Safety Notes

Using the Urology Indication

11 Using the Urology Indication

Intended use: Urology The devices PG130/PG145 may be used for the distention and/or irrigation of the

lower and upper urinary tract, fluid aspiration and monitoring of fluid deficit dur-

ing diagnostic and surgical procedures. The optional suction function can be used

to siphon off secretions. It serves to introduce fluid into the ureter and upper uri-

nary tract during diagnostic and therapeutic urological procedures such as, for

example:

• urethroscopy, urethrotomy interna

• Transurethral resections of the prostata

• Dystoscopy, transurethral resection of bladder tumors

• Nephroscopy, nephro litholapaxy

• Intubated antegrade urethrotomies

• Resection of renal cavity system tumors

The devices PG130/PG145 are used for the controlled distention of the urogeni-

tal and upper urinary tract by infusing a sterile irrigation fluid using a trocar to

improve the visibility of the surgical field during minimally invasive urological

procedures. Please comply with the specific indications and instructions provid-

ed in the manual of your endoscope.

Contraindications The devices PG130/PG145 should not be used on patients with traumatic dam-

age to the ureter, bladder, or kidney. The use on patients with narrowing or ob-

struction of the urethra (e.g. due to large prostata adenoma) is contraindicated

as well.

The devices may not be used for delivering fluids into the upper and lower uri-

nary tract if this procedure is contraindicated.

Technical application scope: Urology The following characteristics apply to the urology indication (only PG130/

PG145):

• The nominal pressure can be preset to a range of 15 to 90 mmHg.

• The nominal flow can be preset to a range of 0.025 to 0.5 l/min.

• The devices feature an instrument recognition function.

• The pump reacts to pressures greater than the set nominal pressure by emit-

ting warnings. The devices have safety thresholds.

Recommended pressure and flow settings The manufacturer recommends the following pressure and flow settings for the

following application areas:

Each surgery and each patient requires different parameters. The values indicat-

ed by the manufacturer are therefore only recommendations and are not intend-

ed to substitute or replace the expertise of the surgeon.

Clinical use When performing monopolar electrosurgery, only non-conductive irrigation flu-

ids may be used. Examples include glycine, sorbitol, mannitol, sorbitol plus man-

nitol, and dextran.

Urethroscopy, cystoscopy 25 mmHg 250 ml/min

TURP, TURB 25 mmHg 500 ml/min

URS 25 mmHg 25 ml/min

PCNL 25 mmHg 500 ml/min

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