Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Clenz
Enzymatic cleaner reagent for automated analyzers
Name
Cat. No.
Package volume
Erba Clenz
HEM00017
1 L
For
in vitro
diagnostic use only
INTENDED USE
Erba Clenz enzymatic cleaner reagent is a stabilized and micro-filtered
proteolytic enzyme solution for regular automated cleaning, rinsing and
washing of hematology analyzers capillaries, tubing and chambers, re-
moving blood component precipitates and lipoprotein deposits on ELite
hematology analyzers.
Erba Clenz enzymatic cleaner reagent should be used only with Erba
reagents. Erroneous results may be obtained if the reagent is applied
with third party reagents. Please refer to the instrument User Manual for
further information.
INGREDIENTS
Sodium chloride
< 1.0%
Proteolytic enzymes < 1.0%
Preservative
<
0.5%
Stabilizers
<
2.0%
In ion-free water
HANDLING PRECAUTIONS
- Erba Clenz enzymatic cleaner is environmental friendly, azide-free rea-
gent, does not contain harmful ingredients.
- Avoid contact with eye, skin and clothing.
- In case of eye or skin contact flush 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 fluid samples should be considered potentially infectious materials.
Treat all blood and other potentially infectious materials with appropriate pre-
cautions. Use gloves, masks and gowns if blood exposure is anticipated.
- Use Good laboratory Practices (GPL) when handling the reagents.
SPECIMEN COLLECTION AND PREPARATION
Erba Clenz reagent is intended for use with blood specimens collected by
vein puncture in EDTA anticoagulant. Specimens for hematological analysis
may be stored for up to 8 hours at 15-30°C or up to 24 hours after collection
when refrigerated (2-8°C).
REAGENT PREPARATION
- This reagent is ready for use and can be applied straight from the con-
tainer, 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 replaced. Con-
nect the reagent inlet to the new reagent container.
- Be sure that the color on each tube, reagent container label and con-
nector in the back of instrument match.
- Avoid any dust or microbial contamination of the tubing and reagents.
Do not pour and mix the remains of a reagent from a container into other
one.
- Prime thoroughly the new reagent and measure backgrounds accor-
ding to the instrument User Manual.
- When installing a new lot of reagent, recalibrate the instrument as
specified in your User Manual.
IVD
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
Hematology reagents
EN
REAGENT STORAGE, STABILITY AND DISPOSAL
Store Erba Clenz enzymatic cleaner reagent between 15 – 30°C.
The shelf life of Erba Clenz is 24 months from the 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 contaminated packaging in
compliance with local regulations.
HEMA/PI/24/17/C Date of revision: 25.7. 2017
50004375
