Labomed Prima C User Manual page 4

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 embryogenesis
9. Monitoring after treatment of dysplasia, regardless of treatment method
10. Evaluation of anogenital condylomatosis
11. Evaluation of vulvo-perineal bowenoid papulosis
12. Preoperative evaluation before genital-tract surgery: hysterectomy, treatment of genital prolapse,
cervicovaginal plastic surgery, etc.
13. Lesion noted on routine gynecologic examination
Contraindications for use

The colposcope is a device for viewing the body from a distance and is not intended for patient
contact. Because of this there are no contraindications for use of a colposcope.
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User's Manual Prima C/ Prima CS COLPOSCOPE
Prima C/ Prima CS
Issue 2.0
Printed on Oct, 2016