Operation Of The Device; Before The Operation; Calibration Of Flow Rates; During The Operation - COOK Medical K-MAR-5200 Handbuch

K-MAR-5200 Instructions for Use

5. Operation of the Device

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IMPORTANT NOTE: To ensure
patient safety, the Pre–Operation Test
(see §3.16) must be performed prior to
each use.
WARNING: BIOLOGICAL
HAZARD. Always use the
Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240). Never
use the device if there is any indication
that the tubing, the filter or the
Vacuum Pump is contaminated.
If the Vacuum Pump is suspected to be
contaminated, do not allow further use
of the device and immediately notify
your authorised service agent to have
the device assessed. The manufacturer
has the right to refuse to carry out
repairs if the products it receives are
contaminated.
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: Always monitor the
aspiration vacuum level. An excessive
vacuum can lead to damage of the
oocyte or other body tissue. See
vacuum warning on page 4.
IMPORTANT NOTE: Operational
Note.
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
decide on the specific technique and procedure that will accomplish the desired clinical effect.

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
Vacuum Line with Hydrophobic Filter (see §3.9) and Foot Pedal (see §3.8 & §3.13).
2. Ensure the device has undergone a Pre-Operation Test (see §3.16).
3. Use the Adjust Vacuum Touch-Pads to select the desired vacuum (see §5.2).

5.2 Calibration of Flow Rates

The first step in IVF is to obtain good quality oocytes. Calibrating the correct flow rate is the key to retrieving the
maximum number of oocytes in optimal condition. The rate of flow through an aspiration needle and tubing is
dependent upon many variables, such as: the differential height between the needle tip and the collection test
tube, the inner diameter of the needle, total length of the system and vacuum pressure according to Poiseuille's
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
aspiration needle and adjusting the vacuum pressure to give the correct flow rate. A flow rate of 20-25 mL/min
equates to 24 to 30 seconds to aspirate 10 mL of water.
The vacuum pressure used with a specific gauge and/or type of ovum pick-up needle is at the discretion of the
clinician performing the procedure.

5.3 During the Operation

1. Insert the aspiration cannula into the follicle under ultrasound vision.
2. Activate the Foot Pedal to aspirate follicular fluid.
3. Deactivate the Foot Pedal when the follicle is empty.
4. The oocyte and follicular fluid are in the collection receptacle.

5.4 Clearing Blockages in the Aspiration Line/Needle

The vacuum pressure can be boosted to clear blockages in the ovum aspiration needle by activating the boost
button on the front panel of the unit. 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.

5.5 After the Operation

1. Use the Standby Touch-Pad to place the Vacuum Pump in standby mode.
2. Remove the Disposable Vacuum Line with Hydrophobic Filter, Power Cord and Foot Pedal.
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