Caldera Benesta CAL-TR1511 Manual de instrucciones - Página 4

Navegue en línea o descargue pdf Manual de instrucciones para Equipamiento médico Caldera Benesta CAL-TR1511. Caldera Benesta CAL-TR1511 7 páginas. Tissue removal device

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Exercise care when inserting or removing the device. Excessive bending

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of the device distal tip can cause the Benesta

cutter to come out of the cutting window. If such damage occurs, replace

the device immediately.

Benesta

Tissue Removal Device

CAL-TR1511 (1 pack)

CAL-TR1513 (3 pack)

The hand-operated Benesta

Figure 1. The parts of the device are listed below:

Locating Mark

Pathology Measurement. Lines

Cutting Window Indicator

Cutting Window

Figure 1. Benesta

Safety Switch: This switch turns power to the entire device on or off

depending on the position of the switch. During shipment, the position is

in the "off" (O) position to prevent any accidental activation. The safety

switch must be turned to the "on" (I) during the preparation phase of an

operative procedure for the device to function and resect tissue.

Trigger: Depressing the trigger actuates cutting action. The device will

continuously cut and allow the passage of fluid and tissue while the

trigger is depressed and will stop as soon as the trigger is released. The

cutting window will remain closed while cutting is not activated, but will

still allow for some fluid outflow in this position.

Outflow Tubing: the outflow tube removes waste fluid and resected

tissue through a compatible suction canister and tissue trap.

Cutting Window: side-facing cutting window at the distal tip

Cutting Window Indicator: indicates orientation of cutting window when

cutting window is not under direct visualization

Distal Tip Locating Mark: Indicates depth relative to hysteroscope and

can be used during initial insertion of the tissue removal device into the

hysteroscope.

Pathology Measurement Lines: contains markings spaced 1mm apart to

help estimate pathology size under direct visualization

Components not included with the Benesta

– Under-buttocks drape

– IV Pole, pressure cuff or fluid management system (FMS)

– Distending media

– Vacuum source, suction canister and tissue trap

– Benesta

Hysteroscope and outflow channel

Tissue Removal Device

Tissue Removal Device is shown below in

Distal Tip

Trigger

Outflow

Tubing

Safety

Switch

Tissue Removal Device

Tissue Removal Device:

– Inflow tubing

– Y-tubing

– Hysteroscope and outflow channel end cap seals

SET-UP

Please review the system configuration diagram in Figure 2 for a diagram

of the system setup.

Figure 2. System configuration diagram

Distending Media Set-Up

It is strongly recommended that isotonic media such as 0.9% Normal

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Saline or Ringer's Lactate be the media used for distending the

endometrial cavity.

Either a purpose-built hysteroscopic fluid management system or a

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protocol for manual estimation of systemic absorption should be in place.

For purpose-built fluid management systems, carefully follow the

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manufacturer's instructions.

If using a manual fluid management system:

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– Procure an intravenous (IV) pole from which to hang either a 1L or

3L bag of distending media at least 40 inches above the patient's

uterus

– A pressure sleeve may be placed around the fluid bag to increase

inflow and uterine pressure and improve visualization during the

procedure.

– When using the Benesta

Y-tubing and connect it to the hysteroscope inflow ports. Connect the

Y-tubing to the fluid bag containing distention media using

compatible inflow tubing.

– When using with the Benesta

channel), make sure the single-use seal is installed in the

hysteroscope (and/or outflow channel).

Position an under-buttocks drape with an integrated fluid reservoir or

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similar fluid collection system that allows estimation of fluid volume.

Connect the outflow tubing to a tissue trap in line with tubing that

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attaches to an appropriate suction canister.

Attach the suction canister to the regulated vacuum source which is set

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to approximately 250 mmHg.

– Make sure the lid is securely attached to the cannister prior to using.

Hysteroscope, open the packaging for the

Hysteroscope (and/or outflow