ORIGINATOR: Bob Horn PRODUCT:
APPROVED: David Bannister for John Stout CELL-DYN® 1700/CS (79)
REF. ECO: Trademark: CELL-DYN is a registered trademark of Abbott Laboratories.
IMPLEMENTATION: Immediate
Next Service Call
Next Failure Optional Instruments Requiring Modification: S/N 30001, 30005, 30010 - 30015, 40001 - 40003, 40006 - 40009, 40011 - 40014 TSB Part/Kit #: N/A TSB Effectivity/
Part(s) Availability: 05-JUL-95
TSB Tracking by Serial # required (IMMEDIATE TSB's ONLY)
YES NO
Upgrade Time: 2.0 Hrs. Validation Time: 1.0 Hrs. Total Mod. Time: 3.0 Hrs.
**NOTE** The instrument must be at TSB Level n/a prior to performing this TSB.
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 49
I. DISTRIBUTION:
Hematology Field Service Worldwide, Hematology CSC, and Hematology TMR's.
II. PURPOSE:
The intent of this document is to provide information and instruction to enable the update of a specific premarket instruments to market release level. This update is divided into two categories, software and regulatory compliance. The software update consists of the loading of the revision B installation disc, and replacing the CCM prom. The second category of this update is regulatory compliance. This category includes three steps which must be taken in order to adhere the instrument to ADD regulatory requirements. These steps include replacing the pump relay board, applying two stickers and destroying the old operations manual.
III. ADMINISTRATIVE NOTES:
All labor and travel to be billed to account #DDDP348-RSC. FSRs performing this TSB are not to include parts usage on call close-out. Parts will not be assigned to FSR inventory.
IV. SPECIAL TOOLS:
N/A
V. PARTS:
REPLACED PARTS: Discard old parts.
**Potential Biohazard & Voltage Hazard. Observe Proper Safety Precautions.**
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 50
COMPATIBILITY:
After modification the above listed instruments will be 100% compatible with market release instrument specifications.
VI. PROCEDURE:
MODIFICATION STEPS:
Refer to the Required Modification Chart, (attachment #3), to determine which steps apply to your specific instrument.
Software update:
A. Loading Rev B software
1. View the MAIN menu, look in the upper left hand corner to verify the instrument software version is less than 1.01.
2. Go to the DIAGNOSTICS menu, type Esc, then Alt-x to exit from Cell - Dyn 1700 program. 3. The current directory should be c:\CD1700.
a. Type del(space)*.* b. Type cd(space)help c. Type del(space)*.* d. Type cd(space).
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 51
4. Insert the installation disk, P/N 9380468, in the floppy drive. Type a:\cs then press enter. 5. When downloading is complete, reboot the instrument and verify the main menu shows
version 1.01.
B. Replacement of CCM EPROM
1. Remove the right side cover to expose the card cage containing the CCM.
NOTE: Insure instrument power is OFF before removing an electrical connection.
2. Remove the two cable connections on the DCM to gain access to the CCM. 3. Disconnect the ribbon cables and remove the CCM from the card cage.
4. Replace the EPROM located in socket U37 with the new EPROM (PN 9380465, version 1.00 dated 1-24-95), Ensure the notch on the EPROM matches the socket.
5. Reinstall board, cables, and cover.
6. To verify the EPROM perform the following steps:
a. Initialize the instrument, enter diagnostics then toggle printer output on (the graphic printer must be installed and powered on).
b. Press raw data and ensure the following line CCM ROM Version: - V1.00 01-24-95 CD1700 appears on the bottom of the printout.
Regulatory concerns:**Potential Biohazard & Voltage Hazard. Observe Proper Safety Precautions.**
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 52
A. Relay Board Replacement
1. Remove the top cover, loosen and fold back the top inner cover to expose the fluid power supply assembly.
NOTE: Insure instrument power is OFF before removing an electrical connection.
2. Locate the Pump relay board, P/N 9601440, label and disconnect all cables.
3. At each corner of the Pump relay board, compress the plastic snap pin and pull each corner of the board free from the pin.
4. Install the new pump relay board, P/N 9601441, and top cover, in the reverse order of disassembly.
5. Initialize the instrument and verify no pressure or vacuum time-out has occurred. B. Aperture Plate Removal Label
1. Remove the upper and lower front covers per procedures in the CELL-DYN 1700 service manual, section 7.
2. Apply the Aperture plate removal procedure label, P/N 9230727, to inside of the lower front cover (See attachment #2).
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 53
C. ETL label
1. View the rear panel of the instrument. Locate the line voltage description to the right of the main power supply and attach the ETL label, P/N9230724, directly to the right (see
attachment #1). D. Operations manual
1. The Cell - Dyn 1700 System Operations Manual, Marketing Draft, must be destroyed. When all regulatory concerns have been addressed sign and return confirmation letter, (attachment #4), to:
Abbott Diagnostics Division 5440 Patrick Henry Drive Santa Clara, Ca. 95054
Attn.: Karen Jones, QSS Manager CHECKOUT:
Verify system operation.
MODIFICATION CONTROL STICKER UPDATE:
When the update is completed, the FSR should mark number 1 on the modification control sticker.
NOTE: The following is a list of attached documents
**Potential Biohazard & Voltage Hazard. Observe Proper Safety Precautions.**
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 54
Attachment 1: ETL Label Location Guide Attachment 2: Aperture Label Location Guide Attachment 3: Required Modifications Chart Attachment 4: Regulatory Compliance letter
TSB# 79-001 - CELL-DYN® 1700/CS MARKET UPDATE Page 55 VOID IF SEAL IS BROKEN VOID IF SEAL IS BROKEN
1700 REAR PANEL 110V
9230724
A12345 ABBOTT MFG FREQUENCY 50/60HZ FUSE 110VAC 5.0 S.B. 120VAC 5.0 S.B. 220VAC 2.5A S.B. 240VAC 2.5A S.B. LINE VOLTAGE 110/120 VAC 220/240 VAC SET FOR 120 When operation at other line is required, refer to operation manual for detail instructions.FOR IN VITRO DIAGNOSTIC USE.