KYRA MEDICAL KTEK2300 Manual De Instrucciones página 6

INSTRUCTIONS FOR USE
Contact Kyra Medical, Inc., if you need to repair or replace the device contact us using the information
from the contact details section.
Cleaning and Disinfection:
WARNING:
•
After each use, clean the device as directed in this instruction for use.
•
Do not submerge the device in liquid. Equipment damage can occur.
•
Use caution in areas where liquid can get into the mechanism.
•
Do not use bleach or products that contain bleach to clean the device. Injury or equipment
damage can occur.
•
Make sure that the device is dry before you store it or use it again.
Wipes:
Wipes may contain up to 2% sodium hypochlorite.
o
Wipes may contain benzalkonium chloride (< or = 0.6% conc.) and didecyl dimethyl ammonium
o
chloride (up to 0.6% conc.)
Wipes may contain benzalkonium chloride (up to 0.6% conc.), didecyl dimethyl ammonium
o
chloride (up to 0.6% conc.) and may also contain polyhexamethylene biguanide (up to 0.6%
conc.).
Sprays:
Sprays may contain up to 2% sodium hypochlorite.
o
Sprays may contain up to .2% benzalkonium chloride and up to 0.2% didecyl dimethyl
o
ammonium chloride (quaternary ammonium chloride solution (QACs) and may also contain
polyhexamethylene biguanide (up to 0.6% conc.).
Sprays may contain up to 2% hydrogen peroxide.
o
Read the cleaning product's directions and follow the instructions on the label. Use caution in areas
where fluid migration may occur:
Wipe device with a clean, dry cloth. Make certain the product is dry prior to reinstalling to avoid damage.
CAUTION: Damage may result if product is cleaned with caustic chemicals or harsh abrasives
ATTENTION: If any KTEK product is damaged or appears to be functioning abnormally, discontinue use
and contact KYRA Customer Service at 1-508-936-3550.
4 Compliance with Medical Device Regulations:
This product is a non-invasive, Class I Medical Device and system is CE-marked according to
Annex VIII, Rule 1, of the Medical Device Regulations (REGULATION (EU) 2017/745).
EC Authorized
Representative:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague,
Netherlands
Property of Kyra Medical, Inc. ©2021
Manufacturing
Information:
Kyra Medical, Inc.
102 Otis St
Northborough, MA 01532 USA
888-611-KYRA (North America)
508-936-3550 (International)
Page 5
EU Importer:
Kyra Medical Europe Limited
69 Esker Woods Drive
Lucan Co Dublin
K78PX45
Ireland
IFU Document Number: 03-0396-REV-F