Endress+Hauser Analytik Jena Biometra TRIO Bedienungsanleitung

Installation Instructions

Biometra TRIO

Triple Powered PCR Thermocycler

Manufacturer Analytik Jena GmbH

Konrad-Zuse-Straße 1

07745 Jena, Germany

Phone: +49 3641 77 70

Fax: +49 3641 77 92 79

E-mail: [email protected]

Technical Service Biometra GmbH

Rudolf-Wissell-Straße 15

37079 Göttingen / Germany

Phone: +49 3641 77 7407

Fax: +49 3641 77 9279

E-mail: [email protected]

General Information http://www.analytik-jena.com

Documentation Number 34-3600-005-23

Edition A (07/2022)

Technical Documentation Analytik Jena GmbH

For a proper and safe use of this product follow the instructions. Keep the

operating manual for future reference.

Biometra TRIO Table of contents

Table of contents

1 Basic information ................................................................................................................................................. 5

1.1 About this manual ............................................................................................................................................ 5

1.2 Intended use ..................................................................................................................................................... 6

2 Security ................................................................................................................................................................. 7

2.1 Safety labeling on the device ........................................................................................................................... 7

2.2 Requirements for the operating personnel..................................................................................................... 8

2.3 Safety instructions for transport and commissioning..................................................................................... 8

2.4 Safety instructions: during operation .............................................................................................................. 8

2.4.1 Summary of safety instructions ....................................................................................................................... 8

2.4.2 Safety instructions – protection against explosion and fire........................................................................... 9

2.4.3 Safety instructions – electrical equipment ...................................................................................................... 9

2.4.4 Handling hazardous substances ...................................................................................................................... 10

2.5 Safety instructions–maintenance and repair ................................................................................................ 10

2.6 Behavior during emergencies .......................................................................................................................... 11

3 Installation and commissioning ........................................................................................................................... 12

3.1 Installation conditions...................................................................................................................................... 12

3.1.1 Ambient conditions .......................................................................................................................................... 12

3.1.2 Power supply..................................................................................................................................................... 12

3.2 Unpacking and setting up the device............................................................................................................... 12

3.3 Setting the operating voltage .......................................................................................................................... 13

3.4 Opening and closing the device....................................................................................................................... 14

4 Operation.............................................................................................................................................................. 16

Table of contents Biometra TRIO

Biometra TRIO Basic information

1 Basic information

1.1 About this manual

Content These are the installation instructions for the 3 models of the thermal cycler Biometra

TRIO. In this text, these models are collectively referred to as “the device”.

As part of the detailed operating manual, these installation instructions contain the first

steps for commissioning the device as well as the safety instructions. For all subsequent

steps, please refer to the detailed operating manual which you will find in electronic for-

mat on the USB flash drive which is part of the delivery. Alternatively, you can browse

the download section for the device on the Analytik Jena website.

The device is intended to be operated by qualified specialist personnel who must ob-

serve all instructions given in the detailed operating manual.

The operating manual provides information about the design and operation of the de-

vice and provides operating personnel with the necessary know-how for safe handling of

the device and its components. Furthermore, the operating manual includes information

on the maintenance and servicing of the device as well as information on potential

causes of malfunctions and their correction.

These instructions apply to devices from software version ME 1.70 - RE 1.46.

Furthermore, the words “protocol” and “program” are used to describe the same term in

these instructions. In this context, a protocol or program is one or several consecutive

temperature increments with the same or varying holding times which can be repeated

in cycles.

Conventions Instructions for actions occurring in chronological order are numbered and combined

into action units.

Warnings are indicated by a warning triangle and a signal word. The type, source and

consequences of the hazard are stated together with notes on preventing the hazard.

Elements of the control and analysis program are indicated as follows:

¡Program terms are in bold (e.g., the System menu).

¡Menu items are separated by vertical lines (e.g., System|Device).

Symbols and signal words used

in this manual

The user manual uses the following symbols and signal words to indicate hazards or in-

structions. These warnings are always placed before an action.

WARNING

Indicates a potentially hazardous situation which can cause death or very serious (possi-

bly permanent) injury.

CAUTION

Indicates a potentially hazardous situation which can cause slight or minor injuries.

Basic information Biometra TRIO

NOTICE

Provides information on potential material or environmental damage.

1.2 Intended use

The device Biometra TRIO is an end-point thermal cycler. The device is designed to am-

plify nucleic acids by iteration cycles of heating and cooling using DNA polymerases in a

PCR reaction.

The thermal cycler is a device for general laboratory use.

The device combines modern design and user-friendly software. The user interface con-

sists of a touch screen. The screen can display the time and status of the temperature

program for each cycle in form of a diagram or a table. The operating personnel can use

the touch screen keyboard to enter information and program parameters directly to the

device.

Its high cooling and heating rates allow using the device for fast PCR applications. They

also reduce the program execution time.

The device and its components may only be used for the analyses listed in the user man-

ual. Only this specified use is regarded as the intended use, ensuring the safety of the

user and the device.

Biometra TRIO Security

2 Security

For your own safety and to ensure error-free and safe operation of the device, please

read this chapter carefully before commissioning.

Observe all safety instructions listed in this user manual and all messages and infor-

mation displayed on the monitor by the control and analysis software.

2.1 Safety labeling on the device

Warning and mandatory action labels have been attached to the device and must al-

ways be observed.

Damaged or missing warning and mandatory action labels can cause incorrect ac-

tions leading to personal injury or material damage. The labels must not be removed.

Damaged warning and mandatory action labels must be replaced immediately!

The following warning and mandatory action labels have been attached to the de-

vice:

Warning symbol Meaning Comment

Warning of a danger

point

Proceed with care when handling bio-

logical and biochemical samples and

when working on the device.

Warning against hot

surface

There is a risk of burning at the heated

lid, the thermal block, the samples,

and the rear of the device.

Mandatory signs/

information sym-

bols

Meaning Comment

Symbol for waste dis-

posal in accordance

with the WEEE directive

Do not dispose of the device as house-

hold waste.

CE marking

For People's Republic of

China only

The device contains controlled sub-

stances. Analytik Jena GmbH guaran-

tees that these substances will not es-

cape in the next 25 years if the device

is only used for the intended purpose.

Ensure ventilation slots

are unobstructed

Ensure that the ventilation slots on

the underside and at the rear of the

device are unobstructed. Make sure

that there are no objects underneath

the device, e.g., paper that may be

drawn against the ventilation slot and

thus interfere with ventilation.

Security Biometra TRIO

2.2 Requirements for the operating personnel

The device must only be operated by qualified specialist personnel instructed in the

use of the device. This instruction also include teaching the contents of this user

manual and of the user manuals of the connected system components. We recom-

mend training by qualified employees of Analytik Jena or its representatives.

In addition to the safety instructions in this user manual, the general applicable

safety and accident prevention regulations of the respective country the device is op-

erated in must be observed and adhered to. The operator must ensure the latest ver-

sion of these regulations.

The user manual must be accessible to the operating and service personnel.

2.3 Safety instructions for transport and commissioning

¡Please verify that the delivery is complete upon receiving the device and check

for possible transport damage. Only start the device when it is free from defects.

Please address any complaints and claims to the manufacturer.

To prevent health damage, the following must be observed when moving the device

in the laboratory (lifting and carrying):

¡The device has no carrying handles. To transport the device, grip the device

firmly at the bottom with both hands and lift it.

¡Empty the sample block before transporting the device. There must be no sam-

ple vessels in the block.

¡Only send the device in its original packaging and with transport locks in place.

¡Risk of damage to health due to improper decontamination! Perform a profes-

sional and documented decontamination of the device before returning it to An-

alytik Jena. The decontamination report is available from Service when register-

ing the return. Without a completed decontamination report, the acceptance of

the device will be refused. The sender may be liable for damage caused by inade-

quate decontamination of the device.

2.4 Safety instructions: during operation

2.4.1 Summary of safety instructions

The operator must make sure that the device and its safety equipment is in sound

condition each time before starting up the device. This applies in particular after

each modification or extension of the device or its repair.

Observe the following:

¡The device may only be operated if all items of protective equipment (e.g. covers

in front of electronic components) are in place, properly installed and fully oper-

ational.

¡The sound condition of the protection and safety equipment must be checked

regularly. Any defects must be corrected as soon as they occur.

¡Protective and safety equipment must never be removed, modified or switched

off during operation.

¡Always ensure free access to the main switch and to the emergency shutdown

switches and locks during operation.

Biometra TRIO Security

¡The ventilation equipment on the device must be in good working condition.

Covered ventilation grilles or slots etc. may cause the device to break down or

may cause damage to it.

¡Modifications, conversions and extensions to the device are only permitted after

consultation with Analytik Jena. Unauthorized modifications can jeopardize the

device’s operational safety and may lead to limitations regarding the warranty

and access to customer service.

¡Be careful to avoid crushing or pinching injuries when closing the device.

¡The use of oil between the samples and the sample block is not necessary to

achieve an improved heat exchange. However, if you still want to use oil, you

should use mineral oil. Do not use silicone oil.

¡Ensure that no liquid enters the interior of the device, for example at cable con-

nections. There is a danger of electric shock.

There is a risk of burns on the device. The following has to be observed:

¡The thermal block, the samples, and the heated lid reach high temperatures.

There is a risk of burns during contact.

¡Keep all combustible materials away from the device.

¡Verify that the lid is securely closed before starting the program. Do not touch

the heated lid during operation.

¡The rapid heating of the thermal block can cause liquids to boil explosively. Al-

ways wear safety goggles during operation.

¡Do not touch hot sample vessels or plates and do not open them as boiling liquid

may escape.

¡Only use consumables such as plates and tubes that are suitable for high tem-

peratures up to 100°C, that fit well into the thermal block without shaking, and

whose lids or sealing foils seal tightly.

2.4.2 Safety instructions – protection against explosion and fire

The device may not be operated in an explosive environment.

2.4.3 Safety instructions – electrical equipment

Lethal voltages may occur in the device! Contact with live components may cause

death, serious injury or painful electrical shock.

¡Work on the electronics may only be carried out by the customer service of Ana-

lytik Jena and specially authorized technicians.

¡The electrical components must be checked regularly by a qualified electrician.

Any defects such as loose connections or faulty or damaged cables must be re-

paired without delay.

¡Before opening the device’s housing, the device must be switched off using the

mains switch and the mains plug must be disconnected from the power outlet.

¡The power plug must be connected to a properly installed and rated power outlet

to ensure that the device meets protection classI (ground connector). Before

connecting the device to the mains network set the correct operating voltage at

the voltage switch on the underside of the device. Do not replace the removable

power cable of the device with a power cable that does not meet the specifica-

tions (with no protective ground conductor). Extensions of the supply cable are

not permitted.

¡In the event of interferences with electric components, the device must be

switched off immediately using the power switch (on the equipment backplate)

and the power supply disconnected from the mains.

Security Biometra TRIO

¡Do not operate the device near sources of strong electromagnetic radiation such

as an unshielded, deliberately operated high-frequency source. Strong electro-

magnetic fields can interfere with the proper operation of the device.

2.4.4 Handling hazardous substances

The operator is responsible for the selection of substances used in the process as well

as for their safe handling. This is particularly important for radioactive, infectious,

poisonous, corrosive, combustible, explosive and otherwise dangerous substances.

When handling hazardous substances, the locally applicable safety instructions and

instructions in the safety data sheets from the manufacturers of the auxiliary and op-

erating materials must be complied with.

¡Protective goggles and rubber gloves have to be worn when handing reagents.

¡When treating only a small number of samples, two empty tubes of the same

height must be placed in the corner positions of the block in addition to the

treated samples. If the number of samples in the block is too low, there is a risk

of the tubes being damaged and sample liquid leaking out.

¡For your own safety, please consider the potential risk of infection of the exam-

ined biological material.

Observe the following:

¡The operator is responsible for carrying out suitable decontamination should the

device become contaminated externally or internally with dangerous substances.

¡Splashes, drops or larger liquid spillages should be removed using an absorbent

material such as absorbent cotton, laboratory wipes or cellulose.

¡In case of biological contamination, wipe the affected area with a suitable disin-

fectant. Then wipe the cleaned areas so that they are dry.

¡The only suitable cleaning method for the housing is wipe disinfection. If the dis-

infectant has a spray nozzle, apply disinfectant to a suitable cloth before using it

on the device.

Proceed with particular care and ensure utmost cleanliness when working with

infectious material because the device cannot be decontaminated as a whole.

¡Before using a cleaning or decontamination procedure other than the one pre-

scribed by the manufacturer, the user is required to check with the manufacturer

that the intended procedure will not damage the device. Safety labels attached

to the device must not be moistened or wiped with methanol.

2.5 Safety instructions–maintenance and repair

The device is generally maintained by the customer service department of Analytik

Jena or specialist personnel trained and authorized by them.

Unauthorized maintenance can damage the device. For this reason, only the activi-

ties described in the user manual in the "Maintenance and care" chapter may be per-

formed by the operator.

¡All maintenance and repair work on the device must only be carried out when

the device is switched off (unless specified otherwise).

¡Allow the device to cool down before any maintenance work or replacement of

system components.

¡Do not use organic solvents or abrasives to clean the device. Exercise caution

when decontaminating the device with disinfectants containing alcohol. The al-

cohol can damage the safety labeling on the device.

¡Only clean the exterior of the device with a slightly moistened, non-dripping

cloth. Use only water and, if required, customary surfactants.

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