ATRAS R4 Operating Instructions
ATRAS R4 Operating Instructions
Operating Instructions
These operating instructions refer exclusively to the scope of delivery of
T&O LabSystems GmbH & Co.KG.
Manufacturer
T&O LabSystems GmbH & Co. KG
Leibnizstraße 7
DE-24568 Kaltenkirchen
Tel: +49-4191 991 3883
E-Mail: [email protected]
Internet: www.to-labsystems.com
Overall Scope of these Operating Instructions
Chapters
1 General
2 Safety Instructions
3 Description of the Machine
4 Initial Operation
5 Operation
6 Error Conditions
7 Maintenance
8 Disposal
Appendix
A Technical Data
B Declaration of Conformity
C Terms and Abbreviations
The first necessary step before commissioning and the first use of the ATRAS R4,
FLASH R4 or TS1500 R4 (further referred to as ‘device’ or ‘sorter’), is reading this
manual and the included safety instructions.
Unawareness of the intended use of the device and the instructions contained in
these operating instructions may lead to incorrect processing, such as faulty sorting of
samples or loss of those, and may also result in injury or death to the user.
General
In this chapter:
1 Introduction ........................................... 2
2 Symbols Used......................................... 2
3 Intended Use ......................................... 2
4 Warranty and Liability ............................ 3
1 Introduction
The device supports your laboratory to run your analyzers more efficiently, by organizing the workload, by
cutting of peak demands and by handling the pre-sorting and registration. The sorter reads the sample
barcode and detects the cap color, queries to the LIS and sorts to different target bins such as chemistry,
hematology, coagulation, STAT and more.
This device as well as all T&O sorting solutions assist your laboratory to comply with the DIN EN ISO 15189.
2 Symbols Used
NOTE
Reference to a special item or document
WARNING
This symbol indicates potential hazards, which can result in damaged equipment,
injury or death and indicates in addition possible failures as a result of wrong
operation of the unit.
BIOHAZARD
This symbol is related to laboratory safety and indicates potential biological
contamination that may endanger the health of living organisms (primarily humans).
ELECTRICAL SHOCK
This symbol indicates areas or components that are related to high voltage (up to 230
V) and can cause an electrical shock and even death when not handled properly
(access reserved for electrically instructed persons only).
3 Intended Use
The device is intended to be used in analytical laboratories for separation, registration and sorting of not
centrifuged primary IVD tubes containing blood or urine samples.
Tubes which reach the laboratory in a bulk are automatically separated to single tubes which are getting
registered and finally directed to specific bulk bins. Sorting happens according to defined sorting rules
coming from the LIS or being stored on the sorter itself.
The device may only be stored and operated indoors. For further information, see chapter ‘Initial
Operation’ and ‘Appendix A – Technical Data’.
If the device is not operated as intended, the protection supported by the device may be impaired.
▪ improper repairs
Safety Instructions
In this chapter:
1 Safety Instructions for the User .............. 2
2 Safety Instructions for the Operation ..... 3
The device contains moving parts. Depending on the operating state of the device, it
can restart automatically after a long-term shut-down.
Do not operate the device with opened hoods or removed covers. Do not reach into
the hopper module during operation. Always pay attention to keep adequate distance
to all moving units such as chain conveyors, ejectors and the conveyor belt.
For activities in the area of the chain drive, the conveyor line and the ejectors it is
possible that items of clothing are caught. Due to this, wear close-fitting clothes and
put jewellery off.
Hopper, chain conveyors and barcode scanner (mirrors) are equipped with sharp
edges due to their specific purpose. Maintenance and cleaning of those parts require
careful handling and wearing of approved protective gloves.
The device could be contaminated by defective sample tubes. Always wear rubber
gloves during cleaning and inspection work.
In the case of contamination, empty the device from all samples and perform a
thorough cleaning and disinfection.
The device contains an isolated box with high-voltage components (up to 230V). This
box is located in the rear device housing. When the inspection flap is opened, this box
becomes accessible and shows the warning sign for electrical shock.
Therefore, the supply line must be unplugged for all work within the device.
Only qualified personnel with electrical training are permitted to open this box!
Any other risks were reduced to an acceptable residual risk by protective measures.
Also observe the protective measures required for cleaning and maintenance in chapter ‘7 Maintenance’!
THE SAFE FUNCTION (SETUP) AND USE OF (OPERATION) OF A SYSTEM IN WHICH THE DEVICE IS
INTEGRATED IS THE RESPONSIBILITY OF THE SYSTEM INSTALLER.
▪ Thoroughly inspect the samples for integrity prior to sorting. Pre-damaged tubes may break and leak
into the device.
▪ Make sure the samples are properly closed to prevent them from leaking into the device.
▪ Some samples are sensitive to vibration. Keep this in mind during the work process and the removal
of samples
▪ Pay attention to the correct pressure and position of the barcode label. Protruding corners of those
labels lead to disturbances in the sorting process (e.g.: stuck or jammed tubes).
▪ Make sure no samples fall to the ground when filling the input hopper (risk of breakage).
▪ Fill up the input hopper no higher than a hand breadth below the upper edge
▪ Make sure that no other objects (e.g.: paper clips or pens) than appropriate sample tubes are put
into the hopper. These lead to disturbances in the separation and sorting. Furthermore, the
mechanical components of the device may be damaged.
▪ Make sure that the hood of the hopper and all other covers of the device are closed during
operation.
▪ Don’t remove tubes out of the running process and do not place tubes manually onto the conveyor
belt, since this may cause harmful interference with the sorting process or inconsistencies in the
data exchange with the LIS.
▪ Avoid forcing samples into the hopper as parts of the device as well as samples could be damaged.
This action will neither eliminate errors nor increase performance.
▪ When fixing errors, blockage or congestion: Inspect all areas to see if any tubes are near the
conveyor units and cannot automatically be processed anymore. Also make sure that samples did
not accidently fall into the “wrong” bin. In case of doubt, the samples must be sorted again.
▪ Make sure no tubes are left in the device after switching it off and before changing sorting rules.
▪ When removing and pushing back bins, careful handling should be observed. Otherwise, samples
may be damaged or lost.
▪ It is recommended to let the hopper run empty before adding more samples. This increases the
chances of sorting according to the FIFO principle.
▪ Check the level of the SIQ bin regularly (even with the limit set).
2. The device is started by placing samples into the hopper. Optionally, sorting can be started
automatically by detecting the filling process or via the start button on the touch display.
3. The separation of the tubes is done via specific transport carriers which carry the separated tubes to
the conveyor belt.
4. The conveyor belt transports the tubes along the barcode scanner.
6. Optional the cap color of the tube is detected by a spectrometer. This option includes a tube spinner to
align the tubes with their cap towards moving direction. Additional sensors allow to detect the tube
dimensions and increase process reliability.
7. Barcode and cap color (if available) are evaluated according to the selected sorting rule and
transmitted to the LIS on request.
8. According to the active sorting rule, the tubes are forwarded to their designated target bins.
9. Once arrived at the target position, each tube is individually ejected into the allocated target bins.
10. Optionally, successful sorting of each tube is monitored by additional sensors and archived, if desired
(therefore, each target bin is identified by an individual barcode).
11. A message appearing on the display and the sound of an acoustic signal (optional) will indicate that a
target bin is full and ready to be replaced. Tubes will no longer be sorted into this bin until it is emptied
and/ or replaced.
12. Target bins can be removed during operation. When removing a target bin, the device remains in
operational state. As soon as sorting into the withdrawn bin is pending the device stops. Only when the
affected bin is back in retracted position, sorting process will be continued.
13. Each time a target bin is replaced and before sorting is continued into an empty target bin, the
corresponding counter must be reset in the ‘details’ menu.
14. Individual limits can be set for each target, including the external inspection bin (further referred to as
‘SIQ bin’ → sample in question).
2 System Overview
The following technical drawings show the device with its different parts and terms. The delivered
configuration may differ from the illustration.
STAT Input
Display
Sample Input
Hood
Bulk Module
Main Switch
Drawer
Target Bin
Space for empty
Target Bins
Sample Input
The device can be equipped as a unit with up to 5 target bin modules, i.e.: 10 target bins plus an external
sample in question (SIQ) bin. Each device comes with at least one bulk module with two target bins.
Furthermore, there is the possibility of an extension of the device with the help of the "extension module"
of T&O LabSystems.
Rubber caps are not allowed, since the failure rate increases depending on the ratio of rubber caps to solid
caps.
Initial Operation
In this chapter:
1 Environmental Requirements ................. 2
2 Orientation ............................................ 2
3 Connection of the Device ....................... 3
1 Environmental Requirements
When installing the device, make sure that the following requirements are met:
The underground must be stable enough to carry the total load of the device as well as the point loads from
the machine feet.
For further information on the environmental requirements as well as to the weight and load of the device,
see “Appendix A- Technical Data”.
2 Orientation
Since all connectors (power supply, network and extension module if applicable) are located on the back of
the device and for service as well as ventilation purposes, the distance from the nearest wall must be at
least half a meter.
Located under the hopper is a drawer for cleaning. An inspection door at the back of the device provides
access to tubes or obstacles if they accidentally got caught in the chain carrier. Make sure that the
inspection door and the drawer can be reached easily.
Cleaning is only allowed for instructed persons, while maintenance is reserved for
trained service personnel only. In both cases, the system must be switched off. For
further information on cleaning and maintenance, see chapter “Maintenance”.
After positioning the device, the height must be adjusted using the adjustable machine feet. Once the
device stands firmly on its machine feed, the castors can be screwed up so that they don’t touch the floor.
For safety reasons, installation, setup and adjustment of the device may only be
performed by trained service personnel.
For detailed information regarding installation and setup of the device please refer to
the separate service documents and instructions.
The device is equipped with an eight-foot (2,5 meters) power supply cable. The main plug is used as a major
disruption to the supply network. Make sure that the connector is easy to access. The connection to the
supply network must meet the following requirements:
EU U.S.
C13 CEE7 / VII C13 NEMA 5-15
If needed, the device can be connected via RJ45 connection with the Laboratory
Information System (LIS). The connector is located at the back of the system. Please follow
the instructions given in the manual for the LIS connection.
Operation
In this chapter:
1 Start Menu and Navigation .................... 2
2 Main Menu ............................................ 3
3 Settings .................................................. 5
4 Tube Log ................................................ 6
5 Status Indicator (LED) ............................. 7
The navigation is done through touch buttons on the display. The selection of one of these buttons leads to
the next level. Return leads back to the previous screen.
The main menu branches into the submenus Start, Setup and Service.
Fig.5- Navigation
▪ Start starts the motors and the sorting process with the sorting program selected.
The software version is hidden but can be displayed by touching the headline in the Service menu. The
access to the service menu is protected by a password and reserved for trained service technicians and
qualified personnel only.
The settings in the service menu should only be made after consultation with the
manufacturer or an authorized representative of the manufacturer/ contractor.
Changes to the settings can lead to malfunctions in the sorting and the
communication and even to the total failure of the device.
2 Main Menu
With selection of Start the device begins the separation and the sorting process. The display changes to
show the Stop button and furthermore Details.
Touching the Stop button results in an immediate stop of the sorting process. Touching the button Details
changes the display to a more detailed view of the running the sorting process. Before recording the sorting
process, it is recommended to reset all values in the Details menu by touching the displayed values.
Fig.6-Main Menu
Bin
The number of sorted sample tubes is displayed for each target bin. If a bin is removed/ missing for which
sorting is pending, a warning message appears on the display. The sorter stops as long as the bin is missing.
Once the bin is in the designated position again, the device continues its operation.
When the maximum amount of tubes per bin is reached, the sorting process stops, and a warning is shown
on the display. The bin needs to be emptied or replaced by an empty bin before the sorting can be
continued. By putting the empty bin back in place, the sorter continues automatically. Also make sure to set
the bin counter to ‘zero’ again. Otherwise, the sorting could stop with a partially filled bin.
Default Bin
Shows the number of sample tubes sorted to the SIQ bin (sample in question). Since the level of this bin is
not monitored by any sensors, it is required to set the limit in the ‘Presets and Hardware’ menu. Additional
checks by the operator are recommended to ensure that the limit is set correctly.
Tubes Sorted
This counter indicates the total number of sorted sample tubes. The counted quantity can be set to ‘zero’
again by touching the counting field.
Total Timeouts
Counter for timeouts since the start of the sorting process.
No Barcode
Counter for not detected barcodes.
No Cap Color
Counter for not detected cap colors.
Colorcode
Shows the currently detected cap color code.
Barcode
Shows the currently detected barcode.
Length
Shows the currently detected length of a tube.
Warning notice
The warnings are displayed for information. The sorting process is stopped automatically depending on the
warning.
If error messages are displayed, the device stops immediately. A message for troubleshooting appears on
the display. Operators’ intervention and the acknowledgement of the message are necessary to continue
sorting.
Also note the warning and error messages in chapter ‘Error Conditions’!
3 Settings
Fig.7-Settings
Language
By pushing the Language button, the following menu provides the possibility to choose between different
languages. The chosen language is confirmed by pressing Return.
Sorting Settings
In this menu the sorting rule can be selected. The sorting rule must be implemented in the system itself
which is done by a service technician or by an experienced operator. Few sorting rules are sufficient to
cover most purposes. Please inform yourself which rules do apply for the task you need to work with. After
the correct sorting rule has been selected, it must be confirmed by pressing the Load button.
The three modes A / B / C refer to the type of communication between the device and the LIS.
The button Enable CapId enables the color identification by switching on or disables by switching off.
This function is very much related to the selected sorting rule. This function enables the tube spinner
mechanism, as well and is linked to the active sorting rule, in case, material and color codes have been
created.
4 Tube Log
Fig.8-Tube Log
Tube Log
Touching the headline of the Main Menu leads to the tube log database.
There are multiple ways to view sample tubes, which have been processed in the past:
barcode, color code, sorting destination, tube length, tube diameter, processing number, data, time and
tube specific errors (if applicable)
Status Indicator
The status indicator provides information about the status of the entire system (ATRAS):
Normal operation with a fault that does not lead to a No special measures required;
GREEN
stop (e.g. waiting for a subsequent module) Empty full rack modules if
flashing
necessary.
YELLOW Stand-by of the entire system Start sorting via the control panel
Error Conditions
In this chapter:
1 Errors ..................................................... 2
2 Error Messages ...................................... 3
3 Warnings ............................................... 6
1 Errors
If errors do occur, look for the information on the display in order to identify the possible cause and follow
the shown instructions for error elimination.
Device stops the sorting. No sample tubes get transported Check hopper.
in the hopper.
Blockages of tubes in the hopper Check the hopper and clear the
area lead to a stop of the chain blockage.
drive system. If the sorter fails to
loosen the blockages itself the
units stops.
Blockages in the area of the belt Check the belt drive system and
drive result in a jam of the chain clear the blockages. Also check the
drive system. rear area for jammed tubes.
Blockages in the area of the belt Check the belt drive system and
transport system clear the blockages. Tubes may
have fallen into the wrong bin.
Check the target bins for wrong
tubes. If in doubt, the tubes
should be sorted again.
Device stops sorting because a The level switch has been Clear the target bin and / or
target bin is detected as full but is activated by one or more tubes. replace by an empty one.
actually only partially filled.
Device does not stop or start and One target bin is missing or not Check the target bins.
indicates that a bin is missing. fully inserted.
2 Error Messages
Error – 1: Couldn’t read setup file
The internally saved config/setup file could not be read.
Possible causes:
>> Restart the device multiple times. Contact a service technician if the error remains.
>> Check all chain conveyors for possible jammed tubes. Take a closer look to the backside cover and to
the drawer. If there is no jam visible, remove all tubes in the area of the chain conveyor. Contact a
service technician if that doesn’t resolve the error.
Error – 4: No answer from (either one of the motors)
The initialization of a motor was not successful.
Possible causes:
>> Restart the device to restart the initialization. If the error is not resolved, contact a service technician.
▪ The tube spinner jammed with a tube and couldn’t finish the normal rotation
▪ Defective position detection
▪ Incorrectly set spinner timing
▪ Faulty config. file
>> Troubleshoot any jammed tubes in and around the tube spinner. Check if a tube is stuck at an
unwanted position. Also check if any further tubes jammed or fell off the belt. If the error is not
resolved, contact a service technician.
>> Clear the area of jammed tubes and inspect the area for lost tubes. Check if a tube is stuck at an
unwanted position. If this occurs without tubes in the affected area, contact a service technician.
>> Clear the area of jammed tubes and inspect the area for lost tubes. Check if a tube is stuck at an
unwanted position. If this occurs without tubes in the affected area, contact a service technician.
If the option ‘bin control’ is available, additional error codes are implemented:
▪ A tube jammed on the belt and fell off the belt/ into the wrong bin
▪ Defective sensors of sorting control in bin x
>> Check the belt area for tube jams or fallen off tubes and check the affected target for wrongly sorted
tubes. If there is no tube jam on the belt/ no tubes fell off, and the error occurs repeatedly, contact a
service technician.
Error – 32: Tube did not arrive in bin x
A tube is supposed to arrive in bin x, but it didn´t.
Possible causes:
>> Check the belt area for tube jams or fallen off/ lost tubes. If there is no tube jam on the belt/ no tubes
fell off, and the error occurs repeatedly, contact a service technician.
If the option „InTrac Output” is used, the following errors can occur in addition
3 Warnings
Warning – 1: Bin Detached
The device cannot start the sorting.
Possible causes:
>> Check if all bins are fully inserted. If all bins are in position and the error is not resolved, contact a
service technician.
Warning – 3: Bin Limit Reached
One or more target bins were detected as full.
Possible causes:
>> Check the bin detected as full. Empty the bin and reset the counter. If this message occurs before
sorting has been started, check the sorting rule for mistakes or contact a service technician.
>> If needed and available choose a valid sorting rule through the menu.
Warning – 6: LIS not initialized
Waiting for communication to the LIS.
Possible causes:
>> Wait for the initialization of the LIS or for further notifications. Switch off the device and replace the
connection cable. Restart the device.
>> Check the upper row for full target bins. Make sure all bins are in the designated position and check
the path between sensor and reflector for interruptions. If all bins are in position and the error is not
resolved, contact a service technician.
>> Check the lower row for full target bins. Make sure all bins are in the designated position and check
the path between sensor and reflector for interruptions. If all bins are in position and empty, but the
error is not resolved, contact a service technician.
If the option „InTrac Output” is used, the following warnings can occur in addition
▪ The sorter processes more tubes than InTrac can take at a time. The processing will continue as
soon as InTrac is ready.
▪ Error of the connected InTrac
>> Check the InTrac display for error messages. Also, follow the operating instructions for the use of
InTrac. This message can also appear, even though all processes work as wanted.
>> Check the network cables of the sorting device and the connected InTrac. Restart both systems by
switching them off/on. If the error persists, contact a service technician.
Maintenance
In this chapter:
1 Cleaning of the Device............................ 2
1.1 Weekly cleaning...................................... 2
1.2 Monthly cleaning (or as needed) ........... 2
2 Control of Maintenance ......................... 3
The device may be contaminated. Always wear rubber gloves which provide suitable
protection for the hands and wrists when cleaning the instrument. When cleaning with
alcoholic cleaning agents, protective goggles are required.
Any obstacles which may collect in the device can result in malfunction in proper
separation, transport or sorting. Therefore, it is important to check periodically if any
obstacles may harm the sorting process.
For regular cleaning of barcode scanner, mirrors and light barriers, only compressed air is
permitted at minimum 20 cm distance. Before cleaning with a damp cloth, the cleaning
drawer below the hopper must be cleared.
Avoid any alcoholic or abrasive cleaning of barcode scanner and mirrors if heavily soiled or
in case of leaked liquids. They could be scratched and lose performance.
Clean the hopper area with a clean cloth which has been dampened with alcohol (ethanol
or isopropyl alcohol) or a mild soap solution. Allow the disinfectant a few minutes contact
time. Wipe off the disinfectant with a damp cloth. Please do not use abrasives at any time
to avoid any damage on the moving parts in the hopper. During cleaning, make sure no
plastic parts are damaged.
Clean the external case, target bins and the conveyor belts by using a mild soap solution.
Surrounding the belt with a clean cloth and moving the belt by hand while inspecting it for
wear and notches is highly recommended. Make sure the belts are dry after cleaning,
since this could affect the reliability of the sorting process. If damaged, belts must be
replaced. In case of heavy polluted inlets of the target bins, they may be exchanged easily.
Covers, hoods and other acrylic parts can be cleaned with standard window cleaner and a
microfibre cloth.
2 Control of Maintenance
This device is designed to work for a long period of time without any direct service.
No preventative maintenance is needed for the electronic components. Apart from the transport belts, a
drive belt in the conveyor unit and the drive chain for the carriers, no direct wearing parts were used.
Any parts like pieces of barcode labels or plastic tips etc. are a risk for proper operation. Therefore,
regularly inspect the device for such parts. If blockages occur, they mostly are related to such parts and
pieces. The chain drive system may catch those pieces and transport them onto the belt drive system.
Therefore, check if the chain drive and carriers run straight and parallel.
To maintain performance, make sure all parts are cleaned regularly, as described in chapter ‘1 Cleaning of
the Device’.
Any further maintenance work is reserved for trained service technicians only and is described separately
in the maintenance instructions.
An annual inspection of this device by a certified service technician is recommended to control the
adjustment and free movement of moving parts.
Disposal
In this chapter:
1 Disposal ................................................. 2
1 Disposal
Before disposal, the device must be decontaminated and cleaned to protect people, environment and
material. When disposing of the device, the respective statutory regulations must be observed.
According to the directive 2002/96 / EC (WEEE), all devices delivered after 08/13/2005 may no longer be
disposed of with household waste. The device belongs to group 8 (medical devices) and is classified in the
business-to-business area. The symbol of the crossed-out bin indicates that the device must not be
disposed of with the trash. The disposal regulations of the individual EU countries may vary. If necessary,
please contact your supplier.
Height 1150 mm
Depth 600 mm
Power supply cable EU: C13, CEE / VII, length: 2.5 m, 3 x 1 mm² (10A / 250 VAC, 50 Hz)
U.S.: C13, NEMA 5-15, length: 2.5 m, 3 x 18 AWG (10A / 125 VAC, 50/60 Hz)
Other countries: the used cable must meet the specific standards and
requirements of the country in which the product is used
Fuse (Mains Input) 5 x 20 mm, 250 VAC/ 150 VDC, 4 A, time lag
Insulation 500 V
Extension module via separate signal cable (24V; 8-pin connector; coded 40°)
System Output
Environmental Requirements
Ambient temperature
- operation +15 °C to +32 °C
- storage -25 °C to +55 °C
- transport -25 °C to +70 °C
Ambient humidity
- operation 40 to 80 %, non-condensing
- storage & transport < 90 %, non-condensing
Features
Options
Terms Explanation
T&O product, synonym for ‘Automatic Tube Registration and
ATRAS / FLASH / TS 1500
Sorting’
Abrasives Scouring agents
Each target bin is optionally identified by a barcode, which
Archiving
allows to archive them
The label code on the sample for identification (material code
Barcode
and/or patient ID)
Cap Closure of tubes
The cap code on the sample for identification (material code
CapID
and/or sample type)
Hopper Input area for the tubes to be separated
Pre-Analytics All processes that take place before the actual sample analysis
The sorting material of the device are tubes that are used for
Sample Tubes
e.g.: blood analysis
Setup Complete configuration for the sorting tasks of the device
‘Sample in question’ bin. Used for tubes which cannot be
SIQ Bin
targeted by any reason
Device which separates tubes coming in bulks, reads tube
Sorter
information and sorts the tubes in reference to defined targets
Text files which defines, where tube with certain tube
Sorting Rules
information shall be sorted to
Human interface. The display which contains information for the
Touch Screen user and otherwise the user can touch software buttons on the
screen to change into different processes
Bins which serve as target where the registered and defined
Target Bin
tubes get sorted to
USB Stick Digital storage medium; short form for ‘Universal Serial Bus’