Preventive maintenance of SFRI

HEMIX-5 hematology
analyzers

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The HEMIX-5 analyzer, if maintained correctly by the user, will require little maintenance by a service
engineer.
However, certain verification/maintenance procedures must be inspected and maintained
periodically by trained service personnel.

Preventive maintenance frequency depends on the daily workload of the customer.

In the HEMIX-5 User Manual and Service Manual the maintenance interval of moving parts and
syringes is determined as to be done after every 10.000 measurement cycles or twice per year.

As a general rule, at least 1 maintenance per year must be performed to ensure correct functioning
and performance according to specification.

SFRI recommends the following frequency for preventive maintenance by field service:

- for instruments with a workload of up to 100 samples/day

Preventive maintenance by field service should be performed once per year

- for instruments with a workload between 100 and 200 samples/day

Preventive maintenance by field service should be performed 2 times per year

- for instruments with a workload above 200 samples/day

Preventive maintenance by field service should be performed at least 3 times per year

To do list and materials needed for a preventive maintenance intervention

Note: there is no difference between the "6 months" or "1 year" preventive maintenance. The same
maintenance protocol must be followed and applied every time.

Procedure Duration: ~ 2 hours

Tools needed:
- hex screwdrivers (1.5, 2, 2.5, 3, 4)
- torx screwdrivers (2.5, 3)
- philips screwdriver (2)
- small size flat screwdriver
- forceps
- tweezers
- syringe (at least 20ml)

Materials needed:
- silicone grease (P/N: S025302), for dilutor piston
- teflon grease (P/N: S025301), for sliding bars
- bleach (~200ml, SFRI Clair 5.1 )

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 - distilled water, ~500ml
- paper towels
- compressed air
- required protective safety equipment (gloves, lab coat, glasses, etc.)

Spare parts needed:

Maintenance KIT for HEMIX-5

Contains:

Part number Description Quantity

S025210 Washing head HEMIX-5 1
S025213 4/1.8 Tygon tube, 1 m 4
S025214 1,27/2,23 Tygon tube (type: S 54-HL) 1
S025218 0,78/2,38 Tygon sampling tube, 26 cm 1
S025227 Piercing needle 1
S025233 Schott syringe with piston white (mounted, 2 ml) 6
S025235 Schott syringe with piston Black (mounted, 2ml) 2

Suggestion of spare parts which are good to have but not necessary at a PM visit:

- RBC Aperture S025230

- WBC Aperture S025237
- 2/2 Valve with Coil S025206
- 3/2 Valve with Coil S025207
- Pressure sensor board S025112

Preventive Maintenance Protocol:

1. First steps / Checking the state of the analyzer

1.1 turn on the analyzer, run background and check if values are within accepted range
1.2 run self-test (electronic and pneumatic), if it is "successful" check if any value is close to the
accepted limit, if it is "failed" troubleshoot accordingly
1.3 in case of high "laser on" or "laser off" DC level run a background cycle and self-test again. If
DC level values are still high there is no action needed at this point but refer to highlighted
part in section "7. Laser head" for proper troubleshooting/maintenance instructions
1.4 from Service/Adjustments run "pressure offset adjustment" and check if values are within
range; change the pressure sensor board (P/N: S025112) if "offset values cannot be adjusted",
message appears or if adjusted value is very close to the limit (refer to SM for limits)

Next step is to bring the analyzer into the proper state where maintenance procedures can be
performed without the risk of liquids spilling on parts. DO NOT skip the 3 procedures listed below:

1.5 from Service menu run "drain TCU" option; follow instructions in the SM regarding this
procedure

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 1.6 from Service menu run "drain Flow cell" option;
1.7 from Maintenance menu empty all 3 chambers(RBC/PLT, WBC, MIX)

At this point maintenance of parts can be started. Open the front cover and remove side covers of
the analyzer.

Inspect:

2. Valves
2.1 check for any dirt or deposit in the valve; if necessary clean inside of valve by pushing DI
water or bleach through it by means of a syringe
2.2 if any sign show that liquid spilled on the valve remove the valve head to see if liquid got also
in the coil, if so, replace the coil.
2.3 activate each valve from service menu; if switching of valve isn’t firm(smooth movement of
membrane) try to clean it or replace the valve head
2.4 check the vent nozzle on valve #5 to be free of dust or any deposit; clean it with DI water if
necessary
2.5 special attention on valve #2: this valve and related tubing must be clean. In case of dirty
valve/tubing, flow of laser waste through valve is restricted and it has direct influence on
optical counts(!) Replace the valve and/or tubing if necessary.
2.6 special attention on valves #34 and #35 as well; these valves and the related tubing must also
be clean and free of any deposit. Replace the valve and/or tubing if necessary.

proceed to step 3.

3. Tubes
3.1 all tubes must be clean inside; any deposit must be cleaned with bleach and rinsed with DI
water or replace the tubing
3.2 check tube connections on valves, chambers, SV, wash head, internal reservoirs etc. all
connection points must be tight, otherwise change that tube portion with new tube
3.3 as a rule if a tube cannot be cleaned sufficiently and/or its’ connection isn’t tight it is
recommended to be changed with new tube

proceed to step 4.

4. Chambers
4.1 all chambers must be clean, free of scratches or cracks
4.2 removal of chambers is recommended to check if no liquid has spilled behind them and also
to see if the electrode is in good condition; change the chamber if any visible crack can be
seen or if the electrode can be moved by hand
4.3 reinstall the chambers

proceed to step 5.

5. Dilutors
5.1 from service menu move dilutors one-by-one and check if large air bubbles are visible in the
syringes or if any leakage sign can be seen on or beneath them; mark the syringe(s) where
you saw large air bubbles getting in near the plunger

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 5.2 perform dilutor pistons cleaning and greasing procedure
- Follow instructions of SM page 132 chapter 11.2.3 and 11.2.4 -;
black-linked pistons should NOT be greased(!)

Use a forceps to close the tube above the syringe you are going to remove. This is to avoid reagent
from internal reservoirs spilling back to the reagent bottle. Remove one syringe at a time only!

5.3 cycle dilutors from service menu again, if any of the syringes does not seal properly
(air bubbles are still getting inside near the plunger) replace the syringe(s)

SFRI recommendation as preventive maintenance: replace syringes after 50.000 measurement

cycles

5.4 clean dilutor optosensors from dust by means of compressed air

5.5 clean the driving pin of dilutors then lubricate them with teflon grease

proceed to step 6.

6. Shear Valve
6.1 inspect tubes on SV for any deposit or discoloration, especially the „4diff waste” and „Laser
in”(refer to fluidic schematic of the analyzer to identify these tubes) tube ; lower section of
laser waste tube might have black color – it can be cleaned with bleach or that tube section
can be changed.

Note: when removing tubes from the SV ports use a small flat screwdriver to help the tube slide off
from the port; to avoid misconnection remove only 1 tube at a time

6.2 check tightness of tubes on SV ports by hand, all tubes connections must be firm; if any tube
comes off easily if pulled by hand that tube section should be changed
6.3 clean the SV optosensors from dust by means of compressed air
6.4 from service menu cycle the SV several times; if the movement isn’t smooth or noise is
coming from driving mechanism, remove the cover behind the SV and lubricate the cogged
wheel/bar with machine grease; apply a thin film of teflon grease to the two ends of the
sliding clutch-bed
6.5 reinstall the driving mechanism cover
6.6 change the blood sensor tube(tube between the needle and SV)

proceed to step 7.

7. Laser head
The laser head doesn’t need to be opened for regular maintenance. Opening the laser head will end
the warranty period for the optical head!

If „laser on” DC level was high during repeated self-test cycles, it might be necessary to clean the FC
manually. This should be done only if „laser on” DC level is still high after the software given “flow
cell cleaning” procedure option was done.

If „laser off” DC level is high that might indicate failure of a component of the laser head. Contact
SFRI Support Team ( support@sfri.com ) for further information and assistance

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 If any deposit can be seen in the „laser in” tube or if „laser on” DC level was high during self-test
than do the following:

7.1 remove the thick, RED coded tygon tube(laser waste) from the tube organizer and connect a
syringe to it
7.2 prepare at least 10ml of 1/1 bleach solution(1 part bleach, 1 part DI water) in a cup
7.3 remove the „Laser in” tube from the SV and immerse it into the bleach
7.4 gently pull the syringe until at least half of the bleach is aspirated or until the „Laser in” tube
is clean.

Never try to push the bleach with the syringe as it will create pressure in the FC assembly and
might cause leakage at the flow cell joints!

7.5 remove the „Laser in” tube from the bleach and pull ~ 20ml of air through it
7.6 reconnect the „Laser in” and „laser waste” tubes to their ports

proceed to step 8.

8. TCU
The TCU unit is a key assembly and proper functioning of this part is vital for good
performance of the analyzer. Therefore with the occasion of periodic maintenance the TCU
unit must also be inspected by service engineer. Inspection is only possible if the TCU unit is
removed from the instrument. Follow instructions of the SM for removal of the TCU.

8.1 clean the fan and heat sink of the TCU from dust with compressed air
8.2 remove the in-line mixer cover and check the 2 tygon tubes for any deposit
8.3 if necessary clean or replace* the 2 tubes with 1,8x4,0 mm tygon tubes cut to the same
length

* Tubes of the in-line mixer are the bottleneck for flow inside the TCU. Any deposit in these tubes will
cause overpressure in the 4diff sample preparation circuit which in worst case will result in tubes
being pushed off from valves and would cause liquid spills inside the analyzer. Natural ageing of
tygon results in loss of elasticity and small decrease of diameter. Ageing is speeded up by the
aggressive reagents (Lyse5P, Diff5P).

SFRI recommendation as preventive maintenance: change the in-line mixer tubes once per year.

8.4 reassemble the TCU unit to its place, follow instructions of the SM

proceed to step 9.

9. Wash head and XY block

9.1 clean the sliding bars of the XY unit with a paper towel and apply a thin film of teflon grease
on them
9.2 clean the optosensor on the XY opto board with compressed air

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9.3 verify the metal ports of the wash head are not loose, replace the wash head if any of the
ports can be moved by hand
9.4 verify the vertical movement of wash head neck inside of the XY block by lifting it up from
the needle holder

Attention: Sharp needle! Risk of injury! Biohazard!

9.5 vertical movement of the wash head must be easy without any obstruction, clean the wash
head neck if movement isn’t smooth
9.6 clean the bottom of wash head

proceed to step 10.

10. Verification/adjustments
From service menu run:
10.1 „pneumatic initialization”
10.2 „fill flow cell”
10.3 „fill TCU”

Run shutdown
Switch on the analyzer

10.4 run background counts until background values are within accepted limit; several
background cycles might be necessary to achieve good values – this is normal
behavior after tubes and subassemblies have been drained and refilled
10.5 run self-test (both) and check that all parameters are within range
10.6 if DC level is still high contact SFRI Support (support@sfri.com) for further
assistance
10.7 from service menu perform wash head and needle position verification; adjust if
necessary
10.8 adjust blood sensor default value(with blood sensor disabled)
10.9 calibrate the blood sensor
10.10 verify calibration with fresh control blood; calibrate the instrument if necessary
10.11 run human samples and check results
10.12 run repeatability test(at least 11 measurements from one fresh human blood with normal
values) and check CV%-s are within specification for all parameters

Periodic/preventive maintenance is done!