HEINE M34403EN Classic+ and SANALON+ Fiber Optics Laryngoscope Blades Instructions
- June 6, 2024
- HEINE
Table of Contents
HEINE Classic+® and SANALON+® F.O.
Laryngoscopes Blades
Instructions
HEINE Classic+® and SANALON+® fiber optics laryngoscope blades
Before using the HEINE laryngoscope blades read these instructions
carefully and keep them in a safe place for future reference.
Safety Information
Range of applications: Laryngoscope blades are designed exclusively for
endotracheal intubation. They should only be used by persons who are trained
in endotracheal intubation.
Safety in use: To ensure that the instrument functions correctly, use
only laryngoscope handles with a green identification mark. Bring the blade
into the normal working position and check that the light switches on. Do not
use the laryngoscope in the presence of a strong magnetic field. The bulb
brightness can reduce during use if the rechargeable battery was not charged
sufficiently before use. We recommend a minimum recharge time of 10 minutes
for HEINE rechargeable batteries in HEINE chargers. After some minutes` use,
the laryngoscope bulb will be hot.
General Safety: To avoid cross-infection, laryngoscopes must be cleaned
and disinfected or sterilized after each use (see instructions for cleaning).
If the laryngoscopes are used regularly, we recommend that replacement bulbs
and batteries, as well as spare instruments, be kept available for use.
Cleaning, disinfection, and sterilization
The following instructions must be incorporated into the hospital or practice
procedures. National guidelines and regulations (e. g. regarding CJK / vCJD)
and the relevant standards and laws must be put into practice. These
procedures must be carried out by suitably qualified personnel.
Procedure after use Remove all traces of contamination immediately after
use to avoid incrustation.
Manual cleaning/disinfection Use only cleaning and disinfection products
that are recommended by the manufacturer for use with fiber optics and
plastics. Follow the manufacturer’s instructions regarding concentration and
duration of use exactly. After this process, rinse the blade with de-
mineralized water and ensure that no deposits remain on them.
Warning: Use of the wrong cleaning and disinfection products or methods
can cause irreparable damage to the laryngoscope.
Ultrasonic cleaning is not permitted!
Automatic cleaning/disinfection The laryngoscope can be cleaned or
thermally disinfected at up to 93 °C in an automatic machine. Use only
cleaning products, which are recommended for use with stainless steel and
plastic (only SANALON+®). The rinsing procedure must ensure that no
deposits are left on the product. Use only de-mineralized water for the final
rinse.
Sterilization
The product can be steam-sterilized with saturated steam at 134 °C for 5
minutes. Sterilization for 18 minutes is also possible. There may be a
reduction in light transmission with repeated long-term steam sterilization,
particularly if the stream quality is not ideal. Any function checks should
include this parameter. Gas-Plasma sterilization is only permitted for HEINE
Classic+® F.O. laryngoscopes.
Observe Operating Instructions
Ambient conditions:
– In use: 10-40 °C
– Storage: 5-45 °C
– Relative humidity: 10% to 75%
– Air pressure: 700hPa to 1060hPa
Equipment is not suitable for use in the presence of flammable mixtures
Nominal voltage: see marking on the lamp housing
Protection against electrical shock (B type):
Applicable Standards: EN ISO 7376
IEC60601-1:1988 + A1:1991 + A2:1995; (Medical Electrical Equipment Part1
General Requirements for Safety)
Warranty
We guarantee these laryngoscope blades for 5 years up to 4000 autoclave cycles
of 134 °C / 5 min. from the date of purchase. We guarantee the proper function
of the unit provided it is used as intended by the manufacturer and according
to the instructions for use. Any faults or defects which occur during the
guarantee period will be repaired free of charge provided they are caused by
faults in material, design, or workmanship. In the case of a complaint of a
defect in the product during the guarantee period, the buyer must prove that
any such defect was present at the time the product was delivered. The usual
legal guarantee and warranty do not apply to incorrect use, the use of non-
original HEINE parts or accessories. (Especially bulbs, like these, are
designed with an emphasis on the following criteria: Color temperature, life
expectancy, safety, optical quality, and performance.) Also excluded are
repairs or modifications made by persons not authorized by HEINE or cases
where the customer does not follow the instructions supplied with the product.
Any modification of a HEINE product with parts or additional parts which do
not conform to the original HEINE specification will invalidate the warranty
for the correct function of the product and further invalidate any warranty
claims that result from such a change or modification. Further claims, in
particular claims for damage not directly related to the HEINE product, are
excluded.
For repairs, please contact your supplier, who will return the goods to us or
our authorized agent.
HEINE Optotechnik GmbH & Co. KG
Kientalstr. 7
82211 Herrsching
Germany
Tel. +49 (0) 81 52 / 38 – 0
Fax +49 (0) 81 52 / 38 – 2 02
E-Mail: [email protected]
www.heine.com
med 4797 1/6.11
93/42/EWG/CEE/EEC