COOK Medical K-MAR5200-US User Manual Download Page 9

9

Vacuum Pump Instructions for Use

3.5 Supply Voltage Selection

The Vacuum Pump can operate on the voltage range 100 – 240 VAC, 50 – 60 Hz. No fuse selection is required.
If the voltage is changed, it may be necessary to replace the Power Cord to an appropriately rated Power Cord.
Ensure that the correct Power Cord is connected.

3.6 Electromagnetic Compatibility

The Vacuum Pump is designed to provide a reliable controlled source of vacuum. It has been tested and found to 
comply with the electromagnetic compatibility (EMC) limits for medical devices as specified by IEC 60601-1-2:2007. 
These  limits  are  designed  to  provide  reasonable  protection  against  harmful  interference  in  a  typical  medical 
installation.
Medical  electrical  equipment  requires  special  precautions  regarding  EMC  and  must  be  installed  and  operated 
according  to  these  instructions.  It  is  possible  that  high  levels  of  radiated  or  conducted  radio-frequency 
electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or 
nearby radio-frequency sources could result in performance disruption of the Vacuum Pump. Evidence of disruption
may include erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs cease 
using the Vacuum Pump and contact your Cook authorised service agent.
Refer to the tables in § 8 of this manual for guidance on electromagnetic emissions, electromagnetic immunity, 
and  recommended  separation  distance  between  portable  and  mobile  RF  communications  equipment  and  the 
Vacuum Pump.

3.7 Device Placement

The Vacuum Pump should be placed on a level secure surface, away from heaters, coolers, air-conditioning outlets, 
mists, splashes and exposure to direct sunlight. It must not be placed in the presence of flammable gases.
The ambient temperature should be b5°C and +35°C for the Vacuum Pump to function correctly. Position 
the vacuum pump such that quick and easy disconnection of the power supply plug is not impeded.

3.8 Connection to the Foot Pedal

• Connect the Foot Pedal to the Foot Pedal Connection on the rear of the Vacuum Pump.
• The connection must snap into place with an audible click.
• Release the plug by pressing on the sides of the Foot Pedal Connection.

3.9 Vacuum Line and Filter

The Vacuum Pump uses a disposable Vacuum Line with Hydrophobic Filter (re-order code K-DVLF-240).  
To prepare and install:
• Connect the silicone tube attached to the filter to the Patient Tube Connection on the Vacuum Pump.
• Connect the luer fitting of the disposable Vacuum Line to the vacuum supply luer fitting 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. 
Connecting to the wrong voltage 
will cause the Vacuum Pump to 
malfunction or may permanently 
damage the device!
The Power Cord must be equipped with 
a safety plug. Use the enclosed Power 
Cord for the connection between the 
power plug and the device socket!
WITHIN THE U.S.A – Use only a listed 
detachable Power Cord, type SJT, 
minimum 18AWGx30, 3 conductors, 
one end configured for NEMA 5-15, 
other end for IEC320/CEE22!
To avoid the risk of electric shock this 
equipment must only be connected to 
a supply mains with a protective earth!

 WARNING: EXPLOSION 

HAZARD. 

Do not use the Vacuum Pump 

in the presence of flammable gases!

 WARNING: ELECTRIC SHOCK 

HAZARD. 

Do not immerse the Vacuum 

Pump!

 WARNING: 

The Vacuum Pump 

should not be used adjacent to or 
stacked with other equipment. If 
adjacent or stacked use is necessary, 
the device should be monitored 
to verify normal operation in the 
configuration in which it will be used.

 IMPORTANT NOTE: 

Use of 

cables other than those specified or 
provided by the manufacturer of this 
equipment could result in increased 
electromagnetic emissions or 
decreased electromagnetic immunity 
of this equipment and result in 
improper operation.

 IMPORTANT NOTE: 

The 

Disposable Vacuum Line and 
Hydrophobic Filter (K-DVLF-240) has 
been designed and tested to handle 
the full vacuum range of the device. 
Other vacuum lines may not be able to 
withstand the full vacuum range.

 WARNING: BIOLOGICAL 

HAZARD. 

Always use the  

disposable Vacuum Line with 
Hydrophobic Filter (K-DVLF-240). Never 
use the device if there is any indication 
that the tubing, the filter or the 
Vacuum Pump is contaminated.

If the Vacuum Pump is suspected to be 
contaminated, do not allow further use 
of the device and immediately notify 
your authorised service agent to have 
the device checked and repaired.

The disposable Vacuum Line with 
Hydrophobic Filter attached to the 
Vacuum Pump are for single patient 
use only and must not be re-used 
or resterilised. Re-use of this device 
may result in cross-contamination 
which may lead to the transmission 
of infectious diseases. Re-sterilisation 
of this device may compromise the 
structural integrity of the device and 
cause product failure. Once used, this 
product is considered as infectious and 
should be disposed of according to local 
policy for disposal of biohazard waste.

3

4

5

6

7

8

1

2

1.

 Vacuum Pump 

5.

 Double Lumen Needle

2.

  Disposable 

6. 

Syringe

Vacuum Line with
Hydrophobic Filter

3.

 Aspiration Line 

7. 

Test Tube

4.

 Flushing Line 

8. 

Test Tube Heater

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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