GIMA 31485 Disposable Speculum Instructions
- July 26, 2024
- GIMA
Table of Contents
DISPOSABLE SPECULUM
31485 Disposable Speculum
All serious accidents concerning the medical device supplied by us must be
reported to the manufacturer and competent authority of the member state where
your registered office is located.
Compatible with
– GIMA: Gimalux, Sigma, Sigma C, Visio2000, Visio5
– Heine: Mini 2000, Mini 3000, K180, Beta 200, Beta 400
– Riester: Ri-Mini, Ri-scope L1, Ri-scope L2, E-scope, Pen-scope
– Kawe: Picolight, Combilight F030, Eurolight F030
– Holtex
– Colson
– Luxamed
Assembly with connector 31493
The disposable speculum is an accessory for otoscopes for direct examination
of the external acoustic duct and the tympanic membrane.
The product or parts of it cannot be used for purposes different from the one
specified in the intended use of the present manual.
The product must be used by qualified medical personnel only in out-patients
department.
The product is not intended for use in operating rooms.
Use: Choose the size of speculum suitable to the acoustic duct to examine.
Insert the speculum into the otoscope head group and clockwise rotate it.
After examining the patient, counter clockwise rotate the speculum, remove it
from it seat and dispose it according to the law in force on the subject of
disposal.
Keep out of children’s reach!
Do not reuse the specula!
Do not sterile the specula in autoclave or with disinfectants! After the use,
remove the specula from the otoscope head and throw them away!
| Lot number
---|---
| Medical Device compliant with Regulation (EU) 2017/745
| Disposable device, do not re-use
| Keep away from sunlight
| Product code
| Manufacturer
| Date of manufacture
| Non-sterile
| Caution: read instructions (warnings) carefully
| Keep in a cool, dry place
| Consult instructions for use
| Medical Device
M31 485-M-R e v .6-02.24
31485 – 31486 – 31487 – 31488 – 31491- 31492
31495 – 31496 – 31497 – 31498 – 31499
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com
Made in China