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CELL-DYN Ruby PM #1

CELL-DYN Ruby Preventive Maintenance Procedure


Customer Name IMSS UMF 26 Serial Number
71467BG
Customer Number Ticket Number
302706 001001FC1066410
City Acapulco FSR Name Rogelio Pérez
Telephone Date
N/A 14-Junio-2021

Completed

Pre-site Investigative Procedures


Interview customer for any on-going issues and order parts as necessary.
Note: If the instrument is experiencing any imprecision or accuracy issues, open another
Service ticket prior to completing the PM.
Ensure PM parts are available per the parts list included in ISA 170-003U.
Verify Abbott Link connection status (if connected) & review message history log for issues.
On-site Investigative Procedures Completed
Verify TSB status of instrument.
Verify customer has performed a recent software back-up and current system back-up CD is
available.
Review Maintenance & Message History Logs and advise customer on replacing the following
list number (L/N) parts.
• 09H32-01, Open Mode Probe, CDRUBY - Replace as-needed.
• 09H06-01, CDRUBY Aspiration Needle - Replace as-needed.
• 91485-01, Perist Pmp TBG-MD - if last replacement is > 1 month.
• 06H92-01, CD32 IN-Line Millipore Fltrs-6 - if last replacement is > 1 month.
• 04H34-01, SRNG 10 ML Kit 35 - Replace as-needed.
• 04H40-01, SRNG 2.5 ML Kit 30/35 - Replace as-needed.
• 28561-01, SRNG 2.5 ML - Replace as-needed.
• 28560-01, SRNG 500 UL - Replace as-needed.
• 92161-02, Waste Outlet Tubing - if last replacement is > 6 months.
• Clean Loader Components – Performed weekly

The removal and replacement instructions for L/N parts are available in the CELL-DYN Ruby
Operations Manual.

Note: Follow local Service Organization processes if it is necessary to charge customer


for LN parts and/or labor.

ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 1 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.
CELL-DYN Ruby PM #1
Reminders  ShortNote  Picture/info on right  CD Ruby Service Manual
 General Attention Activator  CD Ruby Operator’s Manual
SafetyWarning

Overview Instructions & Explanations  Target 3.5 hours


1 1.4 & 17.1 Background Specifications
1 Review Initial Condition

1.1 Wear all PPE


1.2 Review Event Log & Data Log
1.3 Review QC, X-B
1.3a Correct outstanding issues
1.4 Run 1 patient minimum five times in open
mode precision to verify instrument
operation 2
1.5 Observe instrument operation during step
1.5 which will help identify potential issues
1.6 Run 5 samples into WB QCID file. Retain
Note: Reference Customer Control File (the customer might have set
for use at completion of PM
their own means) and or Assay sheet.
1.7 Review and Print: Cal Factors, Dil
Factors, Setpoint screen
2 1.5 & 20.7 Precision Specifications
1.8 Run 7μm SRP, verify data of Optical WBC
CV's before PM is started for reference
later.

2 Decontaminate Instrument
2.1 Flush flow cell and waste lines to WC-1
through V56 using 10% bleach. Let sit
minimum 5 minutes. Replace WC and
tubing from flow cell to WC-1 if damaged
3
2.2 Run 3 tubes 10% bleach through SL to
clean closed aspiration pathway and
decontaminate the blood pathways.

3 Fans
3.1 Inspect 4 external fans for proper operation.
Replace if non-functional & date 3 2.1 Flushing Optical Flow Cell
3.1a Replace fans every 2 years & date CD Ruby Flushing the Optic Flow Cell and WC1.wmv
3.2 Perform Page 469 - Clean Fan Filter  p
9-49

4 Solenoids 6
4.1 In Diagnostic, close all Solenoids, VP-09
Solenoid Operation Verifications
4.2 Press on individual solenoids check that
they are fully closed. (Solenoids no
addition movement)
4.3 Note any solenoids that do click closed for
further action later
 NOTE: Do this before replacing tubing
4.4 Inspect each solenoid for salt buildup,
corrosion or rust
4.5 Note any solenoids that show size of rust or
ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 2 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.
CELL-DYN Ruby PM #1
salt build up. 4 8.2 Bleaching Waste Chambers
5 Front Panel CD ruby cleaning WC3.wmv

5.1 Turn instrument off


5.2 Inspect open & closed mode wash blocks
for damage. Replace as needed.

6 Mixing Chambers
6.1 Inspect RBC & WBC mixing chambers for
corrosion, leaks or excessive buildup
6.2 Confirm metal inlet ports are not loose

7 Reservoir
7.1 Inspect for leaks
7.2 Confirm metal posts are intact & no salt
buildup
7.3 Confirm inlet tubing for diluent is not
crimped or restricted
7.4 Correct as needed

8 Waste Chambers
8.1 Inspect all WC for cracks, leaks, plumbed
correctly
8.2 If WC-3 has a lot of buildup, remove &
clean with bleach 4 5 9.1 Waste Line Check
NOTE: This may take 30 minutes or more
8.3 Replace WC as needed

9 Syringe Drives
9.1 Inspect and Clean Syringe Drives as
needed

10 Peristaltic Pump
10.1 Clean shoe and rollers

11 Solenoids 6
11.1 Blow out each solenoid with canned air
11.2 Clean or Replace damaged solenoids
identified in section 4

12 Tubing & Check Valves 6


12.1 Replace all Silicone tubing in all pinch
valves
12.1a Remember solenoids on VPM
12.2 Inspect all Tygon tubing for damage &
replace as needed
12.3 Replace check valve on vent assembly

13 HGB Flow Cell 7


13.1 Inspect tubing for kinks or damage
13.2 Inspect connections including metal
fittings

ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 3 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.
CELL-DYN Ruby PM #1
13.3 Replace any damaged component 6 4, 12, & 13 Solenoids , Tubing & Check Valves
14 Pressure Sensor CD Ruby Tubing Map
Kit Bag PN 9360024 9360025
14.1 Replace pressure sensor. Tubing PN 93476-01 93476-01
14.2 Turn instrument on and prime. Length (Inch) 1.3 1.5
Quantity 50 15
15 Vacuum /Pressure Subassembly Valve # 1-1 2-7 4-4 6-3 1-5
15.1 Inspect Vacuum & Pressure accumulators 1-2 3-1 4-5 6-4 2-3
for cracks, excessive salt buildup 1-4 3-2 4-6 6-7 2-8
1-7 3-3 5-1 9-1 3-4
16.1a Replace pressure accumulator 1
1-8 3-6 5-2 9-3 6-8
every two (2) years.
2-1 3-7 5-4 9-4 9-2
15.2 If needed, vacuum accumulators can be 2-2 3-8 5-5 9-5 9-7
checked by confirming the resistance 2-4 4-1 5-7 9-6 V3
between the 2 leads is more than 20 2-5 4-2 6-1 9-8
MegaOhms. 2-6 4-3 6-2
15.3 Perform VP-44 Vacuum Accumulator 1
and 2 Rinsing Procedure if needed 
Kit Bag PN 9360239 9360240 9360241 9360242
15.4 Perform VP-16 Vacuum & Pressure Level
Tubing PN 93476-01 93476-01 93476-01 93476-01
Verification/Adjustment  Length (Inch) 2.0 3.0 3.5 4.0
Quantity 1 1 1 2
16 Laser Bench Valve # 5-6 1-3 6-5 V2
V5
16.1 Confirm background within spec 1
16.2 Run at least 1 sample to confirm proper
scatter before performing optical Kit Bag PN 9360243 9360244 9360245
checks/alignment Tubing PN 93476-01 93177-01 93177-01
Length (Inch) 5.5 3.0 8.0
16.3 Verify Optical WBC CVs Quantity 1 1 1
referencing VP-18 Optics Bench Valve # 6-6 V1 V4
Alignment Procedure beginning at step
“Perform Verification” using diluted 7.0
SRP  8 7 14 HGB Flow Cell
16.4 If CVs are out of spec: Ruby VP 39 Flushing HGB Flow Cell.wmv
16.4a Perform complete VP-18 Optics
Bench Alignment Procedure 
NOTE: : If CVs are within specs& no Diff
issue reported by customer, there is no need to
clean or align bench

17 Autoloader
17.1 If excessive diluent on platen, verify
operation of detent pins
17.2 Clean detent pins 9
17.3 Replace tube grippers every 24 months
17.4 Inspect cable and Tube Sensor board for
corrosion replace if needed 10
17.4a Clean or adjust Tube Sensor as
needed VP-58 Tube Sensor Adjustment

17.5 Clean Forward Indexer & Pawls. Confirm
spring action 11
17.6 Clean Sweep Arm Bushings. Do not oil
or lube 12
17.7 Inspect Spring on Sweep Arms. Replace
every 2 years or as needed F1.07
Autoloader Sweep Arm Spring
ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 4 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.
CELL-DYN Ruby PM #1
Replacement Procedure 
17.8 Clean Bar Code Reader. Adjust position
as needed VP-11 Bar Code Reader
8 17.3 WBC Mean Channel & CV Specifications
Verification/Alignment 
17.9 Perform the following VPs: 
17.9a VP-23 Tower Unit Stop Solenoid
Verification
17.9b VP-24 Bar Code Spin Assembly
Verification
17.9c VP-25 Tube Height Sensors (S1/S2)
Verification
17.9d VP-26 Mixer Up/Down Verification
17.9e VP-27 Mixer Head Rotation
Verification
17.9f VP-28 Mixer Bladders Verification
Offset Specifications
17.9g VP-29 Rack Advance & Tube Sensors
Verification Pull the flow cell out of the beam path. Adjust the front mirror Y
17.9h VP-30 Cross Transfer Arms & Rack screw for minimum reading on the DMM. The end result
Sensors Verification should be a reading of < 50 mV for the OFFSETS for both the
17.9i VP-31 Mixer Bladders Pressure 0 and 10 degree photodiodes. With Diluent in the flow cell the
Verification/Adjustment reading should be <100 mV.

18 Data Station 9 18.3 Clean Detent Pins


18.1 Clean inside data station
18.2 Clean keyboard
18.3 Clean external barcode reader
18.4 Clean monitor
18.5 Clean mouse

19 Final Verification Procedures


19.1 After every Verification Procedure print
out results and save when possible.
19.2 Perform VP-15 Vacuum & Pressure
Retention Verification 10 18.5 Inspect Tube Sensor
19.3 Perform VP-05 HGB Current
Verification/Adjustment 
19.4 Set optical Gains and linear Gains
Referencing VP-20, System Gains
Verification /Adjustment..
19.5 Run 5 samples in CBC NOC mode
(saved from beginning of PM) on sample
loader. Compare to results pre & post PM
19.6 Verify Carryover by running 3
backgrounds following step 20.5. 13
19.7 Verify Open and Closed precision &
confirm within specs 2
19.8 Verify Mode to Mode Bias check.
19.9 Run a minimum of one batch in Moving
Average, if customer is monitor X-B
19.10 Review X-B
19.11 \  Verify all controls are within specs
19.12 Perform Calibration, Section 6 as needed

19.13 Verify LIS operation VP-13 LIS
ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 5 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.
CELL-DYN Ruby PM #1
Communication Verification  11 18.6 Clean Forward Indexer & Pawls
19.14 Perform Backup VP-48 Backup
Procedure 
19.15 Close PM Activity on Call Management
System.

12 18.7 Clean Sweep Arm Bushing

13 20.6 Carryover Calculation & Specifications

Talsico® Process Picture Maps™ & all associated intellectual property are owned by Talsico International, ABN 20 419 167 619, & subject to licensing Agreement
End of document

Químico Gerardo Mercado 14-Junio-2021


Inge Rogelio Pérez 14-Junio-2021

ISA 170-003U, March 2016 ©2012, 2016 Abbott Laboratories, Abbott Park, IL 60064 Page 6 of 6
For Internal Use Only
CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions.

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