INHECO ODTC Verification Tool 96 Manuel utilisateur

Doc ID: 900905-000

October 2018

ODTC®Verification Tool

(OVT)

Set Part No.: 790200X



Insert gap closure in ODTC (at position of removable Block)

INHECO

Doc ID: 900905-000

October 2018

reserves the right to modify their

products for quality improvement. Please note that such modifications may not be

documented in this manual.

This manual and the information herein have been assembled with due diligence.

does not assume liability for any misprints or cases of damage resulting

from misprints in this manual. If there are any uncertainties, please feel free to contact

[email protected]. → How to contact INHECO, page 6.

The brand and product names within this manual are registered trademarks and belong

to the respective titleholders.

INHECO

Doc ID: 900905-000

October 2018



 ......................................................................................... 04

General Information ..................................................................................... 04

Explanation of Symbols ............................................................................... 05

Abbreviations and Glossary ........................................................................ 05

Warranty ...................................................................................................... 06

How to contact INHECO .............................................................................. 06

 .................................................................................. 07

Intended Use ............................................................................................... 07

Components - scope of supply .................................................................... 07

Functional Elements .................................................................................... 08

Labels .......................................................................................................... 11

Technical Data............................................................................................. 12

 .................................................................................... 13

Product-specic Risks ................................................................................. 13

Technical Alterations ................................................................................... 14

Malfunctions................................................................................................. 14

.................................................................. 15

Installation OVT control software................................................................. 15

Installation of Data Logger driver................................................................. 15

Network conguration .................................................................................. 16

Energy saving settings of connected PC......................................................16

 ............................................................ 17

Scope of Supply........................................................................................... 17

Initial Operation............................................................................................ 17

Start Verication .......................................................................................... 17

 ............................................................................................... 24

Software Updates ........................................................................................ 24

Support ........................................................................................................ 24

Return for Repair only with RMA Number ................................................... 24

Transportation and Storage ......................................................................... 24

Cleaning....................................................................................................... 24

Decontamination.......................................................................................... 25

Thermal Verication..................................................................................... 25

Shut Down and Disposal ............................................................................. 25

 ........................................................................................ 26

OVT is not connecting to ODTC®................................................................. 26

................................................................................................ 27

Miscellaneous .............................................................................................. 27

 .................................................................................................... 28

CE Declaration ............................................................................................ 28

................................................................................................. 29

Certicate of temperature verication .......................................................... 29

................................................................................................. 31

Certicate of Calibration ............................................................................. 31

INHECO

Doc ID: 900905-000

October 2018

1 

1.1. 

Read the user instructions completely. The manual explains how to handle the ODTC®

Verification Tool (abbreviated: OVT ) with Part#: 790200x.

Part# 7902000-set consists of:

Data Logger connected with the OVT Measurement Head 96 well and Software

Part# 7902001-set consists of:

Data Logger connected with the OVT Measurement Head 384 well and Software

In the following OVT is used for the complete set.

In case the instructions contained in this manual are not followed, injury or product

damage cannot be excluded.

Missing or insufficient knowledge of the manual leads to loss of liability against

INHECO GmbH.

This manual is part of the OVT and must be retained until the device is disposed of and

must be passed on with the OVT when the device is taken over by a new user.

Manual instructions must be followed in order to limit the safety risk during operation of

the OVT.

Security-related warnings in this manual are classified into 4 hazard levels:

- The signal word WARNING indicates hazards which – without precautionary

measures – can result in death or serious injuries.

- The signal word CAUTION indicates hazards which – without precautionary

measures – can result in minor to moderate injuries.

- The signal word NOTE stands for the general precautionary measures that have to

be taken to avoid damaging the device.

- The signal word NOTICE stands for the general measures that help using the device.

Contact INHECO in case there are any uncertainties of how to operate or how to handle

the OVT device.

Your opinion about this manual provides us with valuable insights on how we can

improve this document. Please do not hesitate to direct your comments to

, → How to contact INHECO, page 6.

INHECO

Doc ID: 900905-000

October 2018

1.2. 

Symbol Explanation

Potential danger of injury or death. → signal words WARNING and CAUTION

indicate the severity

Warning: Potential danger of hot surface.

Warning: crushing your nger

· Bullet points indicate steps of instructions.

- Hyphens are used for enumerations.

→Arrows indicate: “refer to” and are mostly an active link

blue writing indicates a software button

1.3. 

The document uses the following terms

ODTC®On Deck Thermal Cycler

OVT ODTC® Verication Tool

 ODTC® Power & Control Unit

 ODTC Verication Tool Data Logger

°C Degree Celsius

Hz Hertz [1/s]

lac Alternating Current

ldc Direct Current

KKelvin

 Kilogram

 relative humidity

TEC Thermo Electric Cooler (Thermoelectric Module, Peltier Element)

 Alternating Voltage

 Direct Voltage

WWatt

IVD In Vitro Diagnostic

FDA Food and Drug Administration

SiLA Standardization in Laboratory Automation

 Process Management Software (control software of automated system)

 Polymerase Chain Reaction

 Next Generation Sequencing

®Vapor Chamber Mount (three dimensional heat pipe)

 Gigabit per second

 Heating and Cooling Rate of ODTC®

 Proof that the ODTC® is working within its specications → Technical Data of

ODTC®Manual

INHECO

Doc ID: 900905-000

October 2018

1.4. Warranty

The warranty period starts on the date of shipment. Any damage caused by operating

the OVT outside the specifications and guidelines leads to the loss of warranty.

INHECO will only accept parts / devices for return that do not pose a threat to the health

of our staff. In particular, the devices may not have been used in Biosafety Level 3 and 4

environments, or have been exposed to radioactive or radiation materials. → Cleaning

and Decontamination, page 24-25.

Devices exposed to Biosafety level 3 and 4 Environments or radioactive materials are

not accepted by INHECO for return.

1.5. 

INHECO GmbH

Address Fraunhoferstr. 11

82152 Martinsried

Germany

Telephone - Sales +49 89 899593 120

Telephone - Techhotline +49 89 899593 121

Fax +49 89 899593 149

E-Mail - Sales [email protected]

E-Mail - Technical - Hotline [email protected]

Website www.inheco.com

Technical Support & Trouble Shooting Instructions:



INHECO

Doc ID: 900905-000

October 2018

2 

2.1. 

The OVT is designed for use as a verification tool to verify the temperature specifications

of fully functional ODTC®. Mechanical / Hardware and Firmware defects / problems

cannot be detected by the OVT. The OVT is not intended to be used to verify other

Thermal Cycler systems.

The OVT devices are delivered with CE- and UL- certification.

The OVT is designed specifically for use in Life Science and In Vitro Diagnostics. The

provided OVT software operates the OVT/ODTC®and evaluates the measurement data

of the OVT system and generates an official verification certificate

When using the OVT in a Biosafety Laboratory Environment, the user is responsible for

labeling the devices according to the WHO Laboratory Biosafety Manual

(ISBN 92 4154650 6) and for operating the devices according to this Biosafety Manual.

The OVT must be used exclusively by service technicians and user of workstation

system who are familiar with the instructions of this manual and the ODTC®Manual.

2.2. 

Before initial operation, make sure that the shipment of your unit and its scope of supply

is complete and no parts are damaged.

In case of parcel or product damages, take photos of the damaged boxes and products

and email them to without delay. Transportation damages

must be reported to INHECO within 7 days of delivery. The following components should

be included in each shipment:

Fig.1: Components (measurement scale not correct)

( 1 ) OVT measuring Head and OVT Data Logger tightly connected with a cable (cable longer than shown in

the image)

( 2 ) USB flash drive with OVT Control Software and Data Logger driver

( 3 a ) USB cable ( 1.5m length ) ( 3 b ) USB cable (3.0m length)

( 4 ) RJ45 Ethernet cable

( 5 ) Socket wrench ( 1.5 mm )

( 6 ) Certificate

( 7 ) Transport case

INHECO

Doc ID: 900905-000

October 2018

2.3. 

The OVT set primarily consist of the Measurement Head and the Data Logger.

Measurement Head and Data Logger are connected by a 1.5m cable.

Fig.2: OVT set (Measurement Head and Data Logger) showing the connection of both

devices

NOTE

Never unplug the connector of the Measurement Head from the OVT Data Logger. It is

secured with a calibration void label. INHECO will not take any liability for quality of the

measurement performed with the OVT if the Measurement Head was disconnected

before.

2.3.1. 

-

The OVT Measurement Head has 5 sensing elements located at the bottom of the

Measurement Head to verify the temperature of the ODTC®Mount and 2 sensing

elements located at the top of the Measurement Head to verify the temperature of the

ODTC®Lid.

Fig.3: Sensing elements at the bottom of the Measurement Head

INHECO

Doc ID: 900905-000

October 2018

Fig.4: Sensing Elements at the top of the Measurement Head

-

The Measurement Head includes a plastic part (Gap Closure) which is xed to the

cable. The Gap Closure has to be manually positioned to the front of the ODTC® (same

position as right removable block) to guide the cable out of the ODTC®and close the

gap.

Fig.5: Gap Closure

INHECO

Doc ID: 900905-000

October 2018

2.3.2. 

The OVT Data Logger contains the metrology and the data processing of the

measurement data. The Data Logger is connected to the Measurement Head by a 1,5m

cable.

Fig.6: Functional elements of the OVT®Data Logger

( 1 ) Connector to Measurement Head (do not separate)

( 2 ) USB connector to PC

( 3 ) Status LED

LED state from top to down

Status LED Description of status

LED0 shows the state "on"

LED1 shows data transmission and is lightened only during data transmission

LED 2 and 3 only for INHECO use

NOTE

Never unplug the connector of the Measurement Head from the OVT Data Logger. It is

secured with a calibration void label. INHECO will not take any liability for quality of the

measurement performed with the OVT if the Measurement Head was disconnected

before.

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