ERBA ELite 3 - Page 75

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Cleaner
Cleaning solution for automated analyzers
Name Cat. No. Package volume
Erba Cleaner HEM00001
1 L
For in vitro diagnostic use only
INTENDED USE
Erba Cleaner is a stabilized and micro-ltered detergent so-
lution for regular automated cleaning, rinsing and washing
of hematology analyzers’ capillaries, tubing and chambers,
removing blood component precipitates and lipoprotein de-
posits on Erba Lachema hematology analyzers.
Erba Cleaner should be used with only Erba Lachema rea-
gents. Erroneous results may be obtained if the reagent
is applied with third party reagents.
Please refer to the instrument’s User Manual for further in-
formation.
INGREDIENTS
Detergents < 1.0 %
Bu󰀨ers < 1.0 %
Preservative < 0.5 %
Stabilizers < 0.5 %
in ion-free water
HANDLING PRECAUTIONS
- Erba Cleaner is environmental friendly, azide-free reagent;
does not contain harmful ingredients.
- Avoid contact with eyes, skin and clothing.
- In case of eye or skin contact ush eyes with copious
amounts of water for several minutes or wash skin area with
water.
- Keep the reagent container closed when not in use.
- Wear laboratory gloves when handling the reagent.
- All body uid samples should be considered potentially
infectious materials. Treat all blood and other potentially in-
fectious materials with appropriate precautions. Use gloves,
masks and gowns if blood exposure is anticipated.
- Use Good Laboratory Practices (GLP) when handling the
reagents.
SPECIMEN COLLECTION AND PREPARATION
Erba Cleaner reagent is intended for use with blood speci-
mens collected by vein puncture in EDTA anticoagulant.
Specimens for hematological analysis may be stored for up
to 8 hours at (+15 to +30) ºC or up to 24 hours after collection
when refrigerated (+2 to +8) ºC.
Please refer to the instrument’s User Manual for further
details.
REAGENT PREPARATION
- This reagent is ready for use and can be applied straight from
the container; no special reagent preparation is necessary.
- Leave the reagent at room temperature for at least 12 hours.
REAGENT REPLACEMENT
- Person installing the reagent must be a trained laboratory
professional.
- Remove the inlet cap from the reagent container to be repla-
ced. Connect the reagent inlet to the new reagent container.
- Be sure that the colour on each tube, reagent container
label and connector in the back of the instrument match.
- Avoid any dust or microbial contamination of the tubing
and reagents.
- Prime thoroughly the new reagent and measure bac-
kgrounds according to the instrument’s User Manual.
- When installing a new lot of reagent, recalibrate the instru-
ment as specied in your User Manual.
REAGENT STORAGE, STABILITY AND DISPOSAL
- Store Erba Cleaner reagent between +15 and +30°C.
- The shelf life of the Erba Cleaner is 48 months from date of
manufacture, if stored at the prescribed temperature range.
- Do not use reagent beyond the expiration date printed on
the container label.
- Discard opened container after 120 days.
- Do not use reagent once frozen.
- Dispose of waste product, unused product and contamina-
ted packaging in compliance with local regulations.
IVD
Hematology reagents
See Instruction for Use
i
Catalogue Number Lot Number
Expiry date
In vitro Diagnostics
Storage Temperature Content
CONT
Manufacturer
REF
CE Mark -
Device comply with
the Directive 98/79/EC
USED SYMBOLS
IVD
HEMA/PI/06/17/B Date of revision: 25. 7. 2017
50003767