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USER

MANUAL

K-MAR-5200
Vacuum Pump

Please familiarise yourself with


the safety instructions
before using the device.
Accessories and devices may
be used only by physicians and
medical assistants with the
appropriate technical qualification.
K-MAR-5200 INSTRUCTIONS FOR USE

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

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

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

This symbol indicates that this product may not be treated as municipal
waste. Please ensure that this product is properly disposed of as
Disposal of this inappropriate waste handling of this product may cause potential hazards
product must be to the environment and human health. For more detailed information
undertaken with regard about disposal of this product, please contact your local city office or Cook
to the WEEE directive Representative.
(2002/96/EC).
EC REP ©Cook 2007
Document No: IFU-MAR52/2
US REP
VERSION 2, October 2007
Service address:
Please refer to your local Cook distributor for details of your nearest
authorised service agent.

WARNING - CONFIDENTIAL PROPRIETARY PROPERTY


This document is owned by WILLIAM A. COOK AUSTRALIA PTY. LTD. It contains confidential proprietary trade secret
information and must not be copied. The document and the information it contains can be used only by the recipient for
the specific use for which it was requested. All other use is strictly prohibited. This document must be returned to
WILLIAM A. COOK AUSTRALIA PTY. LTD. immediately upon request by WILLIAM A. COOK AUSTRALIA PTY. LTD.
By possession of this document, the possessor expressly agrees to comply with these terms.

IFU-MAR52/2
K-MAR-5200 INSTRUCTIONS FOR USE

TABLE OF CONTENTS
EXPLANATION OF PICTOGRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii

HOW TO USE THIS MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv


Warnings, Cautions, and Important Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv
Manual Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv
1. SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

2. ABOUT THE K-MAR-5200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2


2.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.2 Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.3 Precautions for Device Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
3. INSTALLATION AND SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
3.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
3.2 You Need to Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
3.3 Front of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
3.4 Rear of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
3.5 Supply Voltage Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.6 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.7 Device Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.8 Connection to the foot pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
3.9 Vacuum Line and Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
3.10 Activating the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.11 Vacuum Setting Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.12 Set Display Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.13 Foot Pedal Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.13.1 Non-Latching Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.13.2 Latching Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.13.3 Set Foot Pedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.14 Boost Touch-Pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
3.15 Chime Volume Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
3.16 Pre-Operation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
4. INSTALLATION AND SET-UP CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

5. OPERATION OF THE DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13


5.1 Before the Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.2 During the Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.3 Calibration of Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.4 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
6.3 Inspection by and Authorised Service Agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
6.4 Return Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
7. DISPOSABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

8. TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

9. TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

10. LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21


10.1 Liability21
10.2 Life of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

11. INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

IFU-MAR52/2 i
K-MAR-5200 INSTRUCTIONS FOR USE

IFU-MAR52/2 ii
K-MAR-5200 INSTRUCTIONS FOR USE

EXPLANATION OF PICTOGRAMS

The following pictograms appear on the device

Before connection, read the manual!

Standby/On

Increase Vacuum Set-Point


EC REP
Decrease Vacuum Set-Point
ECUS
EC
EC
REP
REP
REP
REP
EC REP
REP
EC REP
EC
EC REP
USBoost
REP Vacuum
US REP
US REP
US REP
US REP
USUS REP
REP
Patient Tube Connection

Foot Pedal Connection

Symbol for type B equipment

C – Tick Marking

CE – Marking

Dispose of in accordance with


WEEE directive (2002/96/EC)

Manufacturer

EC REP
EC REP
REP EC Representative
EC REP
US REP
US REP
USREP
REP North American Representative

IFU-MAR52/2 iii
K-MAR-5200 INSTRUCTIONS FOR USE

HOW TO USE THIS MANUAL


Warnings, Cautions, and Important Notes
Throughout this Instructions for Use, blocks of text may be accompanied by
a pictogram and/or printed in bold type. These blocks are WARNINGS,
CAUTIONS, 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

CAUTION: These instructions point out special service


procedures or precautions that you must follow to avoid
damaging the device!

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 i) to help you find section titles
quickly.
Additionally, an index is on page 22.
There is a troubleshooting guide on page 20 to help you to trouble shoot
problems.

IFU-MAR52/2 iv
K-MAR-5200 INSTRUCTIONS FOR USE

1. SAFETY INSTRUCTIONS
This manual describes the operation and intended use of the device and the
WARNING: Please disposables.
familiarise yourself with
the safety instructions It is essential to use this document to familiarise yourself with the
before using the device. functions and the operation of the device before use.
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 This manual does not provide a detailed description of operation technologies,
device should only be nor is it suitable for introducing a beginner to this operating technique. Only
operated by appropriately physicians and medical assistants under the direction of a physician with the
qualified personnel. appropriate technical qualification may use this device and disposables.
In case the device fails during an operation, a replacement device and
CAUTION: replacement disposables should be kept within reach so that the operation may
Replacement device and be completed.
disposables. Always work with a one-way hydrophobic bacteria filter between the collection
receptacle and the device. This should prevent body fluids from penetrating the
device and keeps possible contaminants from escaping the device and entering
the patient.
Never use the device if there is any indication that the tube, the filter or the
device is contaminated. Do not allow any further use of the device. Immediately
notify your authorised service agent to have the device checked and repaired.
WARNING: Avoid
contamination. Always monitor the aspiration vacuum level. An excessive vacuum can lead to
damage of the oocyte or other body tissue.
There is evidence in the published literature suggesting that the use of higher
WARNING: Monitor vacuum aspiration pressures can lead to the potential for decreased oocyte
the vacuum. quality and, consequently, decreased development and fertilisation potential. For
oocyte aspiration, only use the highest vacuum aspiration pressure necessary to
achieve the required flow rate for the size aspiration needle being used. The
higher vacuum aspiration pressures should only be used if required to clear
CAUTION: Electric blockages or obstructions in the aspiration line or aspiration needle.
shock hazard. The Pre-Operation Test (see §3.16) must be performed prior to each operation.
If a device defect is suspected or confirmed, stop using the device until an
WARNING: No user authorised service agent has checked it.
serviceable parts inside. Internal circuitry is energised whenever the device is connected to mains power
irrespective of whether the device is on or in standby. Always disconnect the
device from mains power before cord replacement, or cleaning. Should any
WARNING: Device
power cord or plug associated with the device become cracked, frayed, broken
can cause explosion in
or damaged it must be replaced immediately.
presence of flammable
gases. To reduce the risk of electric shock, do not remove covers. Refer servicing to an
authorised service agent.
Protect the device from being splashed by liquid. Should any liquid enter the
WARNING: Use
device, discontinue use immediately.
only original disposables.
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).

IFU-MAR52/2 1
K-MAR-5200 INSTRUCTIONS FOR USE

2. ABOUT THE K-MAR-5200


2.1 Intended Use
The K–MAR–5200 is a vacuum pump intended for the aspiration of body
fluids and cells; in particular oocyte aspiration.

2.2 Device Description


The device is designed to maintain a vacuum accurately at a user specified
setting with a range of -10mmHg to -500mmHg when configured to
display mmHg and a range of -1.0kPa to -67.0kPa when configured to
display kPa. In either case, the device will maintain the vacuum within
±5mmHg (0.7kPa).
The device can also boost the vacuum to -500mmHg (or -67.0kPa in kPa
display mode) from any setting.

2.3 Precautions for Device Use


In the event of any electrical or mechanical fault during use or entry of fluid
into the K-MAR-5200, cease use of the device until it has been checked by
an authorised service agent.

IFU-MAR52/2 2
K-MAR-5200 INSTRUCTIONS FOR USE

3. INSTALLATION AND SET-UP


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

1 2

3 4 5

1. K-MAR-5200 User Manual


2. K-MAR-5200 Device
3. K-DVLF-240 Disposable Vacuum Line with Hydrophobic Filter
4. Foot Pedal
5. Mains Cord

Check the device and 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 Vacuum Line and Filter
(item 3) which needs to be handled under sterile conditions.

IMPORTANT 3.2 You Need to Supply


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

IFU-MAR52/2 3
K-MAR-5200 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
-500mmHg (-67kPa).
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.

IFU-MAR52/2 4
K-MAR-5200 INSTRUCTIONS FOR USE

3.4 Rear of the Device

2 1
1

1 Power Cord Mount Used to hold the power cord when


the device is not is 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.

IFU-MAR52/2 5
K-MAR-5200 INSTRUCTIONS FOR USE

3.5 Supply Voltage Selection


WARNING:
ELECTRIC SHOCK The device can operate on the voltage range 100 – 240VAC, 50 – 60Hz. No
HAZARD. Determine if fuse selection is required.
the available voltage If the voltage is changed, it may be necessary to replace the power cord to
corresponds to your an appropriately rated power cord.
device. Connecting to
the wrong voltage will Ensure that the correct power cord is connected.
cause the device to
malfunction or may
permanently damage the 3.6 Electromagnetic Compatibility
device! The K-MAR-5200 vacuum pump has been tested and found to comply with
The power cord must be the electromagnetic compatibility (EMC) limits for medical devices as
equipped with a safety specified by IEC 60601-1-2:2001. These limits are designed to provide
plug. Use the enclosed reasonable protection against harmful interference in a typical medical
power cord for the installation.
connection between the Medical electrical equipment requires special precautions regarding EMC
power plug and the and must be installed and operated according to these instructions. It is
device socket! possible that high levels of radiated or conducted radio-frequency
WITHIN THE U.S.A – Use electromagnetic interference (EMI) from portable and mobile RF
only a listed detachable communications equipment or other strong or nearby radio-frequency
power cord, type SJT, sources could result in performance disruption of the vacuum pump.
minimum 18AWGx30, 3 Evidence of disruption may include erratic readings, equipment ceasing to
conductors, one end operate, or other incorrect functioning. If this occurs cease using the
configured for NEMA 5- vacuum pump and contact your Cook authorised service agent.
15, other end for IEC
320/CEE22!
Grounding will only be
reliable if the equipment
is connected to a
corresponding hospital
grade socket!
3.7 Device Placement
WARNING: The device should be placed on a level secure surface, away from heaters,
EXPLOSION HAZARD. coolers, air-conditioning outlets, mists, splashes and exposure to direct
Do not use the device in sunlight. It must not be placed in the presence of flammable gases.
the presence of
flammable gases! The ambient temperature should be between +5°C and +35°C for the K-
MAR-5200 to function correctly.

WARNING:
ELECTRIC SHOCK
HAZARD. Do not
immerse the device!

IFU-MAR52/2 6
K-MAR-5200 INSTRUCTIONS FOR USE

3.8 Connection to the Foot Pedal


• Connect the foot pedal to the Foot Pedal Connection on the rear of the
device.
• 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


CAUTION: The The K–MAR–5200 uses a Disposable Vacuum Line and filter set (reorder
Disposable Vacuum code K-DVLF-240 ). To prepare and install:
Line and filter set (K-
DVLF-240) has been • Connect the Vacuum Line at the Patient Tube Connection on the
designed and tested to Vacuum Pump.
handle the full vacuum • Connect the Vacuum Line to the vacuum supply of the needle set.
range of the device.
• Connect Syringe to the Flushing Line (if required).
Other vacuum lines may
not be able to withstand
the full vacuum range.

WARNING: AVOID
CONTAMINATION.
3
Always use a one-way AS
PIR
AT
IO

hydrophobic filter.
N

1 FLUSHING
5
Never use the device if
there is any indication
2 4
that the tubing, the filter
or the device is
contaminated.
6

If the device is suspected 7

to be contaminated, do
not allow further use of
the device and 8
immediately notify your
authorised service agent
to have the device Note: This diagram indicates a Cook K-OPSD needle set.
checked and repaired.
1 Vacuum Pump
The vacuum line and
filter attached to the 2 Vacuum Line
vacuum pump are for 3 Aspiration Line
single use only and are
4 Flushing Line
classed as infectious
waste. All infectious 5 Double Lumen Needle
waste must be disposed
6 Syringe
of in a suitable biohazard
container or bag. No 7 Test Tube
sharps shall be placed
8 Test Tube Heater
into biohazard bags. All
sharps should be
The set up is complete and now ready for use.
disposed of in suitable
puncture proof
containers.

IFU-MAR52/2 7
K-MAR-5200 INSTRUCTIONS FOR USE

3.10 Activating the Device


WARNING: • Connect the Power Cord to the Power Inlet. The Standby Indicator
ELECTRIC SHOCK should light up.
HAZARD. Internal
• The device will either be in the standby mode or active mode
circuitry is energised
depending on the last state the device was in when mains power was
whenever the device is
disconnected.
connected to mains
power irrespective of • If the device is in standby, press the Standby Touch-Pad to put the
whether the device is on device into an active state.
or in standby.
3.11 Vacuum Setting Adjustment
• Press and hold the appropriate Adjust Vacuum Touch-Pad.
• The vacuum will adjust in 1 mmHg or 0.1kPa 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 device 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:-
EC REP

US REP

Indicates mmHg Mode

Indicates kPa Mode

3. Press Adjust Vacuum Touch-Pad Increase again to toggle between


mmHg mode and kPa Mode.
EC REP

4. Once the desired


US REP 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.

IFU-MAR52/2 8
K-MAR-5200 INSTRUCTIONS FOR USE

3.13 Foot Pedal Function


The device 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.

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

Mode, retry the EC REP US REP


EC REP

sequence. US REP EC REP EC REP EC REP EC REP US REP

US REP US REP
EC REP US REP EC REP US REP EC REP

US REP US REP
The Vacuum Display should
EC REP US REP now show either:-
EC REP

US REP US REP

Indicates Latching Mode

Indicates Non-Latching Mode

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

3. Press Adjust Vacuum Touch-Pad Decreast to toggle between latching


EC REP
and non-latching mode.
US REP

4. Switch the device into active mode 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.

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K-MAR-5200 INSTRUCTIONS FOR USE

3.14 Boost Touch Pad


• Activate the Foot Pedal.
• The Vacuum Supplied Indicator lights up.
• Press and hold the Boost Touch-Pad, the Boost Indicator lights up.
• The device will reach the maximum vacuum of –500mmHg
(-67.0kPa).
• Release the Boost Touch-Pad.
• The Vacuum Display should reach the pre-selected value within
±5mmHg.

3.15 Chime Volume Adjustment


1. Ensure that the device is in standby mode by using the Standby Touch-
Pad.
REP
2. The Boost Touch–Pad canEC now be used to adjust the volume.
US REP

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.

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K-MAR-5200 INSTRUCTIONS FOR USE

3.16 Pre-Operation Test


WARNING: • Connect the foot pedal and the Vacuum Line and Filter to the device.
ELECTRIC SHOCK
HAZARD. Internal • Switch the device on.
circuitry is energised • Ensure that the device is set to display in mmHg mode (see § 3.12)
whenever the device is
connected to mains • Use the Vacuum Adjust Touch-Pads to select a vacuum between -120
power irrespective of and -170mmHg.
whether the device is on • Activate the Foot Pedal. The Vacuum Supplied Indicator lights up. The
or in standby. chime sounds.
• The Vacuum Display should momentarily decrease (e.g from -170 to
-150mmHg). The pump motor will then be heard to accelerate and
bring the vacuum level back to the set level, within ±5mmHg.
• Close the vacuum line by kinking, press and hold the Boost Touch–Pad.
IMPORTANT
NOTE: It is recommended • The device should achieve and display a vacuum of -500mmHg. Note
that the device be given the vacuum is likely to overshoot and reach -530mmHg.
a pre–operation test • Release the Boost Touch-Pad and the vacuum line.
before each operation.
• Deactivate the Foot Pedal.
• The Vacuum Display should reach the pre-selected value within
±5mmHg.
The Pre–Operation Test is now successfully completed and the device is
CAUTION: If the ready for use in the operating room.
value is not reached or if
the value begins to
decrease again, then there
is a leak. First check the
Vacuum Line and Filter.

CAUTION: If you
should find or suspect
deficiencies in the device
during the described
function control, the
device must not be used
until the authorised
service agent has
repaired it.

Never use the device if


there are obvious
deficiencies, especially
involving the power plugs
or the power supply
connection cables.

Arrange for repair by an


authorised service agent.

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K-MAR-5200 INSTRUCTIONS FOR USE

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 device has been placed in a suitable location.

❑ The device has undergone a Pre-Operational Test.

❑ The vacuum line and filter have been connected.

❑ The foot pedal has been connected.

❑ The device 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.

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K-MAR-5200 INSTRUCTIONS FOR USE

5. OPERATION OF THE DEVICE


This section provides general information about the use of this device. Only
IMPORTANT the physician can evaluate the clinical factors involved with each patient
NOTE: To ensure patient and determine if the use of this device is indicated. The physician must
safety, the Pre–Operation decide on the specific technique and procedure that will accomplish the
Test (see §3.16) must be desired clinical effect.
performed prior to each
use.
5.1 Before the Operation
1. Ensure the device is correctly set up as described in §3 including correct
WARNING: AVOID set up of the vacuum line and filter (see §3.9 ) and foot pedal (see §3.8
CONTAMINATION. & §3.13).
Always use a one-way
hydrophobic filter. 2. Ensure the device has undergone a Pre-Operation Test (see §3.16).
Never use the device if 3. Use the Adjust Vacuum Touch-Pads to select the desired vacuum (see §5.3).
there is any indication that
the tubing, the filter or the
device is contaminated.
If the device is suspected 5.2 During the Operation
to be contaminated, do
not allow further use of 1. Insert the aspiration cannula into the follicle under ultrasound vision.
the device and 2. Activate the Foot Pedal to aspirate follicular fluid.
immediately notify your
3. Deactivate the Foot Pedal when the follicle is empty.
authorised service agent
to have the device 4. The oocyte and follicular fluid are in the collection receptacle.
checked and repaired

5.3 Calibration of Flow Rates


WARNING:
MONITOR THE The first step in IVF is to obtain good quality oocytes. Calibrating the
VACUUM. Always correct flow rate is the key to retrieving the maximum number of oocytes
monitor the aspiration in optimal condition. The rate of flow through an aspiration needle and
vacuum level. An tubing is dependent upon the inner diameter of the needle, total length
excessive vacuum can of the system and vacuum pressure according to Poiseulles’ Law. To
lead to damage of the ensure an optimal recovery rate with minimal damage to the oocyte-
oocyte or other body cumulus complex and zona pellucida, flow rates of 20-25mL/min are
tissue. See vacuum recommended. Calibration can be checked by aspirating water through
warning on page 1. the aspiration needle and adjusting the vacuum pressure to give the
correct flow rate.
For 16 and 17 gauge ovum pick-up needles, the most commonly used
IMPORTANT vacuum pressures range from -80 to -200mmHg (-10.6 to -26.6 kPa) to
NOTE: Operational Note. achieve a flow rate of 20-25ml/min. The vacuum pressure used with a
specific gauge ovum pick-up needle is at the discretion of the clinician
performing the procedure.

WARNING:
BIOLOGICAL HAZARD. 5.4 After the Operation
Observe all hygiene
regulations when 1. Use the Standby Touch-Pad to place the device in standby mode.
disposing of the vacuum 2. Remove the vacuum line and filter, power cord and foot pedal.
line and filter.

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K-MAR-5200 INSTRUCTIONS FOR USE

6. SERVICE AND MAINTENANCE


To preserve the device and ensure its proper functioning, proper service,
IMPORTANT maintenance and storage must be provided for. To protect the patient from
NOTE: To guarantee safe infection, all disposables that come into contact with human tissue (eg. test
operation, it is necessary tubes and tubing) must be sterile. Disposables must be discarded after each
to carry out proper care patient use.
and maintenance of the
device 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.

CAUTION: Do not
sterilise the device!

WARNING: 6.1 Cleaning the Device


ELECTRIC SHOCK
HAZARD. Do not After each use of the device, turn off the device and disconnect the device
immerse the device! from mains power.
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 Functionally Testing


In order to preserve the device and maintain its safety, regular inspections
are necessary for early detection 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.
IMPORTANT
NOTE: This functionality
test must be performed
every six months.

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K-MAR-5200 INSTRUCTIONS FOR USE

6.2.1 Functionality Test


IMPORTANT
NOTE: This functionality
test must be performed
every six months.

Conversion Note: 1
mmHg kPa mBar
1 0.3332 1.3332
2
5 0.7 7
198 26.4 264
200 26.7 267
202 26.9 269
1 Device under test.
500 66.7 667

2 Manometer compatible 0 to -1000 mBar.

1. The basic function test is intended to check the foot pedal and the
CAUTION: If the vacuum.
value is not reached or if 2. Ensure that the device is set to display in mmHg mode (see § 3.12).
the value begins to
3. Connect the Foot Pedal and switch the device on.
decrease again, then
there is a leak. Check the 4. Set the vacuum to -200 mmHg.
Vacuum Line and Filter.
5. Activate the Foot Pedal Function.
6. The vacuum motor and chime should be audible and the Vacuum
Supplied Indicator should light up.
CAUTION: If you
7. Deactivate the Foot Pedal Function.
should find or suspect
deficiencies in the device 8. Connect a silicone tube and a manometer with vacuum measurement
during the described capability to the Patient Tube Connection.
function control, the 9. Activate the Foot Pedal Function.
device must not be used
until it has been repaired 10. The manometer should show a vacuum of -267mBar ±7mBar.
by the authorised service 11. Press and hold the Boost Touch–Pad.
agent.
12. The device should achieve and display a vacuum of -500mmHg ±5
Never use the device if mmHg. Note there may be a small overshoot (around -530mmHg)
there are obvious before the steady state of -500mmHg is reached.
deficiencies, especially
involving the power plugs 13. The manometer shows a vacuum of -667mBar ±7mBar.
or the power supply 14. Release the Boost Touch–Pad.
connection cables.
15. Deactivate the Foot Pedal Function. The basic function test is
Arrange for repair by an completed.
authorised service agent.
If the vacuum display is not correct the device should be serviced by an
authorised service agent.

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K-MAR-5200 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 device
annually.

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.

Liability The manufacturer is free from all


liability for the operational safety of
the device 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 device or disposables.

IFU-MAR52/2 16
K-MAR-5200 INSTRUCTIONS FOR USE

6.4 Return Procedure


WARNING:
All devices or disposables that are returned must be prepared as described
BIOLOGICAL HAZARD.
below for the protection of the service agent and for safety during
The returned product
transportation.
must be clearly marked
with a contamination 1. Clean as detailed in §6.1.
warning and should be
2. Seal in a plastic bag and seal within a second plastic bag.
sealed in a plastic bag
and sealed within a 3. Place in the original packaging.
second plastic bag! 4. Enclose the following information:
• Owner's name
When shipping the • Owner's address
K–MAR–5200 ensure
that any connected • Model type
vacuum line and filter • Serial number of the equipment (see identification plate)
are removed prior to
transport! • Description of the damage or fault.
The manufacturer has the right to refuse to carry out repairs if the products
it receives are contaminated.
IMPORTANT
NOTE: When returning
goods, use the original
packaging. The
manufacturer does not
take responsibility for
damage that has
occurred during
transportation if the
damage was caused by
inadequate transport
packaging.

IFU-MAR52/2 17
K-MAR-5200 INSTRUCTIONS FOR USE

7. DISPOSABLES
Order No. Description
IMPORTANT
K-DVLF-240 Disposable Vacuum Line with Hydrophobic
NOTE: For optimal
Filter.
functioning of the device,
use only original Consists of a 240 cm low volume aspiration
disposables. line and a hydrophobic filter.
The Disposable Vacuum
Line (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.

IFU-MAR52/2 18
K-MAR-5200 INSTRUCTIONS FOR USE

8. TECHNICAL DATA
Classification according to IEC 60601-1
Type of protection against electric shock: Class 1 equipment
Degree of protection against electric shock: Type B
Degree of protection against harmful
ingress of solids and water: IP41
Specifications
Power Supply 100 - 240VAC
Frequency: 50 - 60 Hz
Maximum current: 500mA (115VAC)
250mA (240VAC)
Maximum power consumption: 60VA
Environmental conditions: +5°C to +35°C
Storage and transport directions: Store in a cool dry place
Manufactured and tested to the following IEC 60601-1
standards. IEC 60601-1-2
EN 60601-1
UL 60601-1
AS/NZS 3200.1.0
ISO 10079-1
Performance class: High Vacuum / Low Flow (ISO 10079-1)
Dimensions: 200 mm wide x 100 mm high x 350 mm deep
Weight: 3.2kg (7.1lb)
Vacuum Ranges: -10mmHg to -500mmHg in 1mmHg increments.
-1.0kPa to -67.0kPa in 0.1kPa increments.
Vacuum Range Accuracy: ±5mmHg (±0.7kPa)

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K-MAR-5200 INSTRUCTIONS FOR USE

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

Error and Alarm Indicator Source of Error Elimination of Error

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

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

Chime Volume Adjustment Power supply cord is not Check the power supply
does not adjust. connected. Mains power is connection. (Refer to §3.10)
not turned on.
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)

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

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

Vacuum doesn’t stay on when The Foot Pedal Function Set the Foot Pedal Function to the
foot–pedal is depressed and is set to Non– Latching. Latching. (Refer to §3.13.3)
released.

IFU-MAR52/2 20
K-MAR-5200 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.

8.1 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.

8.2 Life of Product


The life of this product is deemed to be seven years. After this time Cook Australia will not longer be
responsible for this product.

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K-MAR-5200 INSTRUCTIONS FOR USE

9. INDEX
A H
About the K–MAR–5200 . . . . . . . . . . . . . . . . . . . . . . . . 2 How to use this Manual . . . . . . . . . . . . . . . . . . . . . . . . iv
Activating the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Alarm Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
I
Inspection by an Authorised Service Agent . 16
Aspiration Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installation and Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Authorised Service Agents . . . . . . . . . . . . . . . . . . . . 16
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
B Items not Supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Biannual Functionality Testing . . . . . . . . . . . . . . . . 14 Items Supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Boost Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Boost Touch-Pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 10
K
kPa Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
C
L
Calibration of Flow Rates . . . . . . . . . . . . . . . . . . . . . . 13
Latching Foot Pedal Function . . . . . . . . . . . . . . . . . . 9
Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 21
Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Chime Volume Adjustment . . . . . . . . . . . . . . . . . . . 10
Chime Volume Adjustment does not adjust . 20 M
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Mains Cord Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Mains Power Inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connection to the Foot Pedal . . . . . . . . . . . . . . . . . . 7 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Contra-indication for Device Use . . . . . . . . . . . . . . 2 Manual Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Maximum Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
D
Method of Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Degree of Protection . . . . . . . . . . . . . . . . . . . . . . . . . . 19
mmHg Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Desired Aspiration Vacuum is not achieved . 20
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 N
Device Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Non-Latching Foot Pedal Function . . . . . . . . . . . . . 9
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Displays do not Illuminate . . . . . . . . . . . . . . . . . . . . 20
O
Operation of the Device . . . . . . . . . . . . . . . . . . . . . . . 13
Double Lumen Needle . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Original Disposables . . . . . . . . . . . . . . . . . . . . . . . . 1, 18
Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Display Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 P
Patient Tube Connection . . . . . . . . . . . . . . . . . . . . . . . 4
E
Performance Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electric Shock Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Power Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . 6
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Elimination of Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Pre–Operation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Environmental Conditions. . . . . . . . . . . . . . . . . . . . . 19
Explanation of Pictograms . . . . . . . . . . . . . . . . . . . . . iii R
Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Rear of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Regular Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
F Release Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Flushing Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Return Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Foot Pedal Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Foot Pedal Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 5 S
Front of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Functionality Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Safety Plug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Service and Maintenance . . . . . . . . . . . . . . . . . . . . . 14
G
Grounding ....................................... 6

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K-MINC-1000 INSTRUCTIONS FOR USE

S
Set Display Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Set Foot Pedal Function . . . . . . . . . . . . . . . . . . . . . . . . . 9
Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Source of Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Standby Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Standby Touch-Pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Storage and Transport Directions . . . . . . . . . . . . 19
Supply Voltage Selection. . . . . . . . . . . . . . . . . . . . . . . . 6
Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

T
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical Documentation . . . . . . . . . . . . . . . . . . . . . 16
Test Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Test Tube Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Type of Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

U
Unit will not Turn On . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

V
Vacuum Adjust Indicators . . . . . . . . . . . . . . . . . . . . . . . 4
Vacuum Adjust Touch-Pads . . . . . . . . . . . . . . . . . . . . . 4
Vacuum Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Vacuum Display in wrong units . . . . . . . . . . . . . . 20
Vacuum doesn’t stay on when foot pedal is
released . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Vacuum Line and Filter. . . . . . . . . . . . . . . . . . . . . . . . . . 7
Vacuum Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Vacuum Range Accuracy . . . . . . . . . . . . . . . . . . . . . . 19
Vacuum Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Vacuum Setting Adjustment . . . . . . . . . . . . . . . . . . . . 8
Vacuum Stays on when foot pedal is
released . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Vacuum Supplied Indicator . . . . . . . . . . . . . . . . . . . . . 4

W
Warnings, Cautions, and Important Notes . . . iv
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Within the U.S.A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Y
You Need to Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

IFU-MAR52/2 23
PRODUCT MANUFACTURED BY: COOK AUSTRALIA PTY LTD
12 Electronics Street
Brisbane Technology Park
Eight Mile Plains
Queensland 4113 AUSTRALIA
Telephone: +61 7 3841 1188
Fax: +61 7 3841 1288

EC REPRESENTATIVE: COOK IRELAND LTD


O’Halloran Road
National Technology Park
Limerick IRELAND
Telephone: +353 61 33 4440
Fax: +353 61 33 4441

NORTH AMERICAN REPRESENTATIVE: COOK MEDICAL INCORPORATED


P.O. Box 4195
Bloomington
IN 47402-4195 USA
Telephone: +1 812 339 2235
Toll Free: 800 457 4500
Toll Free Fax: 800 554 8335
www.cookmedical.com

IFU-MAR52/2

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