Clements SUC 81030 User manual

Ceevac
High Vacuum High Flow
Portable Suction Pump
SUC 81030
12 VDC 100-240 V~ 50/60 Hz
User Manual
CLEMENTS
Manual No. SUC 81030 008
Issue 2

User Manual
Ceevac High Suction Pump
Manual Number SUC 81030 008 Issue 2 2021 02
Copyright © 2021 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 Ceevac 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 Ceevac High Suction Pump will provide the
standard of service specified.
Due to continual improvements in product design, the
Ceevac 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
Rydalmere 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 (PR)
Italy
0123

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Contents
Description......................................................................... 4
Specifications .................................................................... 5
Environmental Conditions .................................................. 6
Symbols. ..... ..... ..... ...... ..... ..... ..... ...... ..... ..... ..... ...... ..... ..... ... 7
Cautions ........ ..... ...... ..... ..... ..... ..... ...... ..... ..... ..... ...... ..... ..... 9
Controls and Operation.... ...... ..... ..... ..... ..... ...... ..... ..... ..... ... 10
sing FLOVAC Disposable Liners ..................................... 11
Battery Status and Charging .............................................. 13
Cleaning .......... ..... ...... ..... ..... ..... ...... ..... ..... ..... ...... ..... ..... ... 15
Spare Parts........................................................................ 17
Troubleshooting ......... ..... ...... ..... ..... ..... ...... ..... ..... ..... ...... ... 18
Wiring Diagram..... ..... ..... ...... ..... ..... ..... ...... ..... ..... ..... ...... ... 19
Diagnostic Setup...... ...... ..... ..... ..... ...... ..... ..... ..... ...... ..... ..... 20
Return for Repair . ..... ..... ...... ..... ..... ..... ...... ..... ..... ..... ...... .... 20
Periodic Safety Check.... ..... ...... ..... ..... ..... ...... ..... ..... ..... ..... 22
Emissions Guidance Table ................................................ 23
Immunity Guidance Table .................................................. 24
Immunity Guidance Table .................................................. 25
Separation Guidance Table .............................................. 26
Warranty .......................................................................... 30

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4 Description
Description
The Clements Ceevac High Suction Pump is a compact, portable unit
designed to suit the needs of hospitals, doctors’ surgeries and
paramedics in providing a strong source of suction for use in both
indoor and outdoor environments where mains power is unavailable
or interrupted.
Identification
SUC 81030 Ceevac High Vacuum / High Flow Portable 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 Ceevac, consult the instructions for use. Failure to
follow instructions in this manual could cause harm.
Do not use Ceevac for thoracic or low vacuum drainage.
Do not use Ceevac for suctioning of explosive, corrosive or easily
flammable fluids.
Ceevac is not suitable for MRI. Do not place the Ceevac pump in MRI
environments.
Classifications
GMDN 63642
GMDN Term Surgical suction um
GMDN Synonym As irator
Device Class Class IIa (Rule 11)
Electrical Protection (on battery) Internally owered
Protection Ty e BF A lied Part
Sterilisation Not su lied in sterile state
Anaesthetic Rating
NOT Category AP
NOT Category APG
O eration Mode Continuous o eration
Electrical Protection (on vehicle) Class II
Electrical Protection (on mains) Class II

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Specifications
Specifications
Maximum Vacuum -80 kPa [-600 mmHg]
Maximum Flow 21 L/min (through jar) 32 L/min (free air)
Mains Power
Requirement
100 - 240 V~ 50/60 Hz 110 VA
Internal Battery Fully sealed, rechargeable, lead acid battery.
12 V 4.0 Ah ca acity
Battery Run Time Total 60 minutes unoccluded
Charge / Status
Indicator
Light Emitting Diode (LED) lam on control anel
Red / Green / Amber Off / Steady / Flashing
Audible bee when LED is red.
Warning time Minimum 5 minutes
Power Pack /
Battery Charge
External; Powers um . Monitors and charges
battery when mains ower su ly is connected
Pum Piston ty e
Filter Dis osable hydro hobic and bacterial filter
BFE 99.9999%, VFE 0.027 micron
Collection Container 1 litre autoclavable, shatter roof lastic jar
O tional 1 litre dis osable liner jar
Overfill Protection Float valve mechanism
Vacuum Control Needle valve
Gauge Bourdon tube ty e. Dual scale. Accuracy ±5%
Gauge Range 0 to -100 kPa graduated at 5 kPa
0 to -760 mmHg graduated at 50 mmHg
Weight 4.0 kg
Dimensions 360L x 215W x 195H mm
Standard Conditions 25C, Sea level, 100 kPa
Vehicle Power
Requirement
12Vdc 4A

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6 Environmental Conditions
Package Contents
The Clements Ceevac package contains:
• Ceevac portable suction pump
• Charger with mains power supply lead
• Silicone 8 x 14 mm medical suction tubing; 18cm x2, 150cm x1
• 1 litre reusable collection jar with lid assembly
• Cigarette lighter 12 volt 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
O erating Tem erature 5ºC 35ºC
Humidity 10% RH 93% RH
Barometric Pressure 700 hPa 1060 hPa
Tem erature -25ºC 70ºC
Humidity 0% RH 93% RH
Barometric Pressure 500 hPa 1060 hPa
Trans ort and Storage
Shipping with Internal SLA Battery
• Unrestricted USA shipment.
• Complies with IATA/ICAO Special Provision A67 for air transport.
• Recognised by DOT as “Dry Charge” 49 CFR 171 189 for surface
transport.
• Classified per MG Amendment 27 as a non hazardous material
for water transport.
Jar Classifications
GMDN 44943
GMDN Term Suction System Canister, Reusable
Device Class Class I (Rule 1)
Sterilisation Not su lied in sterile state

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Symbols
Symbols
0123
General warning
Consult user manual
Ty e BF A lied Part (suction cannula)
Insulation Class II (double insulation)
Hz Mains ower frequency
Direct current
Battery
On / Off
CE Mark in conformity with CE MEDDEV directive
93/42/CEE and subsequent changes
Manufacturer
REF Model / Reference Number
E24
Ty e a roval E24 R10-060907 according to ECE R10
Automotive EMC Test
~Alternating current

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LOT Lot / Batch Number
SN Serial Number
Fragile
Relative Humidity
Tem erature Range
Atmos heric Pressure Range
C-Tick Mark
Degree of rotection against intrusion by body arts or
objects an against ingress by water.
1st Digit - Penetration of Solids
2 = Protected against solids > Ø 12.5 mm
2nd Digit - Penetration of Liquids
1 = Protected vertical dri ing water
IP21
Kee Cool / Kee out of direct sunlight
Dis ose of electrical roduct according to requirements
of WEEE directive
Symbols

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9
Cautions
Usage
1. Use only for the specified Intended Use.
2. Do not use near flammable substances such as oxygen or
anaesthetic gases.
3. Home care use is restricted to home carers and physically and
mentally competent adults.
4. In home care use, keep accessories out of reach of infants as
small parts can present a choking hazard.
Fluids
1. Keep device clear of water and other fluids. Do not handle pump
with wet hands.
Electrical
1. Use only the supplied power pack / charger.
2. Confirm that electrical rating of power pack matches that of the
mains power. Avoid the use of power boards and extensions.
3. If power pack / charger is used, maintain clear access to the
mains power outlet to facilitate disconnection.
4. Place pump clear of patient and other electronic equipment.
5. When not in use, disconnect power pack from power supply.
6. 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.
Cautions

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10
Operation
1. Place the pump on a flat stable horizontal surface.
2. Connect a short length of silicone tubing from the jar “VACUUM”
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 inlet.
3. Connect the long silicone tubing to the jar “PATIENT” port.
4. Select power source.
1) Connect plug of supplied power pack / charger to power
socket at rear of pump. OR
2) Connect plug of supplied cigarette lighter lead to power
socket at rear of pump. OR
3) Use internal battery.
Controls and Operation
Pump Controls
Vacuum Control
Status LED
Bacterial / Hydro hobic Filter
» Must ALWAYS be fitted «
“IN” or Δ Side
of Filter
“VACUUM” ort
(above float valve)
Push ON /
Push OFF
Switch
Vacuum Gauge
kPa / mmHg
“PATIENT” Port
Connect Patient
Tubing
Power Inlet
(at rear)

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11
Suction Accessories
5. Press switch to turn on pump. (Press again to turn off.)
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 compatible suction cannula.
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 re uired.
Using FLOVAC Disposable Liners
1. Remove liner from package and
extend liner from lid.
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 pump.
5. Press short end of yellow reusable
nipple [6] firmly into matching yellow
port [5] on the lid.
6. Push tubing from filter onto yellow
nipple [6].
7. Connect patient tubing to white inlet
elbow [7]. Connect patient tubing to
suitable suction cannula.
1
2
7
4
3
5
8
6
Note: For disposable jars only, that have a hydrophobic and
antibacterial filter built in to the lid, connection may be made directly
to the pump inlet nipple.
For reusable jars, connection must be made through an inline
hydrophobic and antibacterial filter.

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12 Suction Accessories
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,
the 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.
Disposable Liner Disconnection
1. Switch off pump.
2. Disconnect white elbow together with patient tubing from
“PATIENT” port and close port firmly with attached cap [8].
3. Disconnect yellow nipple [6] from “VACUUM” port [5].
4. Ensure that “TANDEM” port [3] is firmly closed with attached
cap [4].
5. Carefully remove liner from support jar using lid handle and
dispose of according to local protocols for potentially
biohazardous waste.

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13
Battery Status and Charging
LED Colour LED State Battery Status Action
Green Steady Charged Disconnect Charger
Green Flashing Charged
Orange Steady Partially Charged
Red Steady Flat Recharge
Red Flashing Com letely Flat Recharge
Battery Status LED
When the pump is connected to external power the tri colour LED
indicates the charging status, either charging or complete.
When the pump is running, the LED indicates the battery status as
charged, partially charged or flat.
When not connected to power and the pump is switched off, the LED
is off to conserve the remaining battery charge.
Battery Charging
Use only the supplied power pack / charger model
UE60 140429SPA1.
Recharge the battery after each use to maintain the pump’s
maximum standby capacity. When the battery is fully charged the
internal charging control circuit automatically reduces current to a
trickle charge to compensate for battery self discharge.
Charging a flat battery takes approximately 240 minutes.
Ceevac may be placed on charge at any time to restore its battery to
fully charged condition. It is not necessary to wait until the battery is
flat before recharging.
Recharge the battery every three months when pump is not in use in
order to maintain the maximum capacity and service life of the
battery.
Audible Alarm
The red status LED is accompanied by a 0.8 second beep repeated at
an 8.5 second interval.

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14 Battery Service Life
Recycling
The internal SLA battery contains lead. Before disposing of
pump, remove the internal battery and recycle according to local
recycling requirements for lead products.
Battery Service Life
The following chart shows the expected service life of the battery
against the depth of discharge. In summary, maximum service
life of the battery will be obtained from a usage pattern which
limits the discharge depth to 30%.
Battery Service Life
0
20
40
60
80
100
120
0 200 400 600 800 1000 1200
Number of cycles
Cpaacity (%)
Discharge
de th 100%
Discharge
de th 50%
Discharge
de th 30%
Ambient tem erature 20 to 25ºC

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Cleaning
Cleaning
After Each Operation
Empty Collection Jar
1. Switch off pump.
2. Disconnect tubing from jar “PATIENT “ port.
3. Disconnect tubing from jar “VACUUM” port.
4. Carefully remove jar from pump and dispose of aspirated
fluid 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.
Suction Tubing
Suction Tubing should 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 temperatures the suction tubing will discolour and lose
shape.
Collection Jars
Place jars upright or up side down in autoclave not on their
sides. Autoclave to a maximum of 121°C for 15 minutes. Do not
use phenolic solutions as disinfecting agents in polycarbonate
jars.
Bung (Lid)
Unlock bayonet on float cage by rotating cage clockwise.
Disconnect float cage and float from bung (lid) and separate seal
from bung (lid). Place all items upright or up side down in
autoclave not on their sides. Autoclave all items to a maximum
of 121°C for 15 minutes.

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16 Waste Disposal
Check Bacteria Filter
The bacterial/hydrophobic filter is an important device to help protect the pump
and environment from moisture and bacteria taken from patient airways.
Clements recommend that the filter be changed every month or when damp or
discoloured.
Change after every use when the unit is used on infectious patients.
After Every 100 Hours or 2 Months of Operation
• Check all suction tubing and replace if it is perished, soft or
discoloured. Also check the tubing nipples.
• 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, suction tubing, bacteria filter,
internal exhaust 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
Spare Parts

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Troubleshooting
1. The Pump Fails To Operate
• If attempting to run from mains power supply:
♦ Check that the mains power supply lead is firmly connected
and that the power is on at the mains power supply outlet.
• If attempting to run from the internal battery, check the
Battery Status LED on the Control Panel. If it is on (Red) refer
to the Charging the Internal Battery section.
• 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 or rigger release to allow suction.
• Check bacteria/hydrophobic shut off valve filter.
If the pump fails to work and you are unsure why, contact your
service department or return unit to your distributor.
Troubleshooting

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Wiring Diagram
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
Vacuum
Gauge
Switch on pump and occlude inlet. Note maximum vacuum
reading.
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.
2.
Connect a calibrated vacuum gauge directly to inlet and repeat
maximum vacuum reading.
Confirm that pump gauge reads within the specified tolerance.
2. Occluded - acuum check
Max
Vacuum
Gauge
3. Occluded - gauge check
Max
Vacuum
Gauge
Calibrated
Vacuum
Gauge
1. Unoccluded - zero check
Diagnostic Setup
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