SUC 81010 and SUC 81008 Carri Vac High Vac High Flow Suction User Manual Issue 22

Safety Thank you for purchasing this Clements CarriVac 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 CarriVac High Suction Pump will provide the standard of service specified. Due to continual improvements in product design, the CarriVac 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 BMDi TUTA Healthcare direct.

User Manual CarriVac High Suction Pump Manual Number SUC 91005 405 Issue 22 Copyright © 2009 BMDi TUTA Healthcare Pty Ltd The information in this manual was originated by, and is the exclusive property of BMDi TUTA Healthcare 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.

BMDi TUTA Healthcare Pty Ltd Unit 4B, 128-130 Frances Street Lidcombe NSW 2141 Australia Phone: +61 2 9466 5300 Website: www.medaust.com

CLEMENTS

Contents Description ...

4

Specifications ...

5

Controls and Indicators ...

6

Installation and Operation ...

8

Battery Charging and Care ...

10

Transportation and Storage ...

12

Electromagnetic Interference ...

13

Accessories and Spares ...

14

Maintenance and Cleaning ...

16

Troubleshooting ...

18

Diagnostic Setup ...

19

Fuse Replacement, Periodic Safety Check ...

21

Wiring Diagram ...

22

Electrical Diagnostic Procedure...

23

Emissions Guidance Table 201 ...

24

Immunity Guidance Table 202 ...

25

Immunity Guidance Table 204 ...

26

Warranty ...

30

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Description The Clements CarriVac 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 81010, SUC 81008 CarriVac 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.

Classifications GMDN

36777

GMDN Term

Suction unit, electric powered

GMDN Synonym

Aspirator

Device Class

Class IIa

Protection

Class I / Internally powered

Protection

Defibrillation-Proof Type BF Applied Part

Sterilisation

Not supplied in sterile state

Anaesthetic Rating

NOT Category AP NOT Category APG

Operation Mode

Continuous operation

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Description

CLEMENTS

Specifications Vacuum

0 to -80 kPa, 0 to –600 mmHg

Flow

0 to 24 litres of free air per minute (LFAPM)

Mains Power Requirement

SUC 81010 : 230 V 50/60Hz 250 W SUC 81008 : 220 V 50/60Hz 250 W

Internal Battery

Fully sealed, rechargeable, lead acid battery.

Battery Run Time

Total 60 minutes unoccluded

Low Battery

Light Emitting Diode (LED) Lamp located on control panel

Warning time

Minimum 5 minutes

Battery Charger

In built; monitors and charges battery when mains power supply is connected

Charging Time

6 hours, from Low Battery indication

Pump

Diaphragm type

Filter

Disposable bacterial filter Retention > 99.999% (0.3 micron)

Collection Container

1 litre autoclavable, shatterproof plastic jar with self sealing rubber bung

Overfill Protection

Float valve mechanism

Vacuum Control

Needle valve

Gauge

Bourdon tube type. Dual scale kPa and mmHg

Gauge Range

0 to -100 kPa graduated at 5 kPa 0 to -760 mmHg graduated at 20 mmHg

Weight

8.5 kg total including battery and accessories

Dimensions

H 260 mm, W 180 mm, L 420 mm

Standard Conditions

25°C, Sea level, 100kPa

Specifications

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Operator Controls Control Panel

1

3

2

O I

4

5

Pump Base

10 A M P

6

Circuit Breaker Circuit Breaker on base protects unit against overload. Press to reset after allowing to cool. If Circuit Breaker trips again have unit serviced.

Controls and Indicators

CLEMENTS Control Panel Legend Item

Control or Indicator

1

Vacuum Gauge

2

Vacuum Control Knob

3

Suction On / Off Switch

4

Charging Indicator LED

5

Low Battery Indicator LED

Control or Indicator Operation 1.

Vacuum Gauge indicates actual vacuum level in both kPa and mmHg.

2.

Vacuum Control Knob is used to set vacuum to required level. Rotate clockwise to increase vacuum level.

3.

Suction On / Off Switch is used to switch the suction pump on and off. The “ O ” symbol indicates the Off position. The “ I ” symbol indicates the On position.

4.

The green Charging indicator LED indicates that the unit is connected to mains power and the battery is automatically being charged as required.

5.

The yellow Low Battery indicator LED indicates that the battery is not fully charged. When the LED first turns on it indicates that there is only 5 minutes run time remaining. When the battery is fully charged the LED turns off. See section “Charging the Internal Battery” on page 10 for recommendations on charging.

Controls and Indicators

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Installation and Operation The Clements CarriVac comes complete with: • • • • •

Mains power supply lead Yellow medical suction tubing 1 litre collection jar with bung assembly Auxiliary 12 volt power lead Single Use Plastic Handpiece

IMPORTANT The CarriVac High Suction Pump is designed for emergency short term use only. It is not intended for use in operating theatres or where the pump is required to run for long periods. For applications which require continuous vacuum, please contact your distributor for information about the Clements High Suction range of products.

Connecting the Collection Jar To Patient

Blue Bacterial Filter P Suction Pump Unit

Black Rubber Bung with Valve Assembly

Jar

WARNING Always reduce vacuum strength for neonatal and paediatric purposes.

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Installation and Operation

CLEMENTS Operation 1 2 3

Install the Collection Jar and Suction Tubing as described in the Connecting The Collection Jar section on page 6. The CarriVac can be powered by the mains power supply, auxiliary power supply, or the internal battery. Press the green Power Switch down into the on position; the motor will run. Mains Power Connect the unit to the mains power supply and switch the power on at the mains supply outlet. 12 Volt Auxiliary Power Connect the auxiliary power cable to the socket (located to the right of the mains power socket). Connect the plug to a suitable 12 volt 6 amp cigarette lighter socket. Battery Powered Check that the red Low Battery Indicator on the Control Panel is off. If the Low Battery Indicator glows red then refer to the Charging the Internal Battery section on page 8.

4

Occlude the Suction Tubing and adjust the Vacuum Controller by turning the knob, to obtain the required vacuum level, as indicated on the Vacuum Gauge.

Check that there is no loss of vacuum in the Suction Tubing and fittings. Check the Collection Jar to ensure that suction is being applied correctly. Please Note: Although the Collection Jar is fitted with an Overflow Cut Off Valve, the fluid levels should be monitored to prevent spillover into the pump unit.

Installation and Operation

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CLEMENTS Charging the Internal Battery There is no external power pack for the CarriVac portable high suction pump. When the internal battery charge is low an electronic monitor will activate the red Low Battery Indicator. The pump may be run for a further 5 minutes after the LED is illuminated. Continuing to run the pump beyond this point, risks causing permanent damage to the battery. When the power pack is connected the internal charger automatically charges the battery from the mains power supply. 1. Connect the unit to the mains power supply and switch the power on at the mains supply outlet. 2. Maintain the mains power supply to the unit until the Low Battery Indicator goes out. If the battery was fully depleted, charging should take approximately 6 hours. 3. During this time the pump can be run. The electronic charger will continue to charge the internal battery from the mains power supply even though the pump is running 4. When the battery is fully charged the Low Battery Indicator will extinguish. The unit is now ready for use with battery power. 5. When the suction unit is connected via its auxiliary socket to a vehicle 12VDC power source, the internal battery is not charged unless the vehicle battery is being charged. This is to minimise the drain on the vehicle battery. CarriVac may be placed on charge at any time to restore its battery to fully charged condition. It is not necessary to wait until the Low Battery LED is lit before recharging.

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Battery Charging and Care

CLEMENTS Shipping • • • •

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.

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 battery contains lead. Before disposing of pump, remove the internal battery and recycle according to local requirements for lead products.

Battery Charging and Care

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

Parameter

Minimum

Maximum

Temperature

10ºC

40ºC

Humidity

60% RH

95% RH

Barometric Pressure

700 mBar

1060 mBar

Warning Symbols Legend The warning symbols marked on the equipment and their meanings are shown as follows.

Caution, consult accompanying documents

Defibrillation-Proof Type BF applied part

Dispose of product according to requirements of WEEE directive

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Transportation and Storage

CLEMENTS

Electromagnetic Interference This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and the receiver.

•

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

•

Consult the dealer or an experienced radio/TV technician for his or her help.

Changes or modifications to the equipment not expressly approved by Clements could void the user’s authority to operate the equipment.

Electromagnetic Interference

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Accessories and Spares Accessories SUC 80297

Yellow Medical Suction Tubing

SUC 80404 001

Single Use Plastic Handpiece (Pack of 10)

SUC 80350

Metal Handpiece with Fingervalve and Multi Hole Tip

SUC 80490

Metal Handpiece, No Fingervalve with Multi Hole Tip

SUC 81003

1 Litre Collection Jar for Portable High Pumps (Jar Only)

SUC 81004

Bung Assembly for 1 Litre Collection Jar

SUC 81005

Black Float Valve and Cage Assembly for 1 Litre Collection Jar Bung

SUC 81007

Auxiliary 12 volt Power Lead for the CarriVac Portable High Suction Pump

SUC 81009

1 Litre Collection Jar with Bung and Overflow Cut Off Valve

SUC 84100 162

Blue Bacteria Filter (Set of 12)

SUC 84100 400

Hydrophobic Shut-Off Valve Filter

SUC 91005 405

User Manual for the CarriVac High Suction Pump 12 VDC / 240VAC (SUC 81010) and 12V / 220VAC (SUC 81008)

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Accessories and Spares

Suction

CLEMENTS Spare Parts MUL 91000 576

Silicone Suction Tubing

MUL 94004 000

Mains Power Switch Green Rocker

SUC 80332

Gauge Rear Entry with Bracket

SUC 81000 039

Inlet Connection for 1 litre Jar Bung

SUC 81000 121

Motor and Pump for CarriVac

SUC 81010 009

Printed Circuit Board Assembly for SUC 81010

SUC 81010 002

Battery 12 V 4.5 Ah SLA

SUC 84100 103

Exhaust Filter Silencer for Suction Pumps

SUC 84200 502

Suction Inlet Nipple for Collection Jar Bung (Set of 4)

SUC 84200 518

Washer for Overflow Cut Off Valve (Pack of 4)

SUC 84200519

Blue Male Nipple for Bacteria Filter 10)

SUC 84200 520

Blue Male to Female Nipple for Bacteria (Pack of 10)

SUC 81001003

Overhaul Kit for Diaphragm Pump

MUL 94002 994

Circuit Breaker

MUL 94003 725

5 x 20 Fuse T3.0 A 250V

SUC 89107

Kit for Controller (Needle Type) including Controller Body, Spindle with O-Ring and lock nut, Vacuum Control Knob and Screw

Accessories and Spares

(Pack of Filter

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Maintenance and Cleaning After Each Operation Empty Collection Jar To empty collection jar disconnect tubing from pump side and remove jar from pump body. Remove bung from jar and dispose of aspirated fluid according to local protocols. Push Down Here

Lift Edge Here

Lift Edge Here

Lift Edge Here

Step 1

Step 2

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 PVC tubing. Suction Tubing may be autoclaved to a maximum of 121°C for 20 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 136°C for 10 minutes. Do not use phenolic solutions as disinfecting agents in polycarbonate jars. •Bung Disconnect float cage and float from Bung. Place all items upright or up-side-down in autoclave: not on their sides. Autoclave all items to a maximum of 136°C for 10 minutes.

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Maintenance and Cleaning

CLEMENTS Check Bacteria Filter The blue bacterial 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 rings on the Bungs and replace them if they are hard, cracked or perished. Check the fit of the Bung in the Collection Jar. • Check the Overflow Cut Off Valve seals and replace them if they are 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.

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

Maintenance and Cleaning

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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. ♦ Disconnect mains power lead. ♦ Check that the fuses have not blown. The fuses are located in the black plastic mains power supply inlet below the control panel. • If attempting to run from the internal battery, check the Low Battery indicator on the Control Panel. If it is on (yellow) refer to the Charging the Internal Battery section on page 10. • Check that the motor circuit breaker has not tripped. The motor circuit breaker is located on the base plate underneath the pump body. Press the small button to reset the circuit breaker. • Ensure that the Vacuum Gauge on the Control Panel indicates zero. If not, release vacuum.

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 yellow 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 hydrophobic shut off valve filter (if fitted) If the pump fails to work and you are unsure why, please contact your service department or return unit to your distributor.

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Troubleshooting

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

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. Diagnostic Setup

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CLEMENTS Flow Check 1. Occluded - leak check

Max

Jar: SUC 81099 (1 litre) or SUC 80312 (2 litre) Tubing: SUC 80297 (8x13mm)

Vacuum Gauge

Connect pump as shown in diagram. Set vacuum control knob to maximum, and switch on pump. Occlude jar inlet and confirm 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 Jar: SUC 81099 (1 litre) or SUC 80312 (2 litre) Tubing: SUC 80297 (8x13mm)

Vacuum Gauge Calibrated Flowmeter

Collection 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 (or internal shutoff valve if fitted).

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Diagnostic Setup