HEINE mPack mini Manual De Instrucciones página 7

The connected instrument cannot be operated during the charging process! The
illumination of the instrument is switched off as soon as the mPack mini is connected
to a USB power source. Once the charging connection is disconnected, the
instrument illumination is switched on again at the previously set brightness level.
If the connected instrument is defective, the mPack mini shuts down automatically
and issues an error-indicating sequence of flashes.
Use only CE marked USB power supplies (5 V) from reputable manufacturers that
conform with the Class II and safety requirements from the IEC 60950-1 Information
technology or IEC 60601-1 Medical electrical equipment.
Hygienic Reprocessing
Instructions on hygienic reprocessing must be adhered to, based on national standards,
laws and guidelines.
Classification according to KRINKO: non-critical
Spaulding Classification USA: non-critical
Before cleaning, disconnect the device from the power supply.
In the event of suspected contamination, carry out hygienic reprocessing of the
instrument.
The described reprocessing measures do not replace the specific rules applicable
for the establishment.
HEINE Optotechnik only approves the reprocessing agents and procedures named
in these instructions for use.
Cleaning and disinfection may only be carried out by personnel with sufficient
hygienic knowledge.
Observe the instructions of the manufacturer of the reprocessing media.
Do not use any spray disinfectant, or any dripping-wet or heavily-foaming cloths.
Do not reprocess automatically.
mPack mini
Cleaning and disinfection
(Wipe clean and wipe disinfect)
In the presence of contamination or for risky applications, take the mPack mini from its
belt clip and reprocess the belt clip separately (see below).
Clean and disinfect the mPack mini by wiping it.
The cleaning and disinfection must be done with special care at exposed sites such as,
e.g., the operating elements.
During the reprocessing, hold the mPack mini appropriately such that its openings face
downwards.
Recommended agents
Cleaning agent: enzymatic (e.g. neodisher
Disinfectant agent: alcoholic (e.g. Incides
(e.g. Mikrobac tissues), agent ortho-phthalaldehyde (e.g. Cidex
®
peroxide (e.g. PREempt
Belt Clip
Cleaning and disinfection
Wash the belt clip (without the mPack mini) with warm water and a cleaning agent.
Dry the clip and then disinfect it by immersion disinfection.
Recommended combinations of reprocessing agents
Cleaning agent: enzymatic (e.g. neodisher
Disinfectant agent: quaternary ammonium compounds (e.g. neodisher
Maintenance
The device is maintenance free.
We as manufacturer do not stipulate a safety inspection in accordance with § 6 Medical
Device Operator Ordinance (MPBetreibV), ref. attachment 1, for the HEINE product
mPack mini.
The expected operational life of the HEINE
®
Wipes)
®
MED 113158
MediClean)
®
N), quaternary ammonium compounds
MediClean) and
®
mPack mini is 7 years.
®
2017-05-02
OPA) or hydrogen
®
Septo MED)
®
7/40