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ENGINEERING SPECIFICATION PAGE 1 OF 10

PREPARED BY: Aaron Blades S/A. BLADES DATE: 10/10/07
ENGINEERED BY: Aaron Blades S/A. BLADES DATE: 10/10/07
QUALITY ASSURANCE: David Edwin S/D. EDWIN DATE: 10/10/07
MFG. ENGINEER: Drew Guinn S/D. GUINN DATE: 10/11/07
DFTG SIGNOFF: Barb Linseman S/B. LINSEMAN DATE: 10/19/07
AUTHORIZED SIGNATURE: Jim Pomeroy S/J. POMEROY DATE: 10/16/07

SP2C Dual Channel SmartPump Repair Procedure

SCOPE: This ES covers the limited repairs capable on the original version of the InstruMed Dual Channel
SmartPump. These pumps are labeled as InstruMed SP21.1 SmartPumps and are associated with any
SmartPump having a serial number that starts with 215 or 216.

OBJECTIVE: To provide a procedure to support an existing product version in the field that was
distributed by the InstruMed company before the company was acquired by Stryker Instruments.

REFERENCES/ATTACHMENTS: QIP-0059

GUIDELINES:
This procedure is only intended for Dual Channel SmartPumps that were produced as a model type known
as SP2C. They can be identified by a serial number starting with 215 or 216 and will have a label on the
back that indicates their model number as SP21.1. If these conditions are not met, then this procedure
should not be used.

This repair procedure will document the process to follow to perform a battery replacement, a CCFL
Backlight tube repair/replacement and the re-calibration procedures. Any other repair needed that
requires component level replacement is not supported and the pump should be classified as “non-
repairable” and normal internal procedures concerning “non-repairable” items followed.

As the replacement components used in this procedure have the same specifications as the original
components, the level of concern of these repairs is consistent with all other repairs performed by the
Service Unit. A final Quality Inspection Procedure will be performed and documented to ensure the
product performs to “new build” standards before going back out into the field.

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PROCEDURES:
Listed below are the steps to completing a CCFL Backlight Tube Repair/Replace, a Battery Replacement
and re-calibration of the unit. Follow the appropriate procedure accordingly.

CCFL BACKLIGHT TUBE REPAIR/REPLACE PROCEDURE:

(ESD Protection is required during this procedure)

1. Remove the 8 screws holding the back enclosure (4 on one side shown here).

Remove the back enclosure by lifting the back half off of the unit.

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2. Remove the 6 screws holding the metal frame atop the PCB (one side – 3 shown here).

Disconnect all wiring harnesses between the PCB and metal frame (will be either 2 or three
connections – middle one in picture may not always be present as this is the printer cable).

Disconnect the lower air tubing from the metal frame on both sides (only one side shown in
picture) and run them back through the clip connector.

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Remove the metal frame and lay off to one side of the unit. (CAUTION: Metal frame is heavy as it
contains the pump and valve assembly of the unit. Ensure you do not scrape any component on
the PCB when removing the metal frame).

3. Remove the 5 metal screws holding the PCB to the front enclosure.

4. Using small needle nose pliers, twist the 6 LCD mounting tabs until straight (so they align with the
holes in the PCB).

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5. Remove the LCD backlight power connector from the PCB (snap connection). Remove the
kapton tape holding the wires to the PCB. (CAUTION: do not tug on wires as their solder
connection to the CCFL Backlight tube is fragile.)

6. Gently remove LCD from the PCB and place it display down on a clean soft surface. (CAUTION:
DO NOT TOUCH the “gold zebra” connector which is exposed when the LCD is removed from the
PCB. This is an elastimeric connector using gold particles as the conductor medium. Any oil from
fingers or other contaminants will interfere with the zebra’s functionality.)

DO NOT
TOUCH!

7. Using a small flat screwdriver, gently click open the plastic housing on the back of the LCD case
which retains the CCFL Backlight tube.

Click open the housing by

lifting up here.

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8. Carefully remove the CCFL Backlight tube and inspect the solder connections and the
connections within the snap connector.

Example of a burnt out CCFL

tube. Note the discoloration of
the tube. This tube will need
to be replaced

Example of a broken solder

connection. This can be
repaired instead of replaced.

9. If the CCFL backlight tube is broken or cracked, replace with a new tube (5920-011-100).

10. If the CCFL backlight tube’s solder connections are broken, carefully remove the CCFL tube from
the LCD, re-solder the connection and replace the CCFL tube assembly back into the LCD. Re-
install the CCFL plastic housing cover.

11. Reverse this procedure to re-assemble the device. (Before final assembly of the two housings,
perform the visual inspection portion of the QIP that requires the unit to be apart). Use the
following torque specifications on the screws:
PCB to top housing: 12 in/lbs
Pneumatics chassis to PCB/top housing: 12 in/lbs
Rear housing to top housing: 10 in/lbs

12. Test the unit per QIP-0059 and complete repair paperwork as normal with the exception of
electronic PHICA not being entered for these units. Instead, use a hardcopy of the QIP data sheet
for product history purposes.

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BATTERY REPLACEMENT PROCEDURE:

(ESD Protection is required during this procedure).

See pictures from previous section for steps 1 and 2.

1. Remove the 8 screws holding the back enclosure. Remove the back enclosure.

2. Remove the 6 screws holding the metal frame atop the PCB. Disconnect all wiring harnesses
between the PCB and metal frame. Disconnect the lower air tubing from the metal frame on both
sides and run them back through the clip connector. Remove the metal frame (CAUTION: Metal
frame is heavy as it contains the pump and valve assembly of the unit. Ensure you do not scrape
any component on the PCB when removing the metal frame).

3. Disconnect the wires from the battery terminals.

4. Loosen the 7/16” nut to allow the battery hold down arm to swing out of the way.

5. Remove battery and replace with new battery (5920-011-101). Tighten the battery hold down post
hand-tight.

6. Reverse the procedure to re-assemble the components. Use the following torque specifications
on the screws:

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 Pneumatics chassis to PCB/top housing: 12 in/lbs
Rear housing to top housing: 10 in/lbs

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7. Test the unit per QIP-0059 and complete repair paperwork as normal with the exception of
electronic PHICA not being entered for these units. Instead, use a hardcopy of the QIP data sheet
for product history purposes.

RE-CALIBRATION PROCEDURE (to be done with the back cover off of the unit):

1. Connect the unit to AC power and press and release the ON/OFF button.

2. If the unit has a printer port on the bottom, proceed to step 5, otherwise continue on to step 3.

3. Ensure the following conditions are met on the PCB:

a. Dip Switch SW20 position #2 (middle switch) = OFF (up position)

SW20

b. Jumpers connected to pins #2 and #3 (if not, remove six screws holding the
pneumatics assembly to the PCB, raise the pneumatics assembly and reposition the
jumpers. Leave jumpers in this position after finishing procedure.)

Jumpers connected to pins

#1 and #2, so should be
moved over to pins #2 and
#3.

These pins and connection

are on the left side (from
rear of unit) about halfway
up the PCB.

4. Connect the unit to a PC running HyperTerminal by connecting the non-printer interface cable to
the PCB and then the null modem cable to the non-printer interface cable.

Non-printer
interface cable
connected to PCB.

Other end of non-

printer interface
cable for
connection to null-

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5. If not already performed, take DIP SW20 position #2 to the OFF position as per step 3.a. Connect
the unit to a PC running HyperTerminal (to start, double-click HyperTerminal icon on computer
desktop and press CANCEL on first message screen) by connecting a Null Modem cable between
the printer port on the unit (or non-printer interface cable) and the serial port on the computer.

6. Set up the following configuration for the properties of HyperTerminal (performed by clicking on
the Properties icon and then CONFIGURE):
9600 baud rate, 8 data bits, 1 stop bit, no parity, flow control NONE

NOTE: Once properties are configured correctly, establish communication between the unit
and computer by pressing the ENTER key. If communication is not established (you don’t see
the SmartPump main menu screen in the HyperTerminal window), the serial port is not active
and the computer will need to be re-started. Once the computer has re-started and you have
logged back in, re-start HyperTerminal. Set the HyperTerminal properties again as per this
step and press the ENTER key. If you still cannot establish communication between the
computer and the SmartPump, contact the Mfg. Engineer for assistance.

7. First, verify that the serial number for the unit is set correctly. If not, note difference in workorder
and correct the serial number (option 6 from the HyperTerminal main menu).

8. Next, verify that the time, date and year are set correctly. If not, enter correct time/date/year on
the SmartPump by pressing the Cuff 1 Time + and SET/SAVE button simultaneously for 3
seconds and release. Follow the SmartPump screen for updating the time/date/year. The
SmartPump’s time/date/year should now be displayed correctly on the HyperTerminal window.
This time/date/year value will be stored to the calibration record date field upon successful
completion of the calibration process.

9. Both sides will be calibrated at the same time. Use special T-connection tubing labeled for the
SP2C Calibration. Attach one side to cuff 1, one side to cuff2 and the remaining connection to the
pressure chamber (either side of the test stand will work) test setup.

Pressure
TO CUFF 1 COUPLIN
ON SMARTPUMP chamber

TO CUFF 2 COUPLIN
ON SMARTPUMP

+ IN
SP2C Calibration
tubing connection.

MANOMETER

Air Pressure Calibration Configuration

10. Initiate the calibration sequence from HyperTerminal, following the HyperTerminal prompts. Allow
the pressure to stabilize before entering the manometer reading into the HyperTerminal field. It is
common for minor leaks to allow the pressure to decrease slowly during a calibration sequence.

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Be sure the pressure value that is typed into HyperTerminal is exactly the manometer reading at
the moment the enter key is pressed. The system will inflate the cuff to a low pressure first and
prompt for the manometer reading to be entered. Next, it will inflate to a higher pressure and again
prompt for a manometer reading to be entered. Finally, save the new pressure calibration
readings.

11. Once completed, press q on the computer keyboard to exit out of the calibration menu and get
back to the main menu. Disconnect the null modem cable from the unit and the computer and
shut down HyperTerminal.

12. Turn off the SP2C unit. Re-position DIP Switch SW20 position #2 to the ON position (down
position) to ensure printer operation after calibration procedure is completed.

13. Test the unit per QIP-0059 and complete repair paperwork as normal with the exception of
electronic PHICA not being entered for these units. Instead, use a hardcopy of the QIP data sheet
for product history purposes.

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PART NUMBER: ES-0044
DATE CHK’D BY SYM REVISIONS

05fm019, Rev. None