Thermo Scientific TSB140R Manual

Operating and Maintenance Instructions
332019H02 • Revision A • 05/5/2021
Medical Devices
Touch Controller
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IMPORTANT Read this instruction manual. Failure to follow the instructions in this manual can result in
damage to the unit, injury to operating personnel, and poor equipment performance.
CAUTION All internal adjustments and maintenance must be performed by qualified service personnel.
Material in this manual is for informational purposes only. The contents and the product it describes are
subject to change without notice. Thermo Fisher Scientific makes no representations or warranties with
respect to this manual. In no event shall Thermo be held liable for any damages, direct or incidental, arising
from or related to the use of this manual.
© 2021 Thermo Fisher Scientific Inc. All rights reserved.
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Contents
Models......................................................................... 1
Safety Considerations .................................................. 2
General Safety Rules................................................ 3
Safety and Accident Prevention................................ 3
Contraindications ..................................................... 3
Warning on the Refrigerant Gas................................ 4
General Information...................................................... 5
Certification.............................................................. 5
Testing and Warranty ............................................... 5
Purpose, Content and Recipients of the Manual....... 5
Arrangements Prepared by the Customer ................ 6
Product Description ..................................................... 7
Technical Description ............................................... 7
Intended Use............................................................ 7
General Device Features .......................................... 8
Climatic Class .......................................................... 8
Transport and Handling ............................................... 9
Positioning ............................................................... 9
Cleaning................................................................... 10
Wiring and Electrical Connection .............................. 10
Set-Up Operations ................................................... 11
Use of the Internal Compartment and
Material Storage....................................................... 11
Indication for Optimal Use ........................................ 13

Touchscreen Controller Display Functioning................. 14
Touchscreen Controller Operation............................ 14
Panel User Interface ................................................. 15
Temperature Data Backup from SD Card................. 31
Buffer Battery for Alarm in the Event of
Power Failure ........................................................... 36
Connection to External Contacts.............................. 36
Manual Unlocking of the Door .................................. 37
Ordinary and Extraordinary Maintenance...................... 39
Prohibition of Safety Device Removal ....................... 39
Cleaning the Unit Inside and Outside........................ 39
Cleaning the Condenser........................................... 39
Condensate Water Draining...................................... 41
Replacing Buffer Batteries ........................................ 42
Disposal....................................................................... 43
Labeling....................................................................... 44
Device Identification Label ........................................ 44
Consumable Materials ................................................. 46
Troubleshooting........................................................... 47
Touchscreen Troubleshooting...................................... 48
Diagnostic.................................................................... 49
Annexes....................................................................... 53
1. User Data for Technical Support Request............. 53
2. Medical Device Usability....................................... 54
Contact Information ..................................................... 58

Medical Devices -Touch Controller 1| Models
Models
Model Te m p e r a t u re a t
Factory Set-point
TSB140R +2°C to +8°C
TSB250R +2°C to +8°C
TSB400R +2°C to +8°C
TSB700R +2°C to +8°C
TSB1500R +2°C to +8°C
TSB140F -12°C to -25°C
TSB250F -30°C to -40°C
TSB400F -30°C to -40°C
TSB700F -30°C to -40°C

2 | Safety Considerations Medical Devices -Touch Controller
Safety Considerations
Failure to read this manual and any misunderstandings
regarding the instructions contained within it can cause
irreversible damage to the unit as well as create a
source of danger for users and significantly decrease
device performance.
The manufacturer declines all responsibility for any uses
other than those listed below.
Read this user manual carefully.
Any maintenance operations must be carried
out by personnel authorized by the
manufacturer.
The corresponding warranty will become
immediately void in the event of use or
maintenance of equipment not in compliance
with specifications by the manufacturer.
The material contained in this manual is for
informational purposes only. Its contents and
the product itself may be subject to change
without prior notification. In no event shall the
manufacturer be held responsible for any
damage due to use of this manual.
Provide all the information required regarding
operation of the device being tested in order
to request technical support from
manufacturer.

Medical Devices -Touch Controller 3| Safety Considerations
General Safety Rules
Read the manual carefully and follow instructions
contained herein. Do not use the equipment for
purposes other than those for which it was designed.
The user assumes full responsibility in case of
operations carried out without observing the instructions
in the manual.
Safety and Accident
Prevention
This machine has been designed with suitable
measures to assure safety and the health of the user.
The following is a list of protections adopted against
mechanical risks:
-Stability: This machine has been designed and built
in order to guarantee its stability in all foreseen
operating conditions even if the shelves/drawers
are extracted without any risk of tipping, falling or
sudden movement.
-Surfaces, edges, corners: Within the limits
permitted by their functions, accessible parts of the
machine have no sharp corners, sharp edges or
rough surfaces that could cause injury.
-Moving parts: All components with the possibility of
movement have been designed, built and
configured to avoid risk. Some parts are also
protected by fixed guards to prevent contact or
injury.
The following is a list of measures adopted to protect
against other risks:
-Electrical power: This machine has been designed,
built and fit with the aim of preventing risks of
electric shock in compliance with established safety
regulations.
-Noise: This machine has been designed and built to
minimize risks related to the emission of acoustic
noise (always lower than 70 dB).
Contraindications
The refrigerated cabinet must not be used:
- Exposed to weathering.
- With adapters or extension cords.
- In explosive atmospheres or where there is a risk of
fire.
- Near heat sources (radiators, etc.).
List of the main safety rules:
- Do not touch the equipment with
moist or wet hands or feet.
- Do not insert screwdrivers or other
objects into the guards or moving
parts.
- Do not pull the power cord to
disconnect the appliance from the
electrical mains.
- Do not allow the machine to be used
by unauthorized users.
- Before performing any cleaning or
maintenance, disconnect the machine
from the electrical mains by switching
it off and disconnecting the plug.
- In case of failure and/or malfunction,
switch off the machine and do not
attempt to repair or service it on your
own. It is absolutely necessary to
contact qualified personnel.
The following is strictly forbidden:
- Tampering with or removing the
evaporator cover enclosure that
protects the user from a risk of cutting
on the evaporator fins.
- Removal of the data plates fixed in the
inside edge of the motor compartment
that contain technical specifications
and earth connection warnings.
- Removal of the data plate fixed on the
evaporator unit guard and near the
electrical wiring inside the motor
compartment which warns the user to
disconnect power before working on
the unit.
The manufacturer declines any
responsibility for safety of the machine
if the above recommendations are not
observed.

4 | Safety Considerations Medical Devices -Touch Controller
- If the device is built in furniture, proper ventilation
must be guaranteed. On the contrary, warranty will
automatically expire.
Warning on the Refrigerant
Gas
If there is any malfunction, disconnect the equipment
from the mains. Extraordinary maintenance should be
performed only by qualified personnel.
These devices contain R290 as refrigerant
(Flammable Gas).
In this case, some special precautions
should be taken:
1. Position the appliance in an
environment of suitable dimensions in
compliance with EN 378: the
environment must have a volume of
1m3 every 8gr of R290 refrigerant.
The quantity of gas contained in the
circuit is declared on the silver data
plate attached inside the cabinet.
2. Do not use the equipment if damaged.
3. To avoid damages to the refrigerant
circuit, do not use mechanical devices
to accelerate defrost process.
4. Make sure that air grids are always free
to guarantee a certain ventilation to the
device.
5. If there is refrigerant leakage, avoid
using open flames, remove from the
device flammable products and
ventilate immediately the environment.
6. Do not store potential explosive
substances (for example spray cans
containing flammable gases) inside the
device.
7. Do not use electrical appliances inside
the chamber, ATEX approved
appliance.

Medical Devices -Touch Controller 5| General Information
General Information
Certification
Thermo Fisher Scientific refrigerators and freezers
designed for the storage and preservation of human
blood, human body liquids and human body tissues
destined to transfusion, administration and
re-introduction in human body, in accordance with the
definition of Attachment IX, point III, rule 2 of Medical
Devices Directive 93/42/EC and subsequent
modification 2007/47/EC. Following the same directive
these devices fall in class II a.
According to the above mentioned directive (Article 1),
these refrigerators are NOT medical devices;
nevertheless, they are comprehended in the category,
since they are meant to store/manage a medical device,
i.e. a blood bag, destined to store human blood, human
body liquids and human body tissues destined to
transfusion, administration and re-introduction in human
body. Therefore, these devices are defined as
BORDERLINE, and, as such, norms related to the type
of equipment applies, although not strictly related to
medical device directive.
Testing and Warranty
The machine is tested at our factory in accordance with
current regulations and it is shipped ready to use.
The warranty is valid for 12 months from the date of
delivery and establishes the right to repair/replace parts
that are defective, not including electrical and electronic
parts. Apparent defects and any deviations from orders
must be communicated to the manufacturer within 5
days of receipt of the goods under penalty of invalidation
of the warranty. Any other defects (not apparent) must
be communicated within 5 days of discovery, and in any
case within the maximum 6 months warranty period.
The customer will only be entitled to the repair or
replacement of goods, with the absolute exclusion of
any direct or indirect damages of any kind. In any case,
the right to repair or replacement of materials must be
exercised within the maximum time limit provided by the
warranty, with the time limits having been contractually
reduced with respect to those established by law.
Repair or replacement of defective materials will occur
at the manufacturer's factory, where materials must be
delivered with freight prepaid. The manufacturer will
then return them carriage forward.
Purpose, Content and
Recipients of the Manual
This manual has been drafted for the purpose of
providing all the instructions necessary for correct use of
the machine and for maintaining it in perfect condition,
in particular with regard to the user's safety.
The following professional figures shall be defined in
order to identify tasks and responsibilities:
Installer: Qualified technician who performs machine
placement and commissioning in accordance with the
instructions in this manual.
User: Person who after carefully reading this manual,
uses the machine for his own permitted uses.
It is mandatory for the user to read the manual carefully
and make reference to it.
Routine maintenance worker: Qualified technician able
to carry out routine maintenance on the machine by
following the instructions in this manual.
Special maintenance worker: Qualified technician
authorized by the manufacturer who carries out special
maintenance on the machine. The manufacturer
declines any responsibility for improper or unreasonable
use of the machine and for all those operations carried
out on the same ignoring the instructions in this manual.
The manual must be kept in an accessible location
known to all operators (installers, users, routine and
special maintenance workers). No part of this manual
may be reproduced and/or disclosed by any means and
in any form whatsoever.
0051

6 | General Information Medical Devices -Touch Controller
Arrangements Prepared by
the Customer
The following arrangements are set by the customer:
- The machine electrical connection
- Installation site arrangement
- Routine maintenance
- Refrigerator cleaning and the products used for it.

Medical Devices -Touch Controller 7| Product Description
Product Description
Technical Description
The refrigerated cabinet covered by this manual
produces cold by means of low-pressure vaporisation
of a liquid refrigerant such as R290 inside a heat
exchanger (evaporator). The vapor thus obtained is
brought back to the liquid state by means of a higher
pressure mechanical compression (via a compressor)
followed by cooling in another heat exchanger
(condenser). The correct, uniform distribution of air
inside the cabinet is guaranteed by one or more fan
motors depending on the model.
The machine is composed of a modular monocoque
coated with different materials and insulated with
polyurethane foam at a density of 43 kg/m³.
The instrumentation is grouped on the front panel.
On some models, the motor compartment where the
condenser unit and electrical wiring can be housed
closes automatically.
Inside, the machine is equipped with brackets suitable
for supporting wire shelves, extractible drawers and
steel baskets.
The doors on all machines are equipped with a closing
device with automatic return and door lock and easily
replaceable magnetic seals for perfect tightness.
Measures were taken during design and construction to
obtain a machine that meets specific safety
requirements such as internal rounded corners,
condensate liquid drainage, no rough surfaces,
fixed guards on moving or potentially dangerous parts
and so on.
The maximum capacity of drawers load on all Thermo
Fisher Scientific models is 30 kg with weight uniformly
distributed.
Intended Use
All the listed models are suitable for storage.
For this reason, we suggest only storing products that
have already been refrigerated or frozen (depending on
the model).
We declare that any use outside of those allowed by the
machine is considered as “improper use” and therefore
the manufacturer declines all responsibility.
Thermo Fisher Scientific refrigerators and freezers
designed for the storage and preservation of human
blood, human body liquids and human body tissues
destined to transfusion, administration and
re-introduction in human body in accordance with the
definition of Attachment IX,
point III, rule 2 of Medical Devices Directive 93/42/EC
and subsequent modification 2007/47/EC.
In accordance with the same directive, medical devices
fall in class IIa.
Hence, Thermo Fisher Scientific devices can store:
•Blood
•Plasma
• Breast milk
Despite the above definition of medical devices, the
same refrigerators are allowed for storage and
preservation of:
- Drugs, vaccines, reagents properly stored, whatever
nature.
- Generic use substances and materials in hospital,
laboratory or pharmaceutical environment,
not flammable nor explosive.
Note: User must take care of allowed storage
temperature. Since, these units are medical devices,
temperature factory setpoint are adjustable within limits
connected to the intended use and therefore, it is user’s
responsibility to store those substances or material
following the manufacturer guidelines.
All models are for indoor use and cannot
be installed outdoors.
Warranty will immediately expire,
if equipment is installed improperly.

8 | Product Description Medical Devices -Touch Controller
General Device Features
Climatic Class
The unit identification label (see Labeling) reports the
climatic class to which the unit belongs, i.e. the ambient
temperature range between which the unit can work.
The following table explains the meaning of the climatic
class symbols:
IMPORTANT: Breast milk, blood bags and
blood products cannot be stored together with
other material (drugs, reagents and generic
use substances) and must be stored in
accordance with the temperature settings by
the manufacturer and with respect to suitable
storage period.
IMPORTANT: Blood and breast milk cannot
be stored together. It is important to allocate
devices to store one or the other. Avoid mixed
use.
IMPORTANT: Manufacturer declines
responsibility in case staff in charge is not
adequately formed and trained on blood
storage specifications (temperatures and
storage periods) and the correct treatment of
donated breast milk according to the
guidelines (G.U.n.32, 8 February 2014).
IMPORTANT: Manufacturer declines
responsibility concerning previous or following
phases of the product lifecycle.
Device Features
Power supply 230V ±10%
Frequency 50 Hz
Allowed ambient
temperature See climatic class
Storage temperature -10°C to +50°C
Acoustic pressure at 1 mt ≤ 60dBA
Table 1. Climatic Class Symbols
Symbol Ambient Temperature Range
SN from +10°C to +32°C
Nfrom +16°C to +32°C
ST from +18°C to +38°C
Cfrom +10°C to +25°C
Climatic class on the dataplate refers to
the factory setpoint.

Medical Devices -Touch Controller 9| Transport and Handling
Transport and Handling
The machine must be transported and handled solely in
a vertical position and following the instructions printed
on the packaging. This precaution is necessary to avoid
contamination of the compressor with oil which may
cause the rupture of valves of the cooling coils and
problems with electric motor starting.
The accessories supplied with the machine (slides, wire
shelves, drawers, baskets, etc.) are shipped inside the
unit. The machine is fixed on a wooden pallet by means
of screws, wrapped with polyethylene and packaged in
cardboard, a wooden crate or wooden case.
The machine must be handled using a forklift or pallet
truck with suitable forks (fork length at least equal to
2/3 length of the unit).
Positioning
Incorrect positioning can cause damage to the machine
and create dangerous conditions for users; therefore,
the installer must comply with the following general
rules:
Figure 1. Equipment Position
- Set the machine in a sufficiently ventilated
environment.
- Place the machine far from heat sources and far
from sources of electromagnetic interferences
(such as motors, generators, infrared beams,
telephones) which can have negative effects on
equipment functioning.
- Avoid exposure to direct sunlight and air
conditioning flows.
- Remove the supplied accessories and the wooden
pallet base.
- Position the machine with the aid of a spirit level.
If the machine needs to be set down in
order to bring it into the installation location
it is necessary to wait at least 6 hours
before switching it on.
The manufacturer declines any
responsibility for problems due to
transport carried out in any condition
different from those specified above.
Position the machine keeping a minimum
distance of 100 mm from all walls. If the
machine is embedded in any type of
furniture, a correct air flow of the
condensing unit (compressor/fan motors)
must be always ensured. The warranty will
immediately expire, if this is not
guaranteed. (Refer to Figure 1).
For models taller than 1.5 m, installation
with wall fixing brackets is recommended.
100 mm
100
100
mm
100
100
mm
100
m
100
m
m
m
100
m
100
m
m
m
100 mm

10 | Transport and Handling Medical Devices -Touch Controller
Cleaning
Equipment shipped is already cleaned. However, it is
advised to carry out a further washing by following the
instructions below:
- Remove the protective PVC film from the external
surfaces of the machine.
- Clean inside of the chamber with a cloth dampened
with alcohol in order to eliminate the protective oil.
Figure 2. Glass Cleaning Label
Wiring and Electrical
Connection
The electrical system and connection must be set up by
qualified personnel.
Follow the instructions below for safety reasons:
- Do not use extension cords or multiple sockets
(see figure below).
- Do not use inverters for standalone systems
(conversion of direct current into alternating current
or three-phase current) or energy saving connector.
Could cause damage to the electronics.
The glass door must be cleaned using a
cloth dampened with water.
Do not therefore use chemicals.
- Ensure that the system is suitably
sized for the absorbed power of the
machine.
- It is essential to properly connect the
machine to an effective grounding
system set in accordance with
current legislation.
- In the event of incompatibility between
the outlet and machine plug, replace
the outlet with a suitable type,
provided that the part is approved
according to the laws in force.
- If electrical cable is damaged it must
be replaced by a qualified personnel to
prevent any risk.
- If the freezer is supplied without a plug,
connect it directly under the switch
board.
- Do not interpose adapters and/or
reducers.
- Electric socket must not be directly
behind the device and must be easily
accessible.

Medical Devices -Touch Controller 11 | Transport and Handling
Electrical Protections
These devices are equipped with 2 safety fuses
(phase and neutral) with integral protection against
electric shocks, short circuits and over-currents and
according to the standards for laboratory devices.
The fuses can be accessed from the front: Open the
refrigerator door and the fuses will be found behind the
front control unit panel. The activation current of the
fuses must be between 10 A and 16 A.
Figure 3. Fuse Housing
Set-Up Operations
Before turning on the appliance, it is necessary to check
that it has not been damaged during transport, handling
and installation.
Use of the Internal
Compartment and Material
Storage
The stainless-steel rack system allows for the installation
of fully extractable drawers on telescopic guides with
"bayonet connection".
Drawers Installation
Insert the guides into the special slots of racks (Figure 4)
and pull out the telescopic guides by gently pressing on
the white lever (Figure 5), install them on the drawer and
fill the drawer on the guides installed on racks (Figure 6).
Figure 4. Installation of drawer on rack
Figure 5. Guides Installation
Figure 6. Pulling Guides Out
The replacement must be done by
qualified personnel.
- Check the condition of the packaging
(it must not show dents and/or
breakages).
- Check the condition of the external
frame (it must not show dents and/or
breakages).
- Check the condition of the power cord
(it should not have scratches or cuts).
- Check the wheels are stable.
- Check that door opens correctly and
closes hermetically.
- Check door gaskets (they should not
have scratches or cuts).
- Check that display do not show
cracks.

12 | Transport and Handling Medical Devices -Touch Controller
Placing Material Inside the
Compartment
Care must be taken when loading material to avoid
malfunctions and allow air flow to ensure temperature
uniformity inside the refrigerated compartment.
Observe the following instructions:
• Do not place material over the label indicating the
maximum permitted loading level, if present.
• Store material leaving a distance of at least 60 mm
from sides and at least 180 mm from the top of the
compartment (refer Figure 7 and Figure 8).
Figure 7. Correct Material Storage
Figure 8. Incorrect Material Storage
• Do not position material in contact with or near the
temperature probes (Figure 9).
Figure 9. Probes Position
• Do not block air vents (Figure 10).
Figure 10. Air Vents at the Top of the Compartment

Medical Devices -Touch Controller 13 | Transport and Handling
Indication for Optimal Use
The following instructions are provided to the user to
follow in order to get the best equipment performances:
- The power supply must comply with
the information provided on the
technical data plate (+/- 10%).
- The units have been designed and
built to work in environment with
temperatures falling within the climatic
class temperatures indicated on
the technical data plate (see Device
Identification Label) and at a relative
humidity of 60%.
- Do not block the motor compartment
air vents.
- Load stored material gradually at
ambient temperature to grant proper
refrigeration.
- Store material on drawers.
Do not place products directly on the
bottom or against the wall, doors or
fixed guards of the unit (see Placing
Material Inside the Compartment)
- Ensure doors are closed properly.
- Limit door opening frequency and
duration. Each time the door is
opened, the internal temperature will
alter and there will be possible ice
formation on the evaporator
- Keep the defrost water drain outlet
clear.
- Follow a regular maintenance
schedule (see Ordinary and Extraordi-
nary Maintenance).
Every model of freezer is designed to store
material already frozen, especially model
SUPERARTIC. Material load turnover
cannot exceed 5% of the total stored load.

14 | Touchscreen Controller Display Functioning Medical Devices -Touch Controller
Touchscreen Controller Display
Functioning
Touchscreen Controller Operation
Switching On
To switch on the equipment for the first time follow these below instructions:
Table 2. Instructions for switching ON
Sl. No Instructions Graphical Representation
1Connect the plug to the electric socket.
2
Switch on the equipment by pressing the
three blue squares sequentially from left
to right (if pressed correctly, the squares
will become green).

Medical Devices -Touch Controller 15 | Touchscreen Controller Display Functioning
Panel User Interface
Figure 11. Equipment with One Chamber
3Select language and set date and hour.
4User interface will be displayed
Equipment with one chamber
Table 2. Instructions for switching ON
Sl. No Instructions Graphical Representation
Temperature
detected inside
the chamber
INFO 1
Panel
Temperature
graph
Device name
Equipment status
INFO 2 Panel
Working
parameters
Status panel
Setpoint Tempertaure

16 | Touchscreen Controller Display Functioning Medical Devices -Touch Controller
Figure 12. Equipment with One Chamber + Ballasted Temperature Product Probe
Figure 13. Ballasted Temperature Product Probe
User Hardware Interface
Figure 14. Hardware Interface
INFO 1 Panel
Product
temperature
Working
Parameters
This manual suits for next models
8
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