CLEMENTS

HiFlo2
High Vacuum High Flow
Mobile Sucon Pump
SUC84602
220-240 V 50/60 Hz

User Manual

Manual No. SUC84602008

Issue 3
 Safety
Thank you for purchasing this Clements HiFlo2 High
Suction Pump.
For your safety it is imperative that this unit only be
operated by authorised personnel in accordance with the
instructions as described in this manual. Operated in this
way, the HiFlo2 High Suction Pump will provide the
standard of service specified.
Due to continual improvements in product design, the
HiFlo2 High Suction Pump may vary in detail from the
descriptions in this manual. In the event of further
questions please contact your local distributor or ICU
Medical Australia direct.

Familiarise yourself with these Directions for Use

before operating this device.

User Manual
HiFlo2 High Suction Pump
Manual Number SUC84602008 MDR Revision 0
Issue 3 2022-07-12

Copyright © 2022 ICU Medical Australia Pty Ltd

The information in this manual was originated by, and is the exclusive
property of ICU Medical Australia Pty Ltd. It is furnished for customer
information only, and is not an authorisation or licence to make this
product or to furnish this information to others.

Sponsor: CA-MI srl

ICU Medical Australia Pty Ltd Via Ugo La Malfa 13
Unit U, 10 - 16 South St Frazione Pilastro
Rydalmere NSW 2116 Australia 43013 Langhirano (PR)
Phone: +61 2 9466 5300 Italy
Website: www.clements.net.au
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Contents

Description......................................................................... 4
Specifications .................................................................... 5
Environmental Conditions .................................................. 6
Symbols ............................................................................. 7
Cautions ............................................................................ 9
Important Safety Rules ...................................................... 10
Controls and Operation ...................................................... 13
Using FLOVAC Liners........................................................ 15
Cleaning ............................................................................ 16
Spare Parts........................................................................ 19
Troubleshooting ................................................................. 21
Wiring Diagram .................................................................. 22
Diagnostic Setup................................................................ 23
Periodic Safety Check........................................................ 25
Emissions Guidance Table ................................................ 26

Immunity Guidance Table .................................................. 27

Immunity Guidance Table ................................................. 28

Separation Guidance Table .............................................. 29

Warranty ............................................................................ 30

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Description
The Clements HiFlo2 High Suction Pump is a mobile unit designed
to suit the needs of hospitals, doctors’ surgeries and paramedics in
providing a strong source of suction for use in indoor environments
where mains power is available.
Identification
SUC84602 HiFlo2 High Vacuum / High Flow Mobile Suction Pump

Intended Use
To provide a continuous vacuum source, within the stated operating
vacuum range, for the aspiration of fluids and particulate matter in
medical procedures carried out by clinically trained and authorized
personnel.

Contraindications
Before using the HiFlo2, consult the instructions for use.
Failure to follow the instructions in this manual could cause harm.
Do not use the HiFlo2 for thoracic or low vacuum drainage.
Do not use the HiFlo2 for suctioning of explosive, corrosive or easily
flammable fluids.
HiFlo2 is not suitable for MRI. Do not place in MRI environments.

Pump Classifications
GMDN 63642
GMDN Term Surgical sucon pump
GMDN Synonym Aspirator
Device Class
Medical Device Class IIa
Typology (Regulation EU 2017/745)
Electrical Protecon Class II
Protecon Type B Applied Part
Sterilisaon Not supplied in sterile state
NOT Category AP
Anaesthec Rang
NOT Category APG
ISO 10079-1 Designaon High Vacuum / High Flow
Operaon Mode Connuous operaon

4 Description
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Specifications
Maximum Vacuum -90 kPa [-675 mmHg]
Maximum Flow 80 L/min (through jar) 90 L/min (free air)
Mains Power 220 - 240 V 50/60 Hz 385 VA
Requirement
Pump Piston type
Motor PSC AC motor
Fuse F4A L 250V

Filter Disposable hydrophobic and bacterial filter

BFE 99.9999%, VFE 0.027 micron
Collection Container 2x 2 litre autoclavable, reusable jar
Optional 5 litre autoclavable, reusable jar
Optional 2 litre disposable liner jar
Optional 3 litre disposable liner jar
Overfill Protection Float valve mechanism in external trap jar
Vacuum Control Needle valve
Gauge Bourdon tube type. Dual scale. CL 2.5
Gauge Range 0 to -100 kPa graduated at 5 kPa
0 to -760 mmHg graduated at 50 mmHg
Weight 16.5 kg
Dimensions 460W x 850H x 420D mm
Packed Weight 22 kg
Packed Dimensions 500W x 910H x 500D mm
Standard 25 °C, Sea level, 100 kPa
Conditions

Specifications 5
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Package Contents
The Clements HiFlo2 package contains:
• HiFlo2 mobile suction pump
• 2 x 2 litre reusable collection jar with lid assembly
• External trap jar
• Silicone 8 x 14 mm medical suction tubing
1.5m x1, 0.34m x2
• 2-Pin AU plug to IEC 320 power lead
• Disposable antibacterial/hydrophobic filter
• Stepped conical tubing connector

Environmental Conditions
Environmental conditions for operation, transportation and
storage are shown in the following table. In addition, for
vehicular transportation, the unit should be kept upright.

State Parameter Minimum Maximum

Operating Temperature 5 ºC 35 ºC
Humidity 30% RH 75% RH
Barometric Pressure 800 hPa 1060 hPa
Altitude 0m 2000 m
Transport and Storage Temperature -40 ºC 70 ºC
Humidity 10% RH 100% RH
Barometric Pressure 500 hPa 1060 hPa

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Symbols

General warning

Consult user manual

Type B Applied Part (suction cannula)

Insulation Class II (double insulation)

Hz Mains power frequency

~ Alternating current

On / Off

CE Mark in conformity with Regulation EU 2017/745

0123

Manufacturer

REF Model / Reference Number

LOT Lot / Batch Number

Consult user manual before use

Medical Device

Symbols 7
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Symbols

SN Serial Number

Fragile

Relative Humidity Range

Keep Cool / Keep out of direct sunlight

Temperature Range

Atmospheric Pressure Range

Fuse

C-Tick Mark

Dispose of electrical product according to requirements

of WEEE directive

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Cautions

Usage
1. Use only for the specified Intended Use.
2. Only suitably trained and authorised personnel may operate.
3. Keep out of reach of children or non-competent persons.
4. Do not use near flammable substances such as oxygen or
anaesthetic gases.
Fluids
1. Keep device clear of water and other fluids. Do not handle pump
with wet hands.
2. Handle full containers very carefully when transferring to
disposal area, observing local protocols.
Electrical
1. Use only the supplied power cord.
2. Confirm that electrical rating of rating label matches that of the
mains power.
3. Avoid the use of power boards and extensions.
4. Maintain clear access to the mains power outlet to facilitate
disconnection.
5. Place pump clear of patient and other electronic equipment.
6. When not in use, disconnect pump from power supply.
7. Do not pull cable to remove plug from mains power outlet.
General
1. Check the pump and fittings for damage before each use.
2. Do not use without the bacteria/hydrophobic filter correctly
fitted.
3. Switch off pump immediately if overflow float valve is actuated.
4. After use, clean and store away from heat, dust and sunlight.
Repair
1. Refer all service to suitably trained technicians.
2. Use only original spare parts and accessories.
3. No modifications are permitted.

Cautions 9
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Important Safety Rules

1. Check the condition of the unit before each use. The surface of
the unit should carefully inspected for visual damage. Check the
mains cable and do not connect to power if damage is apparent.
2. Before connecting the appliance always check that the electric
data indicated on the data label and the type of plug used,
correspond to those of the mains electricity to which it’s to be
connected.
3. Respect the safety regulations indicated for electrical appliances
and particularly:
• Use original components and accessories provided by the
manufacturer to guarantee the highest efficiency and safety
of the device.
• The device can be used only with the bacteriological filter.
• Never immerge the appliance into water.
• Position the device on stable and flat surfaces in a way that
the air inlets on the back aren’t obstructed.
• To avoid incidents, do not place the aspirator on unstable
surfaces, which may cause it to accidentally fall and lead to a
malfunction and/or breakage. Should there be signs of
damage to the plastic parts, which may expose inner parts of
the energised device, do not connect the plug to the electrical
socket. Do not attempt to make the device work before it has
been thoroughly checked by qualified personnel.
• Don’t use in the presence of inflammable substances such as
anaesthetic, oxygen or nitrous oxide.
• Don’t touch the device with wet hands and always prevent
the appliance coming into contact with liquids.
• Don’t leave the appliance connected to the power supply
socket when not in use.
• Don’t pull the power supply cable to disconnect the plug
remove the plug from the mains socket correctly.
• Store and use the device in places protected against the
weather and far from any sources of heat. After each use, it is
recommended to store the device in its own box away from
dust and sunlight.
• In general, it is inadvisable to use single or multiple adapters
and/or extensions. Should their use be necessary, you must
use ones that are in compliance with safety regulations,
however, taking care not to exceed the maximum power

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supply tolerated, which is indicated on the adapters and

extensions.
4. For repairs, exclusively contact technical service and request the
use of original spare parts. Failure to comply with the above can
jeopardise the safety of the device.
5. Use only for the purpose intended. Don’t use for anything other
than the use defined by the manufacturer.
The manufacturer will not be responsible for damage due to
improper use or connection to an electrical system not complying
with current regulation.
6. Instrument and accessory disposal must be done according to
current regulations in the country of use.
7. WARNING: Do not change this equipment without the permission
of the manufacturer. None of electric or mechanical parts have
been designed to be repaired by customers or end-users. Don’t
open the device, do not mishandle the electric / mechanical parts.
Always contact technical assistance
8. Using the device in environmental conditions different than those
indicated in this manual may harm seriously the safety and the
technical characteristics of the same.
9. The medical device is in contact with the patient by means of a
disposable probe (not supplied with the device). If this device must
be used with a specific suction probe, the end user is responsible
for making sure it complies with the ISO 10993-1 rule.
10. The product and its parts are biocompatible in accordance with
the requirements of regulation EN 60601-1.
11. Operation of the device is very simple and therefore no further
explanations are required other than those indicated in the
following user manual.
12. The medical device requires special precautions regarding
electromagnetic compatibility and must be installed and used
in accordance with the information provided with the
accompanying documents. The HiFlo2 Max device must be
installed and used away from mobile and portable RF
communication devices (mobile phones, transceivers, etc.) that
may interference with the said device.

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13. Any serious incident occurrence in relation to the device

should be reported to the manufacturer and the competent
authority in your country/area. If you have no contact
information of such authority, please contact the
manufacturer or distributor whose contact information is
indicated in this instruction manual.

Under certain failure conditions, the temperature of the

casing (HiFlo2) may become hot and there may be a risk
of burns if you touch those parts.
In any case, the temperatures do not exceed the limit of
105°C (ref. Interpretation Sheet IEC 60601-1 / ISH May
2013)

The manufacturer cannot be held liable for accidental or

indirect damages should the device be modified, repaired
without authorization or should any of its components be
damaged due to accident or misuse.
Any minimal modification / repair on the device voids the
warranty and does not guarantee the compliance with the
technical requirements provided by the Regulation
2017/745 and its normatives

Connection Diagram

OUT IN VACUUM PATIENT

IN

Bacteria / Trap Jar

Hydrophobic
Pump Filter Shutoff
Port Valve
Collection
Jar

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Pump Controls

Vacuum
Bacterial / Hydrophobic Filter Gauge ON / OFF
“IN” or Δ Side
Switch
» Must ALWAYS be fitted « of Filter

Vacuum
Control

Trap Jar

Overflow float
valve fitted
inside trap jar

Overflow float
valve fitted
inside jar
“PATIENT” Port
“VACUUM” port Connect Patient
(above float valve) Tubing
Operation
1. Place the pump on a flat stable horizontal surface.
2. Connect a short length of silicone tubing from the trap jar centre
port to the “IN” (or directional arrow symbol) side of the bacterial/
hydrophobic filter. Connect a short length of silicone tubing from
the other side of the filter to the pump port.
Connect a short length of silicone tubing from the trap jar
peripheral port to the “VACUUM” port of the collection jar.
3. Connect the long silicone tubing to the collection jar “PATIENT” port.
4. Connect supplied power cord to power socket at rear of pump.
Connect power cord to compatible mains outlet.
5. Press switch button to turn on pump. (Press again to turn off.)

Controls and Operation 13

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6. Occlude tubing and adjust vacuum control to the required

vacuum level. (Clockwise = increase)

Always reduce the vacuum level for paediatric and neonatal

patients.
7. Apply suction to patient with a compatible suction cannula
fitted to the patient tubing.
8. When finished, switch off pump by pressing switch.

Ensure that the mains power plug is accessible at all times when
pump is in use, in case a positive disconnection from the mains
power supply is required.

Suction Accessories
The device and its accessories are biocompatible in accordance with
EN 60601-1.

Suction Cannulae
Suction cannulae or suction probes for contact with the human body
should comply with ISO 10993-1 requirements for biocompatibility.

Collection Jar (Canister)

The mechanical strength of the reusable collection jar (canister) is
guaranteed for 30 cycles of cleaning and sterilization. Beyond this,
there may be signs of decay and replacement is recommended.

Silicone Tubing
The number of cleaning and sterilization cycles of the silicone tubing
is dependent on the actual usage. Tubing should be checked for
cracking and other visible signs of wear before re-use.

14 Suction Accessories
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Using FLOVAC Disposable Liners

1. Fit FLOVAC ring bracket to multipurpose rail. 7 9
2. Insert liner bag [1] into the matching size 1 4
support jar [2].
Press edge of lid firmly all around edge to
ensure seal.
3. Close the TANDEM inlet [3] with the attached 3
5
cap [4].
4. Fit jar assembly into FLOVAC ring bracket.
5. Press short side of yellow connector firmly into
matching yellow port [5] on the lid.
6. Using a short length of tubing connect the
yellow connector to centre port of the trap jar. 2
7. Connect patient tubing to white inlet elbow[7].
Connect patient tubing to suitable suction
cannula.
8. Follow steps in Operation section.
If fluid reaches the maximum level the hydrophobic filter in the
lid will operate to prevent further fluid flow. When this
happens switch off pump and replace liner.
Disposal
1. Switch off pump.
2. Disconnect tubing from jar.
3. Remove the white elbow [7] and close the inlet port with
the cap [9] attached to lid.
4. Using the lid handle remove the liner [1] from the support
jar and dispose of liner according to hospital protocol.
5. Retain support jar [2] for reuse.
Support Jar Cleaning
The reusable support jar may be cleaned either with water and
neutral detergents or autoclaved at 121°C for 15 minutes.
Do not use solvents or alcohol for cleaning and disinfection.
These may damage the support jar.
The mechanical integrity of the support jar is guaranteed for
30 cleaning cycles under the specified conditions.
After this, the jar may show signs of wear and replacement is
recommended.

Using FLOVAC Liners 15

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Cleaning
After Each Operation
Empty Collection Jar
The contents of the collection jars, trap jars, suction tubing and
bacteria filter, may contain biohazard wastes. Handle using safe
handling procedures, which may include the use of rubber gloves,
clothing and eye protection, and dispose of according to local
protocols for biohazardous materials.
To empty collection jar disconnect tubing and remove jar from
pump. Remove lid from jar and dispose of aspirated fluid
according to local protocols for potentially biohazardous waste.
Dispose of single use suction cannula according to local
protocols for potentially biohazardous waste.

Clean
Housing
Wipe clean with a damp soapy cloth. Do not immerse or allow
liquid to enter the housing. Do not use abrasive cleaning agents.
Accessories
Before using the device, the manufacturer advises you to clean or
sterilize the accessories.

The filter must not be cleaned or autoclaved.

Wear rubber gloves, apron and eye or face protection

to avoid contact with contaminated substances.

Collection Jars
Separate all parts of the lid. Unlock bayonet on float cage by
rotating cage clockwise. Disconnect float cage and float from lid
(bung) and separate seal from lid (bung).
Wash each part of the jar under cold running water and then
clean every part in hot water (temperature not exceeding 60°C).
Once again, carefully wash each part using, if necessary, a non-
abrasive brush to remove any deposits.

16 Cleaning
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Rinse with hot running water and dry all parts with a soft non-
abrasive cloth. It is possible to wash with commercial disinfectants by
carefully following the instructions and dilution values supplied by
the manufacturer. Do not use phenolic solutions as disinfecting
agents in polycarbonate jars.
After cleaning, leave the parts to dry in an open, clean environment.

Suction Tubing
The silicone aspiration tubes and the conical fitting may be carefully
washed in hot water (temperature must not exceed 60°C). After clean-
ing, leave the parts to dry in an open, clean environment.
Suction Tubing may be sterilised with sterilants determined by local
protocols and compatible with silicone tubing. Suction tubing may be
autoclaved to a maximum of 121°C for 15 minutes. At higher temper-
atures the suction tubing will discolour and lose shape.
Autoclaving
Separate the jar and lid items as detailed in the cleaning section
above.
The following items may be autoclaved in a single steam sterilisation
cycle at 121°C and 1 bar for 15 minutes:
• Jar - position jar upside down in autoclave
• Lid - position lid upside down in autoclave
• Silicone tubing
• Conical connector
• Trap jar - position jar upside down in autoclave

Re-Assembly
Place float valve into overflow cage with the seal facing up. Connect
overflow cage to lid and lock bayonet on float cage by rotating cage
anticlockwise. Place lid seal carefully into groove in lid. Fit lid to jar
and lock securely into place by engaging bayonet and rotating lid
firmly clockwise.

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Check Bacteria Filter

The bacterial/hydrophobic filter is an important device to help protect the pump
and environment from moisture and bacteria from the patient. It is
recommended that the filter be changed every month or when damp or
discoloured. Do not clean, sterilise or disassemble filter.
Change filter after every use when used on infectious patients
or patients whose infection status is unknown.

After Every 100 Hours or 2 Months of Operation

• Check all suction tubing and replace if it is perished, soft or
discoloured.
• Check the seal ring on the lid and replace if hard, cracked or
perished. Check the fit of the lid in the collection jar (canister).
• Check the overflow cut off valve seal and replace if perished or
damaged.

Waste Materials
The contents of the collection jars, trap jars, suction tubing and
bacteria filter may contain biohazard wastes. Handle using safe
handling procedures, which may include the use of rubber gloves and
eye protection, and dispose of according to local protocols for
biohazard materials.

Recycling
At the end of their service life, the pump and accessories should be
dismantled if necessary, and disposed of according to the WEEE
directive.

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Spare Parts
SUC81030009 Kit, Seal, Lid, 1L/2L Reusable Jar (Pack 2)
SUC81030010 Kit, Lid Assembly for 1L/2L Reusable Jar (Pack 2)
SUC81030034 Kit, Float and Cage for 1L Reusable Jar (Pack 2)
SUC81030042 Kit, 2L Reusable Collecon Jar (Pack 1)
SUC84500013 Jar, Support for FLOVAC 3L Disposable Liner
SUC84500112 Kit, Liner Connect Nipple (Pack 5)
SUC84500123 Kit, Disposable 3L Liner (Pack 50)
SUC84600120 Jar, Trap, 220mL for Mulpurpose Rail
SUC84600122 Jar, Sucon, Reusable, 2L, Complete
SUC84600125 Jar, Sucon, Reusable, 5L, Complete
SUC84600135 Jar, Sucon, Reusable, 5L, Jar Only
SUC84600145 Lid, Assembly with Shutoff Valve and Seal for 5L Reusable
Jar
SUC84600155 Seal, Lid for 5L Reusable Jar.
SUC84600171 Silicone Tubing Set for HiFlo2 (1.5m x1, 0.34m x2, Conical
Joiner)
SUC84600176 Filter, Hydrophobic/Anbacterial for HiFlo2
SUC84600100 Rail, Mulpurpose, 5-Posion

Spare Parts 19
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Spare Parts
SUC84600101 Hook, RH for Mulpurpose Rail
SUC84600102 Hook, LH for Mulpurpose Rail
SUC84600103 Cap, for Mulpurpose Rail
SUC84600110 Bracket, Ring for 2L Reusable Jar
SUC84600111 Bracket, Ring for 5L Reusable Jar
SUC84600112 Bracket, Ring for 2L/3L FLOVAC Jar
SUC84600113 Bracket, Ring for Catheter Holder
SUC84600114 Catheter Holder
SUC84600160 Rail, Stainless Steel Standard Medical, 30 x 10
SUC84600201 Motor/Pump for HiFlo2, 200-240V 50/60Hz
SUC84600202 Kit, Piston, Rings for HiFlo2 Pump
SUC84600203 Vacuum Controller + Black Knob for HiFlo2 Pump
SUC84600205 Fuse, F4A L 250V for HiFlo2 Pump
SUC84600206 Gauge, -100 kPa, for HiFlo2 Pump
SUC84602008 User Manual for HiFlo2 Mobile Sucon Pump
SUC84602214 Switch, Illuminated, Main for HiFlo2 Pump

20 Spare Parts
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Troubleshooting
1. The Pump Fails To Operate
• Check that the mains power supply lead is firmly connected
and that the power is on at the mains power supply outlet.
• Check fuse as detailed below.
• Ensure that the Vacuum Gauge on the Control Panel indicates
zero. If not, release vacuum and switch pump off and on.

2. Pump Running But No Vacuum

• Check that all fittings are connected tightly.
• Turn the vacuum controller knob on the control panel and
watch the indicator on the vacuum gauge.
• Ensure that the silicone medical suction tubing is in good
condition and not old and cracked.
• Check the type of handpiece in use as some handpieces
require finger occlusion to assist suction.
• Check trap jar.
• Check bacteria/hydrophobic shut off valve filter.

If the pump fails to work and you are unsure why, please contact
your service department or return unit to your distributor.

Fuse Replacement
The HiFlo2 is fitted with a fuse located in a fuse holder that is
externally accessible
1. Disconnect the pump from the mains power supply.
2. Locate the fuse holder which is mounted on the rear side of
the unit at the lower right-hand side.
3. Pull out the fuse holder.
4. Remove the old fuse and inspect. If blown, replace it with a
new fuse of the correct rating.
5. Replace the fuse holder cover.

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Troubleshooting
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Wiring Diagram

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Wiring Diagram
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Setup for Diagnostic and Performance Testing

Note that the following arrangements are not used for actual
suctioning applications. They are specified to remove
unnecessary variations when diagnosing faults and as a
standard setup for performance measurement.

Vacuum Check
Max

1. Unoccluded - zero check

Vacuum
Gauge

Disconnect all items from inlet and with pump switched off,
confirm that gauge reads zero. A non-zero reading indicates a
faulty gauge.
Set vacuum control knob to maximum, switch on pump and
confirm that gauge reads zero. A non-zero reading indicates
obstruction in internal tubing or connections.

Max

2. Occluded - vacuum check 2. Vacuum

Gauge

Switch on pump and occlude inlet. Note maximum vacuum

reading.

Max

3. Occluded - gauge check Vacuum

Calibrated Gauge
Vacuum
Gauge

Connect a calibrated vacuum gauge directly to inlet and repeat

maximum vacuum reading.
Confirm that pump gauge reads within the specified tolerance.

Diagnostic Setup 23
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Flow Check

1. Occluded - leak check

Max

Vacuum
Gauge

Connect pump as shown in diagram. Set vacuum control knob

to maximum, and switch on pump. Occlude jar inlet and con-
firm that pump achieves the same maximum vacuum as in the
previous vacuum check setup . Any difference indicates leaks in
jar or connections.

2. Unoccluded - flow check

Max

Vacuum
Gauge

Calibrated Collection
Flowmeter Jar

Connect pump as shown in diagram. Set vacuum control knob

to maximum, and switch on pump. Connect jar inlet to
calibrated flow meter and note flow reading.
If flow is significantly below specification, check internal tubing
and pump itself.

24 Diagnostic Setup
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IMPORTANT
There are no user-serviceable components inside.
Maintenance must be carried out by qualified
personnel only.

Periodic Safety Check

The following safety checks should be performed at least every 12
months by a qualified person who has adequate training, knowledge,
and practical experience to perform these tests.
* Inspect the equipment and accessories for mechanical and functional
damage.
* Inspect the safety relevant labels for legibility.
* Verify that the device functions properly as described in the
instructions for use.
* Perform electrical safety check.

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Periodic Safety Check
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EMC Information Tables per EN60601-1-2:2015.

In accordance with EN 60601-1-2 (2015) + A1 (2021) Medical electrical equipment - Part 1-2:
General requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
1) “Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the Accompanying
Documents” (the following tables).
2) “Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.”
3) “The equipment or system should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the equipment or system should be observed to
verify normal operation in the configuration in which it is used.”
The following tables provide information regarding the EMC characteristics of this Medical
Electrical Equipment.
The performance of all functions of the HiFlo2 suction pump are considered essential
performance for the purpose of electromagnetic immunity.

Guidance and manufacturer’s declaration - Electromagnetic emissions

The HiFlo2 suction pump is intended for use in the electromagnetic environment specified
below. The customer or user of the HiFlo2 suction pump should assure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic environment - guidance

Irradiated / Conducted Group 1 The HiFlo2 suction pump uses RF energy only
Emissions for its internal functioning. Its RF emissions are
CISPR11 very low and will not cause interference in
nearby electronic equipment.

Irradiated / Conducted Class B The HiFlo2 suction pump is suitable for use in all
Emissions establishments, including domestic
CISPR11 establishments and those directly connected to
the public low-voltage power supply network that
Harmonic Emissions Class A supplies buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations / flicker Complies

emissions
IEC 61000-3-3

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Emissions Guidance Table
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Guidance and manufacturer’s declaration – Electromagnetic Immunity

The HiFlo2 suction pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the HiFlo2 suction pump should ensure that it is used in such an
environment.
Immunity Level indicated by Compliance Electromagnetic environment -
Test EN 60601-1-2 Level guidance

Electrostatic ± 8 kV on contact The device Floors should be wood, concrete or

discharge ± 15 kV in air doesn’t ceramic tile. If floors are covered
(ESD) change its with synthetic material, the relative
EN 61000-4-2 state humidity should be at least 30%.
Electrical fast ± 2 kV power supply The device Mains power quality should be that
transient / burst lines doesn’t of a typical commercial
EN 61000-4-4 ± 1 kV for input / change its environment or hospital.
output lines state
Surge ± 1 kV differential
The device Mains power quality should be that
EN 61000-4-5 mode doesn’t of a typical commercial
change its environment or hospital.
state
Loss of voltage, 5%UT (>95% dip UT) - Mains power quality should be that of
brief voltage for 0.5 cycle a typical commercial environment or
interruptions 40%UT (>60% dip UT) hospital. If the user of the HiFlo2
and variations for 5 cycle suction pump requires that the
EN 61000-4-11 70%UT (>30% dip UT) appliance operates continuously, the
for 25 cycle use of a backup supply is
<5%UT (>95% dip UT) recommended.
for 5 sec

Magnetic field 30 A/m The device The power frequency magnetic field
EN 61000-4-8 doesn’t should be measured in the
change its intended installation location to
state assure that it’s sufficiently low.
Note UT is the nominal value of the power supply voltage

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Immunity Guidance Table
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Guidance and manufacturer’s declaration – Electromagnetic Immunity

The HiFlo2 suction pump is intended for use in the electromagnetic environment specified below.
The customer or user of the HiFlo2 suction pump should assure that it is used in such an
environment.
Immunity Level indicated by Compliance Electromagnetic environment -
Test EN 60601-1-2 Level guidance
Conducted 3 Vrms V1 = 3 Vrms The portable and mobile RF communication
Immunity 150 kHz to 80 MHz devices, including cables, must not be used
EN 61000-4-6 (for non life- closer to the HiFlo2 suction pump, than the
supporting devices) separation distance calculated by the
equation applicable to the transmitter
Radiated 3 V/m E1 = 3 V/m
frequency.
Immunity 80 MHz to 2.7 GHz
EN 61000-4-3 (for non life-
d = [3.5/V1]√P from 150 kHz to 80 MHz
supporting devices)
d = [12/E1]√P from 80 MHz to 800 MHz
d = [23/E1]√P from 800 MHz to 2.7 GHz

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 distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol.

Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied.
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic
propagation is influenced by the absorption and by reflection from buildings, objects and people.

The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and
cordless) and terrestrial mobile radio, amateur radio devices, radio AM and FM transmitters and
TV transmitters cannot be theoretically and accurately foreseen. To establish an electro-magnetic
environment generated by fixed RF transmitters, an electro-magnetic study of the site should be
considered. If the field intensity measured in the place where the device will be used surpasses
the above mentioned applicable level of conformity, the normal functioning of the device should
be monitored. If abnormal performance arises, additional measures such as changing the
device's direction or positioning may be necessary.

The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3V/m.

28
Immunity Guidance Table
 CLEMENTS

Separation Guidance Table

Recommended separation distances between portable

and mobile RF communications equipment and the
device

The HiFlo2 device is intended to operate in an electromagnetic environment where RF

irradiated interferences are under control. The client or operator of the HiFlo2 device can
help prevent electromagnetic interference by keeping a minimum distance between portable
and mobile RF communication devices (transmitters) and the HiFlo2 device, as
recommended below, according to the maximum output power of the communications
equipment.
Separation distance from the frequency transmitter (m)
Maximum nominal 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
output power of the d = [3.5/V1] √P d = [12/E1] √P d = [23/E1] √P
transmitter W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters with a maximum nominal output power not shown above, the
recommended separation distance in metres (m) can be calculated using the equation
applicable to the transmitter frequency, where P is the maximum nominal output power of
the transmitter in Watt (W) depending on the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied.
Note 2: These guide lines may not be applicable in all situations. The electromagnetic
propagation is influenced by the absorption and by the reflection from buildings, objects and
people.

29
Separation Guidance Table
CLEMENTS

Warranty
ICU Medical Australia Pty Limited ("ICU Medical Australia") warrants that this
product is free from defects in workmanship and materials for a period of 24
months (3 months for batteries) from the date of shipment by ICU Medical
Australia or its authorised agent to the purchaser. Subject to the conditions of
this warranty, if the product fails to operate for any reason within the warranty
period and the product is returned to the place of purchase at the purchaser's
expense, ICU Medical Australia will repair or replace the product free of charge.
If a valid warranty claim is made within 30 days from the date of shipment, then
ICU Medical Australia will also reimburse the purchaser for reasonable freight
costs in returning the product to the place of purchase.

Conditions of Warranty
1. The product must be returned to the place of purchase with proof of
purchase.
2. This warranty is only available to the original purchaser of the product.
3. The product must not have had its serial number removed, defaced or
changed, its casing opened, its power supply altered or have been
tampered with in any other way.
4. This warranty does not cover :
• inadequate or incorrect site preparation;
• improper installation;
• connection to the wrong voltage;
• failure of the product due to misuse;
• the use or operation of the product outside of the physical, electrical or
environmental specifications of the product;
• use in a manner or environment in which the product is not designed to
be used;
• improper adjustment, calibration or operation by the purchaser;
• the use of accessories including consumables, hardware or software
which were not manufactured or approved in writing by ICU Medical
Australia;
• any modifications of the product which were not authorised in writing by
ICU Medical Australia;
• any contamination or leakages caused or induced by the purchaser; and
• inadequate or improper maintenance of the product.
5. This warranty does not cover normal wear and tear.
6. ICU Medical Australia will not be responsible for damage or loss caused
during shipping.

30 Warranty
 CLEMENTS

7. In Australia, apart from any warranties implied by the Trade Practices Act
1974 all other warranties expressed or implied and whether arising by
virtue of statute or otherwise are hereby excluded.
8. Outside Australia, all other warranties expressed or implied and whether
arising by virtue of statute or otherwise (including any warranties implied
by the Vienna Convention) are hereby excluded.
9. ICU Medical Australia's obligations under this warranty are limited to the
repair or replacement of the product, within the terms of this warranty and
the total liability of ICU Medical Australia for loss or damage of every kind
whether arising pursuant to the terms of the sale of the product or
otherwise in connection with the product is limited to the amount paid by
the purchaser to ICU Medical Australia for the product.
10. Apart from any liability imposed by Part VA of the Trade Practices Act, ICU
Medical Australia accepts no other liability for any loss or damage
occasioned (including consequential loss or damages) in any way as a
result of the use of the product.
11. The warranty does not extend to cover damage to the following parts as
they are inherently prone to wear :
• motor brushes
12. This warranty does not extend to cover corrosion due to any cause nor to
any damage to painted or anodised surfaces.
13. ICU Medical Australia will give the purchaser the benefit of any
manufacturer's warranty in respect of any components in the product
which were not manufactured by ICU Medical Australia, if such a
manufacturer's warranty is available.

Warranty 31