95c l ysis b lock in m - quidel corporation fileinstructi 1. gen cauti warn 2. saf during o in case...
TRANSCRIPT
In
95C L
nstruc
Lysis B
ction M
Block
Manuual
Caution: All rights reserved. Quidel Corporation reserves the right to modify this manual at any time without notice.
Any part of the manual shall not be duplicated, reproduced, or translated into any other language without prior written consent from Quidel Corporation.
Before initial use of this instrument, please carefully read this manual!
Instructi
1. Gen
Cauti
Warn
2. SafDuring oIn case oprovidedbe impai
Cauti
Warni
a) AdThe instrleaving t
b) InThe opehave beethe instr
c) PlThe instr(e.g. watinterfere The opeinstrumefrom the Do not uof the in Excessiveshould ndirect an
ion Manual
neral Prac
ion:
Imporeadthe i
ning! The obse
fety operation andof failure to fod by the instrired.
ion: This Quidto ob
ng!
dapter rument is suthe factory. It
nstrument Cerator shall nen authorizedument.
lacement ofrument shouter bath, sinkence of strong
enings on thient body thee ventilation o
use the instrustrument.
e temperaturnot be used innd indirect he
ctice
ortant informd. Failure to onstrument.
warning meerve the instr
d maintenancollow these mument, its sa
instrument isdel Corporatiobserve the fo
pplied with a is strongly re
Casing not disassemd by Quidel a
f instrumenld be placed k, or water ling magnetic fie
s instrumentey should notopenings on t
ument on a lo
re would impn a location seat sources.
Im
mation is conbserve the in
essage requiuctions could
ce of this instmeasures or tafety criteria o
s for indoor uon shall not bollowing requ
a 12 VDC adaecommended
ble the instrre permitted
nt in a low rela
nes). The rooelds.
t are for vent be blocked the instrume
oose or soft s
pair the test pubjected to d
— I —
mportant
ntained in thnstructions co
res careful od result in ser
rument, the the warnings of design and
use.be liable for tirements.
apter. Every id to use the p
rument witho to replace e
ative humiditm shall be w
ntilation/circuor covered. nt.
surface, whic
performance direct sunligh
Notes
he indicated ould result in
operation ofrious persona
following basor notes indd manufactur
the conseque
nstrument isprovided adap
out permissiolements or m
y and low duell ventilated
ulation, In orKeep object
h may block
or result in iht. The instrum
section and damage or a
f the indicatal injury.
sic safety noticated hereinre, and its pre
ences resultin
packaged wpter.
on. Only quamake adjustm
ust area awayd, free of corr
rder to avoids at least 25
air circulatio
nstrument fament should
Importa
should be cabnormal fun
ted step. Fai
tes must be on, the basic predicted use r
ng from user’s
with an adapt
alified personments to the in
y from a waterosive gas, an
d over‐heatin cm (10 inch
n through th
ailure. This inbe kept away
ant Notes
carefully ction of
ilure to
observed. rotection range will
s failure
er before
nnel who nterior of
er source nd free of
ng of the hes) away
e bottom
strument y from all
Instruction Manual Important Notes
— II —
If the instrument is not used for a long period of time, the power cord should be unplugged and the instrument covered with a soft cloth or plastic cover to avoid potential dust contamination.
Caution:
In any of the following cases, immediately turn off the instrument, unplug the power cord from the electrical outlet, and contact the supplier for assistance: Any liquid drops into casing of the instrument. Any spills occur over the instrument. The instrument works abnormally, especially if it generates an unusual sound or odor. The instrument is dropped or its casing is damaged. The function of the instrument obviously changes.
Warning!
Unplug the instrument prior to cleaning. The instrument surface should not be cleaned with corrosive cleaning agents or organic solvents (e.g. alcohol, bleach). Improper cleaning may pose a risk to the device in the long term causing cosmetic damage, and if the improper cleaning persists, possibly causing mechanical failure.
Warning! To reduce the risk of amplicon contamination, wipe the instrument surface with an appropriate solution to remove any RNAse and DNAse that may be present.
Instruction Manual Contents
Contents
Chapter I Introduction ------------------------------------------------------------------------------------------------- 1
Chapter II Features ----------------------------------------------------------------------------------------------------- 2
1. Normal working conditions ----------------------------------------------------------------------------------- 2
2. Transportation and storage conditions --------------------------------------------------------------------- 2
3. Performance ------------------------------------------------------------------------------------------------------ 2
Chapter III Operation Guidance ------------------------------------------------------------------------------------- 4
1. Structure diagram ----------------------------------------------------------------------------------------------- 4
2. Display panel diagram ------------------------------------------------------------------------------------------ 5
3. Instructions for indicator lights and buttons -------------------------------------------------------------- 5
3.1 Instructions for indicator lights ----------------------------------------------------------------------- 5
3.2 Instructions for buttons --------------------------------------------------------------------------------- 5
4. Operation ---------------------------------------------------------------------------------------------------------- 6
4.1 Examination before startup ---------------------------------------------------------------------------- 6
4.2 Startup and operation panel display ----------------------------------------------------------------- 6
4.3 Setting temperature and time values ---------------------------------------------------------------- 6
4.4 Start instrument ------------------------------------------------------------------------------------------ 7
4.5 Stop function ---------------------------------------------------------------------------------------------- 7
4.6 Temperature calibration -------------------------------------------------------------------------------- 7
4.7 Restore factory calibration value -------------------------------------------------------------------- 10
Chapter IV Failure Analysis and Troubleshooting -------------------------------------------------------------- 11
Instruction Manual Chapter I Introduction
— 1 —
Chapter I Introduction
Intended Use: The AmpliVue® 95C Lysis Block is a controlled temperature heater block intended to be used for the heat lysis step of nucleic acids extracted samples with AmpliVue® assays. The product is a dry bath with a microcomputer control. The characteristics of the product are as follows:
Small volume, light weight footprint Digital time and temperature display Metal module to mitigate potential sample contamination Low voltage DC power input for safe utilization Temperature deviation calibration
Instruction Manual Chapter II Features
— 2 —
Chapter II Features
This chapter introduces the usage, transportation, and storage conditions of the instrument, as well as its basic parameters, performance, and functions.
1. Normal working conditions
Ambient temperature: 10C to 30C Relative humidity: ≤70% Power supply: DC12V±0.5V, 60W
Requirements for adapter: (AC100‐240V, 50/60HZ)
Caution: Before using the instrument, please make sure the working conditions meets the above requirements.
2. Transportation and storage conditions
Ambient temperature: ‐20C to +55C Relative humidity: ≤80%
3. Specifications
Name AmpliVue® 95C Lysis Block
Model (SN) M203 (MAW6303‐XXX)
Block type 24 x 1.5 mL, 4 Rows of 6 x 1.5 mL
Temperature Range Setting
0C to 100C
Heating Temperature Range
Room Temperature +5C to 100C
Time Scope 0 to 9 hr 59 min
Heating Rate (25C to 100C)
≤40 min
Temperature Accuracy ≤±0.5C
Temperature Fluctuation ≤±1C
Display Accuracy 1C
Input Power AC 100‐240V 50/60Hz (NRTL/cNTRL Listed, US plug/cords)
Output Power DC12V ±0.5V, 60W (by power supply)
Size (mm) 180×140×140(L×W×H) (not including power supply)
Weight (kg) 1.5 to 2.2
Instructi
4. Instru
ion Manual
ument labeel
— 3 —
Chapter II
Features
Instructi
This chapreparatinstrume
1. Struc
3
① ④
ion Manual
apter introdution before sent for the fir
cture Diagra
3
Transparent
Block
Ch
uces the strustartup. Readrst time.
am
t cover ②
⑤
hapter III
ucture of thed the content
② Operatio⑤ Power So
— 4 —
Operatio
e instrumentts in the cha
n Panel
ocket
on Guidan
, keyboard aapter careful
③ H
Chapter II
nce
and functionly before sta
1
2
4
5
Housing
I Operation G
s of all buttartup when u
Guidance
tons, and using the
Instructi
2. Displ
3. Instru 3.1 Instr When po
Warn
3.2 Instr
ion Manual
lay panel di
uctions for
ructions for in
owered on, a
“HEATING”: indicator ligh
“HOLDING”: set by the us
“COOLING”: on, the instru
ing! The gtemp
ructions for u
START STOP
SET
iagram
indicator li
ndicator light
ll indicator lig
The red indht will turn of
The yellow inser. The “HOL
The green inument is pass
green indicatperature read
using Operati
Button u
TemperatemperaThe flashbutton a
Select abutton a
ghts and bu
ts
ghts will turn
icator light ff when the se
ndicator lightLDING” indica
ndicator lightsively cooling
tor light doesding before ha
on Buttons
used to start
ature and timature and timhing value maagain to move
nd set valuesand both ARR
— 5 —
uttons
on for 5 seco
indicates thaet temperatu
t indicates thaator light will
indicates thg.
s not imply thandling the in
up or stop th
me setting butme values thatany be modife to the next
s by pressing ROW buttons
onds, and the
at the instruure is reached
at the instrumturn on when
at the instru
he heated blonstrument.
e program.
tton. Press tht the instrumfied by the arvalue mode.
or simultaneou
Chapter II
en will turn o
ument is head.
ment is holdinn the set tem
ment is cool
ock is safe to
he button to dent is currentrrow buttons.
mode. Pusly to enter c
I Operation G
ff.
ating. The “H
ng at the temmperature is r
ing. When th
touch. Take
display the tly set to. . Press the SE
Press the STAcalibration m
Guidance
HEATING”
mperature eached.
he light is
note of
ET
ART/STOP ode.
Instructi
4. Oper
4.1 Exam Plea
4.2 Start Plug the All indicawindow setting. A 4.3 Setti
A.
Pre
B.
ion Manual
ration
mination befo
se confirm thInput requirOutput requ
tup and oper
adapter intoator lights anwill show theAll indicator l
ng temperat
Press the “S
previous tem
set value. Th
ss or
Press the “S
Press
The first d
The next d
ore startup
he adapter berement: 100uirement: D
ration panel d
o the correspod display serie current temights will tur
ure and time
ET” button t
mperature se
he first digit
to inc
ET” button a
or t
digit flashes
digit flashes
efore startup0‐240VAC, 50DC12V, ≥60W
display
onding conneial ports will tmperature of n off.
e values
to enter set m
et value; and
in the tempe
crease or dec
after editing
to increase o
— 6 —
. 0/60HZ
ector on the iturn on. Abothe block. Th
mode. The te
d the time dis
erature displ
rease value.
the value. Th
r decrease va
instrument. Tut 3 to 5 secohe time displ
emperature
splay window
ay window w
he next digit
alue.
Chapter II
The instrumeonds later, thlay window w
display wind
w will show t
will flash.
t to the right
I Operation G
nt will be powe temperaturwill show the
dow will show
the previous
will flash.
Guidance
wered on. re display previous
w the
s time
Instruction Manual Chapter III Operation Guidance
— 7 —
C. Repeat this procedure to modify all values in the temperature and time display windows.
NOTE: There is a value limitation for temperature and time setting. The temperature setting range is: 0° to 100°C; the time scope is: 0 to 9h 59 min.
D. To complete the set‐up, wait for 5 seconds after setting the temperature and time. Do not
operate the instrument. The instrument will automatically exit setting mode. The
temperature window will display the current temperature, and the time window will display
the time value which was set by the user.
4.4 Start instrument Press “START/STOP” button to initiate the instrument program. The indicator light (“HEATING” or “COOLING”) associated with the program setting will be turned on. When the instrument reaches the set temperature, the “HEATING” or “COOLING” light will turn off, and the yellow “HOLDING” light will turn on. This indicates that the instrument will maintain the temperature set by the user. When the time on the display screen equals to the setting time, the instrument will beep to indicate the program has been completed. The instrument maintains the programmed temperature until the “START/STOP” button is pressed. When the “START/STOP” button is pressed, the instrument will drop to ambient temperature.
NOTE: Upon adding vials, the temperature of the block may be reduced. The “Heating” light will blink until the block again reaches the set temperature. Ensure that the block temperature returns to the desired temperature before initiating a procedure.
Push the “START/STOP” button twice to restart the timer if needed. 4.5 Stop Function Press the “START/STOP” button to stop the instrument from continuing the program. The corresponding working indicator light will be turned off. 4.6 Temperature calibration
NOTE:
The temperature of the instrument has been calibrated by the factory. The accuracy of temperature conforms to factory standards. If the user needs to calibrate the temperatures, the difference between the two
temperature settings used for calibration should be large, e.g. 40C and 100C.
A. Assemble external measuring instrument.
B. Simultaneously press and to enter temperature calibration mode. At that time, the
time display window will show “C‐1”, which indicates the first calibration point. The temperature
display window shows 0.1°C resolution ratio, as follows:
Instructi
C. Pres
D. Simu
time
E. Simu
disp
wind
“CO
ion Manual
ss or
ultaneously
e, the time d
ultaneously
play window
dow will sh
OLING”) will
Simultan
to adj
press
isplay windo
press
will show t
how “0h 0
l turn on as t
neously pres
ust the temp
and t
ow will show
and
the current
0min.” The
the instrume
ss the two b
— 8 —
perature of t
to set the se
w “C‐2”.
to initiate
temperature
correspond
ent heats or c
buttons
the first calib
cond tempe
the calibrat
e of the inst
ding mode
cools to the f
Chapter II
bration point
rature calibr
tion program
trument, wh
indicator li
first tempera
I Operation G
t in 1C incre
ration point.
m. The tem
hile the time
ght (“HEAT
ature set po
Guidance
ements.
At that
perature
e display
TING” or
int.
Instructi
F. Afte
mea
valu
the
calib
G. Pres
show
The
heat
H. Rep
I. Pres
Cauti
ion Manual
er 30 minute
asure the tem
ue modificati
displayed va
brated.
ss “SET” to m
w the measu
correspondi
ts or cools to
eat Step “F”
ss “SET” to fi
ion:
1.
2.
3. 4.
5.
s, the instrum
mperature of
on mode. Th
alue to the m
move on to th
ured real‐tim
ing indicator
o the second
to complete
nish temper
Calibrate ttemperatuTo ensure 30 min afteCalibrate tCalibrationthe hole, aExit the tetime durin
ment will be
f the instrum
he “HOLDING
measured tem
he second te
me temperatu
r light (“HEAT
temperatur
e the second
rature calibra
emperature ure calibrationthe accuracyer temperatuhe instrumenn point: The and submergeemperature cg the calibrat
— 9 —
in holding m
ment. Press t
G” light shou
mperature va
emperature p
ure, while th
TING” or “CO
re set point.
temperatur
ation and exi
in accordancn may fail. y of the tempure holding. nt with qualifmiddle hole e the thermocalibration mtion process.
mode. Use an
he “SET” but
uld turn off. P
alue. The firs
point. The te
e time displa
OOLING”) wi
re point calib
it.
ce with the ab
perature, the
fied standard of the modumeter bulb in
mode by presThe calibrati
Chapter II
n external m
tton to enter
Press
st temperatu
emperature d
ay window w
ll turn on as
bration.
bove procedu
instrument s
filled thermoule. Please innto the hole. ssing START/Son will be inv
I Operation G
easuring dev
r the temper
or to
ure point will
display windo
will show “0 h
the instrume
ures. Otherw
should be ca
ometer. nstill paraffin
STOP buttonvalidated.
Guidance
vice to
rature
adjust
be
ow will
h 0 min”.
ent
wise, the
librated
oil into
at any
Instruction Manual Chapter III Operation Guidance
— 10 —
4.7 Restore factory calibration value
A. Simultaneously press and Start/Stop button to enter temperature calibration
mode.
B. Simultaneously press the “SET” button and to restore factory calibration value.
Instruction Manual
— 11 —
Chapter IV Failure Analysis and Troubleshooting This chapter outlines possible failure modes and troubleshooting.
Failure Analysis and Troubleshooting
No. Failure Analysis Troubleshooting
1 Indicator lights flash
simultaneously
Overheating alarm (The
block is 3C more than the programmed temperature)
Check whether it is in normal use
2 Temperature display window
shows “001” Open circuit of sensor Contact Quidel
3 Temperature display window
shows “002” Short circuit of sensor Contact Quidel
4 Display window is not turned
on after switching on power supply
Power supply fails to be connected
Check power supply and connect it
Fuse burned Contact Quidel
Others Contact Quidel
5 Temperature display does not conform to actual temperature
Sensor is damaged or inbad contact
Contact Quidel
Caution: The user should not open the housing of the instrument for inspection during the warranty period. For any failures that require opening of the housing for inspection to occur, the supplier or manufacturer should be contacted in a timely manner.
Instructi
ion Manual
M203 –
AmpliVue 9
95C Lysis Blo
— 12 —
ock
Instructi
Autho
The E
Corpora10165 MTel: (80
(85custservtechnic
For in
Consu
ion Manual
orized Rep
uropean C
ate HeadquMcKellar Co00) 874‐15158) 552‐[email protected]@
vitro diagn
lt instruct
presentativ
Communit
uarters ourt, San Die7 (within th0 (outside tom (Custom
@quidel.com
nostic use
tions for u
ve in
ty
ego, CA 921he USA) the USA) mer Servicem (Technical
e
se
— 13 —
M
121 USA
) l Support)
C
S
Manufactu
Catalogue
Serial num
urer
e number
mber
0161
MI1112I (11/12)