(SITE NAME)

Author: Penny Stevens

Document Number:
Effective (or Post) Date:
Date of last review:
Reviewed by:

Review History

Equ22-11
13-Jan-09
27 July 2010
Heidi Hanes

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your labs
specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering
their use in other applications. If you have any questions contact SMILE.

Copy ___of ___

Effective Date:

HEMATOLOGY SECTION
H. PREVENTIVE MAINTENANCE
H.1.

CELL-DYN 3500/3700 ANALYZER PREVENTIVE MAINTENANCE

H.1.1. PRINCIPLE:
1. Optimum operation and maximum reliability of the Cell-Dyn 3500/3700
analyzer can be ensured by performance of the preventive maintenance
procedures on schedules as indicated in this SOP.
2. Daily, weekly, and periodic schedules of all necessary levels of maintenance
are also included.
3. Careful observance of the preventive maintenance schedules and properly
recording data on the preventive maintenance worksheets provides both the
user and service technician with vital information necessary to obtain service
for the Cell-Dyn 3500/3700 analyzer
H.1.2. PROCEDURE:
1. DAILY MAINTENANCE PROCEDURES:
AUTO-CLEAN: It is a cycle designated to clean the Shear Valve, the
WOC Mixing Chamber, the Woc Flow Cell, the Von Behrens WIC
Transducer, the Von Behrens RBC/PLT Transducer, the HBG Flow Cell,
the needle, and all the associated fluidics. This cycle gently removes
any fibrin or debris within the system.
Materials required:
Page 1 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
1.1.1.1. Cell-Dyn Enzymatic Cleaner (cleaner should be at room
temperature)
1.1.1.2. Clean test tube
1.1.1.3. Clean Gauze
1.1.1.4. Warm Water
1.1.1.5. Appropriate personal protective equipment
1.1.2. Procedure:
1.1.2.1. Select the Open Sampler Mode.
1.1.2.2. Carefully wipe the outside of the Open Sampler
Aspiration Probe and the bottom of the Wash Block with
a gauze dampened with warm water and a few drops of
Cell-Dyn Enzymatic Cleaner.
1.1.2.3. From the MAIN MENU screen, press the [SPECIAL
PROTOCOLS] key followed by the [MORE] key to
access the Auto-Clean function.
1.1.2.4. Press the [AUTO CLEAN] key.
Instructions to
performing the procedure are given on the screen.
1.1.2.5. Dispense approximately 1.5mL of Enzymatic Cleaner
into a clean test tube and hold it under the Open Sample
Aspiration Probe.
1.1.2.6. Press the [START] key. Do not press the Touch Plate.
The Auto-Clean Cycle is only initiated by the
[START] key.
1.1.2.7. Continue to hold the test tube under the probe until a beep
is heard. Remove the test tube and discard the remaining
Enzymatic Cleaner.
1.1.2.8. When the Auto-Clean Cycle is completed, press [MAIN]
to return to the MAIN MENU screen.
1.1.2.9. Run at least five (5) background counts before running
controls or patient samples. If the background count is
not acceptable, repeat a background cycle. If the
background count is still not acceptable, notify the
Hematology Supervisor or NCOIC immediately.
Corrective action must be taken prior to reporting patient
results.

Page 2 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
2.1. CLOSED SAMPLER ASPIRATION NEEDLE: This procedure is
performed to remove protein buildup or debris, and to reduce the
possibility of a blockage.
2.1.1. Materials Required:
2.1.1.1.
2.1.1.2.
2.1.1.3.
2.1.1.4.

Cell-Dyn Enzymatic Cleaner

Diluent or distilled water
Three (3) empty purple top test tubes
Appropriate personal protective equipment

2.1.2. Procedure:
2.1.2.1.

Aliquot approximately 2mL of Enzymatic cleaner

into a
purple top test tube.

2.1.2.2.

Aliquot approximately 2 mL of fresh diluent or

distilled
water into each of the other two purple top test tubes.

2.1.2.3.

If necessary, from the Data Station RUN screen,

press the
[CHANGE SAMPLER] key to select the Closed Mode.

2.1.2.4. Press the [SPECIMEN TYPE] key followed by the

[BACKGROUND] key.
2.1.2.5.

Place the Enzymatic Cleaner tube followed by the two

diluent or distilled water tubes in a Sample Loader End
Rack (the one with the black dots on it).

2.1.2.6.

Position the rack in the Sample Loader tray and install

the Sample Loader Safety Cover. The Sample Loader
will not operate unless the Safety Cover is in place.

2.1.2.7.

Press the [START] key on the Sample Loader Control

Panel to initiate the cleaning.

2.1.2.8.

Audible beeps indicate that the cleaning is completed.

2.1.2.9.

Run at least five (5) background counts before running

controls or patient samples. Check that the background
count is acceptable. If the background is not acceptable,
repeat another background count cycle.
If the

Page 3 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
background count is still not acceptable, notify the
Hematology Supervisor of NCOIC immediately.
Corrective action must be taken prior to report patient
results.
2. WEEKLY MAINTENANCE PROCEDURES:
2.1. LOOP SHEAR VALVE: Regular cleaning of the Loop Shear Valve
ensures accurate and precise performance. Any reagent or blood residue
may cause the valve to leak or function improperly.
2.1.1. Materials required:
2.1.1.1.
2.1.1.2.
2.1.1.3.

Distilled Water
Gauze or lint-free tissues
Appropriate personal protective equipment

2.1.2. Procedure:
2.1.2.1.

Remove the Upper Front Cover to gain access to the

Loop Shear Valve.

2.1.2.2.

From the [MAIN MENU] screen, press the

[SPECIAL
PROTOCOLS] key followed by the [CLEAN SHEAR
key. This prepares the Loop Shear Valve for removal
removal and puts the analyzer into NOT READY
state.

2.1.2.3. Turn the Loop Shear Valve Retaining Screw

counter-clockwise until it can be removed.
2.1.2.4.

Grasp the entire valve assembly firmly and pull it

forward with a slight rocking motion until it is free of
the mounting guide.

2.1.2.5.

Rotate the center and front sections in the opposite

direction from the rear section to release any suction
and free the rear section.

2.1.2.6.

Place the rear section with its attached tubes on a

clean
lint-free tissue or gauze in the Loop Shear Valve
compartment.

2.1.2.7.

Rotate the center section and front section in

opposite

Page 4 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
directions to separate the sections.
2.1.2.8.

Place the center section in a container of distilled

water and allow it to soak for the remainder of the
cleaning procedure.

2.1.2.9.

Place the front section with its attached tubes on a

clean lint-free tissue or gauze in the loop shear valve
compartment.

2.1.2.10. Clean the mounting guide with lint-free tissue

dampened with distilled water to remove any blood or
residue.
2.1.2.11. Wipe the inner surfaces of the front and rear sections
with a clean lint-free tissue dampened with distilled
water. Use care to avoid scratching any of the inner
surfaces.
2.1.2.12. Align the lock notch of the rear section with the back
panel of the loop shear valve assembly. Carefully
slide the section back as far as it will go. Avoid
crimping any of the attached tubing.
2.1.2.13. Remove the center section from the distilled water,
and wipe the surfaces with a lint-free tissue dampened
in distilled water. Do not dry.
2.1.2.14. View each surface under reflective light to confirm
that it is clean, free of lint, and fingerprints.
2.1.2.15. Align the center section so that the rim notch in the
outer edge faces to the right.
2.1.2.16. Carefully slide the center section onto the mounting
guide. Carefully slide it back until it touches the
center section.
2.1.2.17. Firmly hold the three sections in place and replace the
loop shear valve retaining screw. Turn the screw
clockwise until it stops.
2.1.2.18. Press the [RESTORE SHEAR VAL] key. The valve
automatically rotates several times. The instrument is
returned to the READY state when the rotation is
finished.

Page 5 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
2.1.2.19. Replace the upper front cover. Press the [MAIN] key
to return to the RUN screen.
2.1.2.20. Run at least five (5) background counts before
running controls or patient samples. If the count is
not acceptable follow the steps as outlined in the SOP.
2.2.

SAMPLE ASPIRATION PERISTALTIC PUMP TUBING: The

tubing in the two Peristaltic Pumps need to be replaced on a regular basis
to ensure proper fluid movement through the instrument.
2.2.1. Materials required:
2.2.1.1.
Sample aspiration Peristaltic Pump Tubing
2.2.1.2.
Appropriate personal protective equipment
2.2.2. Procedure:
2.2.2.1.

From the SPECIAL PROTOCOLS screen, press the

[DISABLE ANALYZER] key.

2.2.2.2.

Remove the upper front cover to gain access to the

Peristaltic pumps.

2.2.2.3.

Locate the Sample Aspiration Pump to the left of

the
Shear Valve.

2.2.2.4.

Pull the release lever away from the pump rollers and
and remove the tubing from the metal brackets that
hold it on each side of the pump rollers.

2.2.2.5.

Disconnect the tubing at the plastic connector.

Connect the new tubing to the plastic connector.

2.2.2.6. Place the collars on the ends of the tubing into the
metal brackets.
2.2.2.7.

Replace the upper front cover.

2.2.2.8.

Press the [ENABLE ANALYZER] key and the

press
the [MAIN] key to return to the Main Menu screen.

2.2.2.9.

Run at least five(5) background counts before

running

Page 6 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
controls or patient samples. If the background count is
not acceptable follow the steps as outlined in this SOP
regarding this matter.
2.3.

SAMPLE LOADER TRAY, RACKS, AND SAFETY COVER: Blood

spills in the tray or racks should be cleaned up immediately to allow
proper movement of the racks. Weekly cleaning is recommended, but
more frequent cleaning may be indicated by the laboratory workload.
2.3.1. Materials required:
2.3.1.1.

Container (large enough to hold a rack) filled with

a

with a mild soap made with warm water.

2.3.1.2.
Clean, warm water for rinse
2.3.1.3.
Clean gauze
2.3.1.4.
Appropriate personal protective equipment
2.3.2. Procedure:
2.3.2.1.
2.3.2.2.

Remove the racks from the Sample Loader Tray.

Wash the racks with warm water and soap. Do
not
allow them to soak in the solution, as the labels will
come off.

2.3.2.3.

Rinse the racks with warm water and dry

thoroughly
with clean gauze.

2.3.2.4.

With the stainless steel tray area with clean gauze

Moistened with water and dry it.

2.3.2.5.

Wipe the stainless steel plate behind the

vent/aspirate
and mixing stations with gauze moistened with water
and dry it.

2.3.2.6.

Clean the mixing heads with gauze moistened

with
water and dry it.

2.3.2.7.

Wash the Safety Cover with warm water and mild

soap, rinse, and dry it.

Page 7 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
2.4.

EXTENDED AUTO-CLEAN: The Extended Auto-Clean Cycle is

designated to clean the Shear Valve, the WOC Mixing Chamber, the
WOC Flow Cell, the Von Behrens WIC Transducer, the Von Behrens
RBC/PLT Transducer, the HGB Flow Cell, the needle, and all the
associated fluidics. The forward and reverse action of the Peristaltic
Pump is used during this cycle to gently scrub and remove any bibrin or
debris within the system.
2.4.1. Material required:
2.4.1.1.
2.4.1.2.
2.4.1.3.
2.4.1.4.
2.4.1.5.

CELL-DYN Enzymatic Cleaner (should be

at room temperature)
Clean test tube
Clean gauze
Warm water
Appropriate personal protective equipment

2.4.2. Procedure:
2.4.2.1.

Select the open mode

2.4.2.2.

Carefully wipe the outside of the Open Sample

Aspiration Probe and the bottom of the Wash Block
with clean gauze dampened with warm water and few
drops of Cell-Dyn Enzymatic Cleaner.

2.4.2.3.

Press the [SPECIAL PROTOCOLS] key

followed by the [MORE] key to access the Extended
Auto-Clean function.

2.4.2.4.

Press the [EXTENDED AUTOCLEAN] key.

Instructions for performing the procedure are given
on the screen.

2.4.2.5.

Dispense approximately 1.5mL of Enzymatic

Cleaner into a clean test tube and hold it under the
Open Sample Aspiration Probe.

2.4.2.6.

Press the [START] key. Do not press the Touch

Plate.
Only the [START] key initiates the
Extended Auto-Clean cycle.

2.4.2.7.

Continue to hold the test tube under the probe until

a beep is heard. Remove the test tube and discard the
remaining Enzymatic Cleaner.

Page 8 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
2.4.2.7.1. The complete procedure takes 21/2 hours.
During this time, the instrument is not
available to process samples or manipulate
data. The cycle may be canceled after 38
minutes by pressing the [CANCEL] key. If
the [CANCEL] key is pressed, a rinse cycle
is initiated that prepares the instrument for
sample processing.
2.4.2.8.

When the Auto-Clean cycle is completed, the

instrument automatically goes into the STANDBY
state. Press the [RUN] key to bring the analyzer out
of the Standby state and prepare it for the sampling
process.

2.4.2.9.

Run at least five (5) background counts before

running controls or patient samples. If background
count is not acceptable, follow the steps as outlined in
this SOP.

3. MONTHLY MAINTENANCE PROCEDURES:

REAGENT SYRINGES: (2.5mL and 0.5mL Syringes). The Reagent syringes need to
be cleaned to prevent reagent residue buildup, which may cause leakage or improper
functioning. Syringes should be cleaned once at a time to ensure that each syringe is
replaced in the correct position.
Materials required:
3.1.1.1. A large container filled with approximately 500ml of
of distilled water.
3.1.1.2. Clean gauze
3.1.1.3. Distilled water
3.1.1.4. Small container of appropriate reagent to refill the clean
syringes
3.1.1.5. Appropriate personal protective equipment
3.1.2. Procedure:
3.1.2.1. From the MAIN MENU screen, press the [SPECIAL
PROTOCOLS] key followed by the [DISABLE
ANALYZER] key.
3.1.2.2. Remove the front covers to gain access to the Syringe
Assembly.

Page 9 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
3.1.2.3. Loosen the Syringe Holder Plate Thumbscrew and
rotate the Syringe Holder Plate into a vertical position.
3.1.2.4. Lift the syringe out of the holder. Note the liquid level
in the syringe so that it can be refilled after cleaning to
approximately this same level.
3.1.2.5. Grasp the metal Luer Lock fitting at the tip of the
syringe that attaches it to the tubing. Carefully turn the
syringe clockwise to release it from the fitting.
3.1.2.6. Dispense the reagent into an appropriate waste
container.
3.1.2.7. Aspirate distilled water into the syringe until it is full.
Continue to pull on the plunger until it is removed from
the barrel.
3.1.2.8. Rinse the plunger and barrel thoroughly with distilled
water.
3.1.2.9. Refill the syringe with the appropriate reagent to the
level noted in step (4) above. Hold the syringe upright
tap the side gently to dislodge any bubbles.
3.1.2.10. Carefully adjust the position of the plunger as necessary
to insert it into the pedestal assembly that moves it up
and down during the cycle.
3.1.2.11.Insert the syringe tip into the Luer Lock fitting and turn
the syringe counterclockwise until the fitting is
finger-tight.
3.1.2.12. Insert the syringe into the V-block holder and the end of
the plunger into its slot in the pedestal assembly.
3.1.2.13. Repeat this procedure to clean the remaining syringe.
3.1.2.14. Return the syringe Holder Plate to the horizontal
position over the syringe. Tighten the thumbscrew until
the plate is secure.
3.1.2.15. When syringes have been reinstalled, press the
[ENABLE ANALYZER] key.
3.1.2.16. Press the [MAIN] key to return to the MAIN MENU

Page 10 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
screen.
3.1.2.17. Run several background counts and observe the action
of each syringe during the cycle. The plunger should
move smoothly up and down, and the syringe should
not leak.
3.1.2.18. Replace the front covers after the operation of the
syringes has been verified.
3.1.2.19. Run at least five (5) background counts before running
Controls or patient samples. If the background count is
Not acceptable, follow the steps outlined in this SOP.
3.2. ANALYZER AIR FILTERS: The Left Side Panel of the Analyzer
contains a set of Air Inlet Filters that clean the air entering the
Analyzer. These filters require monthly removal and cleaning to
maintain a constant, unrestricted airflow.
3.2.1. Materials required:
3.2.1.1.
3.2.1.2.
3.2.1.3.
3.2.1.4.

Running water
Clean Gauze
Small vacuum cleaner (optional)
Appropriate personal protective equipment

3.2.2. Procedure:
3.2.2.1.

Remove the Front Covers to gain access to the

filter
holders on the Left Side Panel.

3.2.2.2.

Grasp the upper filter and slide the holder forward

to
remove it.

3.2.2.3.

Choose one of the following two options:

3.2.2.3.1. Remove the filters from the frames and rinse
with warm water from the inside to the
outside to remove the dust. Blot each filter
with clean gauze to dry the filters before
replacing them.
3.2.2.3.2. Clean the filters by vacuuming them.

Page 11 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
3.2.2.4.

Insert the upper filter holder into its slot. Slide it

back
Into its slot. Slide it back into place until the holder is
Flush with the Front Panel. Repeat this process to
Install the lower filter holder.

3.2.2.5.
3.3.

Replace the Front Covers.

WOC TRANSFER PERISTALTIC PUMP TUBING: The tubing in

the two Peristaltic Pumps need to be replaced to ensure proper fluid
movement.
3.3.1. Materials required:
3.3.1.1.
3.3.1.2.

WOC Transfer Peristaltic Pump tubing

Appropriate personal protective equipment

3.3.2. Procedure:
3.3.2.1.

From the SPECIAL PROTOCOLS screen, press

the
[DISABLE ANALYZER] key.

3.3.2.2.

Remove the Upper Front Cover to gain access to the

Peristaltic Pumps. Locate the WOC Transfer Peristaltic
Pump to the far left of the Flow Panel.

3.3.2.3.

Pull the release lever away from the pump rollers and
remove the tubing from the meral brackets that hold the
pump rollers. Disconnect the tubing at the plastic
container.

3.3.2.4.

Connect the new tubing to the plastic connector.

3.3.2.5.

Place the collars on the ends of the tubing into the metal
brackets. Hold the release open and push the tubing
underneath the pump rollers.

3.3.2.6.

Replace the Upper Front Cover

3.3.2.7.

Press [ENABLE ANALYZER] key, then press the

[MAIN] key to return to the MAIN MENU screen.

3.3.2.8.

Run at least five (5) background counts before running

controls or patient samples. If the background count is
not acceptable, follow the steps as outlined in this SOP.

Page 12 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
3.4.

AS REQUIRED MAINTENANCE PROCEDURES:

3.4.1. The nonscheduled Maintenance procedures (as required) for the
CELL-DYN 3500/3700 analyzer are as follows:
3.4.1.1.
3.4.1.2.
3.4.1.3.
3.4.1.4.
3.4.1.5.
3.4.1.6.

10mL Reagent Syringe

Aperature Plates (WIC and RBC/PLT)
HGB Flow Cell Manual Cleaning
Unclogging the Open Sample Aspiration Probe
Bar Code Reader Window
Flushing the Y Fitting (Open and Closed Modes)

3.4.2. If any of the above maintenance procedures needs to be

performed, refer to Abbott Cell-Dyn 3500/3700 System
Operators Manual, Chapter 9, Pages 9-45 to 9-58, for detailed
procedural instructions.
3.4.3. After any maintenance procedure has been performed, record tech
initials on the Cell-Dyn 3500/3700 Preventive Maintenance
Worksheet.
3.4.4. Notify the Hematology Supervisor or NCOIC of any problems
encountered during maintenance procedures or instrument
malfunction.
H.1.3. APPENDICES:
1.
2.
3.
4.

SOP Approval
SOP Validation Form and SOP Change Control
CELL-DYN 3500 Preventive Maintenance Worksheet
CELL-DYN 3700 Preventive Maintenance Worksheet

H.1.4. REFERENCE: Abbott Cell-Dyn 3500/3700 System Operators Manual, Abbott

Laboratories, 1998, Chapter 9.

Page 13 of 17

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance

SOP VALIDATION
SOP NAME: German Clinic Used For PT, PTT, and Fibrinogen Testing
Clear and specific title and principle:
Comments:

yes / no

All necessary supplies, equipment, and materials are listed:

Comments:

yes / no

SOP is sufficiently detailed to be understood but not overly complex:

Comments:

SOP text adequately describes process/procedure:

Comments:

SOP accomplishes purpose:

Comments:

yes / no

yes / no

yes / no

Reviewed by: (Name & Title) Jose Chavez, CPT, MS, C, Clin Lab Svcs
Signature: __________________

Date: __________________

SOP CHANGE CONTROL

Date

Change

QA

Page 14 of 17

OIC

Med Dir

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance

PATHOLOGY & AREA LABORATORY SERVICE

USA Medical Department Activity Heidelberg
CMR 442
APO AE 09042
IMPLEMENTATION AND CHANGE TO SOPS
SYSTEM & TITLE:
H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance
DATE MEDICAL DIRECTOR APPROVED SOP:
PROJECTED EFFECTIVE DATE OF THE SOP:
SUMMARY OF CHANGE OR SOP TO BE IMPLEMENTED:

NAME

SIGNATURE

Page 15 of 17

NAME

SIGNATURE

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance

SOP APPROVAL
SIGNATURE

DATE

PREPARER
QA COORDINATOR
LABORATORY OIC
MEDICAL DIRECTOR

ANNUAL REVIEW
REVIEWER SIGNATURE
DATE

DATE

REVIEWER SIGNATURE

DOCUMENT COPY CONTROL

LOCATIONS

DATE: __________

Hematology, HDB

Coleman Clinic

Chief, Outlying Clinics

Darmstadt Clinic

Buedingen Clinic

Mannheim Clinic

10

Butzbach Clinic

Stuttgart Clinic

11

Friedberg Clinic

Hanau Clinic

Babenhausen Clinic

Page 16 of 17

# COPIES __________

H. Preventive Maintenance
H.1. Cell-Dyn 3500/3700 Analyzer Preventive Maintenance

DATE SOP RETIRED: __________

Page 17 of 17