic environment—guidance+- 8kV Contact+- 8kV Contact
Floors should be wood, concrete or ceramic+- 2 kV, +-4 kV,+- 2 kV, +-4 kV,
tile. If floors are synthetic, the relative+- 8 kV, +- 15 kV air+- 8 kV, +- 15 kV air humidity should be at least 30%.**±2 kV for powerNot applicableNot applicablesupply lines
DC powered device±1 kV forNot applicable		
input/output lines
No data input/output lines±1 kV line(s) to line(s)Not Applicable
Not Applicable±2 kV line(s) to earth
DC powered device

Voltage dips,<5% UT (>95% dip in UT)		
short interruptions
for 0,5 cycle		and voltage
40% UT (60% dip in UT)
Not Applicablevariations on
for 5 cycles
DC powered
power supply
70% UT (30% dip in UT)
deviceinput lines
for 25 cycles		IEC 61000-4-11 <5% UT (>95% dip in UT) for 5 sec
Power frequency(50/60 Hz)
magnetic field
IEC 61000-4-8

30 A/m30 A/m50/60 Hz50/60 Hz		

Not Applicable		Power frequency magnetic fields should bethat of a typical commercial or hospitalenvironment.

Note: UT is the a.c. mains voltage prior to application of the test level.

** This statement indicates that the required testing was performed in a controlled environment and theHELiOS Reservoir are found to be compliant with regulations.
12 - ENG PN 21157307 C | User Manual

HELiOS
Table 4
Guidance and Manufacturer’s Declaration—Immunity ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration—Immunity
The HELiOS Reservoir is intended for use in the electromagnetic environment specified below. The
customer or user of the HELiOS Reservoir should ensure that it is used in such an environment.
Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment—Guidance

Conducted RF IEC
61000-4-6

3 Vrms6 Vrms (In ISM Bands)
150 kHz to 80 MHz

Not applicable

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

Battery powered
device, No SIP/SOP

Recommended separation distanced = 1,2 √P
Radiated RF IEC
61000-4-3

80 MHz to 2.7 GHz

10 V/m80 MHz—2,7 GHz
80 % AM at 1 kHz

d = 1,2 √P
d = 2,3 √P
where P is the maximum output power ratingof the transmitter in watts (W) according to thetransmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in eachfrequency rangeb.
			Interference may occur in the vicinity of equipment marked with the following symbol:

Test frequency(MHz)

Banda)(MHz)

Servicea)

Modulationb)

385

380–390TETRA 400450

430–470

GMRS 460, FRS 460

Pulse modulationb)
18 Hz
FMC)
±5 kHz deviation
1 kHz sine

Maximum
power (W)Distance(m)

Immunity Test
Level (V/m)

1.8

0.3

27

2

0.3

28

710
745
780
810
870
930
1720
1845
1970

704–787

LTE Band 13, 17

Pulse modulationb)
217 Hz

0.2

0.3

9

800–960

GSM 800/900, TETRA
800, IDEN 820, CDMA
850, LTE Band 5

Pulse modulationb)
18 Hz

2

0.3

28

1700–
1900

GSM 1800; CDMA 1900;
GSM 1900; DECT; LTEBand 1, 3, 4, 25; UMTS

Pulse modulationb)
217 Hz

2

0.3

28

2450

2400–
2570

Pulse modulationb)
217 Hz

2

0.3

28

5240
5500
5785

Bluetooth, WLAN, 802.11
b/g/n, RFID 2450, LTE
Band 7

5100–
5800

WLAN 802.11 a/n

Pulse modulationb)
217 Hz

0.2

0.3

9

NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and theHELiOS Reservoir may be reduced to 1m. The 1m test distance is permitted by IEC 61000-4-3.
For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50% duty cycle square wave signal.
As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it
would be worst case.
abc

PN 21157307 C | User Manual 13 - ENG

HELiOS

Notes

14 - ENG PN 21157307 C | User ManualNotesHELiOSPN 21157307 C | User Manual 15 - ENG

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|21157307-CO~

14 Oct 2021

21157307 C