SUC 81030 Ceevac Portable Suction Pump User Manual Rev 2

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.

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.

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

CLEMENTS Contents Description...

4

Specifications ...

5

Environmental Conditions ...

6

Symbols ...

7

Cautions ...

9

Controls and Operation ...

10

Using 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 ...

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Immunity Guidance Table ...

25

Separation Guidance Table ...

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Warranty ...

30

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CLEMENTS 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 pump

GMDN Synonym

Aspirator

Device Class

Class IIa (Rule 11)

Electrical Protection (on battery)

Internally powered

Electrical Protection (on mains)

Class II

Electrical Protection (on vehicle)

Class II

Protection

Type BF Applied Part

Sterilisation

Not supplied in sterile state

Anaesthetic Rating

NOT Category AP NOT Category APG

Operation Mode

Continuous operation

4

Description

CLEMENTS 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

Vehicle Power Requirement

12Vdc 4A

Internal Battery

Fully sealed, rechargeable, lead acid battery. 12 V 4.0 Ah capacity

Battery Run Time

Total 60 minutes unoccluded

Charge / Status Indicator

Light Emitting Diode (LED) lamp on control panel Red / Green / Amber Off / Steady / Flashing Audible beep when LED is red.

Warning time

Minimum 5 minutes

Power Pack / Battery Charge

External; Powers pump. Monitors and charges battery when mains power supply is connected

Pump

Piston type

Filter

Disposable hydrophobic and bacterial filter BFE 99.9999%, VFE 0.027 micron

Collection Container

1 litre autoclavable, shatterproof plastic jar Optional 1 litre disposable liner jar

Overfill Protection

Float valve mechanism

Vacuum Control

Needle valve

Gauge

Bourdon tube type. 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

25°C, Sea level, 100 kPa

Specifications

5

CLEMENTS Jar Classifications GMDN GMDN Term Device Class Sterilisation

44943 Suction System Canister, Reusable Class I (Rule 1) Not supplied in sterile state

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

Operating

Temperature Humidity Barometric Pressure

5ºC 10% RH 700 hPa

35ºC 93% RH 1060 hPa

-25ºC

70ºC

0% RH 500 hPa

93% RH 1060 hPa

Transport and Storage Temperature Humidity Barometric Pressure

Shipping with Internal SLA Battery • • • •

6

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. Environmental Conditions

CLEMENTS Symbols General warning Consult user manual

Type BF Applied Part (suction cannula)

Insulation Class II (double insulation)

Hz

Mains power frequency Direct current Battery On / Off

0123

E24

CE Mark in conformity with CE MEDDEV directive 93/42/CEE and subsequent changes Type approval E24 R10-060907 according to ECE R10 Automotive EMC Test Manufacturer

REF ~

Model / Reference Number Alternating current

Symbols

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CLEMENTS

LOT

Lot / Batch Number

SN

Serial Number

Fragile

Relative Humidity

Keep Cool / Keep out of direct sunlight

Temperature Range

Atmospheric Pressure Range

C-Tick Mark

Dispose of electrical product according to requirements of WEEE directive Degree of protection against intrusion by body parts or objects an against ingress by water.

IP21

1st Digit - Penetration of Solids 2 = Protected against solids > Ø 12.5 mm 2nd Digit - Penetration of Liquids 1 = Protected vertical dripping water

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Symbols

CLEMENTS

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

9

CLEMENTS Pump Controls Bacterial / Hydrophobic Filter “IN” or Δ Side of Filter “VACUUM” port (above float valve)

» Must ALWAYS be fitted «

Vacuum Gauge kPa / mmHg Status LED

“PATIENT” Port Connect Patient Tubing Push ON / Push OFF Switch Vacuum Control

Power Inlet (at rear)

Operation 1. 2.

3. 4.

10

Place the pump on a flat stable horizontal surface. 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. Connect the long silicone tubing to the jar “PATIENT” port. 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

CLEMENTS

5. 6.

7. 8.

Press switch to turn on pump. (Press again to turn off.) Occlude tubing and adjust vacuum control to the required vacuum level. (Clockwise = increase) Always reduce the vacuum level for paediatric and neonatal patients. Apply suction to patient with compatible suction cannula. 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.

Using FLOVAC Disposable Liners 7 1. 2.

3. 4. 5.

6.

7.

Remove liner from package and extend liner from lid. Insert liner bag [1] into the matching size support jar [2]. Press edge of lid firmly all around edge to ensure seal. Close the TANDEM inlet [3] with the attached cap [4]. Fit jar assembly into pump. Press short end of yellow reusable nipple [6] firmly into matching yellow port [5] on the lid. Push tubing from filter onto yellow nipple [6]. Connect patient tubing to white inlet elbow [7]. Connect patient tubing to suitable suction cannula.

1

8 4

5 3 6 2

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.

Suction Accessories

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CLEMENTS

Disposable Liner Disconnection 1. 2. 3. 4. 5.

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

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.

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Suction Accessories

CLEMENTS 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. LED Colour LED State

Battery Status

Action

Green

Steady

Charged

Green

Flashing

Charged

Orange

Steady

Partially Charged

Red

Steady

Flat

Recharge

Red

Flashing

Completely Flat

Recharge

Disconnect Charger

Audible Alarm The red status LED is accompanied by a 0.8 second beep repeated at an 8.5 second interval.

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. Battery Status and Charging

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CLEMENTS 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 120

Cpaacity (%)

100 80 60 Discharge depth 100%

40

Discharge depth 50%

Discharge depth 30%

20 Ambient temperature 20 to 25ºC

0 0

200

400

600

800

1000

1200

Number of cycles

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.

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Battery Service Life

CLEMENTS

Cleaning After Each Operation Empty Collection Jar 1. 2. 3. 4.

Switch off pump. Disconnect tubing from jar “PATIENT “ port. Disconnect tubing from jar “VACUUM” port. 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.

Cleaning

15

CLEMENTS

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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Waste Disposal

CLEMENTS

Spare Parts SUC 81030 001

Kit, 1L Reusable Collecon Jar (Pack 1)

SUC 81030 005

Support Jar for FLOVAC Disposable 1L Liner

SUC 81030 007

Support Jar for FLOVAC Disposable 2L Liner

SUC 81030 008

User Manual for SUC81030 Ceevac Sucon Pump

SUC 81030 009

Kit, Seal, Lid, 1L/2L Reusable Jar (Pack 2)

SUC 81030 010

Kit, Lid Assembly for 1L/2L Reusable Jar

SUC 81030 011

Power Pack/Charger for Ceevac

SUC 81030 012

Kit, Filter Bacteria/Hydrophobic (Pack 10)

SUC 81030 013

Kit, Silicone Tubing Set, Joiner (Pack 1)

SUC 81030 014

PCBA, Electronic Control for Ceevac

SUC 81030 015

Ba8ery, SLA 12V 4.0Ah for Ceevac

SUC 81030 016

Adapter, Vehicle, 12V, Fused for Ceevac

SUC 81030 017

Switch, ON/OFF for Ceevac

SUC 81030 018

Kit, Vacuum Control for Ceevac/ACeevac

SUC 81030 020

Gauge, Vacuum 0 to -100 kPa for Ceevac/ACeevac

SUC 81030 029

Pump, Motor Unit, 12V Ceevac, Diaphragm

SUC 81030 042

Kit, 2L Reusable Collecon Jar (Pack 1)

SUC 81030 050

Pump, Motor Unit, 12V Ceevac, Piston

SUC 81030 121

Kit, 1L FLOVAC Disposable Liner (Pack 50)

SUC 81030 122

Kit, 2L FLOVAC Disposable Liner (Pack 50)

SUC 81030 132

Support Jar for FLOVAC Disposable 2L Liner

Spare Parts

17

CLEMENTS

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.

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Troubleshooting

CLEMENTS Wiring Diagram

Wiring Diagram

19

CLEMENTS 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 Calibrated Vacuum 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. 20

Diagnostic Setup