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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11
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. WA NING: 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 F
communication devices (mobile phones, transceivers, etc.) that
may interference with the said device.

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12
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 egulation
2017/745 and its normatives
Connection Diagram
PATIENTVACUUMOUT IN
IN
Pump
Por
Bac eria /
Hydrophobic
Fil er
Trap Jar
Shu off
Valve
Collec ion
Jar

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13
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
Pump Controls
Trap Jar
Vacuum
Gauge
“VACUUM” por
(above floa valve)
“PATIENT” Por
Connec Pa ien
Tubing
Vacuum
Con rol
ON / OFF
Swi ch
Bac erial / Hydrophobic Fil er
» Mus ALWAYS be fi ed «
“IN” or Δ Side
of Fil er
Overflow floa
valve fi ed
inside jar
Overflow floa
valve fi ed
inside rap jar

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14 Suction Accessories
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.

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15
Using FLOVAC Liners
1. Fit FLOVAC ring bracket to multipurpose rail.
2. Insert liner bag [1] into the matching size
support jar [2].
Press edge of lid firmly all around edge to
ensure seal.
3. Close the TANDEM inlet [3] with the attached
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.
7. Connect patient tubing to white inlet elbow[7].
Connect patient tubing to suitable suction
cannula.
8. Follow steps in Operation section.
Using FLOVAC Disposable Liners
9
1
2
7
4
3
5
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. emove 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. etain 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.

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16 Cleaning
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. emove 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.
ear 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.

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1
inse 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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18 Waste Disposal
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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19
Spare Parts
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

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20 Spare Parts
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, lluminated, Main for HiFlo2 Pump
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