Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Hypoclean
Hypochlorite cleaning solution for automated analyzers
Name
Cat. No.
Package volume
Erba Hypoclean
HEM00016
1 L
For
in vitro
diagnostic use only
INTENDED USE
Erba Hypoclean hypochlorite cleaning solution is a stabilized and micro-
-filtered hypochlorite solution for intensive oxidative cleaning, rinsing and
washing of hematology analyzers capillaries, tubing and chambers, remo
-
ving blood component precipitates and lipoprotein deposits on ELite hema
-
tology analyzers.
Erba Hypoclean hypochlorite cleaning solution 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
Detergents
<
1.0%
Sodium hypochlorite < 1.0%
Sodium hydroxide
< 0.5%
Stabilizers
<
0.4%
In ion-free water
HANDLING PRECAUTIONS
Erba Hypoclean contains < 0.5% sodium hydroxide and < 1% sodium hypochlorite.
Warning
Hazard statement:
H315 Causes skin irritation.
H319 Causes serious eye irritation.
EUH031 Contact with acids liberates toxic gas.
Precautionary statement:
P280 Wear protective gloves/protective clothing/eye protection.
P302+P352 IF ON SKIN: Wash with plenty of water.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several mi
-
nutes. Remove contact lenses, if present and easy to do. Continue rinsing.
- Avoid contact with eyes, skin and clothing.
- In case of eye contact flush eyes with plenty of water for several minutes
and seek medical advice.
- In case of skin contact wash the skin area with water.
- If swallowed do NOT induce vomiting. Drink plenty of water and seek
medical advice. Beware of aspiration if vomiting does occur.
- Keep the reagent container closed when not in use.
- Avoid any dust or microbial contamination of the reagents.
- Wear laboratory gloves when handling the reagent.
- All body fluid samples should be considered potentially infectious materi
-
als. Treat all blood and other potentially infectious materials with appropriate
precautions. Use gloves, masks and gowns if blood exposure is anticipated.
-
Please refer to the MSDS associated with the reagent.
- Use Good Laboratory Practices (GLP) when handling the reagents.
SPECIMEN COLLECTION AND PREPARATION
Erba Hypoclean reagent is intended for use with blood specimens collec
-
ted 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).
IVD
Hematology reagents
REAGENT PREPARATION
- This reagent is ready to use and can be applied straight from the contai
-
ner, 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. Connect
the reagent inlet to the new reagent container.
- Be sure that the color on each tube, reagent container label and connec
-
tor 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 according
to the instrument User Manual.
- When installing a new lot of reagent, recalibrate the instrument as speci
-
fied in your User Manual.
REAGENT STORAGE, STABILITY AND DISPOSAL
Store Erba Hypoclean hypochlorite cleaning reagent between 15 – 30°C.
The shelf life of Erba Hypoclean 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.
EN
HEMA/PI/25/17/C Date of revision: 25.7. 2017
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
50004376
Summary of Contents for ELite 5
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Page 153: ...ELite 5 User Manual Page 153 of 159 20 5 Fluidic System...
