Caldera Benesta CAL-TR1513 Kullanım Kılavuzu - Sayfa 5

Tıbbi Ekipman Caldera Benesta CAL-TR1513 için çevrimiçi göz atın veya pdf Kullanım Kılavuzu indirin. Caldera Benesta CAL-TR1513 7 sayfaları. Tissue removal device

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– Connect the outflow vacuum tubing to the tissue trap connection on

the cannister lid.

OPERATION

1. Prior to opening the device, inspect the package for any signs of

damage. If damage is found, do not use the device and contact

Technical Support.

2. Open the device by peeling back the corner of the Tyvek® lid

completely to expose the device.

3. Holding the tray securely, grasp the handle of the device firmly and pull

up to release the device from the tray.

4. Remove connected outflow tubing and, leaving the end of the tubing

free, straighten out the tubing so that it is completely unwound.

5. Turn the safety switch from the "off" (O) position to the "on" ( I ) position.

6. Temporarily actuate the Benesta

to introducing into the working channel of the hysteroscope to ensure

that the power is on.

– Do not operate the Benesta

irrigated, open-air environment for an extended period of time as this

may cause damage to the device.

7. Introduce the inactivated Benesta

the working channel of the hysteroscope until the distal tip of the tissue

removal device is visible under clear visualization.

– When used with the Benesta

Benesta

Tissue Removal Device will extend approximately 3.2 cm

from the end of the hysteroscope.

8. Actuate the Benesta

Tissue Removal Device trigger for 2-3 seconds

while under clear visualization and away from any patient tissues to

prime the device with the distending media. You can also retract the

tissue removal device into the hysteroscope until the cutting window is

within the hysteroscope working channel to prime the device.

– If the system is turned off for any reason or the treatment is

interrupted for any reason, remove the device from any tissue, wait

15 seconds and repeat steps 5 through 8 before continuing

9. Rotate to align the cutting window with the target pathology. Rotating

the hysteroscope may be necessary to achieve desired visualization of

the cutting window and target tissue pathology.

10. Bring the cutting window in proximity with the target tissue pathology.

11. Press the trigger to actuate cutting action in a fashion that allows for

excision of the excised tissue.

– The suction pressure and/or media infusion pressure can be

adjusted to optimize visualization and cutting performance.

– Optimal function may be achieved by resecting the tissue in bursts of

a few seconds each. This may aid in maintenance of distension of

the endometrial cavity and facilitate monitoring of the cutting

progress as well as device orientation or position.

12. Do not apply excessive leverage on the device by pushing hard into

target pathology. Excessive leverage on the device does not improve

cutting performance and may result in decreased performance and/or

unintended excision of tissue pathology.

Tissue Removal Device trigger prior

Tissue Removal Device in a non-

Tissue Removal Device through

Hysteroscope, the tip of the

13. Excised tissue is collected in the tissue trap.

Ending the Procedure

1. Retract the Benesta

Tissue Removal Device into the hysteroscope

until the cutting window is within the hysteroscope working channel.

2. Actuate the trigger for a few seconds to ensure that all tissue is

transferred into the tissue trap.

3. Remove the Benesta

Tissue Removal Device from the hysteroscope.

Device Disposal

Dispose of the Benesta

Tissue Removal Device according to your

facility's policies and local, state or Federal procedures for biohazardous

materials, sharp waste, and battery disposal.

Storage

Benesta

Tissue Removal Device should be stored at room

The

•

temperature, away from moisture and direct heat.

The device should not be stored at temperatures below 40°F or above

•

120°F, or in conditions where the humidity is below 40% or above 60%.

Troubleshooting

If the device does not actuate, remove the device from the hysteroscope.

•

Turn the safety switch from the "off" (O) position to the "on" ( I ) position.

Temporarily actuate the trigger to ensure that the power is on before

reintroducing into the hysteroscope.

If the distal tip of the tissue removal device is not visible after insertion,

•

remove the device completely from the hysteroscope. Reintroduce the

inactivated device through the working channel of the hysteroscope until

the distal tip of the device is visible under clear visualization. If the issue

does not resolve, please check the hysteroscope for obstructions and/or

field of view. Ensure vacuum tubing is connected and functioning and

vacuum is set to 250mmHg minimum.

– Note: If troubleshooting steps do not resolve the issue, please

contact Technical Support.

Electrical and Electromagnetic Safety

All equipment performance is considered to be safety-related

•

performance, including any degradation of performance caused by

reciprocal interference. If the product is not put into service in

accordance with the electromagnetic safety requirements in this manual

and fails to perform as specified, the procedure should be aborted

immediately, and biomedical engineering staff should be alerted to the

observed issues

The Benesta

Tissue Removal Device is an applied part Type BF

•

device, meaning that it complies with specific requirement for protection

against electric shock. This device is not suitable for direct cardiac

application.

The type F applied part status of energized hysteroscopes intended for

•

use with a multiplicity of supply units and/or light guide cables is ensured

by, for instance, using only supply units having isolated light guide output

sockets

The standard operating voltage of the Benesta

•

is 7.7V – 9.0V, and the operating current is ~0.2A.

Tissue Removal Device