Bulletin - Phadia · Processing Lid (see UniCAP 100 Bulletin 30) is installed, ... Also Drive Plate 12-3500-71 might in some cases be affected by too wide tolerances

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Bulletin Bulletin 32 October, 2003

155. New spare part. Optical Sensor Kit, EliA Disp. 12-3505-92

When experiencing big problems in dispensing of EliA Well even though the new improved Processing Lid (see UniCAP 100 Bulletin 30) is installed, this new spare part might be helpful. This new Optical Sensor Kit, EliA Well Disp. 12-3505-92 is selected Optical Sensors with specifications at the top end.

The reason for having a special spare part for this field of application is that the number of Optical Sensors within the special specification required for EliA Well dispensing is very hard to find at the manufacturers. We strongly recommend being very restrictive when ordering this spare part, due to the limited supply of these Optical Sensors. Only order this Optical Sensor Kit, EliA Well Disp. when having big problems with EliA Well dispensing. Contact person: Mats Tapper 156. ImmunoCAP Holder Disc, 12-3501-06 and Drive Plate 12-3500-71. The specification of the ImmunoCAP Holder Disc (IHD) has been changed due to that in some cases the ImmunoCAP Holder Disc does not fit properly onto the Drive Plate.The reason for the ImmunoCAP Holder Disc not fitting is that the production tools at our manufacturer seem to have been worn over the years. The new specification for the diameter of the hole is 20.67 +- 0.02 mm (old specification was 20.65 +-0.05 mm). All ImmunoCAP Holder Disc, both as Spare Part and assembled in UniCAP 100 instruments are checked based on the new tolerances since the beginning of this year. IHD as spare parts marked 0304 (April 03) are OK, but some IHD before this manufacturing date might be affected by too tight tolerances. Not all IHD in these batches are affected by the too small inner diameter, it might be just a few. Also Drive Plate 12-3500-71 might in some cases be affected by too wide tolerances. This will lead to that in some rare cases the combination of both IHD: s and Drive Plates in the outer ranges of measurements will not fit together. It seems like it can be Drive Plates manufactured from 1996 and later that are affected. The easiest way of checking the Drive Plate is to measure the outer diameter of the center knob 5 mm from the bottom (see picture below). The diameter should be maximum 20.64 mm at this point. Send a fax (+46 18 16 63 31) to Annika Johansson at Customer Service, Export, and report the number of faulty IHD and Drive Plates you have detected. You will receive a credit note for that number. Then you have to order new IHD and Drive Plates. Contact person: Mats Tapper

5 mm

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157. Check Valve 12-3500-67. The Check Valve 12-3500-67 produced in the new white material (from May-02), might in some cases leak, due to some difficulties in assembling the two plastic halves and the membrane inside. The leakage might not be detected right away when assembling the Check Valve into the instrument, but it might appear a few weeks later.

Also one action to take before replacing the Check Valve is to cut the tubings connected to the Check Valve approximately 1 cm due to that the tubings become wider when connected to the tubing connections on the Check Valve. Check Valves with batch number BHPY, BJAO, BKCG, BLKS, BM87 and BMZD produced from the beginning of this year is modified inside to prevent them from leaking.

Batches number from BHPY and later are OK. If you have detected leakage in Check Valves in the new white material produced from May-02 (0205) to May-03 (0305), and also tried cutting the tubing, and it still is leaking, please scrap them. Send a fax (+46 18 16 63 31) to Annika Johansson at Customer Service, Export, and report the number of leaking Check Valves you have detected. You will receive a credit note for that number. Then you have to order new Check Valves. Contact person: Mats Tapper

Bulletin Bulletin 31 May, 2003

154. Important information regarding test fx5.

In UniCAP 100 method Specific IgE there are two tests (fx5 and fx5E) with the following content and composition: Test name Full name fx5 (Japanese content of the mix) (f1, f2, f4, f13,f14) fx5E (European content of the mix) (f1, f2, f3, f4, f13, f14) If the customer selects fx5 without using a barcode reader, and after the assay run prints out a Patient Report, it will be the Japanese Full name printed on the Patient Report. Contact person: Lars Holmqvist

Bulletin

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Bulletin 30 March, 2003

152. Improved Processing Lid 12-3500-58.

The Processing Lid has been improved in terms of ImmunoCAP/EliA Well dispensing and ImmunoCAP/EliA Well transfer. The improvements are made to get a more stable dispensing and transfer of ImmunoCAP/EliA Wells. The dispensing hole is moved closer to the centre to get a more accurate position over the ImmunoCAP Holder Disc. Also the way the ImmunoCAP Dispensing Sensor reflects ImmunoCAP/EliA Wells has been improved. The ImmunoCAP/EliA Well transfer mechanism is also improved in order to get a more distinctive transfer of ImmunoCAP/EliA Wells to the ImmunoCAP Waste Container. The improved Processing Lid is implemented in instruments from S/N 4697, and in spare part Processing Lid cpl. 12-3500-58 from S/N 6429. Processing Lids ordered now are updated. Contact person: Mats Tapper 153. Misspelling of testnames. When importing methods to UniCAP 100 RM the character apostrophe ' in the full name is encoded as ï for the codes below Code w10 Full name Goosefoot, Lamb's quarters shows as Goosefoot, Lambïs quarters Code f286 Full name Mare's milk shows as Mareïs milk Code Rf286 Full name Mare's milk shows as Mareïs milk Work around Export method from UniCAP 100 - Edit full name for w10, f286 and Rf286 use Notepad or WordPad, highlight ï and then generate code 039 (hold down Alt key, enter 039 on the numerical keyboard and release Alt key) - Import method in UniCAP 100 RM. Contact person: Patric Ejerfeldt

Bulletin Bulletin 29 November 19, 2002

146. Information regarding latest instrument SW 2.06.

A minor problem has occurred on the instruments after upgrading to SW 2.06. Instruments used with a Barcode reader seems to be a bit slower than prior to the upgrade. The reason is the new log file, OPEVENT*.LOG (Operator Event Log), implemented in SW 2.06. If the instrument has a very fragmented Hard Disc it can be some delays when data is written into the new log, since data is written into this log in every Barcode reading. Remedy if a problem like this occur: Run a Defrag/Scandisk. If this does not help, switch off the OPEVENT*.LOG in 6.8.4.4. After switching off the log, the text row in the display shall be: OpEvent Log Enabled: NO? Contact person: Mats Tapper

147. Instruction on connection of COM 1 & COM 2 on 486 CPU Board, 12-3505-21.

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Unfortunately an instruction on how the COM cables on the latest 486 CPU Board shall be connected has been missing. New cables are delivered together with the CPU Board, and the instruction is included in spare part, CPU Board, 12-3505-21 from now on. Below you see the location of the two connectors on the CPU Board.

Contact person: Mats Tapper

148. UniCAP 100 RM using Windows XP

To get proper behaviour when running UniCAP 100 RM in Windows XP, set the display as follows: Click on the “Start” button, go to “Settings”- “Control Panel”- “Display”- “Appearance”- “Scheme”, select Windows Classic (NOT Windows XP Style).

Contact person: Patric Ejerfeldt

149. Pharmacia CAP System/UniCAP CheckCAP, 12-3403-14

The number of CheckCAP in the package has been changed from 100 pcs. to 50 pcs.


COM 2

COM 1

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150. Processing Lid ribbon flat cable and connectors

It has shown over the years that the ribbon flat cable from the Processing Lid rub against the recycling mark on the inside of the Front Cover and gets worn, which may lead to a cable breakdown. It may also lead to that the core of the cable get exposed which might lead to a short circuit. To prevent this from happen a piece of tape should be applied on the inside of the Front Cover to cover the recycling mark. The tape is applied in production on instruments from S/N 4560. Also spare part Front Cover, 12-3500-80 is updated with the tape from September-02. Sheets of tape (one sheet is enough for 5-6 instruments) are available to order from Mats Tapper. The size of the piece of tape shall be 70x100 mm. The connector of the ribbon cable might sometimes have a tendency to disconnect after a number of times opening and closing the Processing Lid. To prevent this from happening you can secure the two connectors to each other with one or two cable ties. The implementation of the cable ties on the ribbon cable connectors was made from S/N 4215 in production. See picture below where the piece of tape should be applied.

151. Power Supply, 12-3500-41

It has been discovered in production that a number of Power Supply, 12-3500-41 has a defect in the screw threads on the screw terminal. The screws are in some cases impossible to unscrew, which causes a problem when replacing the Power Supply Cable. This problem can be related to instrument with S/N between 4400 and 4450 (except 4429, which has already been modified). Also spare part Power Supply, 12-3500-41 might be affected. It is recommended to bring an extra spare part, Power Supply, 12-3500-41 (that you have checked is OK) along when visiting a customer. In case you find a Power Supply with the faulty screw threads, please fill in a complaint form and send it to Diagnostics, Complaints.


14+-2 mm


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Fig 1. A faulty board with the resistor missing

Bulletin

Bulletin 28 September 24, 2002

145. Important information regarding Optical Sensor Kit, ImmunoCAP Dispensing, 12-3505-49.

It has been discovered that a number of Lid Interconnection Boards included in Optical Sensor Kit, ImmunoCAP Dispensing, 12-3505-49, have passed through the quality control at our manufacturer with a component missing on the board. The component missing is a resistor named R1. If a faulty board is placed in an instrument it will be discovered immediately since there will be a problem with the following symptom; Temperature LED on the instrument is constantly flashing, the Processing Chamber air temperature is abnormally low. The reason could be that this resistor is missing. This information is sent out to you to give you a chance to check your stock of Optical Sensor Kit, ImmunoCAP Dispensing and replace any faulty ones. All Optical Sensor Kit, ImmunoCAP Dispensing in central stock have been inspected. The pictures below shows the difference between a correct board and a faulty one.


Fig 1. A correct board. Fig 2. A faulty board with missing resistor marked.

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Bulletin Bulletin 27 June 28, 2002

142. New spare part. Power Supply Cable, 12-3505-81

The investigation around problems with primarely new instruments stopping during assay (Display Freezes), startup problems, problem reading from Floppy Drive, the date in the instrument changed, resetting problems shows that a a part of the problem is the cable between the Power Supply Board and Power Board. The connector connected to the Power Supply is affected by the current that goes through it and becomes hot since the wires and connector pins seem to be undersized. This will lead to poor contact. Especially the +5V is sensitive since all logics and electronics is using the +5V. The reason why we see this now is due to the new CPU Board, new faster hard disks etc. which has lead to higher power consumption. In the new spare part the dimension of the wires is increased and instead of a connector the wires will be connected directly to the Power Supply screw terminals with cable clips. Contact person: Mats Tapper

143. New improved Check Valve, 12-3500-67 The material in Check Valve, 12-3500-67 has been changed. The new material is more flexible and therefore the risk of cracking is more or less eliminated. In the old Check Valve you could often see cracks by the screw holes which lead to leakage and subsequent error messages. Contact person: Mats Tapper

144. New improved Sealing Cloth, 12-3505-24

The material in Sealing Cloth, 12-3505-24 has been changed. The reason for the change is that the old material had a tendency to crack after a few years which can affect the temperature regulation in the Processing Chamber.


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Bulletin Bulletin 26 May 17, 2002

137. New tools required.

In the progress of modernizing and rationalizing production, some Phillips screws have been replaced with Torx screws. This means that you have to expand your tool assortment to be able to service the instrument. The screw sizes replaced for the moment are M4, but in the future there may be other dimensions of screws replaced with Torx. The Torx tool sizes you need now and for the future : TX 6 = M 2 TX 8 = M 2.5 TX 9 = M 3 TX 20 = M 4-M 5 TX 30 = M 6-M 7 Contact person: Mats Tapper

138. Improved ImmunoCAP Carrier Holder. 12-3505-37. The design of the ImmunoCAP Carrier Holder has been improved. A case which is fitted outside the Holder has been added. This should make it more or less impossible to turn the ImmunoCAP Carrier while inserting it in the Holder (if it is turned, which is very, very hard, it is most likely the ImmunoCAP Carrier that breaks and not the Holder). The added case is making it impossible for the slits to bend outwards from the Holder, which is the physical direction in which they will move if a carrier is turned (this is what is causing the ImmunoCAP Carrier Holders to break). Contact person: Mats Tapper

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140. Wash and Pipetting steps in Elia process

Below is the wash and pipetting steps for EliA procedure in UniCAP100 software version 2.00 briefly described. For calculation of the given volumes the following assumptions were made: Pipette-wash volume: 600 µl (300 µl inside + 300 µl outside) per stroke; Wash-rake volume: 560 µl (4 * 140 µl) per stroke; Fluorometer cleaning volume: 400µl per stroke.

Init Process chamber

Possible remaining liquid from an aborted run before is aspirated from process chamber Chamber filled with approx. 11.2 ml rinse to have high humidity in chamber to avoid drying out during assay

Prewash

No prewash is done (prewash option is already built into the software) Total waiting time for optional step: 52.5 sec

Sample pipetting

Before first pipetting the pipette is washed with 15 ml wash solution (to avoid carry over from predilution) Pipette tip to position high up above sample tube Aspirates 25 µl air Goes down to sample surface Stops at contact (0.5 - 0.8 mm below surface) Goes down additionally 1 mm Aspirates 90 µl sample Waits 0.4 s Goes to position high up above sample tube Aspirates 5 µl air Rotates to position above ImmunoCAP (hole in processing lid) Waits 0.3 s Opens the lid of the hole (in the processing lid) Pipette tip goes down into EliA well Dispenses 105 µl Waits 0.3 s Pipette to wash station Wait 0.2 s Pipette is washed on inside and outside with 6.6 ml washing solution After last sample the pipette is washed with 10.2 ml wash to minimize carry over to conjugate

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Sample wash

Vacuum on Wait 0.5 sec Step 1 (aspiration of sample): Movement of the washrake close above the EliA well. Wait 0.3 sec Stepwise movement of the washrake to position close to EliA well bottom Wait 0.5 sec Movement of the washrake to a position close above the EliA well. Dispense 2x 135 µl washing solution Wait 5 sec Cycle 1 (aspiration of wash buffer): Wait 0.3 sec Stepwise movement of the washrake to position close to EliA well bottom Wait 0.5 sec Movement of the washrake to a position close above the EliA well. Dispense 2x 135 µl washing solution Wait 5 sec Repeat of cycle 1 Cycle 2 (aspiration of wash buffer and nozzle cleaning): Vacuum off. Dispense 1x 135 µl washing solution Movement of the washrake into the wash buffer, liquid is displaced to the top of the EliA well and cleans the outside of the washrake. Wait 2 sec Vacuum on Movement of the washrake to position close to EliA well bottom Wait 0.5 sec Movement of the washrake to a position close above the EliA well. Dispense 2x 135 µl washing solution Wait 5 sec Repeat of cycle 1 Washrake to home position Vacuum off Wash solution is pumped back (washrake and tubings are emptied)

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Conjugate pipetting Before first pipetting the pipette is washed with 9 ml wash solution (to avoid carry over from sample) Pipette tip goes to position high up above conjugate vial Aspirates 25 µl air Goes down to solution surface Stops at contact (0.5 – 0.8 mm below surface) Aspirates 90 µl conjugate Waits 0.4 s Goes to position high up above conjugate vial Aspirates 5 µl air Rotates to position above EliA well (hole in processing lid) Waits 0.3 s Opens the lid of the hole (in the processing lid) Pipette tip goes down into EliA well Dispenses 105 µl Waits 0.3 s Pipette arm up 2 mm Wait 0.3 s Pipette to wash station Pipette is washed on inside and outside with 1.2 ml washing solution After last conjugate pipetting the pipette is washed with 6 ml wash to avoid contamination of development solution

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Conjugate wash Same as sample wash Wash solution is pumped back (washrake and tubings are emptied) Process chamber is emptied Process chamber is filled with approx. 14 ml rinse solution Rinse solution is pumped back (washrake and tubings are emptied)

Pipetting of development solution

Before first pipetting the pipette is washed with 13.2 ml wash solution. Pipette tip goes to position high up above dev sol vial Aspirates 25 µl air Goes down to solution surface Stops at contact (0.5 – 0.8 mm below surface) Aspirates 90 µl dev sol Waits 0.4 s Goes to position high up above dev sol vial Aspirates 5 µl air Rotates to position above EliA well (hole in processing lid) Opens the lid of the hole (in the processing lid) Pipette tip goes down to EliA well level Dispenses 105 µl Pipette arm up appr. 8 mm (PHCAP1) Aspirates 5 µl air Pipette to wash station Pipette is washed on inside and outside with 0.6 ml wash solution after each dev sol pipetting After last development pipetting the pipette is washed with 9 ml rinse

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Pre-Pipetting of stop solution Before first pipetting the pipette is washed with 16.2 ml rinse solution Pipette tip goes to position high up above stop sol vial Aspirates 15 µl air Goes down to solution surface Stops at contact (0.5 – 0.8 mm below surface) Aspirates 200 µl stop sol Waits 0.6 s Goes to position high up above stop sol vial Rotates to position above Elution well (hole in processing lid) Opens the lid of the hole (in the processing lid) Pipette tip goes down to Elution well level Dispenses 210 µl Waits 1 s Pipette to wash station Pipette is washed on inside and outside with 1.2 ml rinse solution after each Stop sol pipetting

Transfer of Development solution from EliA well to Elution well

Before first pipetting the pipette is washed with 16.2 ml rinse solution. Pipette tip goes to position high up above rinse station Aspirates 25 µl air Waits 0.3 s Rotates to position above EliA well (hole in processing lid) Opens the lid of the hole (in the processing lid) Pipette tip goes down to EliA well level (fixed position) Pipette aspirates 80 µl development solution Waits 0.4 s Pipette dispenses 80 µl development solution Waits 0.5 s Pipette aspirates 80 µl development solution (end of mixing) Waits 0.5 s Rotates to position above Elution well (hole in processing lid) Goes down to solution surface Dispenses 90 µl Pipette to wash station Pipette is washed on inside and outside with 4.2 ml rinse After last transfer pipetting the pipette is washed with 6 ml rinse

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Wash of elution wells

Loops following sequence 52 times: Fill elution well with 1600 µl Rinse (overfill) Wait 8 s End of loop Loops following sequence twice: Loops following sequence 52 times: Aspirate elution well with cuvette Wait 4 s End of loop End of loop Rinse wash rake Rinse pipette Empty Solution system Put all motors in home Position

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Schemes for the sample and conjugate wash in Elia procedure

Graph 1: Scheme for sample wash and conjugate wash in EliA. Wash rake height and vacuum shown. Note that actual timing may differ from values shown above.

Graph 2: scheme for sample wash and conjugate wash in EliA. Wash rake height, liquid volume in EliA well and vacuum shown. Note that actual timing may differ from values shown above.

Contact person: Andreas Walz

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140. Pipette Holder Arm. 12-3500-62 In order to improve the stability of the Pipette arm movement, the design of the Pipette holder arm has been changed. The change is related to how the flexible plate is fastened to the Pipette arm. The Pipette Holder arm spare part has been updated with the new style items. A metallic plate which is replacing the silver tape to hold the wires in the Pipette Holder arm is also included. Wire cover plates can be ordered separately from Mats Tapper. See picture below.

Contact person: Mats Tapper 141. Improved Fluorometer Tubing Clamp and Tubing. Since the PVC Tubing connected to the Cuvette have a tendency to become stiff after a few years, the material has been changed to TYGON (2.1x0.9). Also the Tubing clamp (NOT included in Tubing Kit 12-3500-69) has been changed in order to make the tubing run smoothly as the Cuvette is going down. These improvements are made in order to prevent the Cuvette from “wobble” when going down into the Elution Wells, which may result in high variations in the results. See picture below.


The Tubing Clamp is divided into two clamps screwed together. The uppermost clamp shall be assembled between the “legs” on the lower clamp. The TYGON Tubing shall go through the uppermost clamp.

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Bulletin

Bulletin 25 December 17, 2001

136. UniCAP 100 – factors and dilution

Background:

In UniCAP 100 it is possible to define several factors to get a correct result. This text describes how these factors relate to each other.

Description:

Dilution method = (Defined in “5.2.8.1 Dilution method”) Definition how a sample dilution should be done, used in conjunction with “Method dilution factor” or “Test dilution factor”. PREDILUTED = Sample tube put in UniCAP 100 contains a diluted sample. INSTRUMENT DILUTION = Sample tube put in UniCAP 100 contains an undiluted sample and dilution is done by UniCAP 100 (dilutions above 1/10 needs an empty tube).

Method dilution factor = (Defined in “5.2.8.2 Dilution factor”) Default dilution factor for all tests included in a method. Selected Dilution method uses this factor to perform dilutions and result calculations (1 = NO dilution).

Test dilution factor = (Defined in “5.2.7.2.14 Dilution factor”) One dilution factor set for each test, if this factor is >1 it overrides the “Method dilution factor”.

Test concentration factor = (Defined in “5.2.7.2.10 Concentration factor”) One conversion factor, converting result to the concentration units defined in Report Type. (e.g. in method UniCAP Autoimmunity Specific IgG test tp 1 mg/l = 13 IU/ml --> Test concentration factor = 13). In EliA method this factor is used to re-calculate the result because El-G calibration curve is developed so you do not have to multiply the result with the dilution factor but the UniCAP 100 software is developed to always multiply with the dilution factor. Example: EliA method dilution factor is set to 100 (dilute samples 1:100) and Test concentration factor is set to 0.01 (Calculation: 100*0.01=1).

Batch factor = (Defined in “5.2.7.2.13 Use batch factor”). A batch factor to adjust for coating variations between batches and also converting from µg/l to U/ml or IU/ml, a code for the factor is printed on the ImmunoCAP Carrier/EliA well package label to be entered or read by bar code. There can be one batch factor for each ImmunoCAP Carrier/EliA well loaded, (i.e. several different batch factors within one Assay Run).

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Relationship:

Dilution method and factors: For each sample UniCAP 100 use the defined dilution method in conjunction with a dilution factor (if the “Test dilution factor” is equal to or less than 1 the program uses the “Method dilution factor”, if not it uses the “Test dilution factor”) to perform the dilution and calculate the result (multiply with dilution factor). The “Test concentration factor” converts result to be expressed according to units selected in Report Type or for EliA method converting for the calculation of µg/l. The “batch factor” is used to adjust different batches of EliA wells to have the same “test concentration factor” and/or to convert between different units used. Changes that will affect the result: Example: EliA method test dsDNA. “Dilution method” = instrument dilution, “Test dilution factor” = 10 If the dilution method is changed from instrument-diluted to pre-diluted the samples needs to be diluted before processing them in UniCAP 100 to get a correct result. (The Quality Control EliA ANA Control is ready to use so it shall not be diluted). Dilution description: 1:10 (dilution factor 10) Direct dilution (No empty tube needed) 81 µl diluent + 9µl Sample. 1:100 (dilution factor 100) Two step dilution (Empty tube is needed) 1. 186µl diluent + 21.5µl Sample in empty tube 2. 81 µl diluent + 9µl liquid from step 1 dilution.

The differences from the expected dilution factor (1:10) in the first dilution step are dependent on liquid remaining in the pipette tip and dilution effects in the pipette (air gap is not separating system liquid and diluent 100 % when taking a “large” volume). Contact person: Patric Ejerfeldt

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Bulletin Bulletin 24 October 31, 2001

134. Service Pack 3, EliA batch factor correction (Art.no. 12-3505-70)

Problem Description: When the operator create Assay Runs with EliA method in UniCAP 100? RM and those are sent to the UniCAP 100? instrument, the operator is NOT prompted to enter the batch factor code when loading EliA well and the default batch factor (1) is used to calculate the result which will be wrong.

Service Pack 3 content: A new UniCAP 100? software version (included in Service Pack 3) is developed in order to solve the described problem. Service Pack 3 also includes Service Pack 2, and also new cut off values for the EliA tests U1RNP and Sm.

Service Pack 3 ordering information: Article No. 12-3505-70. Price is 0.01 in local currency. Except for Japan where it is 1 Yen. Orders are placed the ordinary way, i.e. not via FAX. Service Pack 3 is included in UniCAP 100? instrument software from serial No. 4147 Service Pack 3 is included in UniCAP 100? instrument software version 2.00 Upgrade kit. Note! One diskette can be used to upgrade several UniCAP 100? instruments. and Service Pack 3 cannot be installed on UniCAP 100 instrument software version 1.61 It is mandatory to update all EliA customers using UniCAP 100? with Service Pack 3. This also includes customers starting to use EliA products on UniCAP 100?. The reason is to make sure all EliA customers have the same version and avoid problems in the future; so all EliA users are updated if they start using UniCAP 100? RM in the future. For method update of UniCAP 100? RM software see page 9 (point 2-4) in UniCAP 100? RM Reference Manual. We recommend installing Service Pack 3 in conjunction with UniCAP 100? Upgrade. Software version and method version history

Service Pack No

Software version

Method No

Update

1.61 011 1 012 Low, sIgE, new norm dose for Low and

sIgE 2.00 013 2 014 Update AIgG, sIgG, GliG.

New norm dose for AIgG, sIgG and GliG. Assay/Rinse diff limit is set to 0,600

3 2.02 015 EliA RM (batch factor). New cut off for two new EliA Wells (U1RNP and Sm)


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135. Changes in Spare Parts

- 12-3500-47, Rectifier KPBC25-04, UniCAP 100. There have been a number of problems with the cable that connects the Rectifier to the Power board. This cable has not been available as separate spare part or in any spare part kit up to now. Instead we have supplied cables from scrapped units etc. when needed. The cable is now included in 12-3500-47, Rectifier KPBC25-04, UniCAP 100. - 12-3505-11, Bottle Filters with Tubing (2/pack), UniCAP 100 The tubing in the Spare Part 12-3505-11 are of different types and are not that easy to distinguish between. To secure that correct type of tubing is being used, the tubing will be put in separate and marked plastic bags. - 12-3505-35, Filter Wash Station Outlet, UniCAP 100 The spare part 12-3505-35 is now containing 5 filters instead of 1. Also remember this when it comes to this filter: To have easier access to the filter in the future the filter can be moved to a position closer to the Valve Plate. This is already implemented in production of UniCAP 100 instruments. - 12-3505-32, 12-3505-33 and 12-3505-34, Touch up paint, UniCAP 100. The plastic bottles are no longer used as containers for the paint. The reason is that there were problems with the paint drying out. Instead the paint is stored in small bottles of glass. The cap is having a little paintbrush attached to it for ease of use.

Contact person: Magnus Eriksson

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Bulletin Bulletin 23 September 13, 2001

131. Important information regarding ImmunoCAP Carousel Stepper Motor (12-3500-32)

It has been discovered that a number of motors which are defective have been sent out. The Stepper Motors are marked with No.0039 on the label at the rear of it. Only a few motors marked 0039 are defective. The fault is related to the wiring. The wires have been connected the wrong way around leading to that the motor is turning in the wrong direction. This is normally found out when performing the mechanical calibration. If the mechanical calibration is not performed for some reason any results performed in an assay run will be presented as LOW RU since NO ImmunoCAP transfer will take place.

This information is sent out to you to give you a chance to check your stock of stepper motors and replace any defective ones. Information regarding correct motors is given below. All stepper motors at the central stock have been inspected.

This information is also relevant for 12-3500-30 (Stepper Motor, Sample Carousel), 12-3500-31 (Stepper Motor, Pipette Arm Z-movement) and 12-3500-33 (Stepper Motor, Pipette Arm Z-movement) since it is the same type of motor and wiring except for the length of the wires, but we have only seen wrong wiring on 12-3500-32. The pictures below indicate a correctly wired connector for these stepper motors. Figure 1a and 1b. The connector viewed from the side with text (AMP) Figure 2. The connector

viewed from the side without text


132. Vacuum Pump improvements, #1

There have been reports of an increasing amount of Vacuum Pumps that does not start as they should. Therefore we have investigated the possibility of increasing the value of the capacitor in order to make the motor become “stronger”. The verifications we have made with a 2µF capacitor have shown a positive effect on Vacuum Pumps with starting problems. So, if there is a problem with a Vacuum Pump that does not start as it should it is possible to try with replacing the capacitor instead of the whole Vacuum Pump. The Spare part number is 12-3505-45, Capacitor, Vacuum Pump. Vacuum Pumps with 2µF capacitor has been implemented from UniCAP 100 S/N 3467 and Vacuum Pump S/N 3907.


Orange Yellow

Black Red

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133. Vacuum Pump improvements, #2

There have been many complaints regarding leaking Vacuum Pumps lately. We have identified one of the major problems to be the lamellar valves, also called check valve, on the dry side of the Vacuum Pump. It is the rubber thing inside the Membrane houses that looks like a butterfly. We have changed the surface treatment of this component in order to reduce the problems to a minimum. What happened before was that it dried out and thus the airflow was not sealed as expected, leading to leakage. In the following S/N of the Spare Part 12-3500-59, Vacuum Pump the "butterfly" has the new surface treatment, S/N 4235-4247 and 4301 and upwards. The stock of Vacuum Pump Repair kit, 12-3500-64 is also updated. The updated kits have on row two of the label a batch number, week and year, e.g. 2000-43. We will not stop here, because we will continue the investigations regarding the whole pressure/vacuum system to ensure a more secure function in the future.


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UniCAP 100 Bulletin Bulletin 22 April 27, 2001

129. ImmunoCAP Dispensing Sensor

Lately we have improved the ImmunoCAP Dispensing sensor with a more sensitive type which together with an adjustment possibility on the Lid interconnection board will give us a more robust ImmunoCAP dispensing sensor. It is now available as spare part, Optical sensor kit, ImmunoCAP dispensing, 12-3505-49. It consists of the sensor and the modified Lid Interconnection board. An Instruction how to adjust a trim potentiometer on the Lid Interconnection board is also included in the kit

The new ImmunoCAP Dispensing Sensor is implemented in Processing lid from S/N 4810 and UniCAP 100 instrument S/N 3763. The Processing Lids and UniCAP 100 Instruments are correctly adjusted from manufacturer.


130. ImmunoCAP Holder Discs

There has been a problem with the dispensing of EliA wells due to an unfortunate relation between EliA wells and ImmunoCAP Holder Discs. The reason is that the EliA wells has been produced at its outer end of the width tolerance specification and the ImmunoCAP Holder Discs wash position holes at its inner end of the tolerance specification. This has in some cases lead to EliA well dispensing errors. The ImmunoCAP Holder discs with holes at inner tolerance has a production date of March 2000 and later. Please scrap those if you have instruments running EliA method in your country. All ImmunoCAP Holder Discs we have on stock for the moment is however prepared in order to function properly with the EliA wells as well. The prepared ImmunoCAP Holder Disc where the holes has been widened has a blue dot (not green as communicated before) on the underside of it. See picture. The package box for prepared ImmunoCAP Holder Discs is marked with a year and date (the same date as on the ImmunoCAP Holder Disc). The prepared ImmunoCAP Holder Disc is implemented from UniCAP 100 instrument S/N 3900 When the next batch of ImmunoCAP Holder discs is produced the wash position holes will be at the wider end of the specification, i.e. it should work fine with EliA wells. Those ImmunoCAP Holder Discs will not have the blue dot, instead they will be identified with the production date indication which will be communicated to you. The date label on the package box will however remain also in the future. Contact person: Magnus Eriksson

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122. New Pipette

The new Pipette is now available to order. The order no. is 12-3505-28, Pipette, ver.2. Since the preheating part of the Pipette will be removed there will be a considerable reduction of the price. The new Pipette is not the one and only solver of problems that may exist. However, there are a number of improvements which we believe all to all will give a positive effect. The level sensor tip is made in a metal with “memory”, i.e. less risk of lasting deformations. The surface treatment has been improved. This together with a coating of the electrodes will improve the conductivity and resistiveness against corrosion. This will give us a more robust Pipette. It will NOT be mandatory to update to the new Pipette. The recommendation will be as today, to replace it at preventive maintenance (if applicable) or when suspecting problems with it. There is an instruction included in the Pipette package that gives information regarding some settings in UniCAP 100 instrument software ver. 1.61 required to be performed when changing to the new type of Pipette.


123. QC setup with several allergens and one QC vial.

If several allergens are going to be used as QC for one method and you only would like to load one QC-vial, the procedure below should be followed. It is however advisable to print out the different QC-logs before any of the procedures below are carried out. That is since the existing QC’s will disappear. Please note! If UniCAP 100 RM is used the change must only be done in UniCAP 100 RM, not in the instrument. UniCAP 100 RM will update the instrument with the changes. Proceed as below for UniCAP 100 Instrument QC setup: Go to 6.Install/Service Go to 6.1 Login/Logout and login as a Pharmacia user. Go to 5.Method Go to 5.2 Edit method and select method. Go to 5.2.9.Quality Control. Go to 5.2.9.2.Edit QC and select the QC. Go to 5.2.9.2.2.Identity. In above menu item type the same identity as the other QC’s are defined as. Make sure that the method is saved with the new settings. Proceed as below for a new UniCAP 100 RM QC setup: Go to More Go to Authority and login as a Pharmacia User Go to Methods Select the method and select Open Go to the Quality Control window and select New or Open In the field Identity write the same name for each test that the QC should be defined for. Please note! If the customer for the moment is using one QC vial per test those QC logs will disappear when the Identity (name) is changed. So, it is advisable to print out the QC logs before the Identity is changed.

Contact person: Lars Holmqvist

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124. Cleaning under drive plate

To avoid crystals etc. from getting stuck under the Drive Plate it is important to perform all steps included in the Daily Maintenance procedure. If the Drive Plate is not turning smoothly it could lead to problems when dispensing ImmunoCAP or system liquids. To make it easier to remove the Drive Plate, the Drive Plate shaft can be changed to the new type, (described in UniCAP 100 Bulletin #8, item 51). The design of the new shaft has been slightly changed in order to make sure it does not turn when the Drive Plate is removed and replaced. The change consist of that longitudinal score lines has been added to the shaft. The part number remains the same, 12-3500-72.


125. UniCAP 100 RM – Default method setting

A method with a method number higher than 9 can not be defined as a default method. This will be corrected in the next software version of UniCAP 100 RM.


126. UniCAP 100 RM; QC setup, If Laboratory Test Name differ from Test Name

Problem description: If the Laboratory Test Name is changed to something that differs from the Test Name in the QC setup, it will not be possible to see View/Print the QC-log for actual test. Solution: Suggested work around if the customer have changed the Laboratory Test Name to a name that differs from the Test Name in the QC-setup: When it is needed to View/Print the QC information proceed as follow: 1. Log in (More, Authority) 2. Open the actual method and change the Laboratory Test Name to the same name as

the Test Name. (More, Methods) 3. Save the change. 4. Go to the QC-log (QC) and it will be possible to View/Print the actual QC. 5. Open the actual method and change the Laboratory Test Name to the previous name.

(More, Methods) 6. Save the change. Please note! This problem only occurs if the customer have changed the Laboratory Test Name to a name that differs from the Test Name in the QC-setup. Corrective action: We will correct this in a coming software version.


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127. UniCAP Autoimmunity – New method installation and function.

Background: When two methods are using the same conjugate (UniCAP Specific IgG and UniCAP Autoimmunity sIgG) it accidentally happens that the two kits (that has the same conjugate) have different calibration codes. Since the naming of the two conjugates is the same in their respective method setup, the UniCAP 100 instrument will only ask for one of the methods conjugate and code and not the other methods conjugate and code during loading of reagents. Since the calibration code will be missing for one of the methods it will be impossible to establish a calibration curve or to use curve controls for it. Solution: Immediate workaround: Give the UniCAP Autoimmunity sIgG conjugate a unique name in the method setup. In all examples below the conjugate identity is AIgG. Please note! If UniCAP 100 RM is used the change must only be done in UniCAP 100 RM, not in the instrument. UniCAP 100 RM will update the instrument with the changes. Proceed as described below in UniCAP 100 RM. Go to More Go to Authority and login as a Pharmacia User Go to Methods Select the method UniCAP Autoimmunity sIgG and select Open Go to the Reagents window and the field named Identity In the field Identity type AIgG. Make sure that this change is saved and that the UniCAP 100 instrument is updated with this new method setup. Proceed as described below in UniCAP 100 instrument Go to 6.Install/Service Go to 6.1 Login/Logout and login as a Pharmacia user. Go to 5.Method Go to 5.2 Edit method and select method UniCAP Autoimmunity sIgG. Go to 5.2.2.Edit method – Reagents - Conjugate Go to 5.2.2.3.Identity: Type AIgG Make sure that this setting is saved to the method. Long term solution: Long term solution will be to make it possible to run the calibration curve only in one method and then copy it to the other methods using the same calibration curve and conjugate. This will be implemented in a coming software version.


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128. UniCAP 100 RM; Method setup, QC – Log start date with a year 2000 date – Problems to View/Print QC and CC logs.

A software bug has been found in UniCAP 100 RM, in the functions to view/print QC and CC. If a QC/CC log start date has been defined in the method parameter Start date for log print before year 2000 the QC /CC data from assay runs performed in year 2000 will not be displayed in the QC/CC log Corrective action in UniCAP 100 RM: Remove defined date from Start date for log print in the method setup. Step by step instruction: 1. Go to UniCAP 100 RM Main window and select More. 2. Go to the sub window More - Authority 3. Login as a User with the password ”unicap”, or valid password 4. Go to the sub window More – Methods 5. Select the method for the QC/CC you would like to remove the date from 6. Go to Quality Control/Curve Control by clicking on that button in the Method setup

window. 7. Remove the date from the window Start date for log print 8. Exit the Method window and make sure that a connection to the UniCAP 100

instrument is established. There will be a window expressing that the instrument is being updated with new method information. Click OK when a new window is presenting that the update is successfully performed.

If above instruction are followed, the QC/CC data from assay runs performed during the year 2000 will be present in the QC/CC log. As a consequence of the bug it will not be possible, in a correct way, to limit the number of QC/CC observations in the sheward plot, on screen or printed, with the method parameter Start date for log print. Therefore all QC/CC results stored in UniCAP 100 instrument will now be displayed in the QC –CC log in UniCAP 100 RM. Correction: A correction of this bug will be made in a coming software UniCAP 100 instrument: The QC/ CC logs in UniCAP 100 instrument are working correctly. It includes QC/CC data obtained after the millennium shift.


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UniCAP 100 Bulletin Bulletin 20 January 14, 2000

115. New spare part, Outlet Filter of Pipette Rinse Position

The outlet filter of the Pipette Rinse position chamber is now available as spare part. To have easier access to the filter in the future the filter can be moved to a position closer to the Valve Plate. This will also be implemented in production of UniCAP 100 instruments. The article number is: 12-3505-35, Filter, wash station outlet.


116. New cuvette fitting

In order to secure the cuvette better in its position the dimension of the o-ring holding it has been changed. The shaping of the cuvette holder nut has also been changed in order to improve the fastening of the cuvette. If there is a problem where the cuvette is falling down from its position even though the cuvette holder nut is tightened it is advisable to change the o-ring. The dimension of the new o-ring is 1.6 x 2 mm and the material is EPDM. Each marketing company will get a number of o-rings with the new dimension.


117. Cleanup diskette when swapping instruments

When an instrument for instance has been swapped and is to be sent to a new customer there is normally a wish to clean-up the instrument from old assay runs etc. The easiest way to do this is to run an install diskette. An install diskette can be created by converting a UniCAP 100 instrument software upgrade diskette to an install diskette. The install diskette will first delete all UniCAP data (including runs, methods, logs, test lists, etc) on the hard disk and then install new data. The procedure to convert the diskette is the following:

Edit the AUTOEXEC.BAT file of a UniCAP 100 Instrument Software Upgrade disk. Go to the section:

rem --- Set DTYPE to indicate type of Diskette ---

rem set DTYPE=PROD rem set DTYPE=INSTALL set DTYPE=UPGRADE

1. Change the row “set DTYPE=UPGRADE” to “REM set DTYPE=UPGRADE” 2. Change the row “rem set DTYPE=INSTALL” to “set DTYPE=INSTALL”

Save the file. The diskette has now become an INSTALL diskette and should only be used for the purpose of cleaning up. Of course it is possible to change it back to become an UPGRADE diskette again.


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118. Defrag and Scandisk on slow instruments

To prevent the hard disk from becoming fragmented and files from being corrupted it is advisable to run Defrag and Scandisk with surface scan at least on a yearly basis. It is easiest done by using a prepared diskette. The instrument is normally also getting faster when defrag and scandisk has been run. We will send the necessary files together with an instruction to one person per marketing company, which we believe have enough computer/DOS experience to prepare the diskette.


119. Consumption list, wrong volume

When two methods are using the same conjugate, as for example UniCAP Specific IgG and UniCAP Gliadin IgG, only one conjugate vial will be loaded in the Sample carousel. In the Consumption list wrong volume for the conjugate will be presented, since it will calculate with two dead volumes. This will be corrected in a future software version.


120. Patient report printout. See also UniCAP 100 Bulletin # 14 item no. 90

In order to avoid wrong results from being printed on the Patient report it is recommended to disable the function ”Include tests from another run” in the software menu. Proceed as follows: Go to software menu item 3.1.2. Specific Sample? --> Press yes --> The following will appear on the display: Run: (nn) date time? --> Scroll with no and press yes when the correct assay run is found. Then you have to select sample, the display will present the following: Sample ID: nnnnnn? --> Scroll with no and press yes when the correct sample is found. Then you will see the text INCLUDE TESTS FROM ANOTHER RUN? --> Press no. Now it will only be one result printed on the laboratory report and there will no longer be an average value calculated for this patient sample. In a coming software upgrade each Patient ID test result will individually be printed on the Patient Report and no average value will be calculated and printed.


121. When stored calibration curve has status FLAGGED

It is important that our customers are aware of that when a curve has been FLAGGED they have to press the command shift and enter simultaneously in order to continue loading reagents and also in order to get calculated results for the actual assay run. This function is maybe not optimal but it is the best solution. However, the main use of these key pressings is to reduce the risk of starting an assay run accidentally with no valid calibration curve data and consequently no calculated results for the actual method will be printed.


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UniCAP 100 Bulletin Bulletin 19 September 21, 1999

108. Own created methods in relation to upgrades

It is important that you are aware of that an upgrade diskette will not update your customers own created methods. It is also important to be aware of that the UniCAP 100 instrument can only handle up to 15 methods in the software.


109. Touch up paint

Touch up paint is now available to order. The paint is kept in a can with a brush attached to the cap for ease of use. There are three available colors: 12-3505-32 Touch up paint, White, for all white parts of UniCAP 100 12-3505-33 Touch up paint, Dark Gray, for the Rear Panel 12-3505-34 Touch up paint, Light Gray, for the middle casted part including Front Cover


110. ISA Expansion boards

We used to have a limited number of ISA Expansion boards and upon request we have sent one per marketing company to use for Service purposes. With an ISA Expansion board it is possible to connect a VGA Monitor via an ISA bus VGA board to a UniCAP 100 for service purposes. In the beginning of this year we ran out of boards and there has been requests from marketing companies to get more than one ISA Expansion Board. To meet this request we have now produced an additional number of ISA Expansion boards. If you would like to have additional ISA Expansion Boards please order directly from Magnus Eriksson. The price is 800 SEK, which is equal to the production cost.


111. Possible display problems

It has been found out that two tantalum capacitors on the Panel Board have been wrongly polarized due to a fault in the electronic schematics. It has been like this since the start of production of UniCAP 100. It appears as if the capacitors can cope with the voltage in reverse direction without blowing. Instead the capacitance will slowly drop as time goes which in the end can lead to that the DC/DC converter cannot keep the RS232 voltage within specifications. This could lead to disturbances in the communication between the Panel board and CPU board, which could result in strange characters on the display. It could also result in that the Panel hangs, i.e. no response from keyboard or display. If you suspect that this is the problem you should measure the RS232 voltages, this is easiest done on U41 on the Controller Board, pin 8 for the + voltage which should be higher than +5V volt and pin 13 for the – voltage which should be lower than –5 volt. This is not a common problem but is necessary to be aware of. Since those two capacitors are surface mounted you should replace the Panel board if you find out that it is broken. Also make sure the Panel Board boot PROM is version 2.04 or higher. The problem is corrected in production as from UniCAP 100 instrument S/N 2743 and spare parts (12-3500-21 and 12-3500-24) delivered after 1999-01-20.


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112. UniCAP driver (version 2.01) for MasterCAP AM, behaviour

- No sorting of Sample Id.. Sample list is sent in the MasterCAP AM order. - All tests with a dilution factor except 1(< 1 >) is presented in a window where dilution method (Pre or UniCAP 100) for each or several tests have to be selected, before the Sample list is sent to UniCAP 100. - If a result have a process error, it is presented in a window where the result have to be approved before it is stored, or rejected to be available to be run again.


113. UniCAP 100 RM version 4.01

If ALL tests within a request are "skipped" in UniCAP 100, the request is not available to be run again (wrong status setting for the request) Workaround: Manually setting the status to Not Started (More > Request status) for the particular request. Contact person: Patric Ejerfeldt

114. Change on outer label for conjugate kits

The newly introduced change of Calibration Code at the production will have the effect that the Calibration Code will no longer be printed on the outer label of the conjugate kits for the methods UniCAP Total IgE, UniCAP ECP and UniCAP Tryptase. It will only be stated on the conjugate vial label and on the ImmunoCAP carrier label.

These two codes will then be the combination of numbers which will form the Calibration Code that is used in the software and also printed on the Laboratory report.


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100. Distribution of UniCAP 100 instrument software version 1.61/009 and UniCAP 100 RM version 4.01.

UniCAP 100 instrument software 1.61/009 and UniCAP 100 RM version 4.01 are now distributed to all marketing companies. The diskettes has not been sent to the attention of any specific person, it has just been sent together with an ordinary shipment. As indicated in Core Allergy Marketing Info no.8 and no.12 the time before the upgrade must be finished has been prolonged until September 1999 for UniCAP Total IgE and UniCAP ECP and until June 1999 for UniCAP Tryptase.


101. Possible mechanical problem on the new chassis

A new chassis was implemented from UniCAP 100 instrument S/N 2444. It was not of functional reasons the chassis was changed, it was changed because the old casting mould used when producing the chassis was becoming worn. However, due to the tolerancies in the chassis the Sample Carousel can get stuck/loose steps and “Pipette bent…” or “Cannot find…” errors may occur. It is very rare that this happens, but it is good to be aware since it is something which is not really thought of. The picture below indicates where in the Sample Carousel compartment the Sample Carousel may touch the chassis. If the Sample Carousel touch the chassis remove just a little bit (0.5 millimeter) of the part it is touching.


102. Article numbers to use when ordering TG and/or TPO ImmunoCAP

The correct article number for TG ImmunoCAP is 14-4489-35 (3x16 ImmunoCAP)

The correct article number for TPO ImmunoCAP is 14-4490-35 (3x16 ImmunoCAP)

Contact person: Gerhard Kubiczak

The Sample Carousel might touch this bar.

The Sample Carousel might touch at this side of the Opto sensor case.

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103. Use Paper Feed button when loading Printer Paper

When loading Printer paper in UniCAP 100 it is important not to pull out the paper by hand. Use the Paper Feed button on the Keyboard instead. If the paper is pulled out by hand the Printer is easily damaged.


104. Fluorometer Cuvette at a higher position on new instruments

The way the Fluorometer Cuvette is adjusted has been changed a little bit in production. The cuvette is adjusted against a jig where the calibration position is slightly higher than on an Elution Wells Disc. The difference seen when performing the calibration with an Elution Wells Disc according to the description in the UniCAP 100 Service Manual is that the cuvette stops around a millimeter above the Elution Wells Disc. It can be between 20-30 steps difference, which corresponds to 0.66-1 mm. This is normal and does not affect any function or results. There is no danger to perform the calibration with the Elution Wells Disc according to the Service Manual on a new instrument, but it is not necessary.


105. Wash consumption

When preparing Washing solution according to directions for use 548 ml is prepared. In some cases this amount of Washing Solution is not sufficient. This can lead to increased background levels such as increased values for CC-1. Please follow below examples in order to make sure that enough Washing solution volume is prepared for each assay run occasion.

Example 1. If a full assay run with 48 determinations and no instrument dilutions is performed we recommend you to fill 600 ml of Washing solution to the Wash bottle.

Example 2. If a full assay run (21 patient samples + 21 diluent tubes + 3 controls + 2 Curve controls) with instrument dilutions is performed the Washing solution consumption is increased to 825 ml for methods that require instrument dilutions 1:100. In this case we recommend you to fill 900 ml of Washing solution in the Wash bottle.

Our recommendation is that Washing solution is prepared in another bottle and for each run fill the needed volume to the Wash solution bottle of the UniCAP 100 instrument. Please also remember that the Wash and Rinse bottles have to be emptied and rinsed weekly as well as any other bottle used for storage of prepared Washing solution. For further and more detailed information see Core Allergy Marketing Info no.10/99


106. UniCAP 100 RM Y2K compliance

UniCAP 100 RM, Year 2000 compliance is dependent on the date settings in Windows of the PC (control panel > regional settings > date format).

The short date style must include century (year format yyyy), to work properly.


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107. Barcode (package code) for IgA/IgG diluent

Unfortunately the barcode (package code) for the UniCAP Specific IgA/IgG diluent is missing in the article database in the UniCAP 100 instrument. It is the first three characters that is printed under the barcode on the vial label (A3N) that should be entered to the article database in the UniCAP 100 instrument. The software menu point is 6.6 Article Management and you have to be logged in with laboratory password in order to add this article.


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UniCAP 100 Bulletin Bulletin 17 March 26, 1999

99. Additional information regarding UniCAP 100 instrument software version 1.61 and UniCAP 100 RM version 4.01.

There has been some questions and some things that needs to be clearified when it comes to the upgrade to UniCAP 100 instrument software ver. 1.61/009 and UniCAP 100 RM ver. 4.01. a) 1.61/009 implemented from UniCAP 100 instrument software version 1.61/009 was implemented in production as from UniCAP 100 instrument serial number 2785. Instruments with lower serial number were delivered with UniCAP 100 instrument software version 1.51. There will be a number of instrument which have been tested with 1.51 but are delivered with 1.61/009. Those instruments will have an addendum to the test certificate indicating that it has been tested with 1.51 but delivered with 1.61 and that no values in the certificate are affected by that. b) Cal. code on present kits vs 1.61 The present kits where the Conjugate and ImmunoCAP have the same calibration code can be used also when the instrument has been upgraded to 1.61. The cal. code will then be presented as for instance 32/32. c) The upgrade as such will not change status of existing curves. Existing calibration curves will not be set to Not OK just because of the upgrade. The calibration code will automatically be changed from for instance only 32 to 32/32. d) Using SHIFT + ENTER to bypass messages As from ver. 1.61 the way the instrument presents that a selected calibration code does not correspond to an active, available or flagged calibrator curve has been changed. The reason for this is to avoid running assay runs with no valid calibrators. The new messages are: Not the active Calibrators, Press Enter No Calibrators available, Press Enter Calibrators flagged, Press Enter When ENTER is pressed the display where you are asked to enter the cal. code will appear again. Before it was easy to bypass this message by just pressing YES. Now SHIFT + ENTER has to be pressed to bypass this message. Running an assay without active and approved calibrators will not give any calculated results. However, if the calibrators are flagged and SHIFT + ENTER is pressed and the curve controls are OK in the assay, then calculated results will be printed as normal. e) Do not upgrade if an assay run is loaded. It is not advisable to perform an upgrade if there are any assay runs loaded. Make sure all requests have the status Not Started or Evaluated in UniCAP 100 RM before upgrading, and make sure there are no assay runs prepared in the instrument..

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f) Prolonged update time In order to prolong the time you have available to make the updates we will stock UniCAP Total IgE kits with the present calibration code concept. We will stock kits enough to cover a normal consumption until end September 1999. This means that you have until September to perform the mandatory update for UniCAP Total IgE customers. For UniCAP ECP and UniCAP Tryptase we will come back with additional info if we can prolong the availability beyond May 99 and in such case how long these kits will be available. Note that UniCAP Specific IgE is not affected by the software change from a calibration code perspective. g) Scrap all 1.61/008 diskettes. Make sure to scrap old 1.61 diskettes. The diskettes on which the version is indicated as only 1.61 must be scrapped, the article number in the lower left corner of those diskettes is 12-3501-00/07. The diskettes to use are the ones where the version says 1.61/009 and the article number in the lower left corner is 12-3501-00/09 h) No country specific diskettes. As from ver. 1.61 there are no general country/language specific diskettes any longer. Those are integrated in the 1.61 diskette. Do not use old Method diskettes! When the menu and printout language is selected during installation in the menu (6.4.1.) also the test files are translated. Some countries have country specific settings which are also set by means of a menu. The country is selected in menu 6.4.7 Country Settings? (P&U password required). This menu basically does the same as the former country specific method diskettes did. If the country specific settings are needed, they have to be done with version 1.61. Once it is done it is not necessary to do again. (There might be occasions in the future when special method diskettes need to be distributed. Those diskettes will contain all languages that are translated in the instrument.) i) Washing solution consumption When preparing Washing solution according to directions for use 548 ml is prepared. In some cases this amount of Washing Solution is not sufficient. This can lead to increased background levels such as increased values for CC-1. Please follow below examples in order to make sure that enough Washing solution volume is prepared for each assay run occasion.

Example 1. If a full assay run with 48 determinations and no instrument dilutions is performed we recommend you to fill 600 ml of Washing solution to the Wash bottle.

Example 2. If a full assay run (21 patient samples + 21 diluent tubes + 3 controls + 2 Curve controls) with instrument dilutions is performed the Washing solution consumption is increased to 825 ml for methods that require instrument dilutions 1:100. In this case we recommend you to fill 900 ml of Washing solution in the Wash bottle.

Our recommendation is that Washing solution is prepared in another bottle and for each run fill the needed volume to the Wash solution bottle of the UniCAP 100 instrument. Please also remember that the Wash and Rinse bottles have to be emptied and rinsed weekly as well as any other bottle used for storage of prepared Washing solution.

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For further and more detailed information see Core Allergy Marketing Info no.10/99 j) Text for reporting results outside the curve In general the "value" for quantitative below and above will be <the lowest calibrator point and >highest calibrator point. For exampel for UniCAP Specific IgE it will be <0.35 and >100. It is possible to change this default presented text. If dilution is used it will be reported as <lowest calibrator or >highest calibrator (=default presentation). It will no longer be a multiplication of the lowest/highest calibrator point with the dilution factor if the response for a diluted sample were out of the calibration curve range. However, the presentation for UniCAP Specific IgG method differs from this, see UniCAP 100 bulletin #16. k) New norm dose values for UniCAP Specific and Gliadin IgG methods The norm dose values for the UniCAP Specific IgG and UniCAP Gliadin IgG methods are updated. l) Parameter changed in UniCAP 100 RM initializing file The default setting for Database in the General section is changed from 0 to SqlBase (closing the database engine). This can cause error messages when exiting UniCAP 100 RM.(Windows try to close the application before the database is updated). m) Corrected round off problem in UniCAP 100 RM The automatic round off the software did when method parameters were edited has been changed. For instance if the Expected s value for CC-1 in the UniCAP Specific IgG method was edited and the correct value (0.004) was written the software rounded it to 0.00 which resulted to a false disapproval of CC-1. All places in the software with an automatic round off has been checked and where necessary the round off method has been changed. n) Report type problem When adding/editing a test in a method, the selected Report Type was not valid, the test was reported with a different Report Type. (Everything looked OK in UniCAP 100 RM (method/test/report type) but the Report Type was another Report Type). This is now corrected. o) Main frame and Sample ID If a Main Frame import file contained a Sample Id. or a test for a Sample Id. which was already present in UniCAP 100 RM. The program stopped and showed "Database error". This is now corrected. p) For further details on the news in the softwares see UniCAP 100 bulletins #13, 14

and 16. Contact persons: Lars Holmqvist, Patric Ejerfeldt and Magnus Eriksson

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UniCAP 100 Bulletin Bulletin 16 March 17, 1999 98. Autoimmunity News from Uppsala and Freiburg. Background. In UniCAP 100 instrument software version 1.51 the report type for Autoimmunity tests have been as follows: TG: (Referred in the UniCAP 100 instrument as tg ) When the measured concentration of samples and QC:s were less than the lowest calibrator point it was reported as <172 IU/ml and when it was higher values than the highest calibrator point it was reported as >17200 IU/ml The conversion factor for TG is 86. This means that 172 IU/ml corresponds to the lowest calibrator concentration for the method UniCAP Specific IgG, which is 0,02 mg/l.

TPO: (Referred in the UniCAP 100 instrument as tp) When the measured concentration of samples and QC:s were less than the lowest calibrator point it was reported as <20 IU/ml and when it was higher values than the highest calibrator point it was reported as >2000 IU/ml. The conversion factor for TPO is 10. This means that 20 IU/ml corresponds to the lowest calibrator concentration for the method UniCAP Specific IgG, which is 0,02 mg/l.

Present situation in general(UniCAP 100 instrument software version 1.61/009 and UniCAP 100 RM version 4.01). From UniCAP 100 instrument software version 1.61/009 the report type will change. It will be the same presentation for all tests in a method. The presentation is now a free text string. This means that it is possible to change the text and enter what characters or numbers you would like to type, as long as it does not exceed 8 characters. This means that all methods except for UniCAP Specific IgG presents results that is below the lowest calibrator point as <lowest calibrator point and >highest calibrator point. For example in the method UniCAP Specific IgE; <0,35 kU/l and >100 kU/l . The reason for this change in UniCAP 100 instrument software version 1.61 is that strange calculations are done from the software when results from diluted samples are below or above the lowest or highest calibrator point. Due to this it could be wrong interpretation done from what is presented on the laboratory report when a diluted sample is below the lowest calibrator point. It is also an adaption to how this presentation is done in UniCAP 100 RM.

Present situation for Autoimmunity in (UniCAP 100 instrument software version 1.61/009 and UniCAP 100 RM version 4.01). For this method (tg and tp as an application in the method UniCAP Specific IgG) we have decided to present results which are below the lowest calibrator point as Below and for results higher than the highest calibrator point as Above. This means that it will be the above presentation for all tests in the method UniCAP Specific IgG. It is not possible to define something special in this method for TG and TPO because it will then also affect the other UniCAP Specific IgG tests.

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Interpretation of results with the tests ”tg” and ”tp” in the method UniCAP Specific IgG. Type of sample Test Result <lowest/>highest

calibrator point presented from UniCAP 100 Laboratory report and UniCAP 100 RM

Actual value

QC- tgN* tg Below < 172 IU/ml Patient sample tg Below < 172 IU/ml tg Above > 17200 IU/ml QC- tpN* tp Below < 20 IU/ml Patient sample tp Below < 20 IU/ml tp Above > 2000 IU/ml * Quality control Normal for the analytes UniCAP Thyroglobulin / Thyroid Peroxidase IgG Antibodies Control N

Summary This report presentation will remain until the release of the next UniCAP 100 instrument software version. Meanwhile we are working to find a solution for customers that claim that they should have the previous presentation. At this moment it looks like that we can use the extra class texts field for samples that are below the lowest calibrator point. Regarding this issue you are most welcome to contact Lars Holmqvist or Gerhard Kubiczak for further information.

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UniCAP 100 Bulletin Bulletin 15 February 11, 1999

92. New colour of Pipette Wash Station. In order to make it easier to calibrate the pipette and to see what is actually happening in the Pipette Rinse Chamber when the Pipettte is being washed the colour of the wash station has been changed to white. The physical properties of the wash station has not been changed at all so old and new are fully compatible with each other. This was implemented in production from S/N 2694. The spare part (12-3500-73) is also in white colour from now on. Contact person: Magnus Eriksson 93. Better identification of Rinse and Wash bottles. An improvement when it comes to identification of the Rinse and Wash bottles has been implemented. The caps of the bottles has got a sticker (green for Rinse and blue for Wash) in order to make it easier to put back correct cap on correct bottle when the bottles for instance has been rinsed. This was implemented in production from S/N 2728. The stickers are included in the Label Kit, 12-3501-02. Anyhow, since we believe you would like to get a number of stickers for existing instruments we will make it possible for you to order stickers directly from us. We will, however, only allow one order occasion per marketing company and not more than the number of instruments you have. Please send your orders to Lars Holmqvist before February 23. Contact person: Lars Holmqvist 94. Implementation of a weight on the Bottle filters. The weight mentioned in bulletin #14 item 86 has now been implemented in production from UniCAP 100 S/N 2728. The weight is also from now on included in the ”Bottle filters with tubing” spare part, 12-3505-11. So, if you have the problem with a floating filter our advice is that you replace the filter with tubing to one with weight. We will also distribute a limited number of weights to each subsidiary for emergency matters. Contact person: Magnus Eriksson 95. Colour of UniCAP 100 Sample Carousel Cover. From UniCAP 100 S/N 2741 the colour of the Sample Carousel Cover has by accident changed to a little bit yellowish. The Sample carousel cover is however still transparant. We will correct this at our manufacturer as soon as possible and when the corrected Sample Carousel Covers are available we will let you know. Contact person: Lars Holmqvist

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96. Avoid dripping from Check Valve Module on to the Pipette Pump. The Check Valve module is preventing the instrument from beeing flooded when it is switched off. When the instrument is switched off all valves in the valve plate are opened which would lead to a flooded instrument due to the capillary effects (from the Wash/Rinse bottles to the Wash Rake and Pipette) if it wasn’t for the Check Valve module. The Check Valve module is letting air into the system to prevent from capillary effects. However, changes in air pressure due to temperature changes etc. can lead to drops (also due to the capillary effects) from the little air hole between the Wash/Rinse bottle connections on the Check Valve module. This will only happen if the tubings are connected to the Wash/Rinse bottles and there is liquid in the bottles. In order to avoid liquid drops from the Check Valve Module to end up on the Pipette Pump and thereby damaging the Pipette Pump or the opto sensor of the Pipette Pump, it is advisable to lengthen tubing no.38 by approximately 20 millimeters and lead its way on the outside to the left of tubing no.36. Then the drops, if any, will follow that tubing instead. See picture below:


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97. Logo change The new logo has now been implemented in production from UniCAP 100 S/N 2721. As a consequence of the new logo some other changes have also been implemented at the same time. The colour of the Pipette Arm Cover has changed to blue. The branding text U has been added and the position of the logo is changed. See picture below.

The Pipette Arm Cover spare part (12-3500-81) will be changed to the new blue type. Contact person: Magnus Eriksson

New U text

New logo and other position

New colour of Pipette Arm Cover

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UniCAP 100 Bulletin Bulletin 14 January 20, 1999

80. Additional information regarding upgrade to UniCAP 100 instrument software version 1.61.

a) Compatibility with older software versions. UniCAP 100 instrument software version 1.61 can be used to upgrade UniCAP 100 with instrument software version 1.21 or higher loaded.

b) Switch off/on the instrument once before performing the upgrade Since a backup directory (UNI1BAK.161) is created during the upgrade, consisting of the previous software version installation (including all debug log files), it is recommended to switch UniCAP 100 off and on before an upgrade is done in order to delete all old debug log files. With the backup directory present it is possible to reinstall the previous software version and installation. If the instrument has been switched on for a long time (more than two months) the deletion procedure of old debug log files may take a while. It seems as if the display hangs at “Please wait…” (three dots) but it might be necessary to wait half an hour before the deletion procedure is finished and the instrument proceeds with the boot up. When this is done it is advisable to run defrag. Command: defrag c: /f /h (see also UniCAP 100 bulletin no.12 item #75 for more information). c) Check of the age of debug log files With UniCAP 100 instrument software version 1.61 the age of the debug log files will be checked every night. With previous softwares the age of debug log files were only checked when the instrument was booting up. The default age before deletion of debug log files remain at 30 days. d) What is upgraded? From a general point of view when it comes to methods it is only the test files that are upgraded. The new tests are added to the test list. No existing tests are deleted or edited (except if there have been changes).

Step by step description of an upgrade: 1. Previous version is backed up, to directory UNI1BAK.161 2. Article database (barcode codes) and training mode files are deleted 3. New training mode files are copied to the Hard Disk 4. Language and country specific files are copied to the Hard Disk. The test files (*.TST)

for the different languages are also copied. New tests will be added to the test files, no tests will be deleted. When a test file is translated/language changed, the test file will be translated test by test from the existing language.

5. New article database is copied and METHOD.DEF (containing all our default method and test files) and UPDATE directory are added/copied

6. New System Software and MCD Software is copied to the Hard Disk. 7. New MCD is loaded to the RAM and if that is successful the system version file will be

updated. 8. Switch UniCAP 100 off and on. 9. When the instrument is booting up the first time after the upgrade it will proceed with

the upgrade by checking that all previous upgrades (from ver 1.21 and higher) are implemented. It is also checking the test list. The missing tests are added to the list. Practically what it is doing is that the UPDATE directory is checked for new files that does not exist in the DONE directory. If there is a new file in the UPDATE directory this file will be used to upgrade test files, methods etc..

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e) Important information about discrepancies that may occur after an upgrade to

software version 1.61 has been done.

1. The diskette delivered to you contains UniCAP 100 instrument software version 1.61 and the method version is 008.

2. As from ver. 1.61 there are no general country/language specific diskettes any longer.

Those are integrated in the 1.61 diskette. Do not use old Method diskettes! When the menu and printout language is selected during installation in the menu (6.4.1.) also the test files are translated. Some countries have country specific settings which are also set by means of a menu. The country is selected in menu 6.4.7 Country Settings ? (Pharmacia password required). This menu basically does the same as the former country specific method diskettes did. If the country specfic settings is needed, they have to be done with version 1.61. Once it is done it’s not necessary to do it again. (There might be occasions in the future when special method diskettes needs to be distributed. Those diskettes will contain all languages that are translated on the instrument.)

3. When reporting concentration, the presentation of a value outside the measuring range

is presented as “below” or “above” instead of “<the lowest point” and “>the highest point”. (For instance for UniCAP Specific IgE it was <0.35 and >100.) These texts (above and below) is presented after an upgrade to UniCAP 100 instrument software version 1.61 is done ! As from 1.61 it is possible to customize these texts. It is done in Menu 5.2.6.2.6 and 7.

4. The norm dose ranges for the UniCAP Specific IgG method are updated. However, the UniCAP Gliadin IgG method is not updated (though they should have been updated). If your customer is running UniCAP Gliadin IgG the norm dose values must be updated, preferably done by means of the diskette we will send out (see below). Please, wait a few weeks with the update at these customers.

5. A new Method diskette, version 009, containing the changes (“above” and “below” to

“<the lowest point” and “>the highest point”, and the new normdose ranges for UniCAP Gliadin IgG) will be distributed the week starting with January 25. We will send one per marketing company. If you would like to have more please specify the number you need and reply by e-mail to Petra Thomas before January 15.

6. For US market all venoms and drugs will only be reported with concentration for method version 009.

7. All new instruments that will be delivered with software version 1.61 (starting end of

January) will have method version 009 with all corrections implemented. f) Correction of testnames in UniCAP 100 instrument software version 1.61. The following tests are corrected to below testnames: f76 = alpha-lactalbumin f77 = beta-lactoglobulin

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g) Problem with Barcode reader after upgrade to UniCAP 100 instrument software

version 1.61 With software version 1.61 the port usage for COM 3 is by default unfortunately set to “MONITOR”. This leads to a problem with the functionality of the Barcode reader, if connected to UniCAP 100. The implementation of the possibility to connect a Serial Printer required some changes in some files in UniCAP 100 and “MONITOR” was set as default for COM 3. No communication parameters (baud rate, data bits, etc.) are changed during an upgrade but unfortunately the interpretation of the parameters has been changed. However, the customer can change the port usage themselves by logging in with Laboratory Password (UNICAP, if not changed) and entering the Communication parameter menu 6.7, select COM3 and goto item 5. Port Usage. The usage for COM3 will be set to Barcode by means of the diskette described above (Method version 009). There is no such problem with COM1 and COM2. h) Reduction of startup problems and hang ups during Assay Runs. It has been found that accessing a non installed PC-screen can cause some BIOS to hang the CPU Board. Therefore, Method version 009 will switch off the "DEBUG to PC-screen"-flag (see menu 6.8.4.4) and a new AUTOEXEC.BAT will be copied to the instrument where initialization of screen and keyboard are removed. If you are trouble shooting an instrument and have a VGA-board connected you need to activate the “Debug to PC-Screen” flag again (in menu 6.8.4.4). i) Point of time of Error messages notified after completion of assay run.

When instruments have been powered on for a long time (at least two months) the time between the PC clock and the RTC (Real Time Clock) on the Controller Board may differ. The only adjustment of the clocks is done when UniCAP 100 instrument is powered on. Error messages is timed from the PC clock and Assay run calculation time origin from the RTC on the Controller Board. Due to these facts it could happen that the notification time of error messages was presented as a time which was later than the notification time of when the assay run was evaluated and printed. In UniCAP 100 instrument software version 1.61 the different clocks will be synchronized at the time when the assay run is started. Contact persons: Lars Holmqvist, Magnus Eriksson

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81. Expected s for UniCAP IgA/IgG method curve control (cc-1).

When editing above methods and you are trying to see expected s value for curve control (cc-1) you only see the value 0,00 on the display of UniCAP 100 instrument. The reason is that the display only has space for 4 characters in this field. So, the character from the third decimal for this curve control is not displayed. If you would like to see the expected s value you have to export the method to a diskette from the instrument and open the method file in a text editor, like Notepad. Contact person: Lars Holmqvist 82. Importance of using correct Rinse solution

In order to prevent from growth in the tubings and the Valve Plate it is important to use Distilled water as rinse solution. It must be Distilled water, water that has only been deionized must not be used. If there is a problem with growth it is advisable to rinse and empty the rinse bottle every day in connection with the Daily Maintenance. It is also very important to replace the tubing and filter in the bottles according to the Semiannual Maintenance. Contact person: Petra Thomas 83. Big risk of contamination of Development Solution The Development solution is very easily contaminated. At customers with problems, an advice to avoid contamination is to only use the development bottle in two runs and after that waste it. Do not touch the threads of the reagent bottles when the caps are removed or when the reagent bottle is placed in its position. On the threads there might be rests of Conjugate etc. and then it is easily transferred to the Development bottle if the threads are touched leading to contamination. Contaminated reagents can lead to assay variations causing Curve Controls to change the acceptance of Calibration Curves. Contact person: Petra Thomas 84. Waste of sample when an ImmunoCAP is skipped. When an ImmunoCAP is skipped, using the del key during ImmunoCAP loading, the instrument still pipettes the sample (in dummycap). Due to this it will be a waste of sample. This issue will be prioritized among other issues when deciding what the next software version should contain. Due to this we do not know if it will be corrected in the next software version. Contact person: Lars Holmqvist

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85. UniCAP 100 instruments delivered with certificates.

UniCAP 100 instruments with a serial number higher than # 2447 have one page with a Test Certificate UniCAP 100 included in the UniCAP 100 User’s file in chapter 1. This page is placed last in chapter one. But as from UniCAP 100 instrument software version 1.61 the certificate will be moved to the UniCAP 100 Reference Manual last in chapter 1, since UniCAP 100 User’s file will be a spiral bound book, see bulletin #13 point 79. The certificate contains following information:

Part A) Appearance, ImmunoCAP dispensing unit, Pipetting unit, Wash station, Incubation temperature, Display panel, Input voltage 100 and 240 V, Fluorometer check.

Part B) This part contains test results for Electrical safety.

Part C) This part contains test results for the different volumes.

Part D) This part contains test results for precision of assay run results. Contact person: Lars Holmqvist 86. Floating Wash/Rinse bottle filters It has been discovered that under unfortune circumstances the bottle filter in the Wash/Rinse bottle can float up to the surface of the liquid. The change of production method and the material of the filter nut have lead to more porous properties of the filter nut. This together with a bent tubing and air in the tubing can lead to the floating problem. The tubing is delivered on rolls and at the end of a roll the tubing is naturally bent. So, it is important that you check that the filter does not float up to the surface. In order to make sure the bottle filter does not float up to the surface a weight will be used. The material of the weight is acid-resistant stainless steel. We are for the moment finalizing the test with this weight and if no problems are found, i.e. none of the liquids are affected, the weight will be implemented in production in the beginning of 1999. More information will come when the weight has been implemented in production. Contact person: Magnus Eriksson 87. New Spare parts The Black Plug in the middle of the Processing Lid and the Fastening Pad for the Printer Lid are now available as spare parts. The spare part numbers are: 12-3505-27 Fastening Pad, Printer Lid and 12-3505-29 Black Plug, Processing Lid. Both spare parts come in packages of 5. Contact person: Magnus Eriksson 88. Processing Lid Fan There is a small fan inside the Processing Lid circulating the air in order to keep an even temperature throughout the Processing Chamber. If there are problems with unstable temperature, or for instance it takes very long time before the assay is started (”waiting for temperature”) it is a good idea to check that the fan is running. That is done by pushing the little pin on the right side of the underside of the Processing Lid. Contact person: Magnus Eriksson

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89. New design of Elution Wells Disc In order to get rid of the creeping problem a new Elution Wells Disc has been developed. The shape of the Elution Wells has been changed. It is the corners that have been rounded and thereby the capillary effect is obstructed, i.e. it is much more difficult for the liquid to creep out of the wells. It is still very important to perform Daily maintenance in the correct way with the new Elution Wells Disc. The new Elution Wells Disc is fully implemented in production from S/N 2612. There are however some instruments with S/N below 2612 that also have the new type Elution Wells Disc. If it is of interest to know those S/N please contact Magnus. All Elution Wells ordered on the Spare part number (12-3501-07) is of the new type from now on (week 50). The recommendation of replacing the Elution Wells Disc after 100 runs is still valid. Contact person: Magnus Eriksson 90. Patient report printout present an average value from two values of the same

sample ID and test from two run occasions. When 3.1 Print Patient report ? and 3.1.2. Specific Sample? function is used and Include test from another run ? is selected it will be an average value printed from the results that is available in the database (harddisk) for the selected sample ID and test. The average value will be calculated from the two values of the same sample ID and test from two run occasions. If there is a big difference between the assay run results it can in worst case result in wrong interpretation of the result and report wrong result for that patient. However, if one of the results is connected to an ImmunoCAP error (for example Low RU) it will be notified by the instrument. The average value on the Patient report will also be marked with an error flag. This will at least reduce the probability of reporting wrong result if an error has occurred. It will be error information printed on the Laboratory report as well as on the Patient report. (See UniCAP 100 Bulletin #13 for further information.) In next version of UniCAP 100 instrument software it will no longer be the average value presented on the Patient report. Contact person: Lars Holmqvist 91. Run Defrag regularly to minimize problems with the Hard disk In order to minimize fragmentation problems on the Hard Disk it is advisable to regularly run Defrag (Defrag is a DOS program located to the Hard Disk of UniCAP 100, see also UniCAP 100 bulletin # 12, item 75). UniCAP 100 creates a lot of different files during assay runs which are stored on the Hard Disk. After a while the files are spread out all around the Hard Disk, this will slow down the interaction between the rest of the instrument and the Hard Disk and the files/Hard Disk will be fragmented which can lead to a broken Hard Disk. A recommended interval to run Defrag is once every 6 months. A boot up diskette with the Defrag command (defrag c: /f /h) as the only command in Autoexec.bat can be created and kept at the customer who runs it semiannually in connection with semiannual maintenance. Contact person: Magnus Eriksson

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UniCAP 100 Bulletin Bulletin 13 November 11, 1998

Information regarding the UniCAP 100 Instrument software update to version 1.6 and UniCAP 100 RM software update to version 4.0.

As announced at the PMM this spring and at ISM this autumn, a new upgrade of UniCAP 100 instrument software and UniCAP 100 RM is on the way. It is a mandatory upgrade for both the instrument software and UniCAP 100 RM.

The update is due to that we want to use the same ImmunoCAP for Total IgE, ECP and Tryptase as UniCAP 1000. This has implication on the labels of the ImmunoCAP and, as a consequence, on the Calibration Code. Details described later in this Bulletin.

The timeplan is to send diskettes and manuals from Uppsala week 51, around the 15’Th of December. Kits with the new labels will be sent out starting April – 99, so you have time to get familiar to the changes yourself as well as update all customers. The updates have to be made on all instruments before kits with new labels are delivered to the customer. Otherwise they will not be able to run Total IgE, ECP and Tryptase.

Now, there are also other changes implemented in this updated version, of course. There are changes, which have been asked for by you, the users and by us – changes, which we believe you will welcome.

UniCAP 100 instrument software version 1.6 β. β-versions of instrument software 1.6 will be sent out next week to all Marketing Companies, one to each MC. It is important that you are aware of that this version of the software is intended for your internal testing and preparations only and NOT for customer use !

Please, evaluate this β-version of the software ! If you find anything that you believe needs to be corrected – inform us about it, because you might have special customizing or earlier implemented changes to the methods, which we are not aware of. You will receive these diskettes at the same time as we do System Verification here in Uppsala.

UniCAP 100 RM 4.0 β-version β-versions of UniCAP 100 RM are sent to the 5 countries that make translations to local language. They will start translations and test this version of UniCAP 100 RM. We will test the English version. To the rest of you: If you have special reason, β-versions of UniCAP 100 RM 4.0 β can be sent upon request. Contact Patric Ejerfeldt if you would like to have this version.

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Delivery of UniCAP 100 instrument software version 1.6 and UniCAP 100 RM 4.0 and additional manuals. In order to know how many diskettes and manuals we should send to you, we need to have the number of following items for each subsidiary: ♦ Number of UniCAP 100 instrument software version 1.6 ♦ Number of manuals UniCAP 100 User guide and UniCAP 100 Reference manual. (At least one set of manuals / customer) ♦ Number of UniCAP 100 RM version 4.0 ♦ Number of manuals UniCAP 100 RM Reference manual and UniCAP 100 RM Users

guide. (At least one set of manuals / customer) Note ! It is important that you give an immediate answer to Petra Thomas ! 76. News in UniCAP 100 instrument software version 1.6.

Below you will find a list with new and corrected functions in the UniCAP 100 Instrument software. a). Old assay run is reprinted

When a Lab report for an old assay run is reprinted it will now be the status printed that was valid when the assay run was performed. b). Monthly disinfection

When Monthly disinfection 6.9.2 is performed the text ”Weekly rinse started” was presented on the display. With UniCAP 100 Instrument software version 1.6 the text is changed to ”Monthly disinfection started”. c). Maintenance log

A maintenance log (MAINT.LOG) will be added, containing Daily rinse and Monthly disinfection runs. d). Export log files

It will be possible to export log files with User status. The menu point will have following number: 6.11 Export debug files ? That menu point consists of two sub menu points: 6.11.1 Export debug logfiles ? and 6.11.2 Export debug run files ? In 6.11 1 Export debug files the customer will be able to select (Ucdate.LOG) files to be copied per run date. In 6.11.2 Export debug run files the selection of files to be copied is selected per run number. e). System rinse

System rinse, which is the rinse the instrument automatically performs after each assay run, will be accessible from User status with an own menu number: 6.9.4 System rinse ?. This makes it possible for the customer to perform a rinse of the Elution wells disc. The procedure is also extended to contain rinsing of the Wash rake.

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f). Sample carousel calibration

It will be easier to carry out the Sample carousel calibration correctly. (More information will be sent out via a Service Manual Update) g). New tests

New tests in the method UniCAP Specific IgE will be added in the testlist.

Following tests will be added: Rc 202 - Suxamethonium Rc 209 - Chymopapain Rf 334 - Bovine lactoferrin Rf335 - Lupine seed Rf336 - Jujube Rf337 - Sole Rk213 - Pepsin Rt218 - Virginia live oak Rt219 - Paloverde c74 - Gelatin Rf338 - Scallop h). Edit Test panels

It will no longer be possible to Edit Test panels with the command Shift + Enter when you are in Enter request mode. i). Communication parameters

Communication parameters will not be changed when upgrading UniCAP 100 instrument software. j). Error message text changed

A number of Error message text has been changed. (Assay preparation errors) They are listed below:

Not the active Calibrators, Continue ? is now replaced with the text Not the active Calibrators, Press Enter

No Calibrators available, Continue ? is now replaced with the text No Calibrators available, Press Enter

Calibrators flagged, Continue ? is now replaced with the text Calibrators flagged, Press Enter

Note! The above three cases can be by-passed with the command Shift/Enter.

ImmunoCAP LID OPEN, Continue ? is now replaced with the text Processing Lid is not closed, Continue ?

ImmunoCAP LID NOT LOCKED, CONTINUE ? is now replaced with the text Processing Lid is not locked, Continue ?

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All ImmunoCAP loaded manual. is now replaced with the text All ImmunoCAP loaded manually. Sample lid not in position, Continue ? is now replaced with the text Sample Carousel Cover not present, cont ?

Pressure %d hPa, Continue ? is now replaced with the text Pressure too low (%d hPa), Continue ? k). Calculation of the calibration curve

During calculation of the calibration curve there was an acceptance done on the RU values even if it was too big variation within the curve (eg. more than one inflexion point). Due to this the curve was accepted even if it was impossible to calculate concentrations on the calibrator points and thus no calculated concentration was printed. With software version 1.6 the acceptance of the calibration curve will be done after the calibrator points has been evaluated and curve fitting done. It will be no calibrator point calculations done if there are more than 150 Iterations during the curve fitting and there will be an error message printed on the labreport. l). Correction of a bug: Calibration code was missing on the Laboratory report when two methods were using the same conjugate

Calibration codes were missing on the Laboratory report and on the same printout there were no calculated concentration values for the Samples. The reason to this was when two methods were using the same conjugate and had different status on the calibrators. In this case the Calibration code and calculated concentrations was missing on the Laboratory report. This is corrected in UniCAP 100 instrument software version 1.6. m). Correction of a bug: Fullname text for the test i4 in the method UniCAP Specific IgE was placed wrong.

The Fullname text for the tests i3 and i4 was mixed up. In software version 1.6 this is corrected in the testlist for the method UniCAP Specific IgE. n). Four calibration curves

It is now possible to run four calibration curves with 6 calibrators in one assay run. o). FluoroC

If FluoroC run is not approved a print out (ordinary FluoroC printout) will follow and the operator will be prompted to check Stop solution and to add a new vial of FluoroC via the Load and start menu point. p). UniCAP Total IgE Low Range

UniCAP Total IgE Low Range will now report patient results in kU/l instead of kUA/l.

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q). Cut-off will be possible to relate to tests

Cut-off will be possible to relate to tests, not necessarily for a whole method. Up to 20 different class tables can be added. Due to this it will be possible to define three different presentations, for example Autoimmunity test TG and TP. These values are also possible to define for concentrations that differs from the calibrator points. Below are the default values for TG and TP. TG – Negative <172 IU/ml TG – Equivocal 172 – 344 IU/ml TG – Positive >344 IU/ml

TP – Negative <=60 IU/ml TP – Equivocal 60 – 100 IU/ml TP – Positive >= 100 IU/ml

r). Instrument dilution

Instrument dilution and dilution factor 100 will now be default for the methods UniCAP Specific IgA, UniCAP Specific IgG, UniCAP Gliadin IgA and UniCAP Gliadin IgG. This change will be done for every upgrade that is done. If you do not would like to have this setup for your customers you have to inform them how they should change the setup default to predilution instead. Proceed as follows: 1. Go to 6.1 Login/Logout ? 2. Go to Login and type the laboratory password ”unicap” 3. Go to 5.2 Edit method ? and select the method for which you would like to change the type of dilution method. 4. Go to 5.2.8 Unknowns ? 5. Go to 5.2.8.1 Dilution method ? 6. Select ”Predilution” by pressing No until the text ”Predilution” appear on the display. 7. Save the new dilution method to the method and remember to change for all IgA/IgG methods if you would like to have Predilution as default dilution method. s). Select QC samples during entering of requests It will be possible to select QC samples during entering of requests. It will be possible to define a Manual definition for a QC sample in the method setup. This means that you can have three different statuses for a QC sample. INACTIVE – The QC is defined in the method setup and will not be included in assay runs combined with the method where this QC is defined. MANUAL – The QC can be selected during entering request by typing qc, which is similar to how cal is selected today when you would like include Calibrators in the assay run. This means that it is possible to include all QCs that is defined as MANUAL at the time when entering requests. ACTIVE – The QC with this setup will automatically be included in the assay run if the method for where the QC is defined is selected.

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t). Error message related to a result

When there is an error message related to a result there will be a flag. This flag will be a question mark (?) presented on the Laboratory report. On the Laboratory report it will be a question mark (?) beside each RU replicate for which an error has occurred and also beside the mean RU value. In addition it will be a text ”? MEANS THAT AN ERROR MAY HAVE OCCURED! at the end of the laboratory report. On the Patient report there will be a text ”AN ERROR MAY HAVE OCCURED” for each test that has an error message from the Laboratory report. u). New text in the main display window of UniCAP 100 instrument. UniCAP 100 will be displayed instead of only UniCAP in the main display. v). Diluent in Position G

It will be possible to have Diluent in Position G in the Sample carousel. This position for Diluent will by default be used for the IgA and IgG methods. The setup is defined in software menu point 5.2.1.8 Diluent in pos. G ? x). Text for reporting results outside the curve

The text for reporting results outside the curve is changed. If dilution has been used it will be reported as <lowest calibrator or >highest calibrator (=default presentation). It is possible to change this default presented text. It will no longer be a multiplication of the lowest/highest calibrator point with the dilution factor if the response for a diluted sample were out of the calibration curve range. The same presentation will be done if an undiluted patient sample is below or above the measuring range. y). External serial printer

It will be possible to connect an external serial printer. All printouts will be directed to the external printer. In short this means that all three COM ports at the rear of the instrument can be setup for following different usage: PC REMOTE / BARCODE READER / MONITOR / PRINTER. PC REMOTE can be defined for two COM ports and the other devices can only be setup on one port each. During developing of this function a serial printer HP ThinkJet model 2225D was used. In this case following setup was used: Alternative Print Mode EPSON MX 80 / MX 100 Page length 12 Inch Performation Skip No RS – 232C 9600 Baud - 8 Data bits - No Parity - 1 Stop bit - DSR/DTR Handshake

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z). Monthly calibration codes

Monthly calibration codes will now be generated from the lot number. The two last characters in the barcode will be the lot number and this will also become the calibration code. Today the calibration code for UniCAP Total IgE, UniCAP Tryptase and UniCAP ECP is two characters (e.g. 2V), it is a combination of a specific conjugate lot and a specific ImmunoCAP lot. As from 1.6/4.0 the cal code will no longer be the same for the conjugate and the ImmunoCAP. The stored calibration code will be four characters (e.g. A6B8), the lot number of the conjugate and the lot number of the ImmunoCAP linked together. The stored calibration code will be generated from both the conjugate cal code and the ImmunoCAP cal code. The calibration code for remaining methods (Specific IgE, Specific IgA/IgG, Gliadin IgA/IgG, Total IgE Low Range) will be unchanged. This change affects the following if YES is selected for ”Cal code on ImmunoCAP” in the method setup: * all runs and calibration curves will be stored together with a four-character code, e.g. A6B8 * if a calibration run is performed the operator has to type the cal code for the ImmunoCAP in menu ”Load ImmunoCAP” * printouts of laboratory report, calibrators and overlay plot will show both the conjugate cal code and the ImmounoCAP cal code. * printouts of curve control log, quality control log and run summary will only show the conjugate cal code due to lack of space. * in the method setup ” Cal code on Calibrators” is removed. Contact person: Lars Holmqvist 77. News in UniCAP 100 RM version 4.0

NEWS AND CHANGES IN UNICAP 100 RM VERSION 4.0 FROM VERSION 3.0. 1. Check disk space on hard-disk. To avoid database problems due to insufficient disk space. A function to test how much hard-disk space that is available is implemented. (Help menu on workplace). 2. Y-2000 handled correctly using a four digit format. Imported dates with a two digit format converted to four digit format. 3. Windows NT . The new version is tested with Windows NT v. 4.0. 4. Handling of calibration codes. Equal to the handling in UniCAP 100.

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5. Ini File. Updating of parameters in uc100rm.ini file. 6. Manual. Requst Id. and Requestor Id. Numeric specifications can only handle 15

characters. 7. Communication. Timeouts optimized. 8. Method. 8a. Import (different selections if method exists) Add method, Upgrade method, Upgrade tests and Add tests. 8b. Default dilution for sIgG, sIgA, Gliadin IgG and Gliadin IgA set to 100 instrument dilution. 8c. Import, multiple selection of methods is implemented. 8d. Reporting units for Low Range method changed to kU/L. 8e. Handling diluent in position G of the sample carousel, implemented. 8f. Report type Quantitative Fields Above, Doubtful and Below can only handle 7 characters (correction to avoid error. "Select buffer to small"). 8g. Import, message when using Windows NT corrected. 9. Tests. 9a. Added to Specific IgE method (c74, Rc209, Rf334, Rf335, Rf336, Rf337, Rf338, Rk213, Rt218, Rt219 and Rc202). 9b. Testcodes starting with R sorted alphabetical. 9c. Fullname for i3 and i4 corrected. 9d. Cut-off selection for each test implemented. 10. Mainframe. 10a. Importing instrument dilutions, corrected to handle 5 digits. 10b. Import: Importing already existing request id:s or test not possible. This is

corrected. 11. Request. 11a. Test Panel, Quality Club, Query: Sort order corrected. 11b. Delete test if pre-dilution is changed, corrected. 11c. “duplicate test” viewed incorrectly (some cases) corrected.

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12. Assay Run. Printing Distribution-list error corrected. 13. Get Results. Sorting of Assay Runs reversed (newest at top). 14. Laboratory report. 14a. Message if iterations exceed 150. 14b. Error Messages are connected to Results (confirmation to save results). 15. Curve status. Not affected by editing method parameters (see UniCAP 100). 16. QC. 16a. Selection for Auto-immunity tests implemented. 16b. Y-axis view corrected if concentration is “<0.01”. 16c. QC testname not changeable ( testname disabled). 17. Requestors. Deleting Requestors that still got connections in database not allowed any more. 18. Query.

Problem with different decimal/number delimiters corrected.


78. Updated UniCAP 100 manuals.

UniCAP 100 User's File will be updated according to software 1.6 and renamed to UniCAP 100 User's Guide. A US version of this Guide will be not be done, there will be only one English written UniCAP 100 User's Guide. All other languages will remain. The following changes are made: Chapter 1,2,5,6,7,8 will remain. Chapter 3 and 4 will be moved to the Reference Manual Chapter 9 will be taken away and put into the Product File. Chapter 10 will be removed and made into a separate UniCAP 100 RM User´s Guide packed together with the software. UniCAP 100 User's Guide will be a spiral bound book in size A4. The Reference Manual will also be updated according to software 1.6 and the information from chapter 3 and 4 from the User's File will be added. The Reference Manual will remain a File and there will be no change in number of chapters, just a few changes of chapter names.

Contact person: Petra Thomas

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79. New UniCAP 100 RM manual.

Chapter 10 (User´s Guide UniCAP 100 RM) from UniCAP 100 User´s File is made into a separate UniCAP 100 RM User´s Guide. It will be a spiral bound book in size A5 packed together with the software. Both UniCAP 100 RM User´s Guide and the Reference Manual will be updated according to software 4.0. Contact person: Patric Ejerfeldt

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UniCAP 100 Bulletin Bulletin 12 June 18, 1998 64. Start up of UniCAP 100 after it has been turned off for a longer period. If the instrument has been shut off for more than one month it is important that the UniCAP 100 instrument is turned on at least half a day before the actual assay run is going to be started. This is important to do since the temperature regulating function in the instrument needs to achive stable conditions in order to process the assay run in an optimal way. It is also recommended that an assay run is done with cc:s for optional method for which there are reagents available. This will be an additional check of instrument performance as well as a run in assay. Contact person: Lars Holmqvist 65. Disconnect the Wash/Rinse/Waste tubings before unscrewing the caps. It is important that these tubings are disconnected before the caps are unscrewed. Otherwise the tubing get twisted and also stucked inside the instrument where it cannot be seen. It will give strange assay run results, since for example insufficient wash solution will be distributed if the tubing is twisted or stucked. Contact person: Lars Holmqvist 66. Important to perform all the steps included in the Daily maintenance procedure. It is important to perform all steps included in the Daily maintenance procedure in order to avoid problems with crystals etc. getting stucked under the Drive Plate. In worst cases this could affect the way the Drive Plate is moving and positions for dispensing ImmunoCAPs or dispensing system liquids could be missed. One indication of when there is dirt under the Drive Plate is a strange sound when the Drive Plate is turning. Corrective action: The Drive Plate has to be removed in order to get access to the part of the Process Chamber which is under the Drive Plate. If you have to do this it could be nice to know that it is possible to mount a new Drive Plate Shaft at the same time when you are disassembling these parts. The new spare part has following article number: 12-3500-72 Drive Plate Shaft. If you mount this new Drive plate shaft it will be possible to disassemble the Drive Plate without disassemble the under side of the instrument to remove it. Further information could be read in UniCAP Bulletin # 8 and item # 51. Contact person: Lars Holmqvist 67. Wash volume consumption. It has been observed that some of the UniCAP 100 instruments are consuming more wash solution than 548 ml during one assay run with a full carousel. To assure that all instruments are filled with enough washing solution for an assay run with a full carousel, we recommend the following routine: Fill a bottle with for example enough wash volume for all the runs during one week. Keep that bottle stored in room temperature (The prepared Wash solution is stable one week in room temperature) and fill from that bottle 600 ml in the Wash bottle. By filling 600 ml you assure the Wash volume is sufficient for one assay run with a full carousel with no instrument dilutions requested.

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If instrument dilution is going to be done it will increase the Wash volume consumption. In order to make sure it will be enough Wash volume it is recommended to fill 700 ml in the Wash bottle. Mark the Washbottle for 600 ml and 700 ml. This could be done by measuring 600ml tapwater and pour it into the bottle and mark the obtained upper limit of the water with a waterproof inkpen. Add 100 ml for 700 ml and mark that line the same way as above. Contact person: Lars Holmqvist 68. Statement regarding Instrument dilutions in UniCAP 100. Instrument dilutions are in UniCAP 100 performed according to specifications. The specifications for UniCAP 100 instrument dilutions are defined to be within 80-120% compared to manual dilution. See also previous information in UniCAP 100 Bulletin # 7 item 45. This is also confirmed by customers in several countries using the UniCAP 100 instrument dilution function without experience problems. Contact person: Ondina Klobas-Åsberg 69. Statement regarding ”leaking” Elution wells disc. It has recently been found that two new lot numbers of Elution wells disc are leaking. These lot numbers are one lot produced 9803(March, 1998) and one other produced 9710 (October, 1997). The amount of leakage that was found during investigation at R&D department here in Uppsala was on a level that barely affected the obtained results. However, there should be no leakage and therefore we have started an investigation. The present status for this investigation is that a first action will be done to avoid leakage. The sharp corners in the elution well will be modified. Wells that were modified this way showed no leakage during studies at R&D department in Uppsala. In the meantime there will also be further investigations done regarding material compositions, buffer compositions and production routines. At this stage we still refer to our recommendations from UniCAP bulletin # 8 and item 49. for when it is a good idea to replace the Elution wells disc. We do not recommend that your customers is doing own leakage tests with for example Wash solutions etc. Wash solution will almost destroy the Elution wells disc from a leaking point of view. The intention with the information in UniCAP 100 bulletin # 8 and item 49. was to inform marketing companies and distributors that it could be a good idea to replace the elution wells disc if there were problems with the results and also if they have been used for at least 80-100 assay runs.

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70. UniCAP 100 RM Software Upgrade explanation. To clearify Upgrade versus new Installation selection when upgrading UniCAP 100 RM, we will present this additional information below. In the UniCAP Setup Options window.

If you select ”Upgrade existing installation”. The database is not changed, meaning that new methods and new test in an already existing method(s) will not be added. The uc100rm.ini file is not changed either so new parameter(s) will not be added. To update methods and tests follow the instruction below.

Before upgrading UniCAP 100 RM software: Upgrade instrument software (A new version of UniCAP 100 instrument software have a corresponding version of UniCAP 100 RM. ”UniCAP 100 1.5 needs UniCAP 100 RM 3.0”). This is important when you Export method from the instrument that should be imported to UniCAP 100 RM. 1. Export methods from UniCAP Instrument ( software menu point 5. 5) to a diskette. After upgrading UniCAP 100 RM software: 2. Import method to UniCAP 100 RM ( More > Methods > File > Import ) 3. Make UniCAP 100 RM Update Instrument Methods ( More > Methods > File > Update Instrument). Contact person: Patric Ejerfeldt 71. Daily Maintenance The Daily Maintenance is a very important action that must be performed once a day in order to prevent instrument disorders. With following information we will recommend that your customers are informed that Daily Maintenance includes the following items: * Daily Rinse * Elution Wells Disc * ImmunoCAP holder Disc * Processing Chamber * Processing Lid

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Daily Rinse, 6.9.1: The Daily Rinse procedure is to prevent from blockage, growth and carry over in the instrument. During Daily Rinse there must be distilled water in the wash position. Empty the wash bottle and fill it with distilled water or replace the wash bottle with a beaker filled with distilled water. Never put the wash tubing into the rinse bottle as this causes small amounts of wash solution in the rinse tubings. In this case the remaining amount of Wash solution in the Wash tubing can contaminate the Rinse solution. That can in worst case give problems with crystals etc. that can cause a stucked Wash rake. Elution Wells Disc: Rinse the Elution Wells Disc with distilled water. Dry it carefully, preferably with compressed air. If not available, leave it to dry upside down on paper. Replace it in the instrument. Dirty Elution Wells Disc can lead to problem with FluoroC and high deviation between replicates. ImmunoCAP Holder Disc: Rinse the ImmunoCAP Holder Disc with distilled water. Dry it carefully, preferably with compressed air. If not available, leave it to dry upside down on paper. Replace it in the instrument. Dirty ImmunoCAP Holder Disc can lead to problem with transfer of ImmunoCAP. Processing Chamber: Daily wipe of any remaining liquid in the processing chamber with a tissue. Processing Lid: The Processing Lid can get sticky on the underside. Wipe it off Daily with a tissue moistened with distilled water. In this way functions such as ImmunoCAP transfer is secured. Contact person: Petra Thomas 72. Weekly Maintenance The Weekly Maintenance is the same procedure as Daily Rinse but with the addition that the Wash and Rinse bottles must be emptied and rinsed before filled with distilled water. This is in order to prevent having too old wash/rinse solution left in the bottles and thus prevent growth. Contact person: Petra Thomas

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73. Updated UniCAP 100 User´s File, English version. During spring version 05 of English UniCAP User´s File was released. This correlates to instrument software 1.5. The updates of translated UniCAP User´s Files are in full progress. Below you will find a short description of the main changes made in English UniCAP User´s File version 05. Please order the complete UniCAP User´s File for further information, code no 12-3501-20.

The following pages are affected in the update:

Page 2,each chapter (2.2,3.2 etc.) UniCAP Instrument software Version 1.5 is added

Page 2.10 A note, regarding the importance not to unscrew the cap from the bottles if the tubings are still connected, is added under The Wash/Rinse/Waste bottles.

Page 3.26 The tests TG and TPO are added on UniCAP Specific IgG.

Page 3.27 New page ! UniCAP Total IgE Low Range. Page 4.7 A correction is made in the flow chart. Two curve controls are out of inner limits:

Result assay run not accepted stored curve is deactivated Page 5.10 The method UniCAP Total IgE Low Range is

added. Page 5.14 TG and TPO are added. These are run using the

method for UniCAP Specific IgG. Page 7.5 A note, regarding the importance not to unscrew

the cap from the bottles if the tubings are still connected, is added under TheWash/Rinse/Waste

and One correction is made: The ImmunoCAP Waste Container has to be

emptied after every run. Page 7.6 Weekly Maintenance is added. The procedure for Weekly Maintenance is the same

as a Daily Rinse but with addition that the Wash and Rinse bottles must be emptied and rinsed before filled with distilled water.

Page 9.4, 9.5 UniCAP Kits are added: Total IgE Low Range 14-4497-35 TG ImmunoCAP 14-4489-01 TPO ImmunoCAP 14-4490-01 Page 9.16 New Page ! Kits needed to run UniCAP TG/TPO Page 9.17 New Page ! Kits needed to run UniCAP Total IgE Low Range

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74. Sending back spare parts. In February a message was sent out to all "Dia managers" regarding the importance of disinfecting instruments prior to returning them to production. It was, however, not mentioned anything about spare parts which are to be returned, for example spare parts connected to complaints. Of course spare parts should be disinfected as well where applicable, i.e. item which has been in contact with human serum. Fill in the "Cleaning report" and attach it to the spare part whenever sending back spare parts to us or production. 75. Defrag of UniCAP 100 Instrument. If the instrument is very slow at start up or is generally felt as slow it might help to run defrag in order to defragment and "clean up" the hard disk. The easiest way to do this is to select DOS Command in the menu, 6.8.11.3. Type defrag c: /f /h followed by ENTER. Press NO to answer the question "Send to Printer?". When it is finished with defrag DOS Command will appear on the display again.

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UniCAP 100 Bulletin Bulletin 11 May 20, 1998 63. NEW ! Telephone number for UniCAP Hot line . Unfortunately we have been forced to change telephone number for UniCAP Hot-line. From week 22 (1998-05-25) the UniCAP Hot-line will have the number 070-319 40 90. If you by some reason do not get in contact with the person carrying the UniCAP Hot-line telephone, please leave a message to the network operator and we will soon call you back. Contact person: Lars Holmqvist

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UniCAP 100 Bulletin Bulletin 10 April 1, 1998 56. Cleaning of the Processing Lid When performing the Daily Maintenance according to UniCAP 100 User´s File it is important to also clean the Processing Lid when cleaning the Processing Chamber. Use a moistened paper cloth and wipe of the under side of the Processing Lid. This is not mentioned in the User´s File but we will update the next version with this information. Contact person: Petra Thomas 57. UniCAP Total IgE Low Range During final testing of the software it was found that wrong unit is presented on the Laboratory report for the method UniCAP Total IgE Low Range, kUA/l. The correct presentation should be kU/l. The corrective action is to do following steps: 1. Login as Pharmacia user in menu point 6.1. Login. 2. Go to software menu point 5.2 Edit Method. 3. Go to menu point 5.2.6.2.1 Reference Curve. 4. The text, Concentration Unit A: kUA/l, will appear on the screen.

Change the text to, Concentration Unit A: kU/l 5. Press Mode a number of times until the question, SAVE CHANGES TO METHOD?

appear on the screen. Press Yes. 6. Now the results from this method will have the unit kU/l.

This will be corrected in coming software versions. Contact person: Lars Holmqvist 58. UniCAP 100 Driver for MasterCAP AM UniCAP 100 Driver for MasterCAP AM together with UniCAP Specific IgG method for the tests tg and tp. Do not use UniCAP 100 Driver in MasterCAP AM in conjuction with UniCAP Specific IgG, test tg and tp. Using UniCAP 100 Driver for MasterCAP AM together with UniCAP Specific IgG method for the tests tg and tp, will cause wrong ”result unit” reporting. Since tg and tp using other units than mg/L and MasterCAP only can handle one ”unit”/method this will cause patient reports from MasterCAP RM to print wrong unit ( mg/L instead of IU/mL). Also when sending results to mainframe, if units are sent this will also result in wrong units ( mg/L instead of IU/mL) Contact person: Patric Ejerfeldt

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59. UniCAP 100 RM compatibility with UniCAP 100 Instrument software. UniCAP 100 RM version 3.0 can only be used together with UniCAP 100 Instrument software version 1.5 or higher. The reason is that the UniCAP 100 Instrument software version 1.5 have new fields in the method setup in order to handle autoimmunity tests. These two fields are Concentration unit and concentration factor. If you have instrument software version 1.5 these two fields are included in the method setup and if you export method files from that instrument and try to update UniCAP 100 RM version 2.0 there is a risk that there will be a crashed database in UniCAP 100 RM 2.0. Contact person: Patric Ejerfeldt 60. Strange sound during Disinfection procedure. Some units seems to have an increasing noise when the pipette is going down to the vial where Disinfectant solution is placed. It is related to that the speed of the movements of the pipette is reduced as from software version 1.42 in combination with mechanical tolerances in the cogwheel of the pipette arm. There is no risk of damaging something due to this noise. At the moment we have no solution to the problem but there are ongoing in-house investigations to solve the problem. Contact person: Lars Holmqvist 61. UniCAP Specific IgE – Test list error. The testlist in the method UniCAP Specific IgE has an error. Below is a presentation of how it looks in the test list: -.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.

i2 White-faced hornet 1 Conc Class i201 Horse bot fly 1 Conc Class i3 Common wasp 1 Conc Class i4 Paper wasp (Yellow jacket) 1 Conc Class

-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-.-. The error is that the text (Yellow jacket) is placed at the row for i4 and it should be placed at the row for i3, Common wasp. The corrective action is to do as follows: 1. Login with Pharmacia password at menu point 6.1.1 Login ?. 2. Go to software menu point 5.2 Edit method ?. 3. Select the method: UniCAP Specific IgE 4. Go to menu point 5.2.7.2. Edit test ? 5. Go to menu point 5.2.7.2.2 Full name? and type Test name: i4 and press Enter 6. Deleting the text within brackets(Yellow jacket) by typing Paper wasp and press Enter 7. Go to menu point 5.2.7.2. Edit test ? 8. Go to menu point 5.2.7.2.2 Full name? and type Test name: i3 and press Enter 9. Edit the Full name for the test i3 by adding the text: Common wasp (Yellow jacket) and press Enter 10. Save changes to the method ! If you have UniCAP 100 RM you could do the editing from that software and then update the UniCAP 100 Instrument. Contact person: Lars Holmqvist

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62. Method diskette Ver. 003 not compatible with ver. 1.42 and later. If Method Diskette Ver. 003 is used together with Instrument software Ver. 1.42 or later a timing conflict will appear. It appear as an incubation error; "inc.3 exceeded with n secs", in the end of a run. The reason is that method disk ver.003 contained an old ASSAY.INT file, this is the file controlling the timing of different steps during the assay. As from Instrument Software Ver. 1.42 the Pipette movement is slower. As a result of the slower movement and the timing in the old ASSAY.INT the "inc.3 exceeded with....." error message appeared. Conclusion: Do not use Method disk ver.003 togehter with UniCAP 100 instrument software ver. 1.42 or later. Contact person: Magnus Eriksson

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UniCAP 100 Bulletin Bulletin 9 February 17, 1998 55. Deliveries of new UniCAP 100 Instruments. From this week (1998-02-18) UniCAP 100 Instruments will be delivered with software version 1.51. Background: During control of produced UniCAP 100 Instruments a number of instruments has failed to pass production control of carry over. It was found that the pipette wash volume was insufficient. The reason to this was that a new material was used in the valve plate. To compensate for the new material it was necessary to extend the time for filling the cavity of the valve plate. This change in the software will remain in future coming software versions. It will not affect old instruments since the volume of the cavity in the valve plate is fixed. Should I update to 1.51? No, it is not nessesary to do. All delivered instruments have passed the production control. Contact person: Magnus Eriksson

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UniCAP 100 Bulletin Bulletin 8 10 February 1998 46. Test panel function in UniCAP 100 Instrument. When 6.2 Test panel function is used in UniCAP 100 Instrument software, two errors have been found. 1. When using the function 6.2.2.2. Delete test, all the tests after the deleted test is no

longer printed on the test panel list, using menu 6.2.4 Print test panel. However the tests exist in the software and will be included when the test panel is entered in the request window.

2. When a testpanel is entered in the request window and the edit function pressing Shift+Enter is performed, it is only possible to edit the first test in the panel.

These two errors will be corrected in future coming software versions. 47. New functions and corrections in UniCAP 100 Instrument software version 1.50 (from version 1.42). New functions: 1. It has been added functionality for Autoimmunity tests tg and tp in UniCAP Specific

IgG method. This means that there are two more columns in the UniCAP 100 software menu point 5.2.7.2. Edit test. These two columns gives possibility to calculate test specific Concentration factor and Concentration unit.

2. It will be possible to read 9 characters long barcode information. 3. UniCAP Total IgE Low Range method is added. Corrections: 1. Simulated data is now available for all included methods. 2. It will be possible to use the barcode reader for ImmunoCAP in the IgA/IgG methods.

(The origin to this problem was that the software could not handle the same test for several methods).

3. Problems with country specific characters from external software UniCAP 100 RM, are

corrected. 4. AGf98 in the Gliadin IgA/IgG methods will be handled similar as methods with only one

test, for example like UniCAP Total IgE, when entering test in the Enter request menu point. AGf98 will automatically appear on the display when above methods are selected.

5. When a Pharmacia control for the methods UniCAP Gliadin IgA/IgG and Specific

IgA/IgG is entered the correct answer is now presented on the labreport. It used to be 100 times too low due to that it was not possible to define a predilution factor for a control.

6. Correction of Expected s value for the curve control in the method UniCAP Tryptase. 7. Results for concentration in Laboratory report increased from 4 digits to 5 digits. 48. New functions and corrections in UniCAP 100 RM v. 3.0 (from version 2.0).

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New Functions: 1. Modifications in Specific IgG method. (One more concentration unit added, concentration factor added, tg and tp tests added) 2. Method priority according to UniCAP 100 instrument implemented. 3. Predilution of QC implemented 4. Results for concentration in laboratory report increased from 4 digits to 5 digits. Corrections: 1. An error (the software hangs) that occurs if a request containing 39 tests is imported

from a mainframe. 2. An error that occurs if a request is entered without a dilution factor the request can not

be saved. A default value (1) is set for dilution (predilution or instrument dilution) according to settings in the method.

3. Communication errors such as ”A serious communication error or Timeout errors that occurs when performing method update, Send Assay Run and Get results. A corrected communication file ”dvcmn.dll file date 9711xx” is implemented.

4. When doing translation or modifications with Gupta Edit Windows the method resource file couldn’t be imported.

5. Unload Assay Run didn’t work if the Assay Run contains an instrument dilutionfactor > 10.

6. Version numbers in windows and database changed (2.0 to 3.0). 7. Wrong Sample volume in consumption list for methods with an id. > 9. 8. Get Results from the UniCAP 100 Instrument, no results were reported to the database for samples with an instrument dilutionfactor > 10. 49. ”Leaking” Elution Wells Disc. It has been observed, both internally in Uppsala and at Marketing Companies, that liquid can creep out of the Elution Wells on Elution Well Discs that has been used for a while. The problems related to this has been CC:s and QC:s out of range and also some bad calibrators. It is not always for the same positions. As a tip, with reference to what we know today, it is a good idea to replace the Elution Wells Disc after 80-100 runs. This matter is now under investigation and there are many thinkable solutions to the problem. But, we do not have the final solution yet. Further information will come when we know more. 50. Strange characters on the display. We have now found what is causing the strange characters at start up. The display can be set to run in either 4- or 8 bit mode. Sometimes the display switch to 4-bit mode in an uncontrolled way causing the strange characters. We are working on a new EPROM which will solve the problem. Meanwhile the recommendation is to let the instrument be switched off for half an hour if strange characters appear on the display. If it still doesn’t help it is better to replace only the display rather than the whole Panel Board. When the EPROM is available more info will be sent out (SIL).

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51. New Drive Plate shaft To make it easier to clean under the Drive Plate a new shaft has been designed. The change is how the Drive plate shaft is fitted in the processing chamber. It is now possible to remove the Drive plate from the top by means of a wrench. The lower part of the shaft is screwed in the hole and then the upper part, locking around pin (the part on which the processing lid is locked) is screwed onto the screw from the top. The new shaft is implemented in production from S/N 2046. From now on also the spare part, 12-3500-72 Drive Plate Shaft, is of the new type. 52. Implementation of the new pipette. New delivery time is Q3 1998. 53. Acceptance of calibration curve and curve controls. When performing a calibration curve the response units of each calibration point are checked according to the curve acceptance limits (Norm Dose limits). If all points are within response limits and the precision between replicates is good, the acceptance printed on the Laboratory Report, will be OK. When each calibrator point has been accepted the Rodbard function will start to calculate the curve as close as possible to the expected curve. After a number of iterations (1-150) the curve is calculated and drawn. Since the calculation of the curve starts after the acceptance of the response units for each calibrator point, a situation can occur where the number of iterations exceed 150 and NO CURVE will be calculated. This can occur when two calibrator points differ from the normdose value in each direction, e.g. one calibrator point is close to the upper normdose limit and the other calibrator point is close to the lower normdose limit. In this situation the Rodbard function can not calculate a curve. The result of the situation is that the Acceptance of the curve will still be stated as OK but no concentration will be calculated for the calibration curve or the unknowns. No information about this is printed on the Laboratory Report. It is only shown as a warning on the display when the Rodbard function exceeds 150 iterations. If this situation occurs, a new calibration curve has to be run. In coming software version this will be corrected. The curve controls are accepted upon concentration, kU/l. Each replicate is measured on the stored calibration curve and the values (kU/l) are checked against given limits. There are two levels of limits for acceptance of curve controls, inner and outer limits. These limits are predefined for each method, see menu 5.4 Print Method. For further information regarding acceptance of curve controls, see UniCAP User´s file chapter 4. 54. UniCAP Tryptase At customers running UniCAP Tryptase it is important that you install/update to UniCAP 100 Instrument software version 1.5. The factor Expected s for the curve control has been changed. This change gives a wider range and it should reduce the number of deactivated calibration curves due to that the curve controls is not accepted by the instrument software.

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UniCAP 100 Bulletin Bulletin 7 22 December 1997 45. The situation for UniCAP 100 Instrument dilutions. A study on UniCAP 100 instrument dilutions has been made in Uppsala in order to verify and reproduce results for dilutions with bad cv:s and reproducibilty values reported from some customer evaluations. The study were performed with the following layout. A total number of seven UniCAP 100 Instruments were used. On each instrument three runs were made. Six different serum were included in the study. Each serum was tested with both instrument and manual dilution with three replicates per dilution type. UniCAP 100 Instrument software version 1.40 was used. The result of the investigation was, a CV within instrument and between runs, between 4 and 7 CV%. The comparison between manual and instrument diluted samples was with a range from 93% and 121%. The conclusion of the investigation is that we have not been able to verify the customer situation. All obtained values were within the expected range. We would also like to inform you that our recommendation not to use UniCAP 100 Instrument dilution function from now on is withdrawn. If you obtain strange values or problems related to that instrument dilutions have been performed, it is a recommendation to send us copies of labreports and also logfiles. It is important that they are copied and sent to us as soon as possible due to that the logs are only stored in the UniCAP 100 Instrument software for 30 days. Corrective actions to take is as follows: 1. Check that UniCAP 100 Instrument is maintained accordingly. Both Daily, Monthly,

Semi annual and Annual. 2. Check pipette volume. 3. Check all mechanical calibrations where the pipette tip is involved. 4. Visual look for cracks on the tefloncover of the pipette tip and also check for the

distance and orientation for the level detector tip. 5. Check pipette function with a FluoroC run.

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Bulletin 6 1 December 1997 37. When UniCAP 100 Instrument is dropping liquid from the pipette tip It is very important that the Spring Plate is smoothly aligned to the Magnetic Plate on the Pipette Arm. Particles on top of the Magnetic Plate can cause bad alignment. If this is the case there is a risk that the pipette arm is not steady when the arm is moving and due to this there could be a lot of drops coming from the pipette. This could also be a reason to that the error message ”Pipette bent” occurs frequently without any obvious reason. Corrective action: Step 1. Remove dirt from the Magnetic Plate and if required the Spring Plate and check if they now are smoothly aligned to each other. Step 2. Check if some of the above mentioned parts are bent. Step 3. If this is the case, you should replace the Pipette Holder Arm, article number: 12-3500-62. NOTE ! You should not try to readjust a bent Flexible Spring Plate or the Magnetic Plate in order to get them smoothly aligned to each other, since it is almost impossible to do that properly. 38. UniCAP 100 RM Communication problems Version 2.0 We have found a communication problem which is related to hardware handshake. Different hardware (bios?) is handling the handshake differently, causing an Error ”Seriuos Communication Error or Timeout Errors” in UniCAP 100 RM. The Error is dependent on the data size, transmission speed and instrument processor. (if the data isn’t too big or the speed isn’t too high the instrument can handle the incoming data without using the handshake) We are working on a solution for this Error. 39. Development solution – Pharmacia CAP System/UniCAP Storage condition 1. Development solution is sensitive to low temperatures. Development solution

freezes at -2 °Celsius. In a refrigerator temperatures close to freezing can be observed close to the cooling part of the refrigerator. To avoid storage temperatures close to freezing it is a good idea to store the development kit away from the cooling part of the refrigerator.

2. Pharmacia & Upjohn Diagnostics will improve storing condition at

stock in Uppsala by adding several temperature sensors. The temperature will be logged by a computer that will alert the operating personnel if the temperature is below + 2 °Celsius.

3. The risk that crystals could affect the results is considered as low.

The risk that crystals could block the pipette tip of UniCAP 100 Instrument is also considered as low due to that the crystals appear in the bottom of the vial.

4. Information about transport temperatures as well as temperature storage condition

at customer site will be sent out from Pharmacia & Upjohn Diagnostics Shipping department.

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Conclusion: A number of actions are ongoing at production in Uppsala to avoid crystals in development solution. A stable temperature and also temperature storage condition within specification +2 - +8 °Celsius is important in order to avoid crystals. 40. Barcode reader information We would like to make a correction referring to UniCAP 100 Bulletin #3 and point # 18. Time consuming to enter AGf98 for every patient for the methods Gliadin IgA/IgG. At the moment there are no Article management for these methods in software version 1.40. With software version 1.5 (coming in February) AGf98 will automatically be chosen when the Gliadin method is selected. The article management for Gliadin IgA/IgG and specific IgA/IgG will be included in software version 1.50. 41. Gliadin IgA/IgG and Specific IgA/IgG. These methods are included in method version 006. Method version 006 and software version 1.40 is loaded in the UniCAP 100 instruments from serial number 1251. 42. FluoroC reagents. It is strongly recommended that the FluoroC reagents (FluoroC and Stop solution) are at room temperature before the FluoroC procedure is started. The recommended time to obtain room temperature is at least 0,5 hour. If FluoroC has not reached room temperature the RU-values will increase for each measuring well. This will result in too high standard deviation and no acceptance for the actual FluoroC run. 43. Wash -, Rinse- and Waste- tubings. When unscrewing the caps of these bottles it is strongly recommended to disconnect the tubings before. It is a risk that the tubings can get twisted inside the instrument and due to this no wash or rinse solution will be dispensed. This will affect the results and also cause a service action. 44. Cuvette, package of 100 This is just to inform you that the Cuvette spare part now has become a package of 100, the part number remains the same, 12-3500-91.

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Bulletin 5 31 October 1997 36. Instrument dilutions We have reason to believe that there might be a problem using instrument dilutions for the methods Gliadin IgG / Gliadin IgA / Specific IgG / Specific IgA. Some customers have run several replicates and obtained big variation between the replicates. We have started an investigation regarding this matter. We need to find out if instrument dilution is a general problem, i.e. independent of method, or if it is a problem specific for the methods above. We also need to find out if it is a problem for all instruments or only for some. The investigation will take some time. We want to inform you so you are aware that this can be a problem. The safest way of handling this, until we know more, is not to start up any more customers on this combination: the above mentioned methods and instrument dilutions. Use manual predilution instead. Further information will come when we have the result of the investigation.

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UniCAP 100 Bulletin Bulletin 4 20 October 1997 28. Strange characters on the display When having problems with strange characters on the display the recommendation is to switch off the instrument and then wait at least 10 seconds before switching it on again. In most cases the strange characters will disappear. If that doesn’t help exchanging the Panel Board normally solves the problem. The source of the problem is that there is no hard-wire reset to the display, so when the instrument is switched on too fast after switch off any character can appear on the display. However, a new display will be implemented shortly which hopefully will handle this problem in a better way. 29. Improved Sample Carousel A number of improvements have been implemented to the Sample Carousel: - The bowl has been modified. In every tube position a hole like a cavity has been implemented in order to straighten up the tubes, especially narrow tubes. - All tube holders are checked before they are fitted in the carousel and there are some extra tube holders packed together with the Sample carousel - The Sample Carousel is completely assembled at the production, i.e. the Centre Screw is in position as well as the Bottle Holders. - An instruction how to assemble the Sample Carousel is included in the Sample Carousel box. Just in case the customer take apart the carousel. - The Sample Carousel Bowl is available as a separate spare part, part number 12-3505-23. Can be used if updating existing instruments. 30. New Pipette delayed - again Of course the unexpected occurred. The testing of the first batch of serial produced pipettes was not approved. Since we are having production problems with the new Pipette it is delayed again. It is difficult at this stage to estimate the time for availability in stock, but some time during Q1 –1998 it should be available. More info in next bulletin. 31. Accessories, article number The Accessories box that comes together with UniCAP 100 has now got it’s own article number. The number is 12-3505-26. 32. Leaving UniCAP 100 turned ON Due to the importance of a stable and uniform temperature in the Processing Chamber it is recommended to always keep UniCAP 100 turned ON. The instrument is designed to be switched on all the time and it does not affect the lifetime of the instrument. This also applies if the UniCAP 100 is being used just once a week. The only time the instrument should be turned off is during a longer break, such as vacation. When the instrument is switched off/on after having being used for a long time the start up make take several minutes due to deletion of old log-files etc.

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33. Important steps for you to take before returning instruments In order to obtain a good safety against transmission of infectious disease, it is very important that the instruments are Disinfected accordingly before they are returned. See UniCAP 100 Reference Manual chapter 6, Monthly disinfection and chapter 12, Cleaning Report. Another important issue is that the instruments are packed according to instructions in Chapter 8 of the UniCAP 100 Reference manual. It is also very important that the UniCAP 100 Cleaning Report is placed on a place in the Package box where it is easy to see and read. The accessories must also be sent together with the instrument. The BIOHAZARD sticker on the Waste Bottle must be removed before shipping. Otherwise the shipment is classified as “DANGEROUS GOODS” and must be shipped accordingly which means unnecessarily high transportation costs. If the BIOHAZARD sticker is applied on the Waste Bottle, or the instrument is not disinfected and not shipped the correct way Pharmacia & Upjohn may be prosecuted for it. 34. Levelling of UniCAP 100 If you are having problems with a jamming ImmunoCAP Carousel it may be because there are rests of Wash solution under the Drive Plate. That may occur if the instrument is not levelled horizontally. If the instrument is leaning too much the liquid may be concentrated to one side in the Processing Chamber which will make it easier for it to creep in under the Drive Plate. So, the recommendation is to make sure the instruments are levelled horizontally. This should be done whenever visiting a customer. Also make sure the feet are not screwed in too far. 35. UniCAP 100 RM Release of new software version UniCAP 100 RM 2.0. Note! This version 2.0 is at this date not released in the US. Remember! If the methods have been changed/customised, (allergen names have been translated, new tests added, Internal Quality Controls implemented, changes of Method names etc.) and you want to keep those method changes/customisations when upgrading to a new version of UniCAP 100 RM: It is important to follow the step by step description below. Before upgrading the software: 1. Export methods from UniCAP Instrument ( software point 5. 5) to a diskette. After upgrading the software: 2. Import method to UniCAP 100 RM ( More > Methods > File > Import ) 3. Make UniCAP 100 RM Update Instrument Methods ( More > Methods > File > Update Instrument). During point 3 an Error (intermittent) can occur: “Serious Communication Error” >click OK. Followed by “Cannot update “method name” “ (click OK). To bypass this (after other method(s) have been updated) do as follows: 1. Export the method(s) which couldn’t be updated from UniCAP 100 RM to a diskette ( More > Methods > File > Export ) 2. Import method(s) in UniCAP 100 Instrument from the diskette instead (software point 5.6).

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u100 Bulletin Bulletin 3 2 September 1997 16. Pharmacia IgA/IgG controls. Pharmacia Specific IgG Control L,M,H and Pharmacia Gliadin IgA/IgG Control L,M,H are prediluted and due to that the obtained value is not presented correctly on the labreport for Gliadin IgA, Gliadin IgG, Specific IgA and Specific IgG if Instrument dilution is selected. The value that is printed on the labreport is 100 times too low. To handle this situation you can either run the controls as a patient sample with predilution factor 100 by pressing shift enter when saving that test for the patient id which in this case is the control. In this case there will be no log for the control and the value is consistent with what is printed in the Directions for use. Another way to handle this could be to enter 1/100 of the values for range max/min that is printed in Directions for use when that control is defined in the Method setup (5.2.9.1.Add QC? and 5.2.9.1.9.Range minimum? and 5.2.9.1.10.Range maximum?). In this case the logged Pharmacia IgA/IgG control value will be 1/100 of what is printed in Directions for use and the LOW control will be rounded to two decimals. 17. QC vials - method placed in the UniCAP 100 Sample carousel. QC vials for one method gives one bottle to load for every method even if it is the same control vial that is used for the different methods.This is a limitation in the software . 18. Time consuming to enter AGf98 for every patient for the methods Gliadin IgA/IgG. Difficult and time consuming to enter AGf98 for every patient. One way to handle this is to set all points under 5.2.7.2. (Edit test AGcal) 4-8. to NO for example in method UniCAP Gliadin IgA. In this example the UniCAP Gliadin IgA will work in the same way as UniCAP Total IgE when entering patient name. When enter is pressed the test will automatically be added. If the dilution factor for selected patient should be edited you must go to 1.4.1.2. Edit Sample Id/Change Test. Another way to enter these tests easier and quicker is to connect a barcode reader to the UniCAP 100 Instrument. 19. Test panel function is not working the intended way for methods where Instrument dilution or Predilution is selected. When using the Test panel function in UniCAP 100 Instrument together with Instrument dilution or Predilution it does not work the intended way. It will only be the first patient in the first method that have a dilution factor printed on the Distribution list. This is a bug that will be corrected with the next UniCAP 100 Instrument software update. Meanwhile we recommend you to avoid using test panels including methods where Instrument dilutions or Predilutions is defined. 20. Recommendation to empty ImmunoCAP Waste container after every assay run. It is recommended to empty the ImmunoCAP Waste Container after every run. If the ImmunoCAP Waste Container is full there is a risk that ImmunoCAP will end up in an Elution Well, which can lead to a cracked Cuvette. Furthermore, to prevent runs from not being measured it is advisable to check the Processing Chamber for pieces of glass after every run/daily rinse, just in case the Cuvette has been broken.

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21. ImmunoCAP transfer problems due to that the feets of UniCAP 100 Instrument is screwed in too long. If the feet of UniCAP 100 are screwed in too long, problems with ImmunoCAP transfer can appear. To prevent this from happening, for instance when the customer is moving the instrument, fit a spacer between the Bottom cover and the black foot. The spacer should be 10 mm long. If the instrument is too low the ImmunoCAP Waste container is pushed upwards and thereby it will press the Processing Lid upwards. This will affect ImmunoCAP transfer which in turn can lead to zero responses ( 0 RU values ). 22. Increased number of cuvettes in cuvette spare part pack. After discussions with most of the market companies we are going to make the Cuvette spare part (code no 12-3500-91) become a pack of 100 instead of today’s pack of 2. As the situation is today we have found out that it is better for all parties. This is just an information that we are going to do this change. Magnus will get back to the Service engineers with more information when the change has been implemented. 23. New pipette is delayed. The new pipette for UniCAP 100 Instrument is delayed until the beginning of November - 97. A first batch of multiple produced pipettes will be delivered to us for testing and validation in September. If those pipettes are approved, the production of the new pipette will start and the estimated time when it will be available in stock is beginning of November - 97. That is if the first batch is approved and nothing unexpected occurs. If you are planning to order a lot of the new pipettes, please let Magnus know. That will make it easier for us to plan the production of pipettes and thereby avoid backorder situation. 24. UniCAP driver version 1.0 in MasterCAP AM and instrument dilutions in UniCAP 100 Instrument with software version 1.40. In version 1.0 of UniCAP driver in MasterCAP AM it is not possible to define that an instrument dilution should be done in the UniCAP 100 Instrument. Dilution factors in MasterCAP AM sample list is considered as a predilution factor for calculations done in UniCAP 100 instrument. 25. Pressure to low. Recently we have got a number of questions regarding the message “Pressure to low. Continue?” which can appear at the ImmunoCAP dispensing step if the system pressure is lower than 1200 hPa. There is a possibility to continue, but you have to be aware of the risk of contamination due to bad pipette wash when the pressure is to low. The lower pressure the bigger risk for contamination. So, as you understand it is not really advisable to continue. For the moment we are working with an external check valve. The external check valve will increase the system pressure a little bit. It is the check valve function in the Valve Plate that is not good enough in some instruments, and therefore might need “replacement”. Instead of exchanging the whole Valve Plate one can install the external check valve if the pressure is too low. It will help in most cases. The External Check Valve spare part is planned to be available in October. An improvement of the Check Valve function in the Valve Plate has been implemented from S/N 1220.

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26. News in UniCAP 100 RM 2.0. 1. Consumption List, volume calculation Corrected 2. Overriding Password Implemented 3. Skipped ImmunoCAP dispensing during instrument loading (Instrument v. 1.4) Implemented 4. Query view Corrected 5. QC calculation Corrected 6. Thousand separator in control panel Corrected 7. Method import, lab testname Corrected 8. Export and Import of Assay Run via diskette Implemented 9. Labreport Print same order as entered Implemented 10. ImmunoCAP errors printed on labreport Implemented 11. Main frame file containing apostrof undersandable error message Implemented 12. Request Find, request by birth faster Corrected 13. Main Frame import status not updated when tests are added to an Request Corrected 14. Backup Restore safety question Implemented 15. Main frame and Datafiles export to A:\ Corrected 16. Requestor, Panels, listbox sort order Corrected 17. Main Frame receive and import listbox updating Corrected 18. QC-log calculation for each lot no. Corrected 19. Age until warning split into two messages Implemented 20. Lists corresponding to lists in UniCAP 100 Implemented 21. Request, Method Instrument dilution Implemented 22. Predilution values have to be the same for a Sample Implemented 23. Dilution changable flag (US) in *.ini file Implemented 24. Method comment included on patient report Corrected 25. Method Phadiatop test s selected automaticly Implemented 26. AQC lot no. changable and default 000000 Implemented 27. Requestor listbox Headers above columns in table Corrected 28. Main frame export comma is not used in fullname Implemented 29. Method uppdate, busy computer visualised on screen Implemented 30. QC no stored curves clearer error message Implemented 31. Startup picture corrected (version no. etc.) Corrected 32. Tryptase method added Implemented 33. *.ini file default values updated Implemented 34. Tested to work on Windows NT Implemented 35. Request status updated when entering more test by Main frame Corrected

27. Wrong Article number in UniCAP 100 Users File. In chapter 9 page 16 (section describing Kits/Articles needed for Maintenance) of UniCAP 100 Users File wrong article number is given for Pharmacia Disinfectant kit. The correct article number should be 10-9282-01.

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Bulletin 2 4 July 1997 9) Certificate from production with instrument? For those of you who would like a certificate to come with the instrument, that can be arranged. The certificate shows the results obtained in the acceptence test at the production plant for each specific instrument. If you want it, send an e-mail to Ondina Klobas-Åsberg. 10) New pipette A new pipette is under construction. Evaluation is planned to be ready August/September 1997. 11) When Pharmacia CAP System a-IgE ImmunoCAP is used as an ImmunoCAP for calibrator curve in UniCAP Specific IgE assay. The situation can give about the same level for the two lowest standardpoints, 0,35 and 0,7kU/L. Example 0,35 - 600 RU and 0,7 - 7-800 RU. The remaining calibrator points are within the specified norm-doze values. The corrective action should be to use UniCAP Specific IgE a-IgE ImmunoCAP when the assay run is performed in UniCAP 100. 12) In the English neutral version of the UniCAP 100 User’s file ( 12-3501-20/04) there are some misprints for the Gliadin/Specific IgA/IgG methods. Note: The texts for following article numbers is changed to below texts. Page 9.12 Kits Needed to Run UniCAP Gliadin IgA UniCAP/Pharmacia CAP System Specific IgA Calibrators 10-9304-01 1 curve Contains: 6 Calibrators 1 Vial of each calibrator, 0,2 mL. UniCAP/Pharmacia CAP System 14-4424-01 IgA/IgG Calibrator ImmunoCAP Contains: 16 ImmunoCAP per carrier UniCAP/Pharmacia CAP System 14-4425-35 Gliadin IgA/IgG ImmunoCAP Contains: 3x16 ImmunoCAP per carrier* * 48 Determinations Page 9.13 Kits Needed to Run UniCAP Gliadin IgG UniCAP/Pharmacia CAP System Specific IgG Calibrators 10-9305-01 1 Curve Contains: 6 Calibrators 1 vial of each calibrator, 0,2 mL

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Kits Needed to Run UniCAP Gliadin IgG continued UniCAP/Pharmacia CAP System IgA/IgG Calibrator ImmunoCAP 14-4424-01 Contains: 16 ImmunoCAP per carrier UniCAP/Pharmacia CAP System Gliadin IgA/IgG ImmunoCAP 14-4425-35 Contains: 3x16 ImmunoCAP per carrier* * 48 Determinations Page 9.14 Kits Needed to Run UniCAP Specific IgA UniCAP/Pharmacia CAP System Specific IgA Calibrators 10-9304-01 1 Curve Contains: 6 Calibrators 1 Vial of each calibrator, 0,2 mL UniCAP/Pharmacia CAP System IgA/IgG Calibrator ImmunoCAP 14-4424-01 Contains: 16 ImmunoCAP per carrier UniCAP/Pharmacia CAP System Antigen ImmunoCAP See IgA/IgG antigen list Contains: 16 or 10 ImmunoCAP per carrier Page 9.15 Kits Needed to Run UniCAP Specific IgG UniCAP/Pharmacia CAP System Specific IgG Calibrators 10-9305-01 1 Curve Contains: 6 Calibrators 1 Vial of each calibrator, 0,2 mL UniCAP/Pharmacia CAP System IgA/IgG Calibrator ImmunoCAP 14-4424-01 Contains: 16 ImmunoCAP per carrier UniCAP/Pharmacia CAP System Antigen ImmunoCAP See IgA/IgG antigen list Contains: 16 or 10 ImmunoCAP per carrier 13) If more methods than 8 is stored in UniCAP 100 Instrument software. If you would like to get to the eighth method you have to press “alt” one more time in order to get the method to be presented on the display. 14) New warning in software ver. 1.4 A new warning message has been implemented in Software version 1.4. When the ImmunoCAP dispensing step starts, the Vacuum Pump is started and the System Pressure is measured after 15 seconds. If the pressure is below 1200 hPa a warning message will be given; “Pressure too low (nn)”. (nn) = the actual pressure in hPa. If the value is too low it is advisable to fix the problem, otherwise there might be contamination problems due to insufficient washing.

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15.) Launch of UniCAP 100 RM version 2.0. The launch is delayed due to that bugs were found during final tests of the software. The new launch date is planned to be at the beginning of September. There will however be a possibility to get master diskettes for making updates when really needed at the beginning of August. Further details will be sent out in the middle of August regarding what is new in that software version compared with the previous one.

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............................................................................................................................................ Bulletin 1 12 June 1997 Remenber to order User’s File and Reference Manuals to update yourselfs! You are only sent manuals for previously distributed instruments free of charge. You have to order for your self by your self. 1) Info lacking in User’s File and Reference Manual: Unfortunately there is always somethings noticed just after the manuals are printed. We have discovered that the following information is lacking in the manuals, and ask you kindly to take the information in this form for the time being. - 50 different test panels can be stored in the instrument. Each panel can consist of up to 46 tests, this can be allergens or other ImmunoCAP. Up to four methods can be stored in one panel. - There is a maximum number of iterations that the software will try for the Rodbard calculation. It is 150 iterations. If it does not succed in curve fitting after 150 iterations it will stop, deciding that something is definately wrong with the curve. The number of iterations are not printed on the labreport, only on the display while its calculating. No calculated concentration values will, however, be printed in this case. - If both curve controls or both replicates of the curve control when only one is used, are flagged this counts the same as if one is outside outer limits. The assay run should not be accepted. The stored curve will be deactivated. 2) Instrument dilutions Dilutions can be made 1:2, 1:5, 1:10, 1:20, 1:50 and 1:100. For dilutions 1:2, 1:5 and 1:10 diluent is first aspirated, then serum and then this is dispenced onto the ImmunoCAP. For dilutions 1:20, 1:50 and 1:100 a first dilution step of 1:10 is made in an empty tube, and mixed by the pipette by aspirating up and down a few times. Second the diluent is aspirated, then dilution 1:10 and third this is dispenced onto the ImmunoCAP. Volumes down to 4 ul are used, with good precision of course. 3) Washing solution volume 1000 ml washing solution is sufficient for 2 full caruosels, 2 x 48 determinations. Each run the instrument is primed once with 30 ml washing solution. If you devide it into more assay runs it will not be sufficient. Note that when instrument dilutions are made the use of washing solution is higher.

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4) The instrument says the carrier is empty sometimes though it’s not This is in most cases due to the software, 1.31, does not sense often enough. Software version 1.40 senses more often and these problem should not occur any longer. Sometime we have noticed that carriers that have been laying horizontal for longer time can be unwilling to fall down . We investigated those carriers but did not find any decects, neither that there was too much glycerol. After shaking the carriers a few times they started to fall down as normal. - Shake it! In some case it can be a defect carrier making the ImmunoCAP diffucult to dispense. If it depends on this, it should be in very few cases. Change of carries should revieal the problem. 4) If more than one method is requested choise of positions for conjugate etc are steered by Method Priority Menu point 5.2.1.7 Method Priority regulates the method order. The method priority thats decided in this menu point will be the order used for both conjugates, calibrators and curve controls. (This is of course a parameter that must never be changed.) 5) No contamination problem with IgG / IgA on UniCAP The way that we garantee no contamination or carry over from samples or other calibrators in the IgG and IgA case is the in point 3 above mentioned Method Priority, which steers the IgG and IgA methods always to be placed first inthe run. In UniCAP no samples are ever placed before calibrators either. (plus efficient washing). 6) Bar code recommendation Basically one can say that the specification for a barcode which is intended to be used on UniCAP 100 is as follows: * The barcode reader must have its own Power Supply. * The type of barcodes that are used on reagents, ImmunoCAP carriers etc. are Code 39 and Code 93. So, the barcode reader used must be able to read at least those type of codes. * For the European market the Bar code readers has to be CE-marked. It is possible to read the Barcode on the ImmunoCAP carrier to identify the allergen. The barcode type used on the carriers is Code 93. We have tested four different barcode readers here and we found out that the most user friendly ones were "United Barcode Industries (UBI) Scanplus SP" and "XP". These barcode readers read Code 39 and code 93 and many other barcodes as well without any problems at all.

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7) Unstable mains voltage? It is known that in some countries the mains net are heavily loaded and therefore the voltage is very unstable. At some places the mains voltage becomes too high and at other it is too low. The mains voltage range specifications for UniCAP 100 is +10% - -15% of what the mains voltage selector is set to. There is no Power recovery facility in UniCAP 100 so if the power is lost for a short while during an assay the assay run will stop and be lost. To prevent the instrument from acting unstable of loosing assays it is recommended to use a UPS (Uninterrupted Power Supply) or in some cases transformers in areas where it is known that the mains voltage is very unstable. UPS specifications: To maintain the continuity of the assay an Online UPS must be used. The UPS must be able to handle up to 550 VA. To be CE marked. 8) UniCAP 100 RM Countdown of free positions The countdown of “Free ImmunoCAP positions” and “Free Sample positions” is not presented correctly. When, for example, UniCAP Specific IgE and UniCAP Total IgE are selected in the Assay Run window the correct number of free ImmunoCAP/sample positions are presented. If you then mark a request that only contains tests for one of the methods, the number of fre ImmunoCAP/sample positions will be presented only for that method. This means that all of a sudden there are more free positions. As soon as a request containing tests for the other method is marked, the nuber of free ImmunoCAP/sample positions will be correct.

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Bulletin - Phadia · Processing Lid (see UniCAP 100 Bulletin 30) is installed, ... Also Drive Plate 12-3500-71 might in some cases be affected by too wide tolerances