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INTRODUCTION (continued)
IMPORTANT GENERAL REFERENCES
Preliminary notes
LABOMED is renowned for providing innovative technologies and products in women's healthcare. PRIMA
C / Prima CS colposcopes were developed in cooperation with practicing gynecologists. Experience,
precision, and continuous manufacturing optimization has enabled LABOMED to became the leading
Manufacturer of colposcopic precision instruments, with the largest product range of colposcopes in the
world.
Determination-Appropriate Use
Only LABOMED accessories, bases, and source of light may be utilized with LABOMED colposcopes.
Restrictions, which are stipulated in the directions for use, are to be considered.
The device is designed for application in medical practices and/or clinics.
According to the stipulation of the MPG (German Medical Device law), colposcopes may be operated
only by those persons who have been instructed in the expert handling of the device.
The proper installation and maintenance of the device are vital prerequisites before using the colposcope.
The user should check the functional stability and proper condition of the device before every procedure.
Indications for use
A colposcope may be helpful in the following situation:
1. Major abnormality on pap smear
2. Persistent minimal abnormality on pap smear
3. Abnormalities of squamous or columnar cells
4. Persistence of an inflammatory appearance of the smear despite adequate treatment
5. Presence of keratinized cells suggestive of leukoplasia
6. Symptoms of metrorrhagia, in particular contact bleeding
7. Abnormalities appearance of cervix or vagina by naked eye examination
8. Evaluation after exposure to diethylstilbestrol(DES) or related drugs during embryo genesis
9. Monitoring after treatment of dysplasia, regardless of treatment method
10. Evaluation of anogenital condylomatosis
11. Evaluation of vulva-perinea bowenoid papulosis
12. Preoperative evaluation before genital-tract surgery: hysterectomy, Treatment of genital prolapse,cervico
vaginal plastic surgery, etc.
13. Lesion noted on routine gynecologic examination
6128000-795
Prima C/ Prima CS
Prima C/ Prima CS COLPOSCOPE
Issue 2.2
Printed on November,2020
2
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