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VIEWED/PRINTED:

Calibration Only
Spectris Solaris
©
MEDRAD, Inc. 2007
Prior to use, you are responsible to confirm this copy's revision is the latest released.
This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

This calibration procedure is confidential, proprietary information of MEDRAD, Inc.


It is provided to trained employees of our customers for the sole purpose of
enabling such employees to service customer-owned MEDRAD injectors. This
information may not be shared with third parties or used to service injectors other
than as specified herein. Further restrictions on the disclosure and use of this
information is provided in the Service Training Agreement executed by the
customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the
information provided in this package.

205254 Rev. A Page 1 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

TABLE OF CONTENTS
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1. SCOPE .................................................................. 3
VIEWED/PRINTED:

2. AUDIENCE ............................................................ 3

3. EQUIPMENT.......................................................... 3

4. DOCUMENTATION ............................................... 4

5. CALIBRATION ....................................................... 4

6. PRESSURE CHECK.............................................. 5

7. SYSTEM LEAKAGE TEST .................................... 6

8. FINAL PREPARATION .......................................... 8


Prior to use, you are responsible to confirm this copy's revision is the latest released.
This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

205254 Rev. A Page 2 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

1. SCOPE

1.1 This document outlines the steps required to update, calibrate,


and verify proper performance of the Spectris Solaris MR
Injector System.
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2. AUDIENCE
VIEWED/PRINTED:

2.1 This Preventive Maintenance Procedure is to be performed by


MEDRAD Trained Field Service Representatives and/or Dealer
Representatives.

3. EQUIPMENT

3.1 General Hand Tools

3.2 Leakage Test Box (Fixture No. 1-0-01), Bender Leakage Tester
or NeTech LGK 601 Electrical Leakage Analyzer – Equipment
Number 11153

3.3 Digital Pressure Gauge Assembly – 89301-00-AM-02

3.4 Stellant 200 ml Test Syringe – 3009672


Prior to use, you are responsible to confirm this copy's revision is the latest released.

3.5 PFS 100 Syringe Adapter Kit – 3008169 (If Available)

3.6 PFS 150 Syringe Adapter Kit – 3009580 (If Available)

3.7 DMM (3.5 Digit) True RMS, Tektronix TX1 or equivalent


This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

3.8 PC with Swift (201844 latest version) Software

3.9 Security Key – 403004189

3.10 Pot Calibration Slug – 3009644

3.11 Service Ethernet Cable – 3004687

3.12 Electro Static Dissipation Equipment

3.13 Protective Gloves

205254 Rev. A Page 3 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

4. DOCUMENTATION

4.1 APPLICABLE DOCUMENTS

4.1.1 Bender Box Equipment Configuration – No. 97057-00-SV-01


(MEBV only)
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4.2 REFERENCE DOCUMENTS


VIEWED/PRINTED:

4.2.1 Spectris Solaris Service Manual – No. 200880

4.2.2 Field Service Report (FSR) – No. 92056, 88026, or appropriate


for the location of unit

4.2.3 Field ESD Policy – No. 89057-00-PP-01

4.2.4 Service Call Procedure – No. 94057-00-FI-01

4.2.5 SWIFT Operation Manual – No. 201610

5. CALIBRATION

5.1 Connect PC to CRU. Apply power. Verify that the Control


Room Unit sounds a tone, and when the Safety Screen
appears, activate the Swift program on the PC. NOTE: If the
Prior to use, you are responsible to confirm this copy's revision is the latest released.

Swift program on the PC had been activated already, click the


icon “connect to the injector”.

5.2 Recalibrate the Touch Screen.


This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

5.3 Press Flow Rate. With a pencil point, touch all four corners of
the number 2 and verify that the key activates. Recalibrate
Touch Screen, if needed.

5.4 Enter the following parameters:


• Phase 1, Syringe A, 10.0 ml/second Flow, 15 ml Volume
• Phase 1, Syringe B, 10.0 ml/second Flow, 15 ml Volume
• Phase 2, Syringe A, 5.0 ml/second Flow, 5 ml Volume
• Phase 2, Syringe B, 5.0 ml/second Flow, 5 ml Volume

205254 Rev. A Page 4 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

5.5 Connect a 65 ml and 115 ml syringe. Set plunger to 60 ml and


100 ml marks on the syringe respectively.

5.6 Arm the injector.

5.7 Inject using the start switch.

5.8 Verify that the arm lights stop flashing when the plungers are
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moving.
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5.9 Verify that A and B syringe injects 20 ml and that the plungers
are now on 40 ml (A syringe) and 80 ml (B syringe) marks on
the syringe.

5.10 Go to the History Screen and open the latest file. Verify that the
Total Contrast = 20 ml, Total Flush = 20 ml and pressure limit
indication is NO.

6. PRESSURE CHECK

6.1 Fill both syringes with water and install both onto head. Install
the pressure gauge assembly onto syringe A and remove any
air bubbles.

6.2 Connect PC to CRU.


Prior to use, you are responsible to confirm this copy's revision is the latest released.

6.3 Cycle CRU power and at safety screen activate the Swift
program.

6.4 Run the program “Scripts/Monitor/Pressure (static)” and select


This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

Syringe A; Strain Gauge 1 (Primary) and Strain Gauge 2


(Redundant).”

NOTE: 1 mVDC = 1 PSI.

6.5 Set DVM to DC millivolts, set pressure module to PSI and rotate
the “zero” adjustment until the DVM reads 0 mVDC. Close the
flow control valve.

6.6 Press “Start” on the PC screen. (Do not press the Enable key)
Using the A Forward Load key pressurize the system to the
following pressures on the digital gauge and press the Check for
Air key after achieving each pressure +/- 1 psi. Refer to the
Swift Op Manual, if needed.
• 75 PSI acceptable PC reading

205254 Rev. A Page 5 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

• A side 35.5 –114.5 PSI; B side 37.5 –112.5 PSI


• 175 PSI acceptable PC reading
• A side 139.5 –210.5 PSI; B side 132.5 –217.5 PSI
• 250 PSI acceptable PC reading
• A side 214 –286 PSI; B side 209 –291 PSI
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6.7 Using the Load key, reverse plunger A to remove the pressure
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in the syringe.

6.8 Move the pressure assembly to the B syringe and redo Steps
12.1 to 12.7 substituting the B syringe for the A syringe.

6.9 Verify that the PC readout is within the acceptable ranges for all
pressure transducers for each reading.

6.10 Retract both pistons and remove the pressure gauge assembly.
Remove and discard the syringe.

7. SYSTEM LEAKAGE TEST

NOTE: Leakage checks cannot be performed on units that are


hard wired to a power source. Leakage checks for the injector
must then be performed per hospital requirements. Place “N/A”
Prior to use, you are responsible to confirm this copy's revision is the latest released.

in the corresponding line in Section 13 of the PMP checklist if


leakage is tested as part of scanner system.

NOTE: If unit is equipped with a Continuous Battery Charger,


Section 13 must also be performed on the power cord attached
This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

to the Continuous Battery Charger.

7.1 Perform this step only if the Bender Box is required. Test
leakage according to 97057-00-SV-01.

7.2 MEDRAD LEAKAGE BOX

7.2.1 Connect the CRU power cord to the leakage box. Inspect
power cord condition. Plug the leakage box into the power
source

7.2.2 Leakage box set-up: Set DMM to the lowest millivolt AC range
and connect to the points labeled Meter. With a test lead,
jumper Ground to Probe on the leakage box.

205254 Rev. A Page 6 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

7.2.3 NOTE: For the following leakage tests, measured millivolts is


equal to microAmps (mVAC = µAmps).

7.2.4 Set Ground to Open, Line to Normal. Apply power. Leakage


must be less than 100 mVAC. Record value.

7.2.5 Set Line to Reverse. Leakage must be less then 100 mVAC.
Record value.
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VIEWED/PRINTED:

7.2.6 Set ground to closed.

7.2.7 Disconnect the test lead from the probe jack on the leakage box
and touch any metal part on the head with test lead, ensure the
leakage is less than 10 mVAC. Record the leakage value.

7.2.8 Remove power. Remove the leakage box power cord from the
outlet. Reconnect the CRU power cord and secure.

7.3 NETECH ELECTRICAL SAFETY ANALYZER

7.3.1 Inspect power cord condition. Connect the power cord to the
leakage box. Plug the leakage box into the appropriate power
source.

7.3.2 Leakage Box Set-Up


Prior to use, you are responsible to confirm this copy's revision is the latest released.

7.3.3 Plug unit into the NeTech Electrical Safety Analyzer and the
NeTech Electrical Safety Analyzer into the AC supply.

7.3.4 Set the Mode switch to case leakage.


This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

7.3.5 Set the load selector switch to 601.

7.3.6 Set Outlet to NORMAL. Apply power. Press the Ground switch
to OPEN. Leakage must be less than 100 mVAC for voltages
less than 130VAC (300mVAC with AC voltage greater than
131VAC). Record the leakage value.

7.3.7 Release the Ground switch.

7.3.8 LINE to REVERSE. Press the Ground switch to OPEN.


Leakage must be less than 100 mVAC for voltages less than
130VAC (300mVAC with AC voltage greater than 131VAC).
Record the leakage value.

7.3.9 Release the Ground switch.

205254 Rev. A Page 7 of 8


This calibration procedure is confidential, proprietary information of MEDRAD, Inc. It is provided to trained employees of our customers for
the sole purpose of enabling such employee to service customer-owned MEDRAD injectors. This information may not be shared with third
parties or used to service injectors other than as specified herein. Further restrictions on the disclosure and use of this information is
provided in the Service Training Agreement executed by the customer and trained biomed at the time of training. Please refer to that
agreement or contact MEDRAD, Inc. if you have any questions about the information provided in this package.

7.3.10 Connect a test lead to the Case Ground jack on the NeTech
Electrical Safety Analyzer. Touch any metal part on the head
with test lead. Ensure the leakage is less than 10 mVAC.
Record the leakage value.

7.3.11 Remove the leakage test box from unit. Reconnect unit to AC
supply.
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VIEWED/PRINTED:

8. FINAL PREPARATION

8.1 Clean the area around the injector and sink of all spilled water.
Ensure syringes used during the PM are removed from the
injector and disposed properly. Discard all disposable materials
used while performing this PM. Place all linens used during
calibration in the soiled linen receptacle.

8.2 Apply DCU power.

8.3 Record the software versions from the safety screen on the
PMP checklist.

8.4 Connect with Swift and run the program “Scripts/Clear/Flight


recorder.

8.5 Press Continue. Reset the calibration reminder to next


Prior to use, you are responsible to confirm this copy's revision is the latest released.

calibration due date on the calibration reminder screen.

8.6 Remove power.

8.7 Ensure that all covers are in place and all hardware is present
and secure.
This copy of 205254 Rev A is valid as of May-30-2007 at 11:06:00.

8.8 Ensure that all surfaces are clean.

8.9 Ensure that screws on the SRU have a yellow coating.

8.10 Remove the old Calibration Label and install a completed


Calibration Label.

205254 Rev. A Page 8 of 8