ERBA ELite 5, Руководство пользователя

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Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Hypoclean CC
Hypochlorite cleaning concentrate for automated analyzers
Name Cat. No. Package volume
Erba Hypoclean CC HEM00005 100 ml
For
in vitro
diagnostic use only
INTENDED USE
Erba Hypoclean CC cleaning concentrate is a stabilized and
micro-filtered concentrated hypochlorite solution for inten -
sive oxidative cleaning, rinsing and washing of hematology
analyzers’ capillaries, tubing and chambers, removing blood
component precipitates and lipoprotein deposits on all hema -
tology analyzers (“emergency cleaning”).
Erba Hypoclean CC hypochlorite cleaning concentrate
should be use with only Erba Lachema reagents. 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 %
Sodium hypochlorite < 5.0 %
Sodium hydroxide < 0.5 %
Stabilizers < 0.5 %
in ion-free water
HANDLING PRECAUTIONS
Erba Hypoclean contains < 0.5% sodium hydroxide and < 5% so -
dium hypochlorite.
Danger
Hazard statement:
H314 Causes severe skin burns and eye damage.
EUH031 Contact with acids liberates toxic gas.
Precautionary statement:
P260 Do not breathe vapours.
P280 Wear protective gloves/protective clothing/eye protection.
P303+P361+P353 IF ON SKIN (or hair): Take off immedia -
tely all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water
for several minutes. 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 wa -
ter 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 materials. Treat all blood and other potentially in -
fectious 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 CC hypochlorite cleaning concentrate is
intended for use with blood specimens collected by vein
puncture in EDTA anticoagulant. Specimens for hemato -
logical 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.
REAGENT PREPARATION
- This reagent is ready for use and can be applied straight
from the container; no special reagent preparation is ne -
cessary.
- Leave the reagent at room temperature for at least 12 hours.
USE OF THE REAGENT
- Person using the reagent must be a trained laboratory pro -
fessional.
- During daily maintenance procedure put a proper sample
tube containing Erba Hypoclean CC reagent the sample rotor
and aspirate the cleanser through the probe. Perform clea -
ning cycle as specified in the instrument’s User Manual.
- If the blank is too high or unacceptable result appears pi -
pette Erba Hypoclean CC directly into the appropriate cham -
ber according to the instrument’s User Manual. Wait to per -
form efficient cleaning and measure the blank.
REAGENT STORAGE, STABILITY AND DISPOSAL
- Store Erba Hypoclean CC hypochlorite cleaning concen -
trate between 15 and 30°C.
- The shelf life of the Erba Hypoclean CC is 15 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.
- Dispose of waste product, unused product and contamina -
ted packaging in compliance with local regulations.
IVD
Hematology reagents
HEMA/PI/11/17/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
50003773