Clements SUC84602 User manual
HiFlo2
High Vacuum High Flow
Mobile Sucon Pump
SUC84602
220-240 V 50 60 Hz
User Manual
CLEMENTS
Manual No. SUC84602008
Issue 3
User Manual
HiFlo2 High Suction Pump
Manual Number SUC84602008 MD evision 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.
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.
Sponsor:
ICU Medical Australia Pty Ltd
Unit U, 10 - 16 South St
ydalmere NSW 2116 Australia
Phone: +61 2 9466 5300
Website: www.clements.net.au
CA-MI srl
Via Ugo La Malfa 13
Frazione Pilastro
43013 Langhirano (P )
Italy
0123
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Contents
Description......................................................................... 4
Specifications .................................................................... 5
Environmental Conditions .................................................. 6
Symbols. ...... ..... ...... ...... ..... ...... ...... ...... ..... ...... ...... ..... ...... .. 7
Cautions ........ ...... ..... ...... ...... ..... ...... ...... ..... ...... ...... ...... ..... 9
Important Safety Rules ..... ...... ..... ...... ...... ..... ...... ...... ..... .... 1
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...... ..... ...... ...... ..... ...... ...... ..... ...... ...... ...... ..... ...... .. 3
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4 Description
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 M I. Do not place in M I environments.
Pump Classifications
GMDN 63642
GMDN Term Surgical sucon pump
GMDN Synonym Aspirator
Device Class
Typology (Regula ion EU 2017/745)
Medical Device Class IIa
Electrical Protecon Class
Protecon Type B Applied Part
Sterilisaon Not supplied in sterile state
Anaesthec Rang NOT Category AP
NOT Category APG
Operaon Mode Connuous operaon
SO 10079-1 Designaon High Vacuum / High Flow
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5
Specifications
Specifications
Maximum Vacuum -90 kPa [-675 mmHg]
Maximum Flow 80 L/min ( hrough jar) 90 L/min (free air)
Mains Power
Requiremen
220 - 240 V 50/60 Hz 385 VA
Pump Pis on ype
Mo or PSC AC mo or
Fil er Disposable hydrophobic and bac erial fil er
BFE 99.9999%, VFE 0.027 micron
Collec ion Con ainer 2x 2 li re au oclavable, reusable jar
Op ional 5 li re au oclavable, reusable jar
Op ional 2 li re disposable liner jar
Op ional 3 li re disposable liner jar
Overfill Pro ec ion Floa valve mechanism in ex ernal rap jar
Vacuum Con rol Needle valve
Gauge Bourdon ube ype. Dual scale. CL 2.5
Gauge Range 0 o -100 kPa gradua ed a 5 kPa
0 o -760 mmHg gradua ed a 50 mmHg
Weigh 16.5 kg
Dimensions 460W x 850H x 420D mm
S andard
Condi ions
25 °C, Sea level, 100 kPa
Packed Dimensions 500W x 910H x 500D mm
Packed Weigh 22 kg
Fuse F4A L 250V
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6 Environmental Conditions
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
Opera ing Tempera ure 5 ºC 35 ºC
Humidi y 30% RH 75% RH
Barome ric Pressure 800 hPa 1060 hPa
Tempera ure -40 ºC 70 ºC
Humidi y 10% RH 100% RH
Barome ric Pressure 500 hPa 1060 hPa
Transpor and S orage
Al i ude 0 m 2000 m
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Symbols
General warning
Consul user manual
Type B Applied Par (suc ion cannula)
Insula ion Class II (double insula ion)
Hz Mains power frequency
~Al erna ing curren
On / Off
CE Mark in conformi y wi h Regula ion EU 2017/745
Manufac urer
REF Model / Reference Number
LOT Lo / Ba ch Number
Consul user manual before use
Medical Device
Symbols
0123
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8 Symbols
SN Serial Number
Fragile
Rela ive Humidi y Range
Keep Cool / Keep ou of direc sunligh
Tempera ure Range
A mospheric Pressure Range
Fuse
C-Tick Mark
Dispose of elec rical produc according o requiremen s
of WEEE direc ive
Symbols
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9
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. efer all service to suitably trained technicians.
2. Use only original spare parts and accessories.
3. No modifications are permitted.
Cautions
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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. espect 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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