Safety Instructions; About The K Mar 5200; Intended Use; Intended Users And Use Environment - COOK Medical K-MAR-5200 Handbuch

K-MAR-5200 Instructions for Use

1. Safety Instructions

IMPORTANT NOTE:
Replacement device and disposables.
WARNING: Monitor the vacuum.
WARNING: Use only original
disposables.
2. About the K-MAR-5200
WARNING: Not suitable for use
in an MRI environment
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 qualification 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 filter between the collection receptacle and the Vacuum Pump to
prevent body fluids from entering the device.
Never use the Vacuum Pump 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 assessed.
The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated.
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 greater
than -300 mmHg (-40 kPa) 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 flow 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 confirmed, 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 flammable 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 fluids and cells; in particular oocyte aspiration.

2.1.1 Intended users and use environment

The K-MAR-5200 device is intended to be used by obstetrician-gynaecologists and nursing staff who have received
specialised training in the field of obstetrics and gynecology. Service personnel may install the K-MAR-5200
Vacuum Pump and will routinely service the device.
The K-MAR-5200 Vacuum Pump is intended to be used in a sterile environment, such as an operation theatre, day
surgery theatre or fertility clinic.

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 and Filter (K-DVLF-240) consists of a one-way hydrophobic filter and 240 cm long
low volume vacuum line. The Disposable Vacuum Line and 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.
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