ChemiDoc™ and ChemiDoc MP
Imaging Systems with
Image Lab™ Touch Software
Installation Qualification Protocol (IQ)
Catalog #17001401 and 17001402
ChemiDoc and ChemiDoc MP Imaging Systems Installation Qualification
Table of Contents
Page
Section 1: General Information ............................................................................................... 3
1.1 Scope ........................................................................................................................... 3
1.2 Protocol Guidelines ....................................................................................................... 3
1.3 Executor and Reviewer Identification and Signatures ................................................... 3
1.4 Site Information............................................................................................................ 4
1.5 Section 1 Signatures ..................................................................................................... 4
Section 2: Delivery and Inspection ......................................................................................... 5
2.1 Delivery Confirmation.................................................................................................... 5
2.2 Inspection/Identification of Components........................................................................ 5
Section 3: Installation Qualification Procedure........................................................................ 7
3.1 Environment ................................................................................................................. 7
3.2 Thumb Screw Removal ................................................................................................. 8
3.3 Power Cord Installation ................................................................................................. 8
3.4 Startup and Transilluminator Clearance ........................................................................ 8
3.5 Administrator Setup ...................................................................................................... 9
3.6 Instrument Leveling .................................................................................................... 10
3.7 Printer Installation (Optional)....................................................................................... 10
3.8 Section 3 Signatures ................................................................................................... 10
Section 4: Protocol Exceptions and Actions Taken ............................................................... 11
4.1 Protocol Exceptions and Actions Taken ...................................................................... 11
Section 5: Final Approval and Signatures ............................................................................. 12
5.1 Final Approval and Signatures .................................................................................... 12
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Section 1: General Information
1.1 Scope
This Installation Qualification protocol applies to the ChemiDoc™ (12003153) and ChemiDoc
MP (12003154) Imaging Systems with Image Lab™ Touch software.
This protocol has been prepared to encompass U.S. regulatory requirements. In regions
where requirements differ, such differences or additions shall be noted in Section 4.
1.2 Protocol Guidelines
The protocol guidelines in this procedure shall be followed. If any element does not apply, it
shall be indicated by N/A (not applicable). If any section has not been successfully
completed, indicate the appropriate protocol exceptions and actions taken in Section 4.1.
1.3 Executor and Reviewer Identification and Signatures
This section identifies the persons who will execute and review the installation qualification
protocol.
Executor
Printed Name Institution Signature Initials Date
Reviewer
Printed Name Institution Signature Initials Date
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1.4 Site Information
Table 1-1. Site information.
Reference or work order
number
Date of installation
PO number
Primary contact (name)
Primary contact phone number
Primary contact email
Installation site (lab/dept.)
Institution name
Address
1.5 Section 1 Signatures
Upon completion of this section, the executor and reviewer shall indicate the results, and
then sign and date this page.
Section 1 Completed Executor Signature Date
Successfully
Yes No
Section 1 Completed Reviewer Signature Date
Successfully
Yes No
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Section 2: Delivery and Inspection
2.1 Delivery Confirmation
Inspect the outside of the shipment to confirm receipt of all items listed in Table 2-1.
Table 2-1. Delivery confirmation.
Document Present (Executor Initial)
Shipping manifest (packing list)
Itemized purchase order
Unpacking the ChemiDoc and ChemiDoc MP
Imaging Systems Quick Guide
Observations/comments:
2.2 Inspection/Identification of Components
Inspect the shipment for receipt of all items listed in Table 2-2 and any shipping damage.
Record serial numbers (where applicable) of items listed in Table 2-2.
Table 2-2. Inspection/identification of components.
Description Present/Not Present Serial Number
ChemiDoc or ChemiDoc MP Imaging
System
Accessory box contents
AC power cord N/A
Cat 6 Ethernet cable, 10 ft N/A
Foot leveling wrench N/A
Bubble level N/A
Blot/UV/Stain-Free Tray N/A
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Table 2-2. Inspection/identification of components (continued).
Description Present/Not Present Serial Number
Accessory box contents (continued)
ChemiDoc and ChemiDoc MP Imaging N/A
Systems Safety and Regulatory
Compliance
Setting Up the ChemiDoc and N/A
ChemiDoc MP Imaging Systems Quick
Guide
Getting Started with ChemiDoc and N/A
ChemiDoc MP Sample Trays Quick
Guide
Gel/Blot Alignment Templates for the N/A
ChemiDoc and ChemiDoc MP Imaging
Systems Quick Guide
Band Excision Using the ChemiDoc N/A
and ChemiDoc MP Imaging Systems
Quick Guide
Acquiring an Image with the ChemiDoc N/A
and ChemiDoc MP Imaging Systems
Quick Guide
V3 Western Workflow™ N/A
Imaging Target
Declaration of conformity N/A
Warranty card N/A
Returned goods authorization form N/A
Optional accessories
White Sample Tray (12003026) N/A
Blue Tray (12003027) N/A
UV Safety Shield (12003914) N/A
Thermal Printer (1708089)
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Section 3: Installation Qualification Procedure
Before proceeding with this Installation Qualification, unpack and set up the instrument in
accordance with the Unpacking the ChemiDoc and ChemiDoc MP Imaging Systems and
Setting Up the ChemiDoc and ChemiDoc MP Imaging Systems quick guides.
3.1 Environment
Locate the ChemiDoc or ChemiDoc MP Imaging System so that there is sufficient room to
open and close the front door and UV transilluminator without obstruction (52 x 56 x 62 cm,
W x H x D), as well as 8 cm of clearance from the back for ventilation and access to the AC
power cord. Keep the area clean and free of excessive dust or moisture. It is important to
connect the ChemiDoc or ChemiDoc MP Imaging System to a properly grounded circuit.
Image quality can be affected if other lab equipment, such as centrifuges, shakers, oil-type
vacuum pumps, or freezers, share the same AC power line and/or bench area with the
imager.
Record Pass/Fail information in Table 3-1.
Table 3-1. Environment.
Parameter Specification Pass/Fail
Front door clearance No obstruction when
fully opened
Ventilation clearance Requires ≥8 cm of rear
clearance for both the
air intake and exhaust
ports
Environment Clean, free of
excessive dust,
humidity 10–80%, and
temperature 10–28°C
Power circuit Properly grounded
(100–240 VAC,
50–60 Hz)
Observations/comments:
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3.2 Thumb Screw Removal
Remove the thumb screw in accordance with the Unpacking the ChemiDoc and ChemiDoc
MP Imaging Systems Quick Guide.
Record Pass/Fail information in Table 3-2.
Table 3-2. Thumb screw removal.
Description Specification Pass/Fail
Thumb screw Remove thumb screw and label
3.3 Power Cord Installation
Locate the AC power receptacle on the back of the imager and connect the power cord to the
AC power receptacle in accordance with the Setting Up the ChemiDoc and ChemiDoc MP
Imaging Systems Quick Guide. Plug the other end of the AC power cord into an AC outlet.
Record Pass/Fail information in Table 3-3.
Table 3-3. Power cord installation.
Description Specification Pass/Fail
Power cord From the AC power receptacle to
the AC outlet
3.4 Startup and Transilluminator Clearance
Start the ChemiDoc or ChemiDoc MP Imaging System as described below and check that
there is sufficient room to open the UV transilluminator without obstruction in accordance with
the Unpacking the ChemiDoc and ChemiDoc MP Imaging Systems Quick Guide.
To start the ChemiDoc or ChemiDoc MP Imaging System
1. Press the power switch on the front of the imager. Verify that the power light illuminates
green and steady within a few seconds.
2. Verify that the instrument initializes and that the Welcome screen appears.
Record Pass/Fail information in Table 3-4.
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Table 3-4. Startup.
Description Specification Pass/Fail
ChemiDoc or ChemiDoc Power on and power light
MP Imaging System illumination steady
startup
Image Lab Touch Software
starts and Welcome screen
appears
Transilluminator No obstruction when fully
clearance opened
Observations/comments:
3.5 Administrator Setup
The designated on-site or IT administrator shall log in in accordance with the Setting Up the
ChemiDoc and ChemiDoc MP Imaging Systems Quick Guide instructions.
To log in to the ChemiDoc or ChemiDoc MP Imaging System
1. Tap anywhere on the screen. Using the onscreen keyboard, enter a user name and then
tap Create.
2. When prompted, tap OK to become an administrator and create a password in the box
that appears.
3. Review the Administrator Options dialog and tap Close.
Record Pass/Fail information in Table 3-5.
Table 3-5. Administrator setup.
Description Specification Pass/Fail
Administrator setup Create user
Create password
Observations/comments:
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3.6 Instrument Leveling
Use the bubble level and foot-leveling wrench to ensure that the instrument is level, in
accordance with the Setting Up the ChemiDoc and ChemiDoc MP Imaging Systems Quick
Guide instructions.
Record Pass/Fail information in Table 3-6.
Table 3-6. Instrument leveling.
Description Specification Pass/Fail
Level instrument Instrument is level
3.7 Printer Installation (Optional)
If a thermal printer is present, connect it to the imager and AC outlet in accordance with the
Setting Up the ChemiDoc and ChemiDoc MP Imaging Systems Quick Guide instructions.
Record Pass/Fail information in Table 3-7.
Table 3-7. Printer installation.
Description Specification Pass/Fail
Thermal printer Power cord from printer to the
installation AC outlet
USB cord from printer to the
imager
Observations/comments:
3.8 Section 3 Signatures
Upon completion of this section, the executor and reviewer shall indicate the results and then
sign and date this page.
Section 3 Completed Executor Signature Date
Successfully
Yes No
Section 3 Completed Reviewer Signature Date
Successfully
Yes No
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Section 4: Protocol Exceptions and Actions
Taken
4.1 Protocol Exceptions and Actions Taken
If an exception or deviation has been made to the protocol, or if a part requires replacement,
the executor must document the reason for the exception and list the action taken to correct
the situation. The executor should provide a description, including the section in which the
problem occurred, and list any parts that were replaced.
Table 4-1. Protocol exceptions and actions taken.
Exception(s)
1.
2.
3.
Action(s) Taken
1.
2.
3.
Executor Name Signature Date
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Bio-Rad
Laboratories, Inc.
Life Science Web site bio-rad.com USA 1 800 424 6723 Australia 61 2 9914 2800 Austria 43 1 877 89 01 177 Belgium 32 (0)3 710 53 00 Brazil 55 11 3065 7550
Canada 1 905 364 3435 China 86 21 6169 8500 Czech Republic 420 241 430 532 Denmark 45 44 52 10 00 Finland 358 09 804 22 00
Group France 33 01 47 95 69 65 Germany 49 89 31 884 0 Hong Kong 852 2789 3300 Hungary 36 1 459 6100 India 91 124 4029300
Israel 972 03 963 6050 Italy 39 02 216091 Japan 81 3 6361 7000 Korea 82 2 3473 4460 Mexico 52 555 488 7670 The Netherlands 31 (0)318 540 666
New Zealand 64 9 415 2280 Norway 47 23 38 41 30 Poland 48 22 331 99 99 Portugal 351 21 472 7700 Russia 7 495 721 14 04
Singapore 65 6415 3188 South Africa 27 (0) 861 246 723 Spain 34 91 590 5200 Sweden 46 08 555 12700 Switzerland 41 026 674 55 05
Taiwan 886 2 2578 7189 Thailand 66 2 651 8311 United Arab Emirates 971 4 8187300 United Kingdom 44 020 8328 2000
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