64°C Amplification Block

Instruction Manual

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!

!

Instruction Manual Important Notes

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Important Notes 1. General Practice

Caution:

Important information is contained in the indicated section and should be carefully read. Failure to observe the instructions could result in damage or abnormal function of the instrument.

Warning! The warning message requires careful operation of the indicated step. Failure to observe the instructions could result in serious personal injury.

2. Safety During operation and maintenance of this instrument, the following basic safety notes must be observed. In case of failure to follow these measures or the warnings or notes indicated herein, the basic protection provided by the instrument, its safety criteria of design and manufacture, and its predicted use range will be impaired.

Caution: This instrument is for indoor use. Quidel Corporation shall not be liable for the consequences resulting from user’s failure to observe the following requirements.

Warning!

a) Adapter The instrument is supplied with a 12 VDC adapter. Every instrument is packaged with an adapter before leaving the factory. It is strongly recommended to use the provided adapter.

b) Instrument Casing The operator shall not disassemble the instrument without permission. Only qualified personnel who have been authorized by Quidel are permitted to replace elements or make adjustments to the interior of the instrument.

c) Placement of instrument The instrument should be placed in a low relative humidity and low dust area away from a water source (e.g. water bath, sink, or water lines). The room shall be well ventilated, free of corrosive gas, and free of interference of strong magnetic fields. The openings on this instrument are for ventilation/circulation. In order to avoid over-heating of the instrument body they should not be blocked or covered. Keep objects at least 25 cm (10 inches) away from the ventilation openings on the instrument. Do not use the instrument on a loose or soft surface, which may block air circulation through the bottom of the instrument. Excessive temperature would impair the test performance or result in instrument failure. This instrument should not be used in a location subjected to direct sunlight. The instrument should be kept away from all direct and indirect heat sources.

Instruction Manual Important Notes

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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. Specifications ------------------------------------------------------------------------------------------------------ 2

4. Instrument Label -------------------------------------------------------------------------------------------------- 3

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 Using Operation 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 ------------------------------------------------------------------------- 9

Chapter IV Failure Analysis And Troubleshooting ---------------------------------------------------------------- 10

Instruction Manual Chapter I Introduction

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Chapter I Introduction

Intended Use: The AmpliVue® 64°C Amplification Block is a controlled temperature heater block intended to be used for the heat amplification step of nucleic acids extracted samples with AmpliVue® assays. The product is a dry bath using an advanced 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 Hot lid to prevent evaporation

Instruction Manual Chapter II Features

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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® 64C Amplification Block

Model (SN) M205 (MAT6316-XXX)

Block type 24 x 0.2 mL, 3 Rows of 8 x 0.2 mL

Default Temperature Setting

64C

Temperature Range Setting

0C to 75C

Heating Temperature Range Room Temperature +5C to 75C

Hot Lid Temperature 13C ± 3C higher than the block temperature

Time Scope 0 to 9 hr 99 min

Heating Rate (30C to 75C)

≤10 min

Temperature Accuracy ≤±0.5C

Temperature Fluctuation ≤±1C

Display Accuracy 0.1C

Temperature Uniformity ≤±1 at >40C

Input Power AC 100-240V 50/60Hz (NRTL/cNTRL Listed, U.S. plug/cords)

Output Power DC12V ±0.5V, 60W (by power supply)

Size (mm) 295×185×195 (L×W×H) (not including power supply)

Weight (kg) 3.0

Instruction Manual Chapter II Features

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4. Instrument label

Instruction Manual Chapter III Operation Guidance

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Chapter III Operation Guidance

This chapter introduces the structure of the instrument, keyboard and functions of all buttons, and preparation before startup. Read the contents in the chapter carefully before startup when using the instrument for the first time.

1. Structure Diagram

① Hot Lid ② Block ③ Housing

④ Operation Panel ⑤ Power Socket

1

2

3 4

5

Instruction Manual Chapter III Operation Guidance

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2. Display panel diagram

3. Instructions for indicator lights and buttons

3.1 Instructions for indicator lights

When powered on, all indicator lights will turn on for 5 seconds, and then will turn off.

“HEATING”: The red indicator light indicates that the instrument is heating. The “HEATING” indicator light will turn off when the set temperature is reached.

“HOLDING”: The yellow indicator light indicates that the instrument is holding at the temperature set by the user. The “HOLDING” indicator light will turn on when the set temperature is reached.

“COOLING”: The green indicator light indicates that the instrument is cooling. When the light is on, the instrument is passively cooling.

Warning! The green indicator light does not imply the heated block is safe to touch. Take note of temperature reading before handling the instrument.

3.2 Instructions for using Operation Buttons

Button used to start up or stop the program.

Temperature and time setting button: Press the button to display current values of temperature and time. Press button again to make changes to settings. Each time the set button is pressed a temperature or time value setting will begin to flash. Use arrow buttons to make changes

Select and set values by pressing or mode. These buttons will individually adjust time and temperature if current value is flashing Press the START/STOP button and both ARROW buttons simultaneously to enter calibration mode.

START STOP

SET

Instruction Manual Chapter III Operation Guidance

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4. Operation

4.1 Examination before startup Please confirm the adapter before startup. Input requirement: 100-240VAC, 50/60HZ Output requirement: DC12V, ≥60W

4.2 Startup and operation panel display Plug the adapter into the corresponding connector on the instrument. The instrument will be powered on. All indicator lights and display serial ports will turn on. About 3 to 5 seconds later, the temperature display window will show the current temperature of the block. The time display window will show the previous setting. All indicator lights will turn off. 4.3 Setting temperature and time values

A. Press the “SET” button to enter set mode. The time and temperature display window will show the

previous temperature value. The first figure on the left of the temperature display window will

begin to flash, Press or to adjust value.

B. Press the “SET” button after editing the value. The second figure on the left will flash.

Similarly ,Press or to adjust value.

C. Repeat this procedure to modify all values in the temperature and time display windows.

The figure flashes

The figure flashes

Instruction Manual Chapter III Operation Guidance

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NOTE: There is a value limitation for temperature and time setting. The temperature setting range is: 0° to 75°C; the time scope is: 0 to 9h 99 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 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 full vials, the temperature of the block will 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. Keeping the lid in a closed position without tubes may increase the temperature of the block. To avoid this we recommend keeping an empty 2 mL tube in the block.

4.5 Stop Function Press the “START/STOP” button to stop the instrument from continuing the program. At that time, 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. The time display

window will show “C-1”, which indicates the first point calibration. The first point calibration of

temperature display window shows 0.1C resolution ratio, as follows:

Instruction Manual Chapter III Operation Guidance

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C. Press or the temperature will be adjusted as per stepping value of 1C.

D. Simultaneously press and to set the second temperature calibration point. At that time,

the time display window will show “C-2”.

E. Simultaneously press and to initiate the calibration program. The temperature display

window will show the current temperature of the instrument, while the time display window will show

“0h 0min.” The corresponding mode indicator light (“HEATING” or “COOLING”) will turn on as the

instrument heats or cools to the first temperature set point.

Simultaneously press the two buttons

Instruction Manual Chapter III Operation Guidance

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F. After 30 minutes, the instrument will be in holding mode Use an external measuring device to measure

the temperature of the instrument. Press the “SET” button to enter the temperature value

modification mode. The “HOLDING” light should turn off. Press or to adjust the displayed

value to the measured temperature value. The first temperature point will be calibrated.

G. Press “SET” to move on to the second temperature point. The temperature display window will show

the measured real-time temperature, while the time display window will show “0h 0min.” The

corresponding indicator light (“HEATING” or “COOLING”) will turn on as the instrument heats or cools

to the second temperature set point.

H. Repeat Step“F” procedure to complete the second point temperature calibration.

I. Press “SET” to finish temperature calibration and exit.

Caution:

1. Calibrate temperature in accordance with the above procedures. Otherwise, the temperature calibration may fail.

2. To ensure the accuracy of the temperature, the instrument should be calibrated 30 min after temperature holding.

3. Calibrate the instrument with a qualified instrument. 4. Exit the temperature calibration mode by pressing START/STOP button at any

time during the calibration process. The calibration will be invalidated.

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 Chapter III Operation Guidance

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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 in bad 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.

M205 – AmpliVue 64C Amplification Block Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 quidel.com

MDSS GmbH Schiffgraben 41 30175 Hannover, Germany

Chapter IV Failure Analysis and Troubleshooting

Instruction Manual Chapter III Operation Guidance

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Authorized Representative in

The European Community

Manufacturer

Tel: 800.874.1517 (in the U.S.) 858.552.1100 (outside the U.S.)

custserv@quidel.com (Customer Service) technicalsupport@quidel.com (Technical Support)

1049MI0412D-4 (11/13)

For in vitro diagnostic use Catalog number

Consult instructions for use Serial number