Epithelium Staining Applicator
Structure and Composition
The product is composed of a tip, inner core, polyurethane foam, support bar, barrel, spring, handle and plunger (Figure 1). The support bar labeled in red indicates 12 o’clock.
Figure 1
Intended Use
The Epithelium Staining Applicator is used for collecting and adhering exfoliated cervical cells during a gynecological speculum examination.
Instructions of Use
1. Start by placing the patient in the lithotomy position.
2. Expose the cervix with the aid of a speculum.
3. Use a dry gauze or cotton swab to gently clean the cervix of any secretion or exudate.
4. Remove the Applicator from its packaging.
5. Align the red marked support bar on the Applicator with the 12 o’clock position of the ectocervix.
6. Insert the Applicator until it is covering the entire ectocervix.
7. Press against the ectocervix for 10 seconds ensuring complete contact.
8. Push the plunger labeled with the letter “FRD”, enabling the tapered tip of the Applicator to enter the cervical canal.
9. Press the Applicator against the cervix for 10 seconds.
10. Rotate the plunger to the right, locking the tapered tip in place.
11. Press the Applicator against the cervix for 5 more seconds.
12. Carefully remove the Applicator.
Storage Conditions
Stored in a well-ventilated environment with less than 80% humidity away from any corrosive gases.
Important Notes
1. The Epithelium Staining Applicator should not be used if the packaging appears damaged.
2. The Epithelium Staining Applicator is for single use only.
3. The Epithelium Staining Applicator is not to be used if appears damaged or broken.
Expiration Date
Contraindications and Precautions
Caution needs to be taken when there is bleeding from the cervix and/or vagina. For subtle bleeding, such as stripping, spotting, or mild contact bleeding, the tester may observe a tiny spot of red color change on the Epithelium Staining Applicator, which should not have an impact on identifying any color changes. However, if a significant amount of contact bleeding occurs, a large area of the Epithelium Staining Applicator may be contaminated by the blood, which may lead to false positive, or false negative results due to the interaction between the blood and the color changes.
For optimal FRD™ testing conditions, the collection of cervical exfoliated cells is not recommended in the following：
- Women who are Pregnant or Menstruating
- Women who have had a Hysterectomy
- Women who have flushed or rinsed their vagina with douche in the past 48 hours
- Women who have had cytology or HPV Test performed in the past 48 hours
- Women who have had a colposcopy in the past 7 days
- Women who have has a biopsy in the past 14 days
- Women who have had cervical surgery in the past month
