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CLEMENTS

CLEMENTS

CLEMENTS

CLEMENTS 

 

 

 

22

 

Immunity Guidance Table 

 

Guidance and manufacturer’s declaration 

 Electromagnetic Immunity 

 

 

The Ceevac suction pump is intended for use in the electromagnetic environment specified below. 

The customer or the user of the Ceevac suction pump should ensure that it is used in such an 

environment.

 

Immunity 
Test

 

Level indicated by

 

EN 60601

-

1

-

2

 

Compliance 

Level

 

Electromagnetic environment 

-

 

guidance

 

Electrostatic 

discharge 

(ESD)

EN 61000

-

4

-

2

 

± 8 kV on contact

 

± 15 kV in air

 

The device 

doesn’t

change its 

state

 

Floors should be wood, concrete or 

ceramic  tile. If  floors  are  covered 

with synthetic material, the relative 

humidity should be at least 30%.

 

Electrical fast

transient / burst

 

EN 61000

-

4

-

4

 

± 2 kV power supply

lines

 

± 1 kV for input /

output lines

 

The device 

doesn’t

change its 

state

 

Mains power quality should be that 

of a typical commercial 

environment or hospital.

 

Surge

 

EN 61000

-

4

-

5

 

± 1 kV differential 

mode

 

The device 

doesn’t

change its 

state

 

Mains power quality should be that 

of a typical commercial 

environment or hospital.

 

Loss of voltage, 

brief voltage 

interruptions

and variations

 

EN 61000

-

4

-

11

 

5%U

(>95% dip U

T

)

 

for 0.5 cycle

 

40%U

T

 (>60% dip U

T

)

 

for 5 cycle

70%U

T

 (>30% dip U

T

)

 

for 25 cycle

 

<5%U

T

 (>95% dip U

T

)

 

for 5 sec

 

Mains power quality should be that of 

a typical commercial environment or 

hospital. If the user of the Ceevac 

suction pump requests that the

appliance operates continuously, the 

use of a backup supply is 

recommended.

 

Magnetic field

 

EN 61000

-

4

-

8

 

30 A/m

 

The device 

doesn’t

change its 

state

 

The power frequency magnetic field 

should be measured in the 

intended installation location to

assure that it’s sufficiently low.

 

Note U

T

 is the nominal value of the power supply voltage

 

Summary of Contents for SUC 81025

Page 1: ...ACeevac High Vacuum High Flow Portable Suction Pump SUC 81025 220 240 V 50 Hz User Manual CLEMENTS Manual No SUC 81025 008 Issue 3 ...

Page 2: ...d by authorised personnel in accordance with the instructions as described in this manual Operated in this way the ACeevac High Suction Pump will provide the standard of service specified Due to continual improvements in product design the ACeevac 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...

Page 3: ...tions 9 Controls and Operation 10 Using FLOVAC Disposable Liners 11 Cleaning 13 Spare Parts 15 Troubleshooting 16 Wiring Diagram 17 Diagnostic Setup 18 Periodic Safety Check 20 Return for Repair 20 Emissions Guidance Table 21 Immunity Guidance Table 22 Immunity Guidance Table 23 Separation Guidance Table 24 Warranty 26 ...

Page 4: ...rocedures carried out by clinically trained and authorized personnel Contraindications Before using the ACeevac consult the instructions for use Failure to follow instructions in this manual could cause harm Do not use for thoracic or low vacuum drainage Do not use the ACeevac for suctioning of explosive corrosive or easily flammable fluids ACeevac is not suitable for MRI Do not place in the ACeev...

Page 5: ...able shatterproof plastic jar Optional 2 litre autoclavable shatterproof plastic jar Optional 1 litre disposable liner jar Optional 2 litre disposable liner jar Overfill Protection Float valve mechanism Vacuum Control Needle valve Gauge Bourdon tube type Dual scale Gauge Range 0 to 100 kPa graduated at 5 kPa 0 to 760 mmHg graduated at 50 mmHg Weight 3 6 kg Dimensions 360L x 215W x 195H mm Standard...

Page 6: ... 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 5ºC 35ºC Humidity 10 RH 93 RH Barometric Pressure 700 hPa 1060 hPa Temperature 25º...

Page 7: ...l Type BF Applied Part suction cannula Insulation Class II double insulation Hz Mains power frequency Off CE Mark in conformity with CE MEDDEV directive 93 42 EEC and subsequent changes Manufacturer REF Model Reference Number LOT Lot Batch Number On Alternating current Symbols 0123 ...

Page 8: ...spheric Pressure Range C Tick Mark Dispose of electrical product according to requirements of WEEE directive IP21 Degree of protection against intrusion by body parts 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 dripping water Symbols ...

Page 9: ...only the supplied power cord 2 Confirm that electrical rating of rating label matches that of the mains power Avoid the use of power boards and extensions 3 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 from power supply 6 Do not pull cable to remove plug from mains power outlet ...

Page 10: ...r side of the filter to the pump inlet 3 Connect the long silicone tubing to the 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 to turn on pump Press again to turn off Controls and Operation Pump Controls Bacterial Hydrophobic Filter Must ALWAYS be fitted Vacuum Control IN or Δ Side of Filter VACUUM port a...

Page 11: ...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 ...

Page 12: ...re 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 firm...

Page 13: ...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 solut...

Page 14: ...oured Also check the tubing connectors 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 biohazardous wastes Handle using safe hand...

Page 15: ...1030 009 Kit Seal Lid 1L 2L Reusable Jar Pack 2 SUC 81030 010 Kit Lid Assembly for 1L 2L Reusable Jar SUC 81030 012 Kit Filter Bacteria Hydrophobic Pack 10 SUC 81030 013 Kit Silicone Tubing Set Joiner Pack 1 SUC 81030 018 Kit Vacuum Control for Ceevac ACeevac SUC 81030 020 Gauge Vacuum 0 to 100 kPa for Ceevac ACeevac SUC 81030 042 Kit 2L Reusable Collection Jar Pack 1 SUC 81030 121 Kit 1L FLOVAC D...

Page 16: ...al suction tubing is in good condition and not old or cracked Check the type of handpiece in use as some handpieces require finger occlusion or trigger release to allow suction Check bacteria hydrophobic filter If the pump fails to work and you are unsure why contact your service department or return unit to your distributor Fuse Replacement The ACeevac is fitted with a fuse located in a fuse hold...

Page 17: ...CLEMENTS CLEMENTS CLEMENTS CLEMENTS 17 Wiring Diagram Wiring Diagram ...

Page 18: ... 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 g...

Page 19: ... indicates leaks in jar or connections 1 Occluded leak check Flow Check Max Vacuum Gauge 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 2 Unoccluded flow check Max Vacuum Gauge...

Page 20: ...Return for Repair Before returning the ACeevac for repair the external surfaces and any accessories must be carefully disinfected with a cloth soaked in methylated spirits or hypochlorite based solution The pump and any accessories should then be placed in a bag with a note outlining the disinfection undertaken Failure to follow this procedure will result in the pump being returned unrepaired Equi...

Page 21: ...ow voltage power supply network that supplies buildings used for domestic purposes EMC Information Tables per EN 60601 1 2 2014 In accordance with EN 60601 1 2 2014 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests 1 Medical Electrical Equipment needs special precautions regarding EMC and needs to be insta...

Page 22: ...nput output lines The device doesn t change its state Mains power quality should be that of a typical commercial environment or hospital Surge EN 61000 4 5 1 kV differential mode The device doesn t change its state Mains power quality should be that of a typical commercial environment or hospital Loss of voltage brief voltage interruptions and variations EN 61000 4 11 5 UT 95 dip UT for 0 5 cycle ...

Page 23: ...an the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Radiated Immunity EN 61000 4 3 10 V m 80 MHz to 2 7 GHz for non life supporting devices E1 10 V m Note 1 At 80 MHz and 800 MHz the interval with the highest frequency is applied Note 2 These guide lines may not be applicable in all situations The electro magnetic pro...

Page 24: ...transmitter W 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 12 E1 P 800 MHz to 2 7 GHz d 23 E1 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters with a maximum nominal output power not shown above the recommended separation distance in metres m can be calculated using the equation applicable to the transmitter frequency where P is the maximum no...

Page 25: ...CLEMENTS CLEMENTS CLEMENTS CLEMENTS 25 Notes Notes ...

Page 26: ...able to the original purchaser of the product 3 The product must not have had its serial number removed defaced or changed its casing opened its power supply altered or have been tampered with in any other way 4 This warranty does not cover inadequate or incorrect site preparation improper installation connection to the wrong voltage failure of the product due to misuse the use or operation of the...

Page 27: ...erms of the sale of the product or otherwise in connection with the product is limited to the amount paid by the purchaser to ICU Medical Australia for the product 10 Apart from any liability imposed by Part VA of the Trade Practices Act ICU Medical Australia accepts no other liability for any loss or damage occasioned including consequential loss or damages in any way as a result of the use of th...

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