HEINE M34403EN Classic+ and SANALON+ Fiber Optics Laryngoscope Blades Instructions

June 6, 2024
HEINE

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: info@heine.com
www.heine.com
med 4797 1/6.11
93/42/EWG/CEE/EEC

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