Safety Notes

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General Information
en
3.3 Using the Hysteroscopy Indication
Intended use: Hysteroscopy The devices PG130/PG145 may be used for intrauterine distension, aspiration of
secretory fluids, and monitoring of fluid deficit during endoscopic procedures. It
is used to irrigate the cavum uteri with fluid to prepare for diagnostic and surgi-
cal hysteroscopies. The devices also offer the option of monitoring the volume
difference between the fluid injected into the uterus and the fluid draining from
the uterus (balancing).
The devices PG130/PG145 without fluid balancing may only be used for diagnos-
tic purposes.
Contraindications The devices may not be used to introduce fluids into the cavum uteri when a hys-
teroscopy is contraindicated.
Relative contraindications to endometrial ablation: Surgical skills ("Acute Techni-
cal").
Technical application scope: Hysteroscopy The following characteristics apply to the hysteroscopy indication:
The nominal pressure can be preset to a range of 15 to 150 mmHg.
The nominal flow has 2 settings, LO and HI. The nominal flow levels can be pre-
set to the following ranges in the user menu:
–LO=50-200ml/min
HI = 200-500 ml/min
The pump reacts to pressures greater than the set nominal pressure by emit-
ting warnings. The devices have safety thresholds.
The pump reacts to reaching and exceeding the deficit threshold by emitting
warnings.
The pump reacts to perforation (exceeding the deficit threshold) by emitting
warnings.
The pump reacts to a scale defect by emitting warnings.
3.4 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):
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