Safety Instructions; About The K-Mar-5200; Intended Use; Device Description - COOK Medical K-MAR-5200 Manual De Usuario

K-MAR-5200 Instructions for Use

1. Safety Instructions

WARNING: Please familiarise
yourself with the safety instructions
before using the Vacuum Pump.
WARNING: This Vacuum
Pump should only be operated by
appropriately quali ed personnel.
IMPORTANT NOTE:
Replacement device and disposables.
WARNING: BIOLOGICAL
HAZARD. Always use the
Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never
use the device if there is any indication
that the tubing, the lter or the
Vacuum Pump is contaminated.
If the Vacuum Pump is suspected to be
contaminated, do not allow further use
of the device and immediately notify
your authorised service agent to have
the device checked and repaired.
The Disposable Vacuum Line with
Hydrophobic Filter attached to the
Vacuum Pump are for single patient
use only and must not be re-used
or resterilised. Re-use of this device
may result in cross-contamination
which may lead to the transmission
of infectious diseases. Re-sterilisation
of this device may compromise the
structural integrity of the device and
cause product failure. Once used, this
product is considered as infectious and
should be disposed of according to local
policy for disposal of biohazard waste.
WARNING: Monitor the vacuum.
WARNING: Electric shock hazard.
WARNING: No user serviceable
parts inside.
EXPLOSION HAZARD: Device
can cause explosion in presence of
ammable gases.
WARNING: Use only original
disposables.

2. About the K-MAR-5200

This manual describes the operation and intended use of the Vacuum Pump and the disposables.
It is essential to use this document to familiarise yourself with the functions and the operation of the Vacuum Pump
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.
This manual does not provide a detailed description of operation technologies, nor is it suitable for introducing
a beginner to this operating technique. Only physicians and medical assistants under the direction of a physician
with the appropriate technical quali cation may use this device and disposables.
In case the Vacuum Pump fails during an operation, a replacement device and replacement disposables should be
kept within reach so that the operation may be completed.
Always work with the one-way hydrophobic lter between the collection receptacle and the Vacuum Pump to
prevent body uids from entering the device.
Never use the Vacuum Pump if there is any indication that the tube, the lter 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.
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 vacuum aspiration pressures can
lead to the potential for decreased oocyte quality and, consequently, decreased development and fertilisation
potential. For oocyte aspiration, only use the highest vacuum aspiration pressure necessary to achieve the required
ow rate for the size aspiration needle being used. The boost should only be used to clear blockages or obstructions
in the aspiration line or aspiration needle when the needle is outside the patient.
The Pre-Operation Test (see §3.16) must be performed prior to each operation.
If a Vacuum Pump defect is suspected or con rmed, stop using the device until an authorised service agent has
checked it.
Internal circuitry is energised whenever the Vacuum Pump 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 power cord or plug associated with the device become cracked, frayed, broken or damaged it must be
replaced immediately.
To reduce the risk of electric shock, do not remove covers. Refer servicing to an authorised service agent.
Protect the Vacuum Pump from being splashed by liquid. Should any liquid enter the device, discontinue use
immediately.
Please refer all servicing to the manufacturer's authorised service agent.
Do not use in an area where ammable gases are present.
For your own safety, only use original disposables (see §7).

2.1 Intended Use

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

2.2 Device Description

The Vacuum Pump is designed to maintain a vacuum accurately at a user speci ed setting with a range of
-10 mmHg to -500 mmHg when con gured to display mmHg and a range of -1.0 kPa to -67.0 kPa when con gured
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.

2.3 Precautions for Device Use

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