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K-TEK KTEK9000 Instructions For Use Manual page 8

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INSTRUCTIONS FOR USE
• Wipes may contain benzalkonium chloride (up to 0.6% conc.), didecyl dimethyl
ammonium 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.
• Sprays may contain up to .2% benzalkonium chloride and up to 0.2% didecyl
dimethyl 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.
Read the cleaning product's directions and follow the instructions on the label. Use cau-
tion 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).
4.1 EC Authorized Representative:
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
4.3 UK Authorized Representative:
Emergo Consulting (UK) Limited
c/o Cr360 - UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom
4.5 CH Authorized Representative:
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
©2023 Kyra Medical, Inc.
4.2 Manufacturing Information:
Kyra Medical, Inc.
102 Otis St
Northborough, MA 01532 USA
888-611-KYRA (North America)
508-936-3550 (International)
4.4 EU Importer:
Kyra Medical Europe Limited
Office 2, 12A Lower Main St
Lucan Dublin
K78X5P8
Ireland
8
IFU 03-0235 REV J

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