ALIFAX SI R20-MC Automatic ESR Analyze User Manual

USER MANUAL
Valid for ref code: SI R20-MC
with all Versions of Software 5.00X
Quantitative Capillary Photometry for the
Erythrocyte-Sedimentation Rate (ESR)

In Vitro Diagnostic Medical Device for professional use
© Copyright 2021
This document is exclusive property of ALIFAX s.r.l. confidential and not freely disclosable.
All rights reserved.

SI R20-MC Automatic ESR Analyze

Note: The paragraphs written (as on this note), have been added or modified respect to the previous version of the manual; the same is true in case the chapter appears in blue in the index, this means the chapter has been added or there changes done inside this chapter.
We reserve the right to make changes in the course of technical development without previous notice.
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of Alifax S.r.l.

ALIFAX ESR INSTRUMENTS PRESENTATION

Dear Customer,

thanks for choosing the Alifax technology for the measurement of the Erythrocyte Sedimentation Rate (ESR). Alifax instruments, dedicated to the ESR measurement analysis, are the result of years of technological developing, aimed at create reliable, robust and highly performing instruments. Alifax instrumentation it’ s present in the world from over twenty years, and is recognized in the hematology sector for the technical and technological prerogatives it offers, thanks to which it allows to perform ESR measurements for laboratory blood samples in a very short time and with a very high rate of accuracy.

ESR Introduction
The Erythrocyte Sedimentation Rate (ESR) measured according to the classical sedimentation method (Westegren-1921) detects the sedimentation rate of blood in non-coagulated plasma. The blood sample is left for 60 minutes in a special pipette called Westergren’s wand, the result is expressed in mm/h. Many pathologic processes can lead to an increase in ESR value: infections of various kinds,  naemia, inflam mation or even temporary alteration of biological processes. In the presence of inflammatory processes, the increased blood concentration of inflammation proteins (e.g. fibrinogen and agglomerins) alters and weakens the surface charges of red blood cells, favoring their aggregation, their stacking and the Rouleaux formation, which start to precipitate.
The classical method according to Westergren, is affected by many variables (e.g. lack of perpendicularity of the glass wand to the support surface, during the vibration analysis to which the wands can be subjected, variable temperature, low levels of hematocrit of the sample), described by the international guidelines CLSI H02A-5 Vol.31. N.11 Procedures for ESR Test: Approved Standard – 5th Edition , which is why the technological innovation proposed by Alifax, has been developed with the intention of overcoming these variables and offering, in a very short measurement time, a precise, reliable and repeatable result, free from influences from extrinsic and intrinsic variables of the method.
The red blood cell aggregation phase is the first step necessary for a sedimentary blood sample or not, when the analysis is performed according to Westergren technique. This phase is followed by  thers, of stacking of  red blood cells (Rouleaux formation) and subsequent precipitation and stacking, in a typically sigmoidal pattern,at the end of which, at the 60th minute, the distance travelled by the column of blood in the stick is read, and referred in mm/hour

Picture extracted from the guide lines of CLSI H02A-5 Vol.31 N.11 Procedures for ESR Test: Approved Standard – 5th Edition – Chapter 5 – Principle

The technology applied by Alifax’s ESR instrumentation is Quantitative Capillary Photometry, which allows in just 20 seconds of analysis, to obtain the ESR result of the sample, expressed in mm/hour, as per guidelines and reference method.
Quantitative Capillary Photometry studies the dynamic behavior of red blood cells (RBCs). The blood sample flows in a transparent capillary inside the instrument and the reactivity of the red blood cells is analyzed when this flow is suddenly interrupted: this abrupt interruption, together with the rheological characteristics of the sample itself, and the presence or absence of the proteins of the acute phase in it, starts or not the process of aggregation by stacking red blood cells.
The diagnostic algorithm of the Alifax ESR instrumentation transforms the measurement performed in just 20 seconds of analysis, into a photometric quantity, expressed in mm/hour, without  waiting for the entire stacking, sedimentation and sample stacking process.
The red blood cell aggregation (formation of RBC aggregates), the first step of the sigmoid curve described, is strongly correlated with the end-point results of the classical Westergren method, but is not affected by the interference affecting both the classical method and the modified Westergren- based methods

Advantages of Alifax ESR instrumentation
Preparation of the suitability of the sample
-The system is structurally designed to automatically re-suspend the samples, by complete rotation of the tubes (360°) immediately before the analytical phase of each sample. – In the Alifax ESR instrumentation, a great deal of attention has been paid while designing the part concerning the detection of the physical state of the samples and their correct quantity, as well as the reporting of any anomalies which allows the operator to directly verify the samples, in order to prevent an incorrect response. In fact, if there’s no detection of the sample or it’s insufficient or coagulated, the analysis  is not performed and the problem is indicated by a special message printed and stored next to the sample identifier.
– A similar report is given for samples having a ratio between red blood cells/plasma defining an hematocrit value < 30%. For such samples, the ESR measurement performed by the Alifax ESR instruments is correctly performed, and the instrument prints an asterisk next to the measured value to alert the operator to the patient’s potential state of anemia. A more thorough investigation of the blood parameters of the identified patient could confirm the instruments results.
– Constant thermostating of the sample analysis cell at 37 °C to ensure that the temperature influence on ESR measurement is reduced.
Management of blood sample quantities below standard levels
The sample rate necessary for the analysis (175ul only) is taken by perforating a test tube closed by a special cap piercing system. This system is therefore suitable also in the case of reduced samples, such as those coming from pediatric patients, samples coming from oncology and in all cases of difficult sampling.
Adaptability to laboratory workflows
The operator loads the samples into the instrument using the same racks coming from the cell counter, for a total capacity of 4 racks in continuous access, without any manipulation of the single tube by the operator. The racks and tubes will be returned by the instrument in the same order in which they were loaded. This allows to have a total traceability of the loading order, of the report-sample association, and a high degree of work order, with reduction of the risk of error due to sample manipulation, incorrect positioning in the rack in or out of the instrument. In addition, operators save time and can carry out other activities in the meantime.
Technological modulability
The TEST1 instrument is compact, adaptable to the working needs of the laboratory, can be integrated with other units of the same or different types, in order to allow the management of different workloads, from minor to greater capacity. The instrument can be perfectly integrated in a dynamic haematology routine, since it uses the same racks of the most common blood cell counters on the market and can be inserted before or after the blood count examination. In addition, in the same work session it can house test tubes of different types, simplifying workflows.
Exceeding the low hematocrit variable
Low hematocrit values interfere significantly on the result of ESR processed with the classic and modified Westergren method, as reported in the literature and especially in the current guidelines CLSI H02A-5 Vol.31 No.11 Procedures for ESR Test: Approved Standard – 5th Edition. Chapter 5 – Principle.
Thanks to the technology used, (capillary quantitative photometry), Alifax ESR instrumentation suffers negligible interference. The very short analysis time per sample (20 seconds), and the non-sedimentation based principle of operation, do not allow the low hematocrit to influence ESR measurement by quantitative capillary photometry. This is also described in the recent publication:
Automated measurement of the erythrocyte sedimentation rate: method validation and comparison Ivana Lapić*, Elisa Piva, Federica Spolaore, Francesca Tosato, Michela Pelloso and Mario Plebani Clin Chem Lab Med 2019 : “discussion – […] TEST1 with its capillary photometric kinetic method is less susceptible to variations in erythrocyte morphology or hematocrit levels. “ A further example is given by the following evidence:
The graph below shows an ESR analysis for the same sample whose hematocrit value has been modified by diluting the sample with autologous plasma.
Four cases have therefore been reproduced: hematocrit (Ht) of 45 , 34, 28 and 26
It can be noted that the sedimentation ESR, at the time of 60 minutes, is very different for the 4 samples (about 10mm/h, about 50mm/h about 60mm/h and about 85mm/h), depending on the hematocrit value, which influences the sedimentation dynamics of the sample.
The TEST1 system does not work on the sedimentation principle and therefore is not influenced by the hematocrit value.

As indicated in Appendix C of this manual, the Alifax ESR instrumentation indicates with an asterisk the sample for which an altered plasma/part corpuscles ratio is detected. A more thorough investigation of the hematologic parameters of the identified patient could confirm what has been pre-alerted by the TEST1.
Quality control
A statistical internal quality control of the population, to which the calibrators and latex controls must be added, allow constant verification of the alignment of the instrument, to ensure reliability of the result and optimal inclusion of the instrument in the accreditation processes of the laboratory.

Latex control:
The kits (Latex Controls 6 tests or 30 tests) are based on the use of three samples with known turbidity values, on which the instrument performs photometric measurements related to ESR values.
The 6 test kit consists of 3 test tubes containing 3 ml of synthetic latex solution:
1 x Level 2 Latex Test Tubes (“LATEX Test tube L 2”)
1 x Level 3 Latex Test tube L 3 (“LATEX Test tube L 3”)
1 x LATEX Test tube level 4 (“LATEX Test tube L 4”)
The 30 test kit consists of 15 test tubes containing 3 ml of synthetic latex solution:
5 x Level 2 Latex Test Tubes (“LATEX Test tube L 2”)
5 x Level 3 Latex Test tube L 3 (“LATEX Test tube L 3”)
5 x LATEX Test tube level 4 (“LATEX Test tube L 4”)

The three control levels, Low (level 2), Medium (level 3), and High (level 4), have narrow acceptability ranges that combined with the dedicated software ensure Accuracy and Sensitivity. Below is the reference of a scientific publication on this subject:
A new turbidimetric standard to improve the quality assurance of the erythrocyte sedimentation rate measurement
Elisa Piva, Rachele Pajola, Valeria Temporin, Mario Plebani — Dipartimento di Medicina di Laboratorio, Università degli Studi di Padova, Azienda Ospedaliera di Padova, Padova, Italy — Clinical Biochemistry 40 (2007) 491–495

New scientific work in 2019:

Among the latest scientific work carried out by external bodies, the article Automated measurement of the erythrocyte sedimentation rate: method validation and comparison must be mentioned.
Ivana Lapić*, Elisa Piva, Federica Spolaore, Francesca Tosato, Michela Pelloso and Mario Plebani Clin Chem Lab Med 2019
In this work precision, interference due to sample hemolysis, influence due to the presence of fibrinogen in the sample, carryover, sample stability and hematocrit were analyzed.
Among the results, the correlation obtained between the classic Westergren reference method and Test 1 instrument, on 245 samples analyzed, which was equal to ρ =0.99 with p<0.001, according to Passing-Bablok linear regression analysis:
Y= -0.28 + 1.04x , intercept A -0.28 , [ 95% C.I.: -1.17 to -0.10].
The article is available at http://dx.doi.org/10.1515/cclm-2019-0204

TYPOGRAPHICAL CONVENTIONS

The warnings, notes and symbols described hereafter are used in the current manual, on the instrument and on its packaging.
DISPLAY of WARNINGS and NOTES

The signal word “Danger” and a relating symbol point to imminent dangers.
The non-observance of a danger warning can result in death or at least serious irreversible injury. A damage of the system or an adverse effect on the system function cannot be excluded.
The signal word “Warning” and a relating symbol points to potential dangers.
The non-observance of a warning can result in death or at least serious irreversible injury. A damage of the system or an adverse effect on the system function cannot be excluded.
The signal word “Caution” and a relating symbol point to potential dangers/problems.
The non-observance of safety instructions can result in minor injuries. A damage of the system or an adverse effect on the system function cannot be excluded.
The signal word “Caution” points to potential problems.
The non-observance of a safety instruction can result in damage of the system or an adverse effect on the system function.
The signal word “Note” points to potential problems.
The non-observance of notes can result in an adverse effect on the system function (result deterioration).

USED WARNINGS SYMBOLS

| Caution, risk of danger to person or damage to equipment!
Consult instructions for use!
---|---
| Biohazard!
| Electrical hazard!
| Laser hazard!
| Ground!
| Consult instructions for use
|  Caution, moving parts inside!
|  Mechanical hazard!
|  Cut injury / sharp hazard!
|  Automatic start-up!

OTHER SYMBOLS

| Manufactured by
---|---
| Lot number
| Expiration date
| Temperature limitations
****| CE mark
| ID number
| Serial number
|   Mains in AC voltage
| Weight
|    Fuse
|  Disposal of Electrical and Electronic Equipment
In the European Union, electrical and electronic equipment must not be disposed of with other household-type waste. It must be collected separately. Please observe the relevant legal regulations effective in your country.
|  Size, [L] Lenght, [W] Width, [H] Heigh

Following labels refers to Roller 20PN and contains between others the reference serial number of the instruments

Rx Only (USA) Explanation:
Caution: U.S. Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device

 ROLLER PRESENTATION

ROLLER INTERNAL VIEW

Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for re-use.

ROLLER REAR SIDE VIEW and MAIN FUSES REEPLACEMENT

To replace the fuses use the following procedure:

• Locate the fuses’ box
• Using a flat screwdriver push down the small tongue that keeps the box inside the switch block and pull it out using a small pliers (if necessary).
• Remove completely the fuse box
• Remove completely the fuse box and replace BOTH fuses (*)
• Insert again the fuse box inside the Main Switch block pressing it firmly to assure the box’s tongue fits on the hook.

(*)
The fuse which is placed in appliance inlet shall be replaced only by a T2A L 250 V dimensions 5×20 mm.
A T2A L 250 V it is suitable for both 115 and 230 Vac ±10%.
(**) See page 11 “Transient Emissions and Interference”

NSTRUMENT PLASTIC COVER REMOVING

To remove instrument’s plastic cover proceed as follows:

Remove the 4 screws using a Phillips screw driver and then unthread the cover form the instrument pulling a bit both sides and then lifting up the whole plastic cover.

Remove the 2 screws located at the instrument’s upper rear side using a Phillips screw driver, there are also two screws located below the loading door, these also must be removed, then unthread the metallic cover pulling toward you and then lifting up.

WARNINGS FOR A CORRECT USE OF THE INSTRUMENT

The following safety instructions must be observed at all times, both before and during operation and during maintenance.

Handling of Instructions for use Manual
User Manual is provided for Your safety and gives important instructions for the handling of the system described.

• Read all instructions!
• Keep the instructions for use manual nearby the system.
• he instructions for use manual must be accessible to the user at any time.

Roller20-MC system is designed and manufactured in accordance with the safety requirements for electronic and medical systems. If the law issues regulations concerning the
installation and/or operation of the instrument, then it is the operator’s responsibility to adhere to them.
The manufacturer have done everything possible to guarantee that the equipment functions safely, both electrically and mechanically. The systems are tested by the  manufacturer and supplied in a condition that allows safe and reliable operation.

GENERAL SAFETY

Non-Observance of Warnings
The non-observance of warnings can result in serious personal injury and material damages.

• Follow all warnings included in this manual.
• If the instrument has been stored in cold places, wait at least 30 minutes before switching ON the instrument for the first time in order to avoid eventual damages due to dew presence on internal parts of the instrument.

Use of the System according to Intended Use only
mproper use of the instrument, not in compliance with the manufacturer specifications, could lead protection impairment and damages to both operator and/or instrument as well as can result in wrong results, damage of the system and personal injury.

• The handling and maintenance of the system must only be performed by trained and authorized personnel.

• Before the operation of the system, the Instruction for use manual must have been read and understood.

• The instrument must only be used in accordance with its intended use.

• The instrument is designed for indoor uses only.

• For professional in vitro medical diagnostic use only. The English language knowledge is required in those countries where neither Italian nor French nor Spanish nor  German is spoken.

• Use only the consumables and accessories described herein within their expiration date.

• Keep away any kind of objects, liquids, or substances not required for the instrument’s use from the instrument.

• The manufacturer assumes no liability for any damages, including those to third parties, caused by improper use or handling of the system, installation not in compliance  ith the manufacturer’s specifications, use of the instrument not in security, use of not suitable materials regarding those specified in the user’s manual, use of the instrument for various scopes different from those for which it has been designed and built, use of the instrument by not expert staff person or however non-authorized to the use of the
  instrument and/or in case the sanitization procedure will not be carried out if required.

• This instrument is not intended for use by persons with reduced physical, mental and sensorial capabilities or lack of experience and knowledge, unless they have been given supervision or preliminary instructions for the use of the analyzer by a person responsible for their safety.

N CASE UNAUTHORIZED SOFTWARE IS INSTALLED ON THE INSTRUMENT, THIS MIGHT GENERATE MALFUNCTIONING OF THE INSTRUMENT AND/OR EVENTUALLY UNRELIABLE ANALYTICAL RESULTS; FURTHERMORE INSTALLING UNAUTHORIZED SOFTWARE INVALIDATE THE WARRANTY OF THE INSTRUMENT.

OPERATIVE SAFETY

Mobile Phones
Do not use a mobile phone next to a running system.

Instrument use in routine

• Instrument uses a technology that allows the measurement of the ESR at a stabilized temperature of 37°C (±0.5°C) / 98,6°F (±0,9°F)

• Before starting a new session, the instrument visualizes a control check-list, is mandatory to verify all check that all the parameters in the check-list are as expected,  otherwise contact the Technical Service

• TEST1 is an In Vitro Diagnostic Medical Device for professional use only. The English language knowledge is required in those countries where neither Italian nor French nor Spanish nor German is spoken.

• Use only consumables and accessories described in the user manual.

• Consumables good must be used respecting the expiration date.

• Check the level of the discharge tank before starting the measurement operation. If the tank has reached the safety level, dispose of it or empty it, following the safety regulations and procedures in the laboratory and local regulations.

• Carry-out appropriate “WASHING PROCEDURES” to a good instrument maintenance

• Important: to avoid capillary obstruction from rubber particles it is suggested to use maximum two times the same washing tubes.

• Keep away any kind of objects, liquids, or substances not required for the instrument’s use.

• Check if the tube contains at least 800 uL of blood and verify that the blood is not neither haemolysed nor coagulated. Use exclusively blood samples withdrawn in EDTA anticoagulant (K2 or K3).

• Use preferably tubes with a capacity of 3 ml verifying that the sample volume should in any case not exceed the 50-60% of the total volume of the test-tube in order to optimise the blood homogenization.

• The mixing is done rotating completely upside-down the sample tube.

• Samples mixing is done at the beginning of the analysis with the purpose of disaggregating erythrocytes. A possible ineffective disaggregation could affect the results
  given by the instrument which measures system is based on the detection of the kinetics of aggregation of the red cells

• In the event paediatrics samples are used, the minimum volume suggested is 500 uL,

• It is possible to use “BD Microtainer MAP®” tubes directly (also in conjunction with other 13×75 tubes) on allmodels without the use of adapter (but could be necessary to verify the needle offset adjusting its excursion in case of volumes lower than 500 uL

• Start the analysis within 4-6 hours from vein-puncture, otherwise keep the samples in refrigerator at +4÷8 °C (+39,2 / +46,4 °F), for a maximum of 24 hours. If the samples have been conserved in refrigerator at +4 ÷ 8 °C (+39,2 / +46,4 °F), it is necessary to leave them at room temperature at least for 30 minutes before their analysis, even if it is in any case suggested to let the samples remain at room temperature preferably for about 60 minutes, then, execute the analysis within 4 hours.

• Remove from the refrigerator the box containing the Latex Control that must be stored in the refrigerator at + 4÷8 °C (+39,2 / +46,4 °F).
  To use the Latex Controls, please refer to the IFU included inside the Latex Control Box.

• Do not pour liquids or leave to fall anything inside the fridge and thermostat units. In such case, switch OFF IMMEDIATELY the instrument and call the Technical Service. Do not try to remove any object, even if visible, when the unit is switched ON.

• In case of a sample tube is broken inside the instrument, it is mandatory to call the Technical Service

• An acoustic signal will be activated when the loading door remains opened. Close the door to allow the system to progress with the analysis.

MECHANICAL SAFETY

Danger of Electrocution or Mechanical Injury by Missing or Opened Protective Covers
To avoid serious injury with lethal consequences due to electrocution or injury by the system (e.g. contusion, cuts etc.), protective covers must not be opened or removed by no reason by user; only authorized Technical Service Engineers or manufacturer Engineers can remove protective covers.

• Do not remove the panels neither camper the reading sensor.
• The internal carriage moves over a sliding guide which is an “auto lubricating” guide, so it is not necessary to lubricate or add any kind of oil or grease along the rails of the carriage guides.
• Maintenance operations may only be carried out by technical personnel authorised by the manufacturer.
• Switch off the system, separate it from the mains supply and protect it against restarting.
• For your safety, if any part should be damaged, ask for the immediate replacing with original spare parts, specially for the parts connected to mains (power cord, fuse-holder and mains switch V)
• Use only peripherals authorized by the Manufacturer

Maintenance must be carried out only by qualified Technical Engineers authorized by the manufacturer

• Use only original spare parts supplied by the manufacturer.
• Use only peripherals authorized by the Manufacturer
• Make sure that nobody works on the system and that all covers are attached and closed before you reconnect the system to the mains supply.
• Perform maintenance works with highest caution.
• Only perform maintenance works described in this manual.
• The unit shall be inspected and maintained each 30 000 analyses.

ELECTRICAL SAFETY
Electrocution/Fire Hazard!
Non-observance of rules and regulations can cause serious personal injury with lethal consequences and material damage.
National rules and legal regulations for the safe electrical operation of the system must be observed.

During Installation please be sure

• Avoid improper connection of the system and the peripheral devices to mains supply can cause serious personal injury with lethal consequences and material damage (e.g. fire).
• Use only connection and extension cables with a protective conductor and sufficient capacity (performance, power) to connect the system and the peripheral devices to the mains supply.
• Supply cord shall have cross section area at least 3×0,75 mm2 or at least AWG 18
• Never interrupt the grounding contacts.
• Grounding of the system and its peripheral devices to the same protective earth potential must be ensured and it is connected to a mains socket with a Protective Earth terminal before its use
• The use of a multi plug is not allowed!
• Damaged connecting cables can cause serious personal injury with lethal consequences. Damaged connecting cables must be replaced immediately!
• No objects may be placed on the connecting cables.
• Connecting cables must be laid so that they cannot be squeezed or damaged.
• Connecting cables must be laid so that they do not lay in accessible or drivable areas.
• Switch OFF the instrument and unplug power cable before connecting any external peripheral as external bar code readers, printer cables and/or RS232 serial cables and  for maintenance. 

Danger due to Improper Place of Installation
Improper place of installation of the system can cause accidents with serious injuries with lethal consequences, fire or serious system damages because the system cannot be switched off or be separated from the mains supply.

• Ensure the place of installation of the system is so that the power supply and mains switch are easily accessible and disconnectable from the power grid.
• Unit shall be connected to external installation with overcurrent device max of 16 Ampere or 20 Ampere (Usa / Canada).
• The instrument has to be installed on a dry surface sheltered from sun light to avoid sun rays hit the door sensor when the door is open generating unplanned consequences.
• The manufacturer does not assume any responsibility for eventual damages to persons or things due to improper, installation not in compliance with the manufacturer’s specifications.

Electrocution/Fire Hazard!
During the normal routine working please:

• Keep away any kind of objects, liquids, or substances not required for the instrument’s use.
• Do not pour liquids or leave to fall anything inside the fridge and thermostat units. In such case, switch OFF IMMEDIATELY the instrument and call the Technical Service.
  Do not try to remove any object, even if visible, when the unit is switched ON.

Electrocution/Fire Hazard!
During Maintenance/ Technical Service activities be sure to:

• Immediately separate the defective system from the mains supply, if a safe usage is no longer possible.
• Secure the defective system against reconnection.
• Label the defective system clearly as being defective.

Battery Handling
The product may contain an internal lithium manganese dioxide, vanadium pentoxide, or alkaline battery or battery pack. There is risk of fire and burns if the battery pack is not handled properly. To reduce the risk of personal injury:

• Do not attempt to recharge the battery.
• Do not expose to temperatures higher than 60°C (140°F).
• Do not disassemble, crush, puncture, short external contacts, or dispose of in fire or water.
• Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to the instructions.
• Replace only with the spare designated for this product.
• Battery for computer SI205001 is aNi MH #MH60B3AL3; a 3,6 V e a 60 mAh.

Transient Emissions and Interference Resistance
The instrument meets the requirements described in standard IEC 61326 and IEC61326-2 on transient emissions and interference resistance.

• This instrument can cause radio interference in domestic environment. In this case it may be required to take action to eliminate such interference.
• Before setup and operation of the instrument, the electromagnetic environment should be evaluated.
• Do not use the instrument in the vicinity of sources with excessive electromagnetic radiation (e.g. unshielded, deliberately operated high frequency sources) since they could interfere with the proper operation of the instrument
• Avoid if possible the connection to mains through plug adapters and choose an electrical outlet far from any strong impulsive voltages, usually generated from centrifuges, refrigerators, elevators and freight elevators.
• Avoid the use of the instrument near electromagnetic sources like for example CB’s, radio transmitting units and similar
• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference.
• Peripherals to be connected to the ports on the rear side of the instrument (see page 5) must comply with IEC 60950-1 or IEC 62368-1 for IT equipment (to comply with clause 6.6.1 of the standard).

BIOLOGICAL SAFETY
Risk of infection!
he instrument, can be exposed to potentially infective materials; system therefore must be treated as being potentially infectious, is thus indispensable to adopt all the precautions and warnings necessary apt to avoid the contact (mandatory the use of gloves and glasses during vial and needle manipulation) in accordance with national laws.
Improper handling of infectious parts can cause skin irritations, illnesses and possibly to death.

• Use appropriate gloves!
• Use an appropriate lab coat!
• Avoid contact between skin/mucous membrane and samples/test reagents or parts of the instrument.
• Clean, disinfect and decontaminate the system immediately if potentially infectious material has been spilled.
• Do not use broken or chipped tubes or bottles.
• Observe the instructions in the package inserts for a correct use of the reagents.

Waste and Disposable procedures

• Observe local and national provisions, legislation and laboratory regulations.
• Observe the legal regulations for the handling of infectious material.
• Dispose used vials, following the standard safety procedures in use in the laboratory.

Maintenance
During Maintenance/ Technical Service activities be sure to:

• use gloves to protect agains any possible accidental contact with infectious materials presents inside instrument .
• if during maintenance the instrument has been stored /moved to a cold places, wait at least 30 minutes before switching ON again the instrument for the first time in order to avoid eventual damages due to dew presence on internal parts of the instrument.
• It is mandatory to do the sanitization (use gloves and protective glasses) and locking drawers procedure before maintenance or before send back to the manufacturer

LABELS

THE FOLLOWING LABELS ARE STUCK AS WARNINGS ON THE INSTRUMENT AND MUST NOT BE REMOVED.

Instrument plate label|
---|---
Electrical shock hazard label – disconnect the power cord|
Earthing point label|
 Probe cleaning warning label|
Biohazard label with indications about tank replacement|
Voltage identification label|
Biohazard label|
Warning label|
Fuse indication label|
Instrument identification label|
Label for technical assistance number|
External barcode reader port|
Serial communication port|
Logo Alifax|
Waste tank reference label|
Push label|
MET conformity label|
EAC conformity label|

PROCEDURE OF INSTRUMENT WASTE AT THE END OF ITS OPERATIONAL LIFE

As stated in the European directive 2012/19/EU related on waste of electrical and electronic equipment (WEEE), appropriate measures should be adopted to minimize the disposal of the instrument as unsorted municipal waste and to achieve a high level of separate collection of WEEE, according to the applicable local laws and rules.
The crossed-out wheeled bin symbol on side, placed also close to the plate of the apparatus, points out the necessity of the separate collection of the electrical and electronic  equipment (WEEE).
The separate collection of this instrument at the end of its life is organized and managed by your distributor. The user who is going to get rid of it will therefore contact his distributor and follow the system that he has adopted in order to dispose the separate collection of the equipment that has reached the end of its working life.
The unauthorized disposal will be pursued according to the local laws and the rules in the nation of use. Fines will be effective, proportionate and dissuasive.

UNPACKING AND INSTALLATION

The unpacking of the instrument is done directly by Alifax (or local Distributor) Field Service Engineer

INSTRUMENT START-UP

INSTRUMENT DESCRIPTION and start-up
The installation and instrument Start-up is done directly by Alifax (or local Distributor) Field Service Engineer

WASTE TANK EMPTY / REPLACEMENT

Roller family uses an internal control system to check the level of waste tank:

• at every switch ON of the instrument
• ALWAYS PAY ATTENTION WHILE CLOSING AND OPENING THE TECH. DOOR, TO AVOID ACCIDENTAL DAMAGE TO THE TUBING.
• at every washing procedure start-up
• at the beginning of every cycle of analysis the instrument controls the level of liquid inside the waste tank, using the peristaltic pump to aspire from the tank. If the pump aspires material, the reading unit detects the presence of the material and blocks the operation of the instrument, informing via display that the waste tank needs to be replaced.
• It is important to NOT REMOVE/CUT waste tank discharge tube because the length is designed specifically for measure safely the level of the waste tank and advise the operator to replace the tank.

Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for re-use.

6.0 – WASHING TANK LEVEL CONTROL

This tank doesn’t have any kind of liquid level control, it is suggested at least once per day check the level of washing water inside the tank.

INCREASE AVAILABILITY TEST USING THE SMART CARD

All Alifax instruments need a personalized smart card in order to enable the analysis of blood for the ESR determination. The instrument is supplied with 200 test for first demos and first analysis, but a warning message is displayed at the begin of each analysis session alerting the user that test availability increase is required.

WARNING!! If during the analytical cycle there is no test availability, the instrument will set itself in idle and will not allow any kind of activities up when the availability will be increased using the specific smart card.
To increase availability, it is necessary to have a personalized smart card (the sizes are from 1.000, 4.000, 10.000 and 20.000 test plus the new Multicode card of 5.000 test that can enable 500 test a time using some card codes as described on chapter 17.1).
From Main Screen (if the card is inserted while the display shows a different menu, it will not consider itV) insert the appropriate smart card in the reading slot, facing the card with the contacts toward the right side, as displayed on the following picture:

The instrument will printout and display the current availability, only for the credits enabled, then it will check the personalization, the number of credits and which type of credit are enabled:

• If the instrument’s personalization is different from the one programmed in the card it will reject the card.
  Then after pressed “OK” the instrument asks to remove the card and comes back to Main Menu. In this case the credits don’t increase.

• If the instrument have no personalization, it will acquire the one set in the smart card. Then after pressed “OK” the instrument asks to remove the card and comes back to Main Menu. In this case the credits increase as is possible to see in the printout.
• If the personalization is the same as the one stored in the card, the instrument, after pressed “OK”, asks to remove the card and comes back to Main Menu. In this case the credits increase as is possible to see in the printout.If, for some reason, the card inserted is defective the instrument will show a message informing about that, then after pressed “OK”, the instrument asks to remove the card and comes back to MAIN MENU.
• In case of not properly card loading: possibly malfunction causes are explained in the follow chapter 6.1.

Please refer to chapter 17.1.2 to see the complete and detailed explication and procedures to set the warning level and to see the availability.
Starting from April 2019 a smart card with a new graphical layout is available on the market; below example refers to the 10000 test.

7.1 – SMART CARD ERRORS

The possibly malfunction causes usually are:

1. The smart card is not properly inserted (upside-down) or the Card contact plaque wouldn’t be in the lower position faced to the instrument.
2. The reader contacts don’t allow the Card to be read.
3. Out Std error means the card has a number of tests that is outside the normal ranges: 1.000 – 4.000 – 5.000 – 10.000 – 20.000
4. Not valid Card means the card has already been previously loaded, so the instrument is not able to load again, or the card is not personalized for this instrument.

If the instrument displays error OUT STD 24384 means the card has been inserted upside down or with the contacts facing the left side instead the right side

Please refer to chapter 17.1.2 to see the complete and detailed explication and procedures to set the warning level and to see the availability.
Please notice, with new Software 5.00A, in case during the smart card insertion or during the downloading of the credits from smart card to instrument, one or more of the following error happens:

Refer to troubleshooting at chapter 11, errors 31, 32 and 3

7.2 – PAPER ROLL LOADING – REPLACEMENT
In the event the paper ends, instrument shows on screen a message informing paper has ended:
Replace the roll is simple and quick:
Pull the plastic lever of the printer, lift up the plastic cover and remove the plastic core (if present) of the old roll

Keep the plastic cover up and insert the new roll of paper being sure to pull it a bit in order to allow paper being captured and pressed by printer’s rubber roll.
Close the plastic cover and press the “advance paper” button to check if paper is coming out correctly; after that press OK on the display Wait while instrument finish the internal checks.

SWITCH ON AND MAIN MENU

Start the instrument by pressing the switch on upper backside; at the first daily switch ON wait 3 minutes before starting an analysis cycle to allow the thermal stabilization.
Instrument uses a technology that allows the measurement of the ESR at a stabilized temperature of 37C°±0.5°C (98,6°F±0.9°F)
The instrument automatically will start the internal check up and then display will show the following image:

This instrument is controlled using the “Touch Screen”, each option, function, process will be activated/deactivated simply touching the screen in the corresponding “button”.
To be even more user friendly, as you can see, the main screen sets up ready to uses highlighting the 4 main buttons in order to allow the operator begin analysis without necessity to “look around” for the operative buttons.
ATTENTION: buttons “Empty Roller” and “Mixer”, are not available with this kind of instrument.

Available buttons are displayed in the upper screen side:

• Main: allows accessing to common use functions like measure, wash, standard and Q.C.;
• Setup: allows accessing to some common use functions like Date and Time, Flag List, Settings and also to specific functions protected by passwords (accessible only to technical service);
• Availability: allows accessing to set the test credit warning alarm, to printout the availability of credits and for use the blocks of the card with divisible credit;
• Comm: allows accessing to communication functions protected by passwords (accessible only to technical service);
• Tech: allows accessing to the whole Technical Menu, protected by passwords (accessible only to technical service);
• More: allows accessing to some info, like useful information and technical phone numbers, or to the data of the last session.

MENU DESCRIPTION

In the next pages will be explained the functionality of each menu.

WARNING!! Remember that not all the functions inside each one of the menus are freely accessible; the instrument has three levels of access:

Level 1 Operator Access: free without password can access only some functions like date & time
Level 2 Coordinator: require password can access Level 1 and the Setup functions
Level 3 Technical Service: require a password, allow access to all functions; this password is ONLY for Technical Service and Alifax Manufacturing dept.
For more details on the three level access, please refer to chapter 16.1.

9.1 – MAIN MENU
Main Menu:
Pressing “Main” in the MAIN SCREEN, the instrument shows the following options

9.1.1 – MEASURE MENU
WARNINGS:
! When using the external withdrawal procedure, it is mandatory to use gloves and all the others protective tools, precautions and warnings necessary to avoid the contact in accordance with national laws.
Remember also that, is mandatory to mix with an external mixer the blood samples, because the instrument doesn’t have the internal rotor. For the mixing, is mandary to use an external mixer such us a rotating wheel or a tilting bed set at 32 rpm and 140 mixing cycles to allow a suitable homogeneization of the samples prior to the analysis.
Pressing the option “Measure” (from Main Menu or Main Screen), the instrument, shows this screen:
Then, ONLY if the analysis is done after a washing procedure, the instrument will execute a “Priming procedure”. In this case avoid the use of a sample with small amount of blood (e.g. 100 µL or less) but prefer a sample of 3ml or a sample of the day before.

After press “OK” on the first screen, take the first sample of the session, uncap, insert inside the external probe and press “START”, otherwise press “Back” to come back to the Main Menu. If “START” button was pressed, instrument will take a small amount of blood form the tube (about 50 µL), then it will issue 3 beeps, this means the tube MUST be removed from the probe.

Next the blood is moved inside the reading unit to prepare the capillary receive the blood, meanwhile the instrument ask to wipe the probe.
For clean the external tip, use simple paper napkin without adding any kind of detergent. Clean gently the tip moving from the top to the bottom, do not pull too hardly in order to avoid to damage the tip.

After the priming, instrument asks to identify the sample to be analyzed; so the option are:
Autogenerated ID:
If the instrument doesn’t have an external bar code reader (EBCR) and/or the sample tube doesn’t have a Bar Code Label, it is possible to insert the tube allowing the instrument to autogenerate a progressive ID.
After have pressed “Measure” in the Main Menu, the instrument shows the following message:
now pressing “Auto” the instrument will self-generate the sample’s ID and then, pressing OK.

• Manual ID (typed manually):
After press “Manual ID” button, the instrument allows the user to type the sample ID with the touch keyboard and press Enter (←) to enter the ID.
The auto-generated code is a numeric code that is generated from instrument with the following fields: cycle number, instrument serial number (s/n), wheel number and sample position into the wheel (see right side example)

• External Bar Code Reader (EBCR):
If the sample is identified by a BCR, read it using the external scanner. The instrument will show the read ID number on the screen.
WARNING!! The tube MUST be inserted ONLY AFTER the instrument shows on the display the read ID as in the following example:

Then, in all cases, once pressed “OK” instrument asks to sample the tube just identified previously; after pressing “START” the instrument will aspire the blood. In case of mistake, pressing the “Back” button, instrument returns to previous screen were user can re-insert the ID.

Note: when the aspiration of the sample is finished, instrument will beep 3 times, this means the tube must be removed from the external tip and recapped.
During the analysis, the instrument will ask to clean the external probe. To clean the external tip, use simple paper napkin without adding any kind of detergent. Clean gently the tip moving from the top to the bottom, do not pull too hardly in order to avoid to damage the tip.
At the end of the analysis, instrument show on the screen the result (and also print it if the flag “print in run” is enable), than after press “OK” button, reappears the ID insertion screen and so you can choose if analyse another sample, or pressing “Back” button, to end the session, then the instrument asks to “close the front door” pressing the “OK” button.

VERY IMPORTANT:
In case of use of the external withdrawing tip, it is mandatory to clean it following the washing procedure in order to avoid blood dries inside the tip causing the formation of blood clogs inside it. The tip must be washed within 10 minutes after last sample analysis.

9.1.1.1 – ANALYSIS RESULTS (Display and Printouts)
After the sample analysis the instrument will show on display results and also printout each sample analysis’s result.

During the analysis the instrument will display on the screen the result obtained. Based on the printer setup, the printer will printout the results in “real time” (that means after each single analysis).
The printout result looks like the one showed here:

Attention, if the waste tank is full (the control is executed automatically by the instrument before beginning a new session); Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for re-use of the waste tank before starting a new session; otherwise, the instrument remains in standby until when the waste tank is replaced / emptied.

9.1.1.2 – ANALYSIS RESULTS DURING SECOND TAKE OF SAMPLE
This function allows, in case of the sample value is not detectable (NF or NR), to try a second taking.
With this function, the instrument asks to following a specific procedure.
When the value of one sample is not detectable, the instrument shows this screen:

Then, is possible to choose if analyse again the sample or not, in fact, pressing “YES” button, the instrument asks to analyse again the sample and after pressing “START” button, is executed again the analysis procedure. Otherwise, pressing “NO” or “Back” button, the instrument doesn’t analyse again the sample and then shows, prints and sends to host (if is present) the value NF (-4) or NR (-2).

NOTE 1: Every failed attempt, is saved inside the “Error Log” (visible only with technical password) in this way:
1ST NF EXT = failed first take, not detected continuous blood flow;
2ND NF EXT = failed second take, not detected continuous blood flow;
1ST NR EXT = failed first take, sample not detectable;
2ND NR EXT = failed second take, sample not detectable;

NOTE 2: The meaning of messages NF (sent to LIS as -4) and NR (sent to LIS as -2) is the following:

NF (-4) means that No blood Flux was detected from the instrument, usually because
a. the test-tube was removed before the three beeps or
b. there wasn’t enough blood or
c. a clot is obstructing the withdrawal tip (in this case a washing will solve the error)

NR (-2) means sample Not Reliable because the instrument detected the blood stream but there wasn’t any red cells aggregation kinetics on this blood. In this case, try to repeat the sample and if
NR message again appears, verify the patients’ blood profile for possible pathologies.

WASH MENU

This procedure is designed to guarantee the capillary and all the hydraulic circuitries are maintained clean and free of blood residuals.
Considering the instrument uses a capillary tube in which blood, water and latex flows, it is normal that the internal walls of the capillary tend to become opaque, and also to remain dirty because some blood residual parts remain inside the capillary.

Washing options:

• Washing using 1 test tube (standard washing);
• Maintenance washing (using 1 test tube with water and one test-tube with chorine);
• End of working day washing procedure (wash and sleep).

At the end of every washing procedure the software, with the attempt to reach the original value (called white value) which is an absolute number 3800, updates an internal compensator factor value according to the read water value (e.g. Wt. 3796).
To every incorrect washing procedure, (water value >4095 or water value <2100 due to water mixed with bubbles, anomalous water flow, etc.) the instrument will generate a PHOTOMETER NOT OK error and a new washing procedure will be requested.

10.1.1 – WASHING USING 1 TEST TUBE (STANDARD WASHING)
This option is used when the instrument requires or needs to be washed in a “normal” way (e.g. when the instrument asks by itself for a washing after three successive NF messages).
After this washing has ended the instrument is ready to continue working, but if not, try with washing for maintenance (chapter 10.1.2)
This procedure requires to 1 test tube filled 3/4 with distilled water;

Wash:
Pressing “Wash” (from Main Menu or Main Screen) the instrument will set itself to be ready to perform a wash cycle
At this point, the instrument shows these screens:

Now the operator, after pressing “OK” on the first screen, and after inserting the washing tube inside the probe, can press “START” button to start the washing procedure. Otherwise if “Back” button is pressed, the instrument comes back to Main Menu.
At the end of the washing cycle, the instrument will printout a report in which it shows the parameters of the photometer.
If the procedure was successful, so without any type of error, the instrument will report “PHOTOMETER OK”.
If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has not been executed correctly.

Now pressing “OK”; the instrument will display the following message that suggest to repeat the washing procedure.
Attention, if the waste tank is full (the control is executed automatically by the instrument before beginning a new session); Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for reuse of the waste tank before starting a new session; otherwise, the instrument remains in standby until when the waste tank is replaced / emptied.

Now pressing “OK”; the instrument will display the previous message that suggest to repeat the washing procedure.
In both case, at the end of the washing procedure, the instrument asks to close the front door:

Then, after press “OK” button, the instrument comes back to Main Screen.

10.1.2 – WASHING PROCEDURE FOR MAINTENANCE
For a good maintenance of the instrument and in case the needle and/or capillary are obstructed, carry-out this procedure using distilled water and Sodium Hypochlorite (5% of dilution).
This procedure should be done on a daily basis; in any case it is mandatory before the quality control procedure using the Latex Controls or just before powering off the instrument or if the instrument will be left idle for some hours (e.g. more than 2 hours).

• Execute the first washing, selecting “Wash” and using 1 test-tube filled ¾ with distilled water.
• Execute a second washing, selecting “Wash” and using first 1 test-tube filled up ¾ with sodium hypochlorite (diluted at 5%).
• Execute a third washing (rinse) “Wash” and using 1 test-tube filled ¾ with distilled water.
• This procedure can be carried out also of capillary and/or probe in the event obstructed

Attention, if the waste tank is full (the control is executed automatically by the instrument before beginning a new session); Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for re-use of the waste tank before starting a new session; otherwise, the instrument remains in standby until when the waste tank is replaced / emptied.

10.1.3 – WASHING PROCEDURE IN CASE OF USE OF LATEX CONTROLS

The washing procedure in case of LATEX CONTROLS, is the same of the previous procedure described (washing procedure for maintenance). It must be used every time before starting with the control process in order to carry-out quality control of the instrument.

If the instrument is controlled using Latex Control Kit, this procedure MUST be done every time latex controls are used.
At the beginning of each Latex Controls session:

• Execute one first washing, selecting “Wash”, then option “Internal”, load 2 test-tube filled ¾ with distilled water in positions 1 and 2 of the rotor
• Execute a second washing selecting “Wash” then option “Internal ” and to load in position a 1 testtube filled up ¾  with sodium hypochlorite (diluted at 5%), while in position 2, atest-tube filled up ¾ with distilled water.
• Now is possible to execute the Latex Control session. Choose the option “Standard” located inside “Main” menu. Load in position a 1 test-tube filled up ¾ with distilled  ater, then the three latex- tubes and the others two tests-tube filled up for ¾ with distilled water following the instructions indicated on the screen.

10.1.4 – END OF WORKING DAY WASHING PROCEDURE (Wash and Sleep)

This option is used at the end of the working day and offers the possibility to maintain the capillary moist overnight. This is useful because all the hydraulic circuitry remains filled with water.
The advantage of this procedure is that all residual blood particles that eventually have remained inside the capillary, are kept moist avoiding them to remain stuck over the internal capillary walls.
Attention: before to launch this Wash and Sleep procedure, we recommend a first Washing with a testtube filled ¾ with distillate water, a second Washing with a tube filled ¾ with chlorine and finally the following Wash and Sleep procedure:

Lavaggio finale:
To activate the procedure select “Wash”

This procedure of washing MUST BE EXECUTED at the end of each working day in order to guarantee a good and efficient maintenance of the instrument.
Attention, if the waste tank is full (the control is executed automatically by the instrument before beginning a new session); Waste tank must be disposed once it becomes full unless users are allowed by local government regulations to utilize laboratory policies and procedures to dispose of contaminated waste by using precautions to empty the tank and to sanitize it for re-use of the waste tank before starting a new session; otherwise, the instrument remains in standby until when the waste tank is replaced / emptied.

10.1.4 – WASHING ERRORS

If for any reason the washing procedure reports “PHOTOMETER NOT OK” means that the washing cycle has not been executed correctly or has been found anomalies in the system.
The possible causes of malfunctioning could be:

• It has been used an empty WASH tube,
• Washing reference level lower than 2100
•  Washing reference level inside the range (2100 – 4095) but not detected sample’s end
• Washing reference level higher than 4095
• Detected air bubbles during the washing procedure

STANDARD (Latex control )

With the purpose of guarantee an always optimum performance of the instrument, the daily use of the latex control kit is recommended.

Latex Controls kit is a valid check tool to monitor the reliability of the analyzer during its working life. The kit is supplied in a box. It can contain three test tubes filled with Latex that allow executing a total of 6 controls (sale code SI 305.100-A) or it can contain five test tubes filled with Latex that allow executing a total of 30 controls (sale code SI 305.300-A ). Before starting the Control process, the analyzer can require a washing procedure. In this case, the operator should carry-out a washing procedure as “WASHING USING 2 TEST TUBES”, chapter, explains.

At the end of the control process, the instrument reports the value obtained by the sensor, as can be seen here below in the facsimile screenshot.
At the same time the instrument also printout an hardcopy of the results as the facsimile strips present here on the right side.
Speaking in general terms, “level 2”, “level 3” and “level 4“ corresponds to the ESR intervals that indicatively represents the low, medium and high ESR areas (in any case take as official reference the laboratory intervals for the classification of the ESR results)
The effective reference ranges to be used to confirm that the instrument is “in control”, are in any case those indicated in the Latex Controls Box’s outer label.
If the obtained results are into to the expected ranges, independently they are close each other or separate (but in any case inside the acceptable range) means that the analyzer is calibrated correctly.
On the contrary, if one or more of the results is / are out of the expected ranges, it is recommended to call the Technical Service to carry out a functional verification of the analyzer.
PRINCIPLE OF METHOD
The Latex Controls kit is based on the use of three samples with known turbidity values, on which the analyzer performs transmittance measurements related to ESR values. The results obtained should fit the expected ranges. Otherwise the calibration of the instrument shall be verified.
Please refer to chapter 14.0 for quality control and statistical tools.

At the beginning of each Latex Controls session:

• Execute one first washing, using 1 tube filled ¾ with distilled water (see chapter 10.1)
• Execute a second washing, first using 1 tube filled up ¾ with sodium hypochlorite (diluted at 5%), then wash again using a test-tube filled up ¾ with distilled water.
• Now is possible to execute the Latex Control session. Choose the option “Standard” located inside Main Menu and following the below procedures.

IMPORTANT: Remember that with this configuration, more than the previous warnings, is mandatory to mix manually or with an external mixer the 3 latex tubes, because the instrument doesn’t have the internal rotor. Then for the mixing, it is advisable the use of an external mixer or a good manual mixing by reverting smoothly top-down each single latex tube at least for 30 times (30 seconds).

Material:

• 1 tube “Tube 1” filled ¾ with distilled water;
• 3 tubes “Tube 2” , “Tube 3” and “Tube 4” of Latex control;
• 2 more tubes “Tube 5” and “Tube 6” filled ¾ with distillated water.

Checks:

• If the Latex expiration date has been passed, the instrument will abort the procedure without performing the control;
• If the three tubes don’t belong to the same kit, if not will tell the inserted codes are inconsistent, in that case press “Exit” and the instrument will return to Main Menu;
• If more than 6 weeks has passed after the first piercing date of the inserted triplet, the instrument will abort the procedure without performing the control;
• If the loaded triplet has been used more than 6 times, the instrument will abort the procedure without performing the control;
• If the hydraulic circuit is dirty (not washed after last analytical session), the instrument asks to make a wash.

If all checks are ok, the instrument will begin the control procedure.
Sequence:

1. Instrument asks to open the front door, then after pressing “OK” asks to read the three codes of the latex’s triplet:
   Remember to insert the codes in this order: “Tube 2”, “Tube 3”, “Tube 4”, and also in this case, is possible to insert the code Manually, pressing the Manual ID button and typing the number with the keyboard, or using the Memo button in order to recall a previously memorized code, or using the EBCR (External Barcode Reader) to read the bar codes on Latex Control tubes #2, #3 and #4.

2. After the codes insertion, take the first water tube (“Tube 1”)insert it inside the probe and press “START”
   Otherwise if “Back” button is pressed, the instrument comes back to Main Screen

3. After wash, Instrument asks to perform the Priming, then after mixing well the tube (“Tube 2”) insert it inside the probe and press “START”, instrument will perform a PRIMING procedure aspiring a small quantity of latex and then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE, and meanwhile the instrument does the priming it asks to wipe the probe
   IMPORTANT: Remember to mixing well the tubes with an external mixer or manually by reverting smoothly each single latex tube for at least 30 seconds.
   

4. After priming, the instrument asks again the “Tube 2”, so after mixing well the tube, reinsert it in the probe and pressing “START”, the instrument aspires the prefixed aliquot of latex, then will issue 3 beeps, this means the tube MUST BE REMOVED FORM THE PROBE, and meanwhile the instrument does the priming it asks to wipe the probe
   The same procedure will be repeated for “Tube 3” and “Tube 4” of latex.
   IMPORTANT: Remember to mixing well the tubes with an external mixer or manually by reverting smoothly each single latex tube for at least 30 seconds.

5. After latex, take the second water tube (“Tube 5”) to run first washing after latex, followed by another washing with the third wash tube (“Tube 6”)
   

6. Finished the washing procedures, instrument will displays and prints the expected values and the obtained values, the after pressing “Exit” it comes back to Main Screen.

11.1 – Latex Control Printout

12.0 – MIXER (Not Available in this model)
This feature is not available in this model of instrument
13.0 – EMPTY ROLLER (Not Available in this model)
This feature is not available in this model of instrument

STATISTICS

ROLLER family analyser provides a series of control tools for an effective product performances monitoring; such control tools are the following:

1. Photometrical check done during each washing.
2.  For laboratory quality control it is then important to have at disposal a control system reproducible, reliable and easy to handle.
   This system is available using the Latex Control kit (Ord. code SI 305.100-A/SI 305.102-A or SI 305.300-A/ SI 305.302-A) that was designed expressly for Alifax ESR family. Please refer to chapter 11.0 for latex control procedures.

Pressing “Q.C.”, (from Main Menu) the instrument displays the Statistical Main Menu:

14.1 – WASHING QUALITY CONTROL PRINTOUT – Graph meaning
This function allows to printout statistical data about the washings executed on the instrument:
The printout of the washing control allows to estimate the efficiency of the photometer. The diagram visualizes the trend of washing values detected by the two sensors which are directly correlated to the photometric signal. Normally, the instruments are regulated automatically around to an absolute value of 3800 during the washing with distilled water. This value tends to move down during the time, because of the residues of biological material inside the capillary.
Pressing “Print (5-1)” activates the printout that represents the behaviour and the tendency of the photometric values correspondents to the values of the water.
How can see from the graph below, the instrument shows the trend of the last 30 days, from which is easy to identify any possible drift or abnormal values.

14.2 – INSTRUMENT VERIFICATION USING THE LATEX CONTROL KIT

The Latex Controls kit (Ord. code SI 305.100-A/SI 305.102-A or SI 305.300-A/ SI 305.302-A) is a valid tool for the functional verification of the analyser Roller 20. The results of the control simulate three ESR values, a first level (around 9 mm/h), one intermediate level (around 19 mm/h) and a high level (around 65 mm/h). By comparing the results obtained from the analyser with those reported on the kit package it will be very easy to control if the instrument is reporting reliable results or not. In this way, the instrument can be kept monitored during its whole operational life.
It is necessary to strictly follow the instructions for use included into the Latex Controls kit and at the end of the procedure compare the printed results from the analyser against the values reported in Table 2 on the package kit box: if the results obtained by analyser fits the expected range reported on Table 2 , it means that the analyser is calibrated.
On the contrary, if one or more results are different from the ones reported on the kit package, it is recommended to call the Technical Service for a functional verification and calibration of the apparatus. Below are reported all the menus and printouts, where the user can check the data regarding the Latex Control kit

Results obtained during the latex control procedure are stored by the instrument; it is therefore possible to print out a report pressing the key “Print (4-1)”. With this option it is possible to visualize the tendency of the instrument and being able to find eventual drifts that will require an accurate control of the instrument. The graphical printout cover the last 30 days.
The trend of the latex must be interpreted as a tendency pointer.
The starting reference are the values obtained during the calibration and then, for every control executed with the Latex Kit, the trend will show how much the read latex values drifts from the reference values printed on the box and also on the printout report generated during each control procedure. Analysing the diagram it is possible to observe that:
The sensors (that have the same value) show the reference marker which represents the drift from the reference (1) obtained from the analyser against the reference values.
This trend, when is completely full, represents a maximum of 30 days of analysis, therefore anomalous tendency in the daily values, against the reference is easily identifiable. Consequently the customer is able to understand if there is systematic error or an instrument error. Data are shown from the oldest (lower part) to the most recent (upper part of the diagram).
Note: In this trend is shown a second value same to the first, this for maintain the compatibility to the old our sensor. This value is completely irrelevant from the point of view of measurement, and will be disabled in to the our next software release.
Explication of the printout report:
In order to better understand the meaning of the results printed out, imagine a series of three controls with values of 9, 19 and 65 mm/h (values of reference). Executing the
control of the analyser, if the values will be identical (9, 19 and 65 that is the ideal case), there won’t be a shift (y=1.00x) and the dots symbol will printed exactly on the column 1, as on the first line on the aside graph. On the contrary, if for example the shift is +1,00% (y=1.01x) the dots will be positioned between column 1 and column +10%, like the fourth white dot in the graph aside. At the bottom are printed out the Average of DEV% values (AV) and the Standard Deviation (STD).
Results obtained during the latex calibration procedure are stored by the instrument; it is therefore possible to print out a report pressing the key “Datalogger”. With this option it is possible to visualize precise information about all calibrations done, like the LOT and the KIT of the triplet, the date of withdrawal, old and new Model Fact, the type of withdrawal and the priming latex flag.
Printout explanation:

SETUP MENU

Setup Menu:
Pressing “Setup” from the Main Screen, the instrument shows the following options 15.1 – LOG IN-OUT
With the Menu “Log In-Out” in Setup Menu, the instrument allows the user to log in or out with the appropriate passwords.

pressing “LOGIN” the instrument will display a keyboard to type the password, type the proper password (see table in the next page), then press the “left arrow” to confirm or “Back” to exit without change anything, in both cases, the instrument will display again the previous screen, then press “Back” to return in Main Screen.
To Logout, access again to this function, press “Log In – Out” (in the Setup Menu), this time press “LOGOUT” and the instrument will return to level 1. Pressing “Back” is possible to go back to Main Screen.

Password levels:

elementary setup functions. When the instrument is switched off,  the instrument loose this password, so next time the instrument is switched on it will be setup as level 1 (base level).
3| “LOGIN – TECH LEVEL” (Typing the password “xxxx” not given on this manual) this level is only for Technical Service Personnel.

15.2 – CPS MENU

CPS:
This function’s accessibility is linked to a password level.
Pressing “CPS” (in the Setup Menu) without any password level activated, the instrument will display:

Pressing “Back” the instrument comes back to the Main Screen.

15.3 – CPS’ PARAMETERS
Then pressing “Parameters” will be displayed CPS’s parameter but without the possibility to modify anything as showed in the next image:

Pressing “OK” the instrument comes back to the CPS Menu.

15.4 – CPS Read ADC
This function allow technician to verify CPS’s Analog-Digital Converters reference (without the possibility to modify anything if not logged as technical service).

Pressing “Read ADC” will be displayed CPS’s Analog-Digital Converters reference, in particular:
DAC: which is changeable refers to the power emitted by the LED inside the reading unit. This value changes every time a latex procedure is done and the change is adjusted in order to obtain a value of DAC which guarantees a water value as close as possible to the reference value of 3800 (printed out during washing procedure). DAC reference number goes from 0 to 1023; normal working range goes from 500 to 850.
ADC: refers to the effective value that each sensor reads (in other words is the sensibility of the sensor) , in this case this value changes continuously and each value is independent from the others. ADC reference number goes from 0 to 4095. There is no specific working range even if the normal value should be around 1300 – 1800

Pressing “OK” the instrument comes back to the CPS Menu. Remember that, to modify DAC’s values is mandatory a technical password.

15.5 – MIX MENU (Not Available)

Pressing “Mix” (in the Setup Menu), the instrument will display:

Because this function is not available with this kind of Roller. Then press “Back” to come back to Main Screen.

15.6 – DATE TIME MENU
This function’s accessibility is linked to a password level.
Without a password:
Pressing “Date time” (in the Setup Menu), the instrument will display:

Pressing “Back” the instrument comes back to Main Screen.

With a User Password (after logged, please see chapter 15.1):
Pressing “Date time” (in the Setup Menu), this time the instrument will display:

Now, pressing “SET” the instrument allow to modify TIME or DATE values;

• If the change is applied to DATE, the instrument will ask to modify in the following order: Year, Month and Day, to modify these parameters, just type the desired value;
• If the change is applied to TIME, the instrument will ask to modify in the following order: Hour, and Minute, to modify these parameters, just type the desired value.

 then press the “left arrow” to confirm or “Back” to exit without change anything, then the instrument will display again the previous image with the DATE or TIME new value. Pressing “Back” is possible to go back to Main Screen.

15.7 – FL (Flag List) MENU

15.8 – SETTINGS MENU
This function’s accessibility is linked to a password level.
Without a password is possible to access only few functions
Pressing “Settings” (in the Setup Menu), the instrument will display:

15.8.1 – SOFTWARE VERSION
This instrument uses 5 different processors to work, this means that not all of them necessarily have the same or last version installed; to know which software version is installed in each processor press “SW version” the instrument will display software version’s installed.

15.8.2 – PRINT EXPANDED
This function, if activated, allow to printout the IDs and ESR results on double height; to access the function press “Print exp.” the instrument will display:

In this example the function is set to “YES”
Pressing “Back” the instrument will display again the Setting Menu screen.

15.8.3 – PRINT IN RUN
This function, if activated, allow to printout the IDs and ESR results after the corresponding sample analysis (in “real time”); to access the function press “Print in run.” the instrument will display:

In this example the function is set to “YES”
Pressing “Back” the instrument will display agaithe Setting Menu screen.

15.8.4 – LANGUAGE SETUP
This function, if activated, allow to setup the language in which will be displayed messages and warnings; to access the function press “Language” the instrument will display:

Available languages are:

• English
• Italian
• Spanish
• French
• Russian

Just press the desired language, in this case English to setup the instrument in English language

Pressing “Back” the instrument will display again the Setting Menu screen.

15.8.5 – SETTINGS MENU with “USER LEVEL” PASSWORD LEVEL ACCESS
As stated before, to have the possibility to modify these parameters it is necessary to be logged as “user level” (see chapter 15.1) otherwise the instrument will not allow to access the function.
After logged with User password, the instrument will show this screen (inside the Setting Menu):

Pressing “Back” the instrument comes back to the Main Screen:
15.8.6 – WASH TIME
This option allows to modify the delay of time (in minutes) for the alarm activation for a washing procedure requesting. The counter’s countdown starts at the end of the analysis cycle.
To access this function, press “Wash Time” (in the Setup Menu after a user login), the instrument will display:
To modify the waiting time, just type the desired value (from 1 minute to 240 minutes).

AVAILABILITY MENU

Pressing “Availability” from Main Screen, the instrument shows the following options :

16.1 – SHOW AVAILABILITY
Pressing “Show” in Availability menu, the instrument will show this screen: Press “Back” to come back to Main Screen.

16.1.1 – PRINT AUTONOMY

Pressing “PRINT”, the instrument will print out the remaining number of credits for each active parameters.

Press “Back” to come back to Main Screen.

16.1.2 – AUTONOMY WARNING LEVEL
Without a password:
The instrument only show the actual value of the Autonomy Warning Level (1000 by default):

With a User Password (after logged, please see chapter 15.1):
The instrument will display:

Pressing “SET” the instrument allow to modify threshold level (from 5 to 63000) using the keyboard, so to increase availability type the desired warning value, then press the “Left Arrow” to confirm or “Back” to exit without change anything, in both cases, the instrument will display again the previous screen with the new warning reference. Then press “Back” to go back to Main Screen

16.1.3 – CARD WITH DIVISIBLE CREDIT
If a card with divisible credit has been loaded, pressing “USE” it is possible to use one by one the special codes, for increase the availability in blocks of 500 credits (till to 4500 credits for each card).

After pressing “USE” button, the instrument will show this screen:

Where in base of the Serial Number (SN) of the card and the number of the block (B.), typing the correct code is possible to load the 500 credits. Then after typed the code, press “Left Arrow” to confirm or “Back” to exit without change anything. The instrument controls the code and if is correct, it loads the 500 credits and prints this: Then it comes back to Availability Menu.
Otherwise, if the code is wrong the instrument shows this:

Then press “OK” to come back to Availability Menu, and try again to type the code.
When the number of blocks become ‘0’ (zero), the button “USE” become invisible, and is no longer possible to load the credits, until a new card with divisible credit is loaded.

Pressing “Back” it is possible to go back to Main Screen.

COMM MENU (Technical password required)

Under this menu resides all the functions and options related with the communication between Roller 20 and a Host Computer. To modify the whole parameters’ values is MANDATORY to login using the Technical Service password (see chapter 15.1).
Without a password
This function do not work without a password level and the instrument will display the following message

TECH MENU (Technical password required)

Under this menu resides all the functions and options related with the TECHNICAL CONFIGURATION of Roller 20. To modify the whole parameters’ values is MANDATORY to login using the Technical Service password (see chapter 15.1).
Without a password
This function do not work without a password level and the instrument will display the following message

MORE MENU

Pressing “More” from Main Screen, the instrument shows the following options:

19.1 – INFO MENU

Pressing “Info” from More Menu, the instrument will show this screen: Where are written some information and references about the Technical Assistance for the instrument, then press “Back” for return to Main Screen.

19.2 – LAST SESSION MENU

Pressing “Last Session” from More Menu, the instrument shows:

Because with this kind of Roller, this function is not available, so the instrument will always display this screen, then press “OK” for return to Main Screen.

SWITCHING OFF

Before switching OFF the instrument it is mandatory to use the WASHING procedure (see chapter 9.0).

Then the instrument can be switched OFF using the back side push-button.
When the instrument is switched ON if the washing was done previously, the instrument is immediately ready for work, on the contrary it warns the user that is advised to run a washing procedure. These messages are useful to start correctly the analytical cycle only if the washing procedure was performed.

SANITIZATION PROCEDURE

The following procedure must be executed before:

1. Collection/shipment of the instrument from laboratory after a demo or for replacement/reparations.
2. Technical service repair or check inside the instrument.

Protection tools and suggested materials to be used:

1. Glasses.
2. Latex gloves.
3. Absorbing paper towels.
4. Plastic bag for waste disposal .

For the description of sanitization procedures of a working instrument: refer to the Sanitization Form (Appendix B)
The Sanitization Form MUST be filled up and accompany the instrument.
In case the sanitization cannot be executed due to a failure of the washing system, contact your Local Technical Service.
Note: we suggest to make a copy of the Appendix B at each sanitization and to fill it according to the sanitization procedure.

ERROR LIST

ERRORS THAT CAUSE INSTRUMENT’S BLOCKAGE:

transmission of the data. Switch off the instrument, wait 10 seconds and switch on again
E14| Debu gging parameters| CPS — Internal Serial Communication Protocol error, switch off the instrument, wait 10 seconds and switch on again
E15| Debugging parameters| EXT— Eeprom — Error during external eeprom access, switch off the instrument, wait 10 seconds and switch on again
E16| Debugging parameters| RTC — Error during internal communication, switch off the instrument, wait 10 seconds and switch on again
E18| Debu gging parameters| COMM — Error during internal data transmission, switch off the instrument, wait 10 seconds and switch on again
E20| Debugging parameters| MOT — The same of Error ‘E00’, command START movement OK, but not received command of END movement. Switch off the instrument, wait 10 seconds and switch on again
E21| Debu gging parameters| PUMP — Not detected home sensor for peristaltic pump even after three complete rotations, check if square magnet is present on the pump’s rotor.
E26
E01| Debu gging parameters| E26 – (Generic error) Mechanical movimentation. E01 – (Specific error) Stall Rotor.
E31| | MOTOR. (peristaltic pump) During movement of the pump there are detected motor stalls. (limited to CPS-MC Module), switch off the instrument, wait 10 seconds and switch on again board
E32| | COMM Error in the internal communication with the cryptographic module; switch off the instrument, wait 10 seconds and switch on again
E33| | COMM Error timeout in the internal communicating with the cryptographic module, switch off the instrument, wait 10 seconds and switch on again
E34| | COMM Error in the decreasing of availability of tests inside the cryptographic ,module in the internal communicating with the cryptographic module, switch off the instrument, wait 10 seconds and switch on again

In case one of the mentioned errors is reported, for don’t lose the current session, press the “OK” button, then the instrument automatically tries again the last operation (move again the motor) and if this time the error not occurred, it will continue with the analysis.
The voices: MOT, COMM, CPS, RTC, EXT_Eeprom belongs to the electronic board that compose the instrument. This electronic boards contains parts and electronics components that CAN NOT BE ADJUSTED BY THE LOCAL FIELD ENGINEER. It is possible just to check the presence/absence of the square magnets on the syringe, carriage and peristaltic pump.

PROGRAMMED MAINTENANCE PROCEDURE

Frequency
30.000 TEST

Part  to check| Description of checks (please fill in the checks done)
---|---
External Probe| □ Check for any damage or obstruction of the probe (In case of damages, to replace the probe, contact the Technical Assistance)
Pump tube| □ Replace it, even if it seems not damaged.
PTFE tubing| □ Check the status of PTFE tubing from probe to the reading block (CPS) and from this one to pump, and from pump to waste tank, replace the tubing if deformed or damaged .
□ Check if blood flow is normal and regular.
Pump| □ Check the rotation of pump, pay attention to rolls are regularly rolling.
□ Verify the regularity of pressure of rolls due to springs. If some squeaking is heard while the rolls  operate, lubricate the rolls spraying them with a bit of silicon oil.
□ Check if the magnets stuck on the head of pump are present, check the sensor, and look if the sensor, on the commands panel, is lighted when the magnets face the sensor during rotation.
CPS MC module| □ Check its calibration as described in the chapter 9.1.3
□ The calibration can be adjusted using the calibration kit SI 305.400, composed by a series of optical filters and the calibration procedure.
Reset of counters| □ When all the described checks are performed at the level of 30.000 test, reset the Maintenance Counter (Only Technical Service).  When reset, the instrument will alert the operator when other 30.000 test are
performed, to call technical service. To reset the counter, enter in RESET MENU

60.000 TEST
Perform all checks reported for the 30.000 test as above described and also:

Pump speed reducer| □  Check the oscillation of the reduction gear shaft into the bearings. If the oscillation is higher than 0,5 mm evidencing also a grease leakage, replace the reduction gear.
---|---
Repeatability check| □ Execute this test loading a certain number of samples available (max 60), repeat the analysis three cycles consecutively.
□ Compare the results to verify the instrument repeatability.

ROLLER – REFERENCES

Manufacturer:

ALIFAX S.r.l.
Production Site:
Via Merano 30 33045 Nimis (UD) Italy
Tel +39 0432 547454
Fax +39 0432 547378
Legal Site:
via F. Petrarca 2
Isola dell’Abbà
35020 Polverara (PD)
Tel. +39-049-0992000
e-mail info@alifax.com
web www.alifax.com
VAT: IT04337640280

The instrument is CE certified
According to directive 98/79/EC relative to In Vitro Diagnostic Medical Devices
The instrument is MET certified for the North American market by MET Laboratories Inc.

APPENDIX A (NF meaning )

It appears when the system is not able to aspirate blood.
It could be possible:

• The excursion of the needle is not enough and accordingly the needle cannot aspirate blood. If this is true, you should call the technical service in order to increase the excursion of the needle inside the test tube:

• The excursion of the needle is too high and accordingly the needle cannot aspirate blood because its tip is over the blood level. If this is true, you should call the technical service in order to reduce the excursion of the needle inside the test tube:

• Air access into the capillary during aspiration.
  If this is true, the terminal part of the capillary which touches the needle base could be ruined.
  The capillary, therefore, has to be replaced and the analogical board adjusted. To do that, call the technical service.

• The needle is obstructed partially for a limited flow. The photometer,  therefore, reads blood mixed with air. Check or replace the needle.

• The pump rubber tube is not able to aspirate blood correctly. The technical service should be called in order to replace the tube.

APPENDIX B (NR meaning )

NR is a printed out message which warns the operator that the result is no reliable.
It means that the specimen has been recognised in the reading cell at the beginning of the measuring phase but no cells aggregation was detected. A possible cause could be due to the blood not well mixed, suspected clots in the capillary or in the reading cell or eventually not enough blood inside the sample tube. As a consequence of previous causes, sample analysed is reported as NR because not reliable. A possible solution is in the pre-mixing of the specimen (refer to page 37) and the successive analysis cycle.

APPENDIX C – IMPROVEMENTS ON SOFTWARE VERSIONS from 5.00A
Version 5.00A

• Universal Software for R20-PN and R20-MC.
• Handling of the new smart card reader

Version 5.00B

• Fixed a minor bug of the syringe movement during washing cycles

Version 5.00C

• Fixed a minor bug on the handling of the smart card reader module

APPENDIX D – SANITIZATION FORM
This module must be filled by the Laboratory / Technical Service Engineer before shipping the instrument.
This document MUST be attached to the instrument.
Description of sanitization procedures to be done by the Laboratory:
Switch ON the instrument:

• Execute the washing procedure

1. Perform a first wash using two tubes filled with distilled water
2. Perform a second wash using one tube filled with sodium hypochlorite and one tube filled with water

Remove the waste tank and dispose it following the standard safety procedures in use in the laboratory
If due to a failure, the instrument cannot be switched ON, mark as NOK .

Description of sanitization procedures to be done by the Technical Service Engineer:
Wear protection tools (glove and glasses) and remove the cover of the instrument.
If Laboratory Operator marked the washing procedure as NOK, verify if it is possible to make in some way the washing procedures.

• Execute the washing procedure

1. Perform a first wash using two tubes filled with distilled water
2. Perform a second wash using one tube filled with sodium hypochlorite and one tube filled with water

Remove the waste tank and dispose it following the standard safety procedures in use in the laboratory

If due to a failure, the instrument cannot be switched ON, mark as NOK .

To continue with the sanitization procedure, switch OFF the instrument and unplug it from the power supply cable.

• If some part inside the instrument are contaminated with blood:

1. Spray the parts with a disinfectant (cationic surfactants).
2. Collect liquid from the sprayed parts with absorbing paper towels.
3. Wash with water and dry with paper

For the disposal of the contaminated effluents and the Waste Tank, follow the standard safety procedures in use in the laboratory.

• If there are no parts contaminated with blood:
  Wash with water and dry with absorbing paper
  For the disposal of the contaminated effluents and the Waste Tank, follow the standard safety procedures in use in the laboratory.

In the event contaminated material is penetrated inside the instrument (thermostated plate) IT IS MANDATORY TO INDICATE ON the INSTRUMENT and on the SANITIZATION SHEET that contaminated material has percolated inside the instrument and it has not been possible eliminate using the external sanitization procedure.
MANDATORY:
If the sanitization was carried on, please cut the lover right side of the page (or make a photocopy) and include the tag in the shipping documents.

ATTACHMENT 1
ESR_PTDS_SIR20-MC_PTDS

determination.
DESCRIPTION:| Model with manual external withdrawal tip for pediatric test- tubes and for test tubes that can be
uncapped.
ANALYSIS PRINCIPLE:| Quantitative Capillary Photometry for the Erythrocyte- Sedimentation Rate (ESR)
· At the first daily switch ON wait 3 minutes before starting an analysis cycle  to allow the thermal stabilization.
· Instrument uses a technology that allows the measurement of the ESR at a stabilized temperature of 37C°±0.5°C (98,6°F±0.9°F)
RESULTS:| Given in mm/h in the range from 2 to 120 mm/h.
SAMPLE REQUIREMENTS:|  : In case of use of sample coming from patients affected by an oncological pathology, we remark that ESR result of those samples could be eventually NOT reliable as explained in section “method limitations” paragraph 2.
· the sample must be of whole blood collected in EDTA anti-coagulant.
· the blood sample must be neither coagulated nor hemolyzed.
· Samples mixing is done at the beginning of the analysis with the purpose of disaggregating erythrocytes. A possible ineffective disaggregation could affect the results given by the instrument which measures system is based on the detection of the kinetics of aggregation of the red cells.
· The use of sample tubes with different volumes could affect the performance of the instrument
Manual withdrawal:| – the minimum blood volume for the withdrawal (dead volume) is 100 microliters
– the minimum blood working volume required for the analysis is about 30 microliters except for
the first sample from which supplementary 50 microliters are approximately withdrawn for priming.
. – samples separation inside the capillary by air bubble.
TUBE REQUIREMENTS:|

Test-tubes 13×75 mm (0,512 x 2,953 inches) like BD Vacutainer® or BD Microtainer® or Greiner Bioone or with 13 mm (0,512 inches)diameter  and from 75to 83 mm (2,953
– 0,3268 inches) high, cap included like, for example, the Sarstedt tubes that measure 11,5×66 mm  (0,4528×0,2598 inches) without cap. Compatible also with test tubes Terumo Venoject II® models VP-DK052K, VP-DK052K05 and VJ- DK052E004
– It is possible to use “BD Microtainer MAP®” tubes directly (also in conjunction with other 13×75,
0,512 x 2,953 inches tubes) but could be necessary to verify the needle offset adjusting its excursion
in case of volumes lower than 500 uL
– It is possible to use “Sarstedt S-Monovette EDTA®”, “Tapval® pediatric tube”, “BD Vacutainer®
pediatric tube” tubes; for these models of test tubes it is required the use of specific test tube adapters as well as it could be necessary to verify the needle offset adjusting its excursion in case of volumes lower than 500 uL

PEDIATRIC TUBE COMPATIBILITY
For tubes not listed here, please contact
you Alifax Distributor| Roller20-PN
With mixer, internal and external withdraw| Roller20-MC
Without mixer,  external withdrawn only
---|---|---
| Sarstedt  S-Monovette EDTA 1.2 ml
pediatric C5:E10tube and SI195595
Tube Adapter| Internal mixing Internal withdraw
External withdraw also| External  mixing
External withdraw only
---|---|---|---
| Tapval pediatric tube and SI195590
Tube Adapter| Internal mixing Internal withdraw
External withdraw| External  mixing
External withdraw only
|  BD Vacutainer  pediatric tube  and   SI195593
Tube Adapter| Internal mixing Internal withdraw
External withdraw| External mixing
External withdraw only
| BD Microtainer MAP  from 250 to 500 uL  pediatric cuvette into 13x75mm tube
with pierceable cap No tube adapter required| Can be used together with other 13x75mm test-tubes if the blood
volume is at least 250uL and the
following shrewdness: turn upside down each tube and give a flip to the cap for bring down the blood towards the cap just before loading the tube into the rotor| External mixing
External withdraw only
| Sarstedt Microvette 500 K3E Code 20.1341.100 Capillary pediatric test tube for 500uL and  SI205052 Tube Adapte| Internal mixing (use centrifuged
mixing) Internal withdraw (minimum 300uL) External withdraw (less than 300 uL)| External mixing
External withdraw only
| Sarstedt Microvette 200 K3E Code  20.1288.100 Capillary pediatric
Test tube for 200uL and  SI205052
Tube Adapter| Internal mixing (use centrifuged
mixing)
No internal withdraw (too few blood 200uL) External withdraw (200 uL is enough)| External mixing
External withdraw only

Please notice all above tubes, have been tested mechanically to check compatibility with the instrument rotor and piercing system.
There is not available any specific comparative performance information about them.

OPERATIVE PERFORMANCES

•  Could be used 30 uL of blood for analysis, suitable for pediatric samples
• Results available in 18 seconds after starting manual withdrawal
• Thermoplastic cover with lid for protecting withdrawal probe.
• New Smart Card with divisible credit enabled by codes.
• Photometer check after each washing, to ensure continuous control of the instrument.
• New photometer (CPS-MC) with two detectors for ESR analysis and blood flow management.
• Automatic washing request programmable at the end of each cycle
• Management of Latex Controls kits for TEST1 family analyzers (Ord. code SI 305.100-A/SI 305.102-A and SI 305.300-A/SI 305.302-A).
• In the event customer uses collecting tubes with 4ml capacity, it is possible to obtain good correlation with the method used into the laboratory with the following tips:

1. Using the gain of the instrument during correlation with lab reference method
2. Increasing the mixing time (on R20-MC the mixing MUST BE DONE only externally).
3. If the CBC has the venting function, possibly execute first the CBC analysis and then the ESR analysis

Manual withdrawal:

• Start the analysis within 2-4 hours from vein-puncture, otherwise keep the samples in refrigerator at +4÷8 °C (39.2÷46.4°F) for a maximum of 24 hours. If the samples have been conserved in refrigerator at +4÷8 °C (39.2÷46.4°F), it is necessary to leave them at room temperature at least for 30 minutes before their analysis, even if it is in any case suggested to let the samples remain at room temperature preferably for about 60 minutes, after that, test should be executed within 4 hours.
• Minimum volume required is 100 uL except for the first sample from which supplementary 50 microliters are approximately withdrawn for priming.
• verify that the sample volume should in any case not exceed the 50-60% of the total volume of the test-tube in order to optimise the blood homogenization.
• To mix the sample, use an external mixer set at speed of 32 rpms and 140 cycles of mixing to allow a suitable homogenization of the samples; alternatively use a tilting bed.
• In the event customer uses collecting tubes with 4ml capacity, it is possible to obtain good correlation with the method used into the laboratory with the following tips:

1. Using the gain of the instrument during correlation with lab reference method
2. Increasing the mixing time (this can be obtained using an external mixer before the ESR analysis or/and increasing the mixing time of the ESR analyzer).
3. If the CBC has the venting function, possibly execute first the CBC analysis and then the ESR analysis.

Error notice:
The instrument in case of error or malfunction, reports this situation with a specific message on the screen plus with an acoustic intermittent signal of 62,5 dBA.

ANALYTICAL PERFORMANCES (obtained with 3 ml test-tubes):

Agreement with TEST1: R2 = 0.91
Repeatability: mean CV% = 5.7% on the whole range 2 – 120 mm/h
Reproducibility: mean CV% = 5.1% on the whole range 2 – 120 mm/h
Stability of samples stored for 24 h at room temperature:
In order to view the effects of different methods of storage on the ESR value, 272 K3EDTAanticoagulated whole blood samples, some of which have been stored at 4 °C (39.2°F) and some others at room temperature, have been analysed after 4 hrs and after 24 hrs on TEST1 device. Good correlation was found between the results taken at 4 hrs and those taken at 24 hrs on the samples stored at 4 °C (39.2°F) (r=0.980). Those stored at room temperature did not correlate quite as well as those stored at 4 °C (39.2°F), but still had very good correlation (r=0.917)(1).

METHOD LIMITATIONS:

1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood and transient(2), not a hematic matrix component (at corpuscular / molecular level). The procedures used to determine the ESR cannot be calibrated as they are susceptible to a variety of errors (temperature, hematocrit, erythrocyte mean corpuscular volume, plasma viscosity, etc.)(2). Based on the acquired experience,TEST1 family instruments (TEST1, MicroTEST1, Roller20LC, Roller20PN, Roller20MC, Roller10PN and JO-PLUS), are limitedly affected by these variables. For this reason it is possible to observe instrument performances deviations compared to other procedures if the above variables are not taken into account.

2. Erythrocyte sedimentation remains an only partly understood phenomenon….is a nonspecific reaction (from a clinical point of view)…(2) that is affected by several technical aspects(3). The ESR is often normal in patients with cancer…(3). International guidelines for diagnosis and management of multiple myeloma do not mention the Erythrocyte Sedimentation Rate (4) . It is then necessary to point out that even though TEST1 analytical performances have been confirmed in patients affected by multiple myeloma (5,6), there have been some cases of patients affected by multiple myeloma in which TEST1 has reported clinically negative ESR values in comparison to other methods. Based on this experience there could be cases in which Roller gives low ESR results likewise TEST1 in presence of Multiple Myeloma. Furthermore in presence of this disease and/or other oncological pathologies it is possible to observe deviations form other methods since other phenomena in addition to the rouleaux formation can contribute to the sedimentation like for example amorphous aggregates formation (crystallization of paraproteins or mineral materials like calcium) resulting from bone tissue alteration.
   It is then highly recommended to perform other tests together with the ESR in the diagnosis of cancer since a normal ESR value is not enough to exclude that the patient is not affected by this pathology.

3. Samples mixing is programmed at the beginning of the analysis with the purpose of disaggregating erythrocytes. An inefficient disaggregation could affect the results given by the instrument that in fact measures erythrocytes aggregation kinetics.

4. The above instrument performances have been obtained using test tubes with a capacity of 3 ml and 13×75 mm size with K3EDTA anticoagulant. The use of such tubes optimizes the mixing phase and consequently the results reproducibility. 

 ENVIRONMENTAL AND PHYSICAL SPECIFICATIONS

Permissible environment conditions for operation:
Temp.: from +10÷30°C (50÷86°F)
Humidity: from 15% to 85% – no dew

Permissible environment conditions for transportation and storage:
Temp.: from -20÷70°C (-4÷158°F)
Humidity : from 5% to 95% – no dew

Size and weight:

[L] Length: 24 cm (9.4488 inches)
[W] Width: 38 cm (14.964 inches)
[H] Height: 45 cm (17.71 Inches)
Weight: 11 Kg (24.251 Lb)

Packaging: Cardboard box

[L] Length: 65 cm (25.591 inch)
[W] Width: 34 cm (13.386 inch)
[H] Height: 50 cm (19.685 inch)
Gross Weight: 15 Kg (33.069 Lb)
Volume: 0,1105 m3 (3,902 F3 )
Pallet: No

ELECTRICAL SPECIFICATIONS

Voltage: 115 / 230 Vac ±10%
Frequency: 50/60 Hz
Classification: Class I (EN61010-1 – IEC 1010-1 – CEI 66-5)
Power consumption: 40 VA

OTHER OPERATIVE SPECIFICATIONS:

Heat dissipation in the environment: about 136 BTU/hour

Noise:
39,5 dB(A) standby
53.4 dB(A) printing
50.2 dB(A) working/washing

Maximum rated altitude: 3000 mt asl
Communication:
2 serial RS232 ports located on the rear side of the instrument:
Port 1 (DB25) is dedicated to connect an external scanner
Port 2 (DB) is dedicated to connect the instrument to an Host Computer
1 USB serial ports (for future applications)
Functioning:
The instrument is designed to remain switched ON 24 hours a day, it is however suggested to switch it off at the end of the working day, applying previously a washing procedure using 3 washing tube (distillate water, chlorine, distillate water) to ensure a long capillary’s and sensors’ life.
Restrictions : Indoor user appliance
Rated pollution degree: Grade 2
Working life of the instrument: 10 years (if maintenance is done correctly)
INTERNAL QUALITY CONTROL
Latex Controls:
With the purpose of guarantee an always optimum performance of the instrument, the daily use of the latex control kit is recommended.
Latex Controls for TEST1 family analysers allow the control of the calibration stability of TEST1, MicroTEST1; Roller10, Roller20LC, Roller20PN, Roller20MC, Roller10PN and JO-PLUS.
They are available in two kinds of test tubes:

• 13×75 mm Greiner:

Latex Controls (6 tests) – code SI 305.100-A; Latex Controls (30 tests) – code SI 305.300-A

•  11,5×66 mm Sarstedt: Latex Controls (6 tests) – code SI 305.102-A; Latex Controls (30 tests) – code SI 305.302-A

CONSUMABLES
Printer Paper:
Thermal roller paper 58 ±1/mm (0.2283 inch ± 0.004inch) x Max 32 mm(0.126 inch)
Smart Card:
Conform to ISO 7816-1 specifications – 85.6 x 54 x 0.8 mm (33.7 x 21.26 x 0.315 inch) Coded using Alifax proprietary algorithm.
Available for 1,000 (Ord. code SI 195.901) – 4,000 (Ord. code SI 195.904) – 10,000 (Ord. code SI 195.910) – 20,000 (Ord. code SI 195.920) tests / Universal Card; furthermore from Sw. version 5.00 it is available also the 5,000 test (SI 195.950) Multicode Card for TEST1 family analysers (TEST1, MicroTEST1, Roller20LC, Roller20PN, Roller20MC, Roller10PN
Waste Tank:
500 ml plastic tank with screw cap to collect blood and washing effluents. SI205801
Wash Tank:
500 ml plastic tank with screw cap for the water used to wash the instrument. (Available only on SI R20 PN Model) SI195145
OPTIONAL AVAILABLE TOOLS

Patient identification: External CCD bar-code reader (SI195820)

REGULATORY INFORMATIONS:

Classification| IVD|
---|---|---
EAN13 Code| 805604014340|
CND Code| W02029001| Not Applicable
FDA-CFR Code| Product code: GKB| Regulation Number: 864.5800 Automated sedimentation rate device
GIVD Code| 23.09.10.01| Other HHIHC Hardware + accessories + consumables + software
GMDN Code| 56691| A mains electricity (AC-powered) laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen. The device operates with minimal technician involvement and complete automation of all procedural steps

REFERENCES:

1. E. Heverin (Galway-Mayo Institute of Technology, Ireland): ”Comparison of the Westergren method versus the TEST1 technique for determining the Erythrocyte  Sedimentation Rate”, May 2002, private communication
2. NCCLS “Reference and Selected procedure for the Erythrocyte Sedimentation rate (ESR) Test; Approved StandardFourth Edition”, Vol. 20 No. 27
3. Sox HC, Liang MH: “The Erythrocyte Sedimentation Rate”, Annals of Internal Medicine 1986; 105:515-523.
4. NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology “Multiple Myeloma” (V.I.2007)
5. Ajubi et al.: “Determination of the lenght of sedimentation reaction in blood using the TEST1 system: comparison with the Sedimatic 100 method, turbidimetric  fibrinogen levels, and the influence of M-proteins”, Clin Chem Lab Med 2006; 44 (7): 904-906
6. Mercurio S. et al.: “Comparison between two methods for ESR measure in patients affected by myeloma”, 37° SIBioC National Congress, 11-14 October 2005 Rome.
7. H02-A5 vol 31 No.11 PROCEDURES FOR THE ERYTHROCYTE SEDIMENTATION RATE TEST; APPROVED STANDARD – FIFTH EDITION

ALIFAX S.r.l.
via Petrarca 2/1 — 35020 POLVERA RA (PD) — ITALY
Tel. +39 0490992000
e-mail: info@alifax.com
VAT: IT04337640280
ALIFAX S.r.l.
via Merano 30 — 33045 NIMIS (UD)— ITALY
Documents available on: www.alifax.com

References

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