VACUUM PUMP

Vacuum 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.

MEDICAL
Vacuum Pump Instructions for Use

General Information
Copyright
WARNING:
READ THIS MANUAL. This manual contains information that is subject to copyright. All rights reserved. This manual should not be
Please familiarise yourself with the photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the
contents of the manual before using approval of William A. Cook Australia Pty. Ltd.
the device. Failure to comply with these Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as
instructions may result in damage to such. It should therefore not be assumed that the absence of the trademark indicates that any given designation is
device, device contents, and/or patient not subject to trademark protection.
or user injury. This device should only Users of William A. Cook Australia Pty. Ltd. products should not hesitate to contact us if there are any unclear points
be used by qualified personnel. or ambiguities in this manual.

WARNING:
ELECTRIC SHOCK HAZARD.
The equipment is to be used only with
electrical systems complying with all
IEC, CEC and NEC requirements.

WARNING:
Any adjustment, modification or
repairs to the equipment should be
carried out by persons authorised to
perform them.

Disposal of this product must be This symbol indicates that this product may not be treated as municipal waste. Please ensure that this product
undertaken with regard to the WEEE is properly disposed of as inappropriate waste handling of this product may cause potential hazards to the
directive (2002/96/EC). 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.

3
Vacuum Pump Instructions for Use

Table of Contents
EXPLANATION OF PICTOGRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
HOW TO USE THIS MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings and Important Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Manual Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1. SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2. ABOUT THE K-MAR-5200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Device Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.4 Precautions for Device Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. INSTALLATION AND SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 You Need to Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 Front of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.4 Rear of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.5 Supply Voltage Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.6 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.7 Device Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.8 Connection to the Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.9 Vacuum Line and Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.10 Activating the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.11 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 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.4 Clearing Blockages in the Aspiration Line/Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.5 After the Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6. SERVICE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.1 Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.2 Biannual Functionality Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.2.1 Functionality Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.3 Inspection by an Authorised Service Agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.4 Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7. DISPOSABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8. TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
9. TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10. LIMITED WARRANTY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.1 Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.2 Life of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
11. INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4
Vacuum Pump Instructions for Use

Explanation of Pictograms
The following pictograms appear on the Vacuum Pump and the Disposable Vacuum
Line with Hydrophobic Filter (K-DVLF-240)

Before connection, read the manual! EC REP EC Representative

Refer to IFU – Mandatory REF Catalogue Code

Standby/On SN Serial Number

Degree of enclosure protection from

Increase Vacuum Set-Point IP41 solid objects and liquids

Decrease Vacuum Set-Point (1) Do not reuse

Boost Vacuum (1) Do not use if packaging is damaged

Patient Tube Connection (1) Keep away from sunlight

Foot Pedal Connection (1) Keep dry

Symbol for type B equipment (1) Batch code

CE – Approval Marking Note (1): Symbols are on sterile Disposable Vacuum Line
with Hydrophobic Filter (K-DVLF-240) packaging
only.
UL – Approval Marking

Dispose of in accordance with

WEEE directive (2002/96/EC)

Manufacturer

How to use this Manual

Warnings and Important Notes
Throughout these Instructions for Use, blocks of text may be accompanied by a pictogram and/or printed in
bold type. These instructions point out special service procedures or precautions that must be followed to avoid
damaging the device. These blocks are WARNINGS and IMPORTANT NOTES and they are used as follows:

WARNING: The personal safety of the patient may be involved. Disregarding this information could result
in injury to the operator, device or the contents!

WARNING: Biological hazard

WARNING: Electric shock hazard

WARNING: Explosion hazard

IMPORTANT NOTE: This provides special information that facilitates maintenance or clarifies important
instructions. Please pay particular attention to the 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.

5
Vacuum Pump Instructions for Use

1. Safety Instructions
This manual describes the operation and intended use of the Vacuum Pump and the disposables.
WARNING: Please familiarise It is essential to use this document to familiarise yourself with the functions and the operation of the Vacuum Pump
yourself with the safety instructions before use.
before using the Vacuum Pump.
Failure to follow these instructions can result in serious injury to the patient or the operating team and can lead to
damage or breakdown of the device and disposables.
WARNING: This Vacuum
Pump should only be operated by This manual does not provide a detailed description of operation technologies, nor is it suitable for introducing
appropriately qualified personnel. a beginner to this operating technique. Only physicians and medical assistants under the direction of a physician
with the appropriate technical qualification may use this device and disposables.
IMPORTANT NOTE: In case the Vacuum Pump fails during an operation, a replacement device and replacement disposables should be
Replacement device and disposables. kept within reach so that the operation may be completed.
Always work with the one-way hydrophobic filter between the collection receptacle and the Vacuum Pump to
WARNING: BIOLOGICAL prevent body fluids from entering the device.
HAZARD. Always use the disposable Never use the Vacuum Pump if there is any indication that the tube, the filter or the device is contaminated. Do not
Vacuum Line with Hydrophobic Filter allow any further use of the device. Immediately notify your authorised service agent to have the device checked
(K-DVLF-240). Never use the device if and repaired.
there is any indication that the tubing, Always monitor the aspiration vacuum level. An excessive vacuum can lead to damage of the oocyte or other body
the filter or the Vacuum Pump is tissue.
contaminated.
There is evidence in the published literature suggesting that the use of higher vacuum aspiration pressures
If the Vacuum Pump is suspected to be (greater than -300 mmHg) can lead to the potential for decreased oocyte quality and, consequently, decreased
contaminated, do not allow further use development and fertilisation potential. For oocyte aspiration, only use the highest vacuum aspiration pressure
of the device and immediately notify necessary to achieve the required flow rate for the size aspiration needle being used. The boost should only be used
your authorised service agent to have to clear blockages or obstructions in the aspiration line or aspiration needle when the needle is outside the patient.
the device checked and repaired.
The Pre-Operation Test (see §3.16) must be performed prior to each operation.
The disposable Vacuum Line with
If a Vacuum Pump defect is suspected or confirmed, stop using the device until an authorised service agent has
Hydrophobic Filter attached to the
checked it.
Vacuum Pump are for single patient
use only and must not be re-used Internal circuitry is energised whenever the Vacuum Pump is connected to mains power irrespective of whether the
or resterilised. Re-use of this device device is on or in standby. Always disconnect the device from mains power before cord replacement, or cleaning.
may result in cross-contamination Should any power cord or plug associated with the device become cracked, frayed, broken or damaged it must be
which may lead to the transmission replaced immediately.
of infectious diseases. Re-sterilisation To reduce the risk of electric shock, do not remove covers. Refer servicing to an authorised service agent.
of this device may compromise the Protect the Vacuum Pump from being splashed by liquid. Should any liquid enter the device, discontinue use
structural integrity of the device and immediately.
cause product failure. Once used, this
product is considered as infectious and Please refer all servicing to the manufacturer’s authorised service agent.
should be disposed of according to local Do not use in an area where flammable gases are present.
policy for disposal of biohazard waste. For your own safety, only use original disposables (see §7).

WARNING: Monitor the vacuum.

WARNING: Electric shock hazard.

WARNING: No user serviceable

parts inside.

EXPLOSION HAZARD: Device

can cause explosion in presence of
flammable gases.

WARNING: Use only original

disposables.

2. About the K-MAR-5200

2.1 Indications for Use
The Cook Vacuum Pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using
low flow, intermittent vacuum.

2.2 Contraindications
There are no known contraindications for these devices.

2.3 Device Description

The Vacuum Pump is designed to maintain a vacuum accurately at a user specified setting with a range of
-10 mmHg to -500 mmHg when configured to display mmHg and a range of -1.0 kPa to -67.0 kPa when configured
to display kPa. In either case, the device will maintain the vacuum within ±5 mmHg (0.7 kPa).
The device can also boost the vacuum to -500 mmHg (or -67.0 kPa in kPa display mode) from any setting.
The disposable Vacuum Line with Hydrophobic Filter consists of a one-way hydrophobic filter and 240 cm long
low volume vacuum line. The disposable Vacuum Line with Hydrophobic Filter is used to connect ovum aspiration
needles to the Cook Vacuum Pump to prevent contamination of the unit. It is supplied sterile in peel-open packages
and is intended for single-use.

2.4 Precautions for Device Use

In the event of any electrical or mechanical fault during use or entry of fluid into the Vacuum Pump, cease use of
the device until it has been checked by an authorised service agent.

6
Vacuum Pump Instructions for Use

3. Installation and Set-up

An installation and set-up checklist has been included at the end of this section (see §4). This may be used to help
IMPORTANT NOTE: It is ensure correct preparation.
important to retain packaging for
future use. (Refer to §6.4 - Return
Procedure) 3.1 Unpacking
Items supplied
Please find the following items supplied:

1 2

3 4 5

1. User Manual
2. Vacuum Pump
3. Disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240)
4. Foot Pedal
5. Power Cord
Check all items immediately upon receipt to make sure the contents are complete and that nothing is 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

IMPORTANT NOTE: Items The following items are not supplied:
required that you need to supply are
listed here. • Test Tube Heater and test tubes.
• Aspiration Fluid.
• A source of sterile distilled water.

7
Vacuum Pump Instructions for Use

3.3 Front of the Device

9
3

8
1 10 12
4 4

7 11
5 6
2

1. Standby Indicator Indicates the powered on state, Green = Active, Orange = Standby.
2. Standby Touch-Pad Toggles the device between Active and Standby State.
3. Vacuum Display Displays the measured vacuum.
4. Vacuum Adjust Indicators Indicates Set-Point adjustment.
5. Vacuum Adjust Touch-Pad Decrease, Press to decrease the Vacuum Set-Point.
6. Vacuum Adjust Touch-Pad Increase, Press to increase the Vacuum Set-Point.
7. Boost Touch-Pad Press to boost the vacuum to -500 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

2 1
1
4

1. Power Cord Mount Used to hold the Power Cord when the device is not in use.
2. Mains Power Inlet Connect the appropriate Power Cord to this point.
3. Foot Pedal Connection Connect the Foot Pedal to this point.
4. Release Tab Release button for Foot Pedal Connection and disconnection.

8
Vacuum Pump Instructions for Use

3.5 Supply Voltage Selection

WARNING: ELECTRIC SHOCK
HAZARD. Determine if the available The Vacuum Pump can operate on the voltage range 100 – 240 VAC, 50 – 60 Hz. No fuse selection is required.
voltage corresponds to your device. If the voltage is changed, it may be necessary to replace the Power Cord to an appropriately rated Power Cord.
Connecting to the wrong voltage Ensure that the correct Power Cord is connected.
will cause the Vacuum Pump to
malfunction or may permanently
damage the device! 3.6 Electromagnetic Compatibility
The Power Cord must be equipped with The Vacuum Pump is designed to provide a reliable controlled source of vacuum. It has been tested and found to
a safety plug. Use the enclosed Power comply with the electromagnetic compatibility (EMC) limits for medical devices as specified by IEC 60601-1-2:2007.
Cord for the connection between the These limits are designed to provide reasonable protection against harmful interference in a typical medical
power plug and the device socket! installation.
WITHIN THE U.S.A – Use only a listed Medical electrical equipment requires special precautions regarding EMC and must be installed and operated
detachable Power Cord, type SJT, according to these instructions. It is possible that high levels of radiated or conducted radio-frequency
minimum 18AWGx30, 3 conductors, electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or
one end configured for NEMA 5-15, nearby radio-frequency sources could result in performance disruption of the Vacuum Pump. Evidence of disruption
other end for IEC320/CEE22! may include erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs cease
To avoid the risk of electric shock this using the Vacuum Pump and contact your Cook authorised service agent.
equipment must only be connected to Refer to the tables in § 8 of this manual for guidance on electromagnetic emissions, electromagnetic immunity,
a supply mains with a protective earth! and recommended separation distance between portable and mobile RF communications equipment and the
Vacuum Pump.
WARNING: EXPLOSION
HAZARD. Do not use the Vacuum Pump
in the presence of flammable gases!
3.7 Device Placement
The Vacuum Pump should be placed on a level secure surface, away from heaters, coolers, air-conditioning outlets,
WARNING: ELECTRIC SHOCK mists, splashes and exposure to direct sunlight. It must not be placed in the presence of flammable gases.
HAZARD. Do not immerse the Vacuum The ambient temperature should be between +5°C and +35°C for the Vacuum Pump to function correctly. Position
Pump! the vacuum pump such that quick and easy disconnection of the power supply plug is not impeded.

WARNING: The Vacuum Pump 3.8 Connection to the Foot Pedal

should not be used adjacent to or
stacked with other equipment. If • Connect the Foot Pedal to the Foot Pedal Connection on the rear of the Vacuum Pump.
adjacent or stacked use is necessary, • The connection must snap into place with an audible click.
the device should be monitored
• Release the plug by pressing on the sides of the Foot Pedal Connection.
to verify normal operation in the
configuration in which it will be used.
3.9 Vacuum Line and Filter
IMPORTANT NOTE: Use of The Vacuum Pump uses a disposable Vacuum Line with Hydrophobic Filter (re-order code K-DVLF-240).
cables other than those specified or To prepare and install:
provided by the manufacturer of this
equipment could result in increased • Connect the silicone tube attached to the filter to the Patient Tube Connection on the Vacuum Pump.
electromagnetic emissions or • Connect the luer fitting of the disposable Vacuum Line to the vacuum supply luer fitting of the needle set.
decreased electromagnetic immunity • Connect a Syringe to the Flushing Line of the needle set (if required).
of this equipment and result in
improper operation.
Note: This diagram indicates a Cook K-OPSD needle set.
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. 3
Other vacuum lines may not be able to 2
withstand the full vacuum range.
1 5
WARNING: BIOLOGICAL
HAZARD. Always use the
disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never 4
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 6
contaminated, do not allow further use 7
of the device and immediately notify
your authorised service agent to have 1. Vacuum Pump 5. Double Lumen Needle
the device checked and repaired. 2. Disposable 6. Syringe
The disposable Vacuum Line with Vacuum Line with
Hydrophobic Filter attached to the 8 Hydrophobic Filter
Vacuum Pump are for single patient 3. Aspiration Line 7. Test Tube
use only and must not be re-used
or resterilised. Re-use of this device The set up is complete and now ready for use. 4. Flushing Line 8. Test Tube Heater
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.

9
Vacuum Pump Instructions for Use

3.10 Activating the Device

WARNING: ELECTRIC SHOCK
• Connect the Power Cord to the Power Inlet. The Standby Indicator should light up.
HAZARD. Internal circuitry is energised
whenever the Vacuum Pump is • The Vacuum Pump will either be in the standby mode or active mode depending on the last state the device was
connected to mains power irrespective in when mains power was disconnected.
of whether the device is on or in • If the Vacuum Pump is in standby, press the Standby Touch-Pad to put the device into an active state.
standby.

3.11 Vacuum Setting Adjustment

• Press and hold the appropriate Adjust Vacuum Touch-Pad.
• The vacuum will adjust in 1 mmHg or 0.1 kPa steps depending on the Display Units Setting.
• The selected value appears in the Vacuum Display.
• When the desired vacuum is reached release the Touch-Pad.

3.12 Set Display Units

The measurement units that the Vacuum Pump can display are mmHg and kPa. This setting is indicated by either
the mmHg Indicator being lit or the kPa Indicator being lit.
The factory setting is mmHg.
To change this setting:
1. Ensure that the device is in standby mode by using the Standby Touch-Pad.
2. Press Adjust Vacuum Touch-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 Vacuum Pump has two Foot Pedal settings, Latching and Non–Latching.
The factory setting is Non–Latching.
To determine the setting of the device depress the Foot Pedal and observe the behaviour of the device.

3.13.1 Non-Latching Foot Pedal Function

• Press and hold the Foot Pedal.
• The vacuum is applied and a chime sounds every few seconds until the Foot Pedal is released.
• Release the Foot Pedal.
• The vacuum is disconnected and the suction stops.

3.13.2 Latching Foot Pedal Function

• Press and release the Foot Pedal.
• The vacuum is applied and a chime sounds every few seconds.
• Press and release the Foot Pedal.
• The vacuum is disconnected and the suction stops.

10
Vacuum Pump Instructions for Use

3.13.3 Set Foot Pedal Function

IMPORTANT NOTE: This
keystroke must be entered correctly to To change the setting.
change the Foot Pedal Function. 1. Ensure that the Vacuum Pump is in standby mode by using the Standby Touch-Pad.
If the Vacuum display does not indicate 2. Press the following sequence of Touch-Pads on the front panel to enter set Foot Pedal Function mode where
Latching or Non-Latching Mode, retry Adjust Vacuum Touch-Pads are , and Boost Touch-Pad is .
the sequence.

The Vacuum Display should now show either:

Indicates Latching Mode

Indicates Non-Latching Mode

If neither of these are displayed, repeat steps 1 & 2.

3. Press Adjust Vacuum Touch-Pad Decrease to toggle between Latching and Non-Latching mode.
4. Switch the device into active mode using the Standby Touch-Pad to exit the procedure.
5. To test that the Foot Pedal Function has been set, depress the Foot Pedal and the device should behave
accordingly.

3.14 Boost Touch-Pad

With a disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240), test tube, and needle set attached:
• Activate the Foot Pedal.
IMPORTANT NOTE: The boost
• The Vacuum Supplied Indicator lights up.
vacuum may not reach -500mmHg
when testing with large gauge needle • Press and hold the Boost Touch-Pad , the Boost Indicator lights up.
sets due to lower flow resistance. • 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 using the Standby Touch-Pad.
2. The Boost Touch-Pad can now be used to adjust the volume.
3. Each touch of the Boost Touch-Pad adjusts the volume in a sequence of 4 steps from minimum volume to
maximum volume.
The steps are displayed on the Vacuum Display with each touch of the Boost Touch-Pad.

No Volume

Minimum Volume

Medium Volume

Maximum Volume

4. You can now set the volume to suit your preference.

11
Vacuum Pump Instructions for Use

3.16 Pre-Operation Test

WARNING: ELECTRIC SHOCK
HAZARD. Internal circuitry is energised • Connect the Foot Pedal and the disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) to the Vacuum Pump.
whenever the Vacuum Pump is • Switch the device on.
connected to mains power irrespective • Ensure that the device is set to display in mmHg mode (see § 3.12).
of whether the device is on or in
standby. • Use the Vacuum Adjust Touch-Pads to select a vacuum between -120 and -170 mmHg.
• Activate the Foot Pedal. The Vacuum Supplied Indicator lights up. The chime sounds.
IMPORTANT NOTE: It is • The Vacuum Display may momentarily decrease (e.g from -170 to -160 mmHg). The Pump Motor may then be
recommended that the Vacuum Pump heard to accelerate and bring the vacuum level back to the set level, within ±5 mmHg.
be given a pre-operation test before • Close the Vacuum Line by kinking, press and hold the Boost Touch-Pad.
each operation. • The device should achieve and display a vacuum of -500 mmHg. Note the vacuum is likely to overshoot and may
reach -530 mmHg.
IMPORTANT NOTE: If the • Release the Boost Touch-Pad and the Vacuum Line.
vacuum value is not reached or if the • Deactivate the Foot Pedal.
value begins to decrease again, then
• The Vacuum Display should reach the pre-selected value within ±5 mmHg.
there is a leak. First check the
disposable Vacuum Line with
Hydrophobic Filter. The Pre-Operation Test is now successfully completed and the Vacuum Pump is ready for use in the operating room.

IMPORTANT NOTE: If you

should find or suspect deficiencies
in the Vacuum Pump during the
described function control, the device
must not be used until the authorised
service agent has repaired it.
Never use the Vacuum Pump if there
are obvious deficiencies, especially
involving the power plugs or the power
supply connection cables.
Arrange for repair by an authorised
service agent.

4. Installation and Set-up Checklist

Check the following:

!"All items have been supplied.

!"The packaging has been safely stored for future use.
!"All non-sterile items have been removed from plastic covers.
!"The Power Cord is correct for your region.
!"The Vacuum Pump has been placed in a suitable location.
!"The Vacuum Pump has undergone a Pre-Operation Test.
!"The disposable Vacuum Line with Hydrophobic Filter have been connected.
!"The Foot Pedal has been connected.
!"The Vacuum Pump has been activated.
!"The Vacuum Display has been set to the desired units.
!"The vacuum has been adjusted to the desired value.
!"The Foot Pedal Function has been set to the desired setting.

12
Vacuum Pump Instructions for Use

5. Operation of the Device

This section provides general information about the use of the Vacuum Pump. Only the physician can evaluate the
clinical factors involved with each patient and determine if the use of this device is indicated. The physician must
IMPORTANT NOTE: To ensure decide on the specific technique and procedure that will accomplish the desired clinical effect.
patient safety, the Pre–Operation Test
(see §3.16) must be performed prior to
each use. 5.1 Before the Operation
1. Ensure the Vacuum Pump is correctly set up as described in §3 including correct set up of the disposable
WARNING: BIOLOGICAL Vacuum Line with Hydrophobic Filter (see §3.9) and Foot Pedal (see §3.8 & §3.13).
HAZARD. Always use the 2. Ensure the device has undergone a Pre-Operation Test (see §3.16).
disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never 3. Use the Adjust Vacuum Touch-Pads to select the desired vacuum (see §5.3).
use the device if there is any indication
that the tubing, the filter or the
Vacuum Pump is contaminated.
5.2 Calibration of Flow Rates
If the Vacuum Pump is suspected to be The first step in IVF is to obtain good quality oocytes. Calibrating the correct flow rate is the key to retrieving the
contaminated, do not allow further use maximum number of oocytes in optimal condition. The rate of flow through an aspiration needle and tubing is
of the device and immediately notify dependent upon many variables, such as: the differential height between the needle tip and the collection test
your authorised service agent to have tube, the inner diameter of the needle, total length of the system and vacuum pressure according to Poiseuille’s
the device checked and repaired. Law. To ensure an optimal recovery rate with minimal damage to the oocytecumulus complex and zona pellucida,
flow rates of 20-25 mL/min are recommended. Calibration can be checked by aspirating water through the
The Disposable Vacuum Line with aspiration needle and adjusting the vacuum pressure to give the correct flow rate. A flow rate of 20-25 mL/min
Hydrophobic Filter attached to the equates to 24 to 30 seconds to aspirate 10 mL of water.
Vacuum Pump are for single patient
The vacuum pressure used with a specific gauge and/or type of ovum pick-up needle is at the discretion of the
use only and must not be re-used
clinician performing the procedure.
or resterilised. Re-use of this device
may result in cross-contamination
which may lead to the transmission 5.3 During the Operation
of infectious diseases. Re-sterilisation
of this device may compromise the 1. Insert the aspiration cannula into the follicle under ultrasound vision.
structural integrity of the device and 2. Activate the Foot Pedal to aspirate follicular fluid.
cause product failure. Once used, this 3. Deactivate the Foot Pedal when the follicle is empty.
product is considered as infectious and
should be disposed of according to local 4. The oocyte and follicular fluid are in the collection receptacle.
policy for disposal of biohazard waste.
5.4 Clearing Blockages in the Aspiration Line/Needle
WARNING: Always monitor the The vacuum pressure can be boosted to clear blockages in the ovum aspiration needle by activating the boost
aspiration vacuum level. An excessive button on the front panel of the unit.The boost should only be used to clear blockages or obstructions in the
vacuum can lead to damage of the aspiration line or aspiration needle when the needle is outside the patient.
oocyte or other body tissue. See
vacuum warning on page 4.
5.5 After the Operation
IMPORTANT NOTE: Operational 1. Use the Standby Touch-Pad to place the Vacuum Pump in standby mode.
Note.
2. Remove the disposable Vacuum Line with Hydrophobic Filter, Power Cord and Foot Pedal.

13
Vacuum Pump Instructions for Use

6. Service and Maintenance

To preserve the Vacuum Pump and ensure its proper functioning, proper service, maintenance and storage must
IMPORTANT NOTE: To be provided for. To protect the patient from infection, all disposables that come into contact with human tissue (eg.
guarantee safe operation, it is test tubes and tubing) must be sterile. Disposables must be discarded after each patient use.
necessary to carry out proper care and
maintenance of the Vacuum Pump
and disposables. Regular checks to
confirm correct functioning of the device
are recommended! New and repaired
products must be prepared and tested
according to the manual instructions
before you use them.

WARNING: Do not sterilise the

Vacuum Pump!

WARNING: ELECTRIC SHOCK

6.1 Cleaning the Device
HAZARD. Do not immerse the Vacuum After each use of the Vacuum Pump, turn off the device and disconnect the device from mains power.
Pump! Using an aqueous 70% alcohol (eg. ethanol or isopropyl) solution, moisten a cloth and wipe all external surfaces of
the device. Prevent any fluid from entering the device.
Do not use a 100% alcohol solution to clean the device, this may cause damage to the front surface.

6.2 Biannual Functionality Testing

IMPORTANT NOTE: This
functionality test must be performed In order to preserve the Vacuum Pump and maintain its safety, regular inspections are necessary for early detection
every six months. of possible malfunctions.
Regulations stipulate that the user or a qualified technician must regularly test the device to assess its functionality
and electrical safety. These tests must be performed on a biannual basis.

6.2.1 Functionality Test

Conversion Note:
mmHg kPa mBar
1 0,13332 1,3332
5 0,7 7
198 26,4 264
200 26,7 267
202 26,9 269
500 66,7 667

1 2

IMPORTANT NOTE: If the

vacuum value is not reached or if the 1 Vacuum Pump under test.
value begins to decrease again, then 2 Manometer compatible 0 to -1000 mBar.
there is a leak. Check the disposable
Vacuum Line with Hydrophobic Filter.
1. The basic function test is intended to check the Foot Pedal and the vacuum.
2. Ensure that the Vacuum Pump is set to display in mmHg mode (see § 3.12).
WARNING: If you should find 3. Connect the Foot Pedal and switch the Vacuum Pump on.
or suspect deficiencies in the Vacuum 4. Set the vacuum to -200 mmHg.
Pump during the described function 5. Activate the Foot Pedal Function.
control, the device must not be used
until it has been repaired by the 6. The Vacuum Motor and Chime should be audible (refer to §3.15 if no chime) and the Vacuum Supplied Indicator
authorised service agent. should light up.
7. Deactivate the Foot Pedal Function.
Never use the Vacuum Pump if there
are obvious deficiencies, especially 8. Connect a silicone tube and a manometer with vacuum measurement capability to the Patient Tube
involving the power plugs or the power Connection.
supply connection cables. 9. Activate the Foot Pedal Function.
Arrange for repair by an authorised 10. The manometer should show a vacuum of -267 mBar ±7 mBar.
service agent. 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 to the Vacuum Pump display
±7 mBar.
13. Release the Boost Touch–Pad.
14. Deactivate the Foot Pedal Function. The basic function test is completed.
If the Vacuum Display is not correct the Vacuum Pump should be serviced by an authorised service agent.

14
Vacuum Pump Instructions for Use

6.3 Inspection by an Authorised Service Agent

WARNING: No user serviceable
parts inside!
Inspections at least once a year For ongoing operational safety of the device, an authorised service
agent must maintain the Vacuum Pump annually as per SMA30001. The
service agent will assess the operational functionality of the vacuum
system.

Authorised service agents All services such as alterations, repairs, calibrations etc., may only be
performed by the manufacturer or by service agents who are authorised
by the manufacturer as per SMA30001.

Liability The manufacturer is free from all liability for the operational safety of the
Vacuum Pump if the device has been wilfully opened and unauthorised
persons have performed repairs or alterations on it during the warranty
period.

Certification The device owner will receive a signed certificate from the service agent
for all inspections or repairs. This certificate states the type and scope
of the services rendered, the service date and the name of the service
company.

Technical documentation If the manufacturer provides technical documentation, this does not
authorise the user to perform repairs, adjustments or alterations to the
Vacuum Pump or disposables.

WARNING: BIOLOGICAL 6.4 Return Procedure

HAZARD. The returned product
must be clearly marked with a All devices or disposables that are returned must be prepared as described below for the protection of the service
contamination warning and should agent and for safety during transportation.
be sealed in a plastic bag and sealed 1. Clean as detailed in §6.1.
within a second plastic bag! 2. Seal in a plastic bag and seal within a second plastic bag.
When shipping the Vacuum Pump 3. Place in the original packaging.
ensure that any connected disposable
4. Enclose the following information:
Vacuum Line with Hydrophobic Filter is
removed prior to transport! • Owner’s name
• Owner’s address
• Model type
IMPORTANT NOTE: When • Serial number of the equipment (see identification plate)
returning goods, use the original
packaging. The manufacturer does not • Description of the damage or fault.
take responsibility for damage that has The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated.
occurred during transportation if the
damage was caused by inadequate
transport packaging.

7. Disposables

Order No. Description

IMPORTANT NOTE: For optimal K-DVLF-240 Disposable Vacuum Line with Hydrophobic Filter.
functioning of the Vacuum Pump, use Consists of a 240 cm low volume aspiration line and a one way hydrophobic filter.
only original disposables.
The disposable Vacuum Line with
Hydrophobic Filter has been designed
and tested to handle the full vacuum
range of the Vacuum Pump.
Other vacuum lines may not be able to
withstand the full vacuum range.
The disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240) is a
single use device.

15
Vacuum Pump Instructions for Use

8. Technical Data
Classification according to IEC 60601-1

Type of protection against electric shock: Class I equipment

Degree of protection against electric shock: Type B

Degree of protection against harmful ingress of solids and water: IP41

Specifications

Power Supply: 100 - 240 VAC

Frequency: 50 - 60 Hz

Maximum current: 500 mA (115 VAC)

250 mA (240 VAC)

Maximum power consumption: 60 VA

Environmental operating conditions: +5°C to +35°C

10% to 75% RH
700 hPa to 1060 hPa

Storage and transport directions: +5°C to +40°C

10% to 75% RH

Manufactured and tested to the following standards: IEC 60601-1: 1988 + A1: 1991 + A2: 1995
IEC 60601-1: 2005
IEC 60601-1-2: 2007
ISO 10079-1: 1999
VACUUM PUMP WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH:
ANSI/AAMI ES60601-1(2005 + C1: 09 + A2: 10),
CAN/CSA-C22.2 No. 60601-1(2008), E363262

Performance class: High Vacuum / Low Flow (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 of the Vacuum Pump should assure
that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions The Vacuum Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference in nearby electronic equipment.

RF emissions
Class B
CISPR 11

Harmonic emissions
Class A The Vacuum Pump is suitable for use in all establishments, including domestic establishments and those
IEC 61000-3-2
directly connected to the public low voltage power supply network that supplies buildings used for
Voltage domestic purposes.
fluctuations/flicker
Complies
emissions
IEC 61000-3-3

16
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 The Vacuum Pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference in nearby electronic equipment.
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A The Vacuum Pump is suitable for use in all establishments, including domestic establishments and those
IEC 61000-3-2
directly connected to the public low voltage power supply network that supplies buildings used for
Voltage domestic purposes.
fluctuations/flicker
Complies
emissions
IEC 61000-3-3

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 ± 6 kV contact ± 8 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic
discharge (ESD)
± 8 kV air ± 15 kV air material, the relative humidity should be at least 30%.
IEC 61000-4-2
Electrical fast ± 2 kV for power ± 2 kV for power
transient supply lines supply lines Mains power quality should be that of a typical commercial or hospital
(EFT) ± 1 kV for input/ N/A for input/output environment.
IEC 61000-4-4 output lines
Surge ± 1 kV line-to-line ± 1 kV line-to-line Mains power quality should be that of a typical commercial or hospital
IEC 61000-4-5 ± 2 kV line-to-ground ± 2 kV line-to-ground environment.
<5% UT (>95% dip in
UT) for 0.5 cycles
Voltage dips, short 0% UT for 0.5 cycle Mains power quality should be that of a typical commercial or hospital
interruptions and 40% UT (60% dip in UT)
0% UT for 1 cycle environment. If the user of the Vacuum Pump requires continued operation during
voltage variations for 0.5 cycles
70% UT (30% dip in UT) power mains interruptions, it is recommended that the Vacuum Pump be powered
on power supply 70% UT (30% dip in UT) from an uninterruptible power supply or a battery.
input lines for 25 cycles
for 25 cycles
IEC 61000-4-11 0% UT for 5 seconds Note: Compliance level in accordance with IEC61000-4-11 Ed. 2.0
<5% UT (95% dip in UT)
for 5 seconds
Power frequency
Power frequency magnetic fields should be at levels characteristic of a typical
(50/60Hz) magnetic 3 A/m 30 A/m
location in a typical commercial or hospital environment.
field IEC 61000-4-8
Portable and mobile RF communications equipment should be used no closer
to any part of the Vacuum Pump, including cables, than the recommended
Conducted RF 3 Vrms 6V separation distance calculated from the equation applicable to the frequency of
IEC 61000-4-6 0.15 to 80 MHz the transmitter.
Recommend separation distance
d = 0.6 √P
Radiated RF 3 V/m 3 V/m Recommend separation distance
IEC 61000-4-3 80 MHz to 2.5 GHz 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 surveya should be less than the compliance level in each frequency rangeb
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.

17
Vacuum Pump Instructions for Use

Recommended separation distance between portable and mobile RF communications equipment and the Vacuum Pump
The Vacuum Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the Vacuum Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Vacuum Pump as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power m
of transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √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 rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects,
and people

9. Troubleshooting
IMPORTANT NOTE: Should any errors persist, contact your COOK distributor.

Error and Alarm Indicator Source of Error Elimination of Error

Vacuum Pump will not turn on. Power supply cord is not connected. Mains Check the power supply connection. (Refer to
power switch is not turned on. §3.10).
Displays do not illuminate. The device is in standby mode. Check that the Standby Indicator is illuminated
orange. Press the Standby Touch-Pad. (Refer to
§3.10).

Desired aspiration vacuum is not achieved. Foot Pedal is defective. Disconnect the Foot Pedal from the rear of the
device without applying pressure to the Foot Pedal
and re-connect the Foot Pedal.
Leak in the Vacuum Line or the Filter is wet. Change the Vacuum Line and Filter. (Refer to §7).

Chime Volume Adjustment does not adjust. Power supply cord is not connected. Mains Check the power supply connection. (Refer to
power is not turned on. §3.10).
The device is not in standby. The device is functionally active, press the Standby
Touch-Pad to place the device in standby. (Refer
to §3.15).

Vacuum Pump displays the Vacuum in wrong The Display Units setting is set to either Set the Display Units setting to desired units, either
units. mmHg or kPa. mmHg or kPa. (Refer to §3.12).

Vacuum stays on when the Foot Pedal is The Foot Pedal Function is set to Latching. Set the Foot Pedal Function to Non–Latching.
depressed and released. (Refer to §3.13.3).

Vacuum doesn’t stay on when Foot Pedal is The Foot Pedal Function is set to Non– Set the Foot Pedal Function to the Latching. (Refer
depressed and released. Latching. to §3.13.3).
Vacuum Pump displays an error code in the form Device has an internal fault. Contact service agent.
of ER1 to 5.

18
Vacuum Pump Instructions for Use

10. Limited Warranty

COOK AUSTRALIA warrants to the purchasers of this device that at time of manufacture, the product was prepared and tested in accordance with good
manufacturing practices and guidelines specified by the Australian Therapeutic Goods Administration or relevant competent authority.
In the event of product failure under normal use, due to defects in material or workmanship, within a period of one (1) year from the date of purchase, the
product will be repaired, or at Cook’s option, replaced, at no charge. This limited warranty does not apply to products subjected to abnormal use or conditions,
improper storage, damaged by accident, misuse or abuse, improper line voltage or to products altered or serviced by anyone other than Cook Australia or its
authorised agent.
The foregoing limited warranty is exclusive and in lieu of all other warranties whether written, oral, expressed or implied. In particular, Cook Australia does not
warrant that the product is suitable for the needs of the purchaser and there are no warranties given as to merchantability or fitness for a particular purpose.
Cook Australia’s representations concerning fitness for purpose or suitability for use by any purchaser does not extend beyond those representations set out
in the Cook Australia literature that accompanies the product. Cook Australia assumes that the purchaser is experienced in the use of this device and is able to
judge from his/her own expertise the suitability or otherwise of the product for the intended use. Cook Australia conducts a technical advisory 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 discontinue this product without notice.

10.1 Liability
Because Cook Australia has no control or influence over the conditions under which this device is used, over its method of use or administration, or on handling
of the product after it leaves its possession, Cook Australia takes no responsibility for the results, use and/or performance of the product. Cook Australia expects
that use of the product will be confined to trained and expert users.
In no event will Cook Australia be liable for any direct or indirect damages including incidental, consequential or special damages, arising out of or in connection
with the use or performance of the product.
If the manufacturer provides you with technical documentation, this does not authorise you to perform repairs, adjustments or alterations on the device or
disposables.
No representative of Cook Australia and no vendor or lessor of the product is authorised to change any of the foregoing terms and conditions, and the purchaser
accepts the product subject to all terms and conditions herein, subject always to any contrary provisions which are necessarily implied by stature or law
notwithstanding the within terms and conditions.

10.2 Life of Product

The expected service life of this product is deemed to be seven (7) years. After this time Cook Australia will no longer be responsible for this product.

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Vacuum Pump Instructions for Use

11. Index
A N
About the K–MAR–5200...................................................................................................6 Non-Latching Foot Pedal Function ........................................................................... 10
Activating the Device..................................................................................................... 10 O
Alarm Indicator ................................................................................................................ 17 Operation of the Device................................................................................................ 13
Aspiration Line ....................................................................................................................9 Original Disposables ..................................................................................................6, 15
Authorised Service Agents .......................................................................................... 15
P
B Patient Tube Connection .................................................................................................8
Biannual Functionality Testing ................................................................................... 14 Performance Class........................................................................................................... 16
Boost Indicator ....................................................................................................................8 Power Consumption ...................................................................................................... 16
Boost Touch-Pad ..........................................................................................................8, 10 Power Supply .................................................................................................................... 16
C Pre–Operation Test ......................................................................................................... 12
Calibration of Flow Rates .............................................................................................. 13 R
Certification ....................................................................................................................... 15 Rear of the Device ..............................................................................................................8
Checklist ............................................................................................................................. 12 Regular Inspections ........................................................................................................ 14
Chime Volume Adjustment does not adjust ......................................................... 17 Release Tab ...........................................................................................................................8
Chime Volume Adjustment ......................................................................................... 11 Return Procedure ............................................................................................................ 15
Classification ..................................................................................................................... 16
Cleaning the Device ....................................................................................................... 14
S
Safety Instructions .............................................................................................................6
Connection to the Foot Pedal ........................................................................................9
Safety Plug ............................................................................................................................9
Contraindications ...............................................................................................................6
Service and Maintenance ............................................................................................. 14
D Set Display Units .............................................................................................................. 10
Degree of Protection ...................................................................................................... 16 Set Foot Pedal Function ................................................................................................ 11
Desired Aspiration Vacuum is not achieved .......................................................... 16 Set-Up .....................................................................................................................................7
Device Description.............................................................................................................6 Source of Error .................................................................................................................. 17
Device Placement...............................................................................................................9 Specifications .................................................................................................................... 16
Dimensions ........................................................................................................................ 16 Standby Indicator ...............................................................................................................8
Display Units ..................................................................................................................... 10 Standby Touch-Pad ............................................................................................................8
Displays do not Illuminate ........................................................................................... 17 Storage and Transport Directions ............................................................................. 16
Disposables ....................................................................................................................... 15 Supply Voltage Selection.................................................................................................9
Double Lumen Needle .....................................................................................................9 Syringe ...................................................................................................................................9
E T
Electric Shock Hazard........................................................................................................6 Technical Data .................................................................................................................. 16
Electromagnetic Compatibility .....................................................................................9 Technical Documentation ............................................................................................ 15
Elimination of Error ......................................................................................................... 17 Test Tube Heater .................................................................................................................9
Environmental Conditions ........................................................................................... 16 Test Tube ................................................................................................................................9
Explanation of Pictograms ............................................................................................. 5 Troubleshooting .............................................................................................................. 17
Explosion Hazard ................................................................................................................6 Type of Protection ........................................................................................................... 16
F U
Flushing Line ........................................................................................................................9 Unit will not Turn On ...................................................................................................... 17
Foot Pedal Connection .....................................................................................................8 Unpacking.............................................................................................................................7
Foot Pedal Function................................................................................................. 10, 11
Front of the Device ............................................................................................................8
V
Vacuum Adjust Indicators ...............................................................................................8
Functionality Test ............................................................................................................ 14
Vacuum Adjust Touch-Pads ............................................................................................8
G Vacuum Display in wrong units ................................................................................. 17
Grounding.............................................................................................................................9 Vacuum Display ..................................................................................................................8
H Vacuum doesn’t stay on when Foot Pedal is released ....................................... 17
How to use this Manual....................................................................................................5 Vacuum Line and Filter .....................................................................................................9
I Vacuum Pump .....................................................................................................................9
Indications for Use .............................................................................................................6 Vacuum Range Accuracy .............................................................................................. 16
Inspection by an Authorised Service Agent .......................................................... 15 Vacuum Ranges ............................................................................................................... 16
Installation and Set-Up.....................................................................................................7 Vacuum Setting Adjustment ....................................................................................... 10
Items not Supplied ............................................................................................................7 Vacuum stays on when Foot Pedal is released ..................................................... 17
Items Supplied ....................................................................................................................7 Vacuum Supplied Indicator ............................................................................................8

K W
kPa Indicator ........................................................................................................................8 Warnings and Important Notes.....................................................................................5
Weight ................................................................................................................................. 16
L Within the U.S.A ..................................................................................................................9
Latching Foot Pedal Function ..................................................................................... 10
Liability ......................................................................................................................... 15, 17 Y
Limited Warranty ............................................................................................................. 17 You Need to Supply ...........................................................................................................7

M
Mains Cord Mount .............................................................................................................8
Mains Power Inlet ...............................................................................................................8
Maintenance ..................................................................................................................... 14
Manual Structure ................................................................................................................5
Maximum Current ........................................................................................................... 16
mmHg Indicator..................................................................................................................8

20
 Americas: EDI – www.cookmedical.com/edi.do
Phone: +1 812.339.2235, 800.457.4500, Fax: 800.554.8335
E-mail: orders@cookmedical.com

Manufacturer
WILLIAM A. COOK AUSTRALIA PTY. LTD.
95 Brandl Street, Brisbane Technology Park, Eight Mile Plains, Brisbane
MEDICAL
QLD 4113, AUSTRALIA

© COOK 10/2017 IFU-MAR52_US-1