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17

Vacuum Pump Instructions for Use

Guidance and manufacturer’s declaration – electromagnetic emissions

The Vacuum Pump is intended for use in the electromagnetic environment specified below. The customer or the end user of the Vacuum Pump should assure 
that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emissions  
CISPR 11

Group 1

The Vacuum Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and 
are not likely to cause any interference in nearby electronic equipment.

RF emissions  
CISPR 11

Class B

The Vacuum Pump is suitable for use in all establishments, including domestic establishments and those 
directly connected to the public low voltage power supply network that supplies buildings used for 
domestic purposes.

Harmonic emissions  
IEC 61000-3-2

Class A

Voltage 
fluctuations/flicker 
emissions  
IEC 61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunity

The Vacuum Pump is intended for use in the electromagnetic environment specified below. The customer or the end user of the Vacuum Pump should assure 
that it is used in such an environment.

Immunity Test 

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic 
discharge (ESD) 
IEC 61000-4-2

± 6 kV contact
± 8 kV air

± 8 kV contact
± 15 kV air

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 
(EFT)  
IEC 61000-4-4

± 2 kV for power 
supply lines
± 1 kV for input/
output lines

± 2 kV for power 
supply lines
N/A for input/output

Mains power quality should be that of a typical commercial or hospital 
environment.

Surge  
IEC 61000-4-5

± 1 kV line-to-line
± 2 kV line-to-ground

± 1 kV line-to-line
± 2 kV line-to-ground

Mains power quality should be that of a typical commercial or hospital 
environment.

Voltage dips, short 
interruptions and 
voltage variations 
on power supply 
input lines  
IEC 61000-4-11

<5% U

T

 (>95% dip in 

U

T

) for 0.5 cycles

40% U

T

 (60% dip in U

T

for 0.5 cycles
70% U

T

 (30% dip in U

T

for 25 cycles
<5% U

T

 (95% dip in U

T

for 5 seconds

0% U

T

 for 0.5 cycle

0% U

T

 for 1 cycle

70% U

T

 (30% dip in U

T

for 25 cycles
0% U

T

 for 5 seconds

Mains power quality should be that of a typical commercial or hospital 
environment. If the user of the Vacuum Pump requires continued operation during 
power mains interruptions, it is recommended that the Vacuum Pump be powered 
from an uninterruptible power supply or a battery.
Note: Compliance level in accordance with IEC61000-4-11 Ed. 2.0

Power frequency 
(50/60Hz) magnetic 
field IEC 61000-4-8

3 A/m

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical 
location in a typical commercial or hospital environment.

Conducted RF 
IEC 61000-4-6 

3 Vrms 
0.15 to 80 MHz

6 V

Portable and mobile RF communications equipment should be used no closer 
to any part of the Vacuum Pump, including cables, than the recommended 
separation distance calculated from the equation applicable to the frequency of 
the transmitter. 

Recommend separation distance

 

d = 0.6 √P

Radiated RF  
IEC 61000-4-3

3 V/m  
80 MHz to 2.5 GHz 

3 V/m

Recommend separation distance

 

d = 1.2 √P 80 MHz to 800 MHz 
d = 2.3 √P 800 MHz to 2.5 GHz 
where P is the maximum output power rating of the transmitter in watts (W) 
according to the transmitter manufacturer and d is the recommended separation 
distance in metres (m). 
Field strengths from fixed RF transmitters, as determined by an electromagnetic  
site survey

a

 should be less than the compliance level in each frequency range

b

  

Interference may occur in the vicinity of equipment marked with the following  
symbol:

Note:

 At 80 MHz and 800 MHz, the higher frequency range applies.  

Note:

  These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects 

and people. 

a

  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and 

FM radio broadcast  and TV broadcast  cannot  be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF 
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Vacuum Pump is used 
exceeds the applicable RF compliance level above, the Vacuum Pump should be observed to verify normal operation. If abnormal performance is 
observed, additional measures may be necessary, such as reorienting or relocating the Vacuum Pump.

b

 Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m. 

Summary of Contents for K-MAR5200-US

Page 1: ...uum Pump User Manual Please familiarise yourself with the safety instructions before using the device Federal Law USA restricts this device to use by or on the order of a physician M E D I CA L VACUUM PUMP ...

Page 2: ......

Page 3: ...s inappropriate waste handling of this product may cause potential hazards to the environment and human health For more detailed information about disposal of this product please contact your local city office or Cook Medical Representative COOK 2017 Document No IFU MAR52_US 1 Service address Please refer to your local Cook Medical distributor for details of your nearest authorised service agent W...

Page 4: ...Vacuum Setting Adjustment 10 3 12 Set Display Units 10 3 13 Foot Pedal Function 10 3 13 1 Non Latching Foot Pedal 10 3 13 2 Latching Foot Pedal 10 3 13 3 Set Foot Pedal 11 3 14 Boost Touch Pad 11 3 15 Chime Volume Adjustment 11 3 16 Pre Operation Test 12 4 INSTALLATION AND SET UP CHECKLIST 12 5 OPERATION OF THE DEVICE 13 5 1 Before the Operation 13 5 2 Calibration of Flow Rates 13 5 3 During the O...

Page 5: ... Safety Instructions see 1 Manual Structure This manual has a table of contents page 2 to help you find section titles quickly Additionally an index is on page 16 There is a troubleshooting guide on page 15 to help you to trouble shoot problems The following pictograms appear on the Vacuum Pump and the Disposable Vacuum Line with Hydrophobic Filter K DVLF 240 Before connection read the manual Refe...

Page 6: ...hould any liquid enter the device discontinue use immediately Please refer all servicing to the manufacturer s authorised service agent Do not use in an area where flammable gases are present For your own safety only use original disposables see 7 WARNING Please familiarise yourself with the safety instructions before using the Vacuum Pump WARNING This Vacuum Pump should only be operated by approp...

Page 7: ...s damaged The manufacturer will only honour claims for compensation which are forwarded immediately to the sales representative or the authorised service agent Remove all items from plastic covers except the disposable Vacuum Line with Hydrophobic Filter item 3 which needs to be handled under sterile conditions 3 2 You Need to Supply The following items are not supplied Test Tube Heater and test t...

Page 8: ...00 mmHg 67 kPa 8 Boost Indicator Indicates the Boost Function is active 9 mmHg Indicator Indicates that the display will show the vacuum in mmHg 10 kPa Indicator Indicates that the display will show the vacuum in kPa 11 Patient Tube Connection Barb fitting for connection to the Vacuum Line and Filter 12 Vacuum Supplied Indicator Indicates that vacuum is being supplied 3 4 Rear of the Device 1 Powe...

Page 9: ...g of the needle set Connect a Syringe to the Flushing Line of the needle set if required Note This diagram indicates a Cook K OPSD needle set The set up is complete and now ready for use WARNING ELECTRIC SHOCK HAZARD Determine if the available voltage corresponds to your device Connectingtothewrongvoltage will cause the Vacuum Pump to malfunction or may permanently damage the device The Power Cord...

Page 10: ...h Pad Increase once the Vacuum Display will flash up either Indicates mmHg Mode Indicates kPa Mode 3 Press Adjust Vacuum Touch Pad Increase again to toggle between mmHg mode and kPa mode 4 Once the desired setting is achieved switch the device into active mode 5 The appropriate indicator should now be lit up 6 The device should be displaying in the appropriate units 3 13 Foot Pedal Function The Va...

Page 11: ...e Foot Pedal The Vacuum Supplied Indicator lights up Press and hold the Boost Touch Pad the Boost Indicator lights up The device will reach a maximum vacuum of 500 mmHg 67 0 kPa A small overshoot may occur up to 530 mmHg Release the Boost Touch Pad The Vacuum Display should reach the pre selected value within 5 mmHg 3 15 Chime Volume Adjustment 1 Ensure that the Vacuum Pump is in standby mode by u...

Page 12: ...tive of whether the device is on or in standby IMPORTANT NOTE It is recommended that the Vacuum Pump be given a pre operation test before each operation IMPORTANT NOTE If the vacuum value is not reached or if the value begins to decrease again then there is a leak First check the disposable Vacuum Line with Hydrophobic Filter IMPORTANT NOTE If you should find or suspect deficiencies in the Vacuum ...

Page 13: ...3 2 Ensure the device has undergone a Pre Operation Test see 3 16 3 Use the Adjust Vacuum Touch Pads to select the desired vacuum see 5 3 5 2 Calibration of Flow Rates The first step in IVF is to obtain good quality oocytes Calibrating the correct flow rate is the key to retrieving the maximum number of oocytes in optimal condition The rate of flow through an aspiration needle and tubing is depend...

Page 14: ... 8 Connect a silicone tube and a manometer with vacuum measurement capability to the Patient Tube Connection 9 Activate the Foot Pedal Function 10 The manometer should show a vacuum of 267 mBar 7 mBar 11 Press and hold the Boost Touch Pad 12 The Vacuum Pump should achieve and display a vacuum of 500 5 mmHg Note there may be a small overshoot up to 530 mmHg Check the manometer reading corresponds t...

Page 15: ... safety during transportation 1 Clean as detailed in 6 1 2 Seal in a plastic bag and seal within a second plastic bag 3 Place in the original packaging 4 Enclose the following information Owner s name Owner s address Model type Serial number of the equipment see identification plate Description of the damage or fault The manufacturer has the right to refuse to carry out repairs if the products it ...

Page 16: ... ISO 10079 1 Dimensions 200 mm wide x 100 mm high x 350 mm deep Weight 3 2 kg 7 1 lb Vacuum Ranges 10 mmHg to 500 mmHg in 1 mmHg increments 1 0 kPa to 67 0 kPa in 0 1 kPa increments Vacuum Range Accuracy 5 mmHg 0 7 kPa Guidance and manufacturer s declaration electromagnetic emissions The Vacuum Pump is intended for use in the electromagnetic environment specified below The customer or the end user...

Page 17: ...econds Mains power quality should be that of a typical commercial or hospital environment If the user of the Vacuum Pump requires continued operation during power mains interruptions it is recommended that the Vacuum Pump be powered from an uninterruptible power supply or a battery Note Compliance level in accordance with IEC61000 4 11 Ed 2 0 Power frequency 50 60Hz magnetic field IEC 61000 4 8 3 ...

Page 18: ...tay on when Foot Pedal is depressed and released The Foot Pedal Function is set to Non Latching Set the Foot Pedal Function to the Latching Refer to 3 13 3 Vacuum Pump displays an error code in the form of ER1 to 5 Device has an internal fault Contact service agent Recommended separation distance between portable and mobile RF communications equipment and the Vacuum Pump The Vacuum Pump is intende...

Page 19: ...sory service which can be consulted by a purchaser or intended purchaser on an advisory basis After one 1 year from the date of purchase this device will be repaired for a repair charge equal to the cost of parts labour and transport Before returning a product for any reason please contact your nearest Cook distributor for assistance and instructions Cook Australia reserves the right to change or ...

Page 20: ...or 8 L Latching Foot Pedal Function 10 Liability 15 17 Limited Warranty 17 M Mains Cord Mount 8 Mains Power Inlet 8 Maintenance 14 Manual Structure 5 Maximum Current 16 mmHg Indicator 8 N Non Latching Foot Pedal Function 10 O Operation of the Device 13 Original Disposables 6 15 P Patient Tube Connection 8 Performance Class 16 Power Consumption 16 Power Supply 16 Pre Operation Test 12 R Rear of the...

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Page 24: ...acturer WILLIAM A COOK AUSTRALIA PTY LTD 95 Brandl Street Brisbane Technology Park Eight Mile Plains Brisbane QLD 4113 AUSTRALIA Americas EDI www cookmedical com edi do Phone 1 812 339 2235 800 457 4500 Fax 800 554 8335 E mail orders cookmedical com ...

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