Operator Manual
HIAC 9705
LIquId PArtICLe CountIng SyStem
9705
Operator Manual
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Table of Contents
1 Introduction
1.1 Product Overview...................................................................................11
1.2 Operation Conventions .......................................................................... 12
1.3 Accessories............................................................................................12
2 Initialization
2.1 Inspection and Unpacking......................................................................13
2.2 9705 Components..................................................................................14
2.3 Fluid Connections .................................................................................. 14
2.3.1 Connecting the Drain Line ........................................................ 14
2.4 Electrical Connections ........................................................................... 15
2.4.1 USB Communications ..............................................................15
2.4.2 Power Cable ............................................................................. 15
2.5 Syringe Installation.................................................................................15
2.6 Loading Printer Paper............................................................................19
2.7 Initial Power On......................................................................................21
3 System Setup
3.1 Settings Overview ..................................................................................23
3.2 Changing the Language.........................................................................24
3.3 Display Settings ..................................................................................... 25
3.4 Changing the Date and Time.................................................................26
3.5 Setting Particle Sizes.............................................................................27
3.5.1 Adding a Size ...........................................................................27
3.5.2 Editing a Size............................................................................ 28
3.5.3 Deleting a Size .........................................................................28
3.6 Setting Flow Rate...................................................................................28
3.7 Setting Backlight Timeout ...................................................................... 29
3.8 Configuring Sounds ............................................................................... 31
3.9 Changing the Needles ........................................................................... 32
3.10 Connecting the Large Volume Adapter.................................................. 35
3.10.1 Connecting the Large Volume Adapter to Sample Needle.......35
3.10.2 Connecting the Large Volume Adapter to the Sampling Probe 41
3.10.3 Shortening the Adapter Tube Length .......................................44
3.10.4 Alternate Use of Lab Stand as Sample Bag Hanger ................ 47
3.10.5 Calculating Tare Volume .......................................................... 48
3.11 Changing the Syringe Size .................................................................... 49
3.12 Changing Sample Parameters............................................................... 49
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3.13 Automatically Printing Results ............................................................... 51
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3.14 Password Protection..............................................................................52
3.14.1 Enabling Password Protection.................................................. 52
3.14.2 Changing the Password ...........................................................53
3.14.3 Disabling Passwords ................................................................ 54
4 Operating the 9705
4.1 Touch Screen Familiarization ................................................................ 55
4.2 Preparing Samples ................................................................................ 56
4.3 Loading Samples into the Accu-Swirl .................................................... 56
4.4 Loading Samples with the Large Volume Adapter................................. 57
4.5 Running a Sample ................................................................................. 57
4.5.1 Adding Notes ............................................................................ 58
4.5.2 Editing Notes ............................................................................ 58
4.6 Printing Results...................................................................................... 58
4.6.1 Automatically Printing Results .................................................. 58
4.6.2 Manually Printing Results ......................................................... 59
4.7 Operating with PharmSpec....................................................................59
5 Maintenance Procedures
5.1 Overview................................................................................................61
5.2 Cleaning the 9705.................................................................................. 61
5.3 Flushing the 9705 .................................................................................. 62
5.4 Syringe Maintenance ............................................................................. 62
5.5 Sensor Port Cleaning.............................................................................62
6 Diagnostics and Troubleshooting
6.1 Error Messages......................................................................................65
6.2 Troubleshooting Steps........................................................................... 65
6.3 Diagnostics Screen................................................................................ 65
6.3.1 Status Tab ................................................................................ 66
6.3.2 Calibration Tab ......................................................................... 68
6.3.3 Factory Tab ..............................................................................68
6.3.4 Sensor Log Tab ........................................................................ 70
Appendix A:Service Procedures
A.1 Return Procedures................................................................................. 71
A.2 Technical Support Information............................................................... 71
Appendix B:Specifications and Accessories
B.1 Performance Specifications ................................................................... 73
B.2 Accessories............................................................................................73
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Appendix C:Certifications
C.1 Overview................................................................................................75
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Manual Overview
About This Manual
The information in this manual has been carefully checked and is believed to be accurate.
However, Hach Ultra assumes no responsibility for any inaccuracies that may be contained in
this manual. In no event will Hach Ultra be liable for direct, indirect, special, incidental, or
consequential damages resulting from any defect or omission in this manual, even if advised of
the possibility of such damages. In the interest of continued product development, Hach Ultra
reserves the right to make improvements in this manual and the products it describes at any
time, without notice or obligation.
Published in the United States of America
Hach Ultra P/N: 701242 Edition 1, March 2006
Copyright © 2006 by Hach Ultra Analytics, Inc.
All rights reserved. No part of the contents of this manual may be reproduced or transmitted in
any form or by any means without the written permission of Hach Ultra.
Safety Conventions
WARNING
A warning is used to indicate a condition which, if not met, could cause serious personal injury
and/or death. Do not move beyond a warning until all conditions have been met.
CAUTION:
A caution is used to indicate a condition which, if not met, could cause damage to the
equipment. Do not move beyond a caution until all conditions have been met.
e:
A note is used to indicate important information or instructions that should be considered
before operating the equipment.
General Safety Considerations
• All service procedures should be conducted by properly trained service personnel.
• Make sure the Model 9705 Liquid Particle Counting System is properly installed and all
hydraulic connections are correctly installed before operation. All safety guidelines
should be observed.
• Follow all procedures in “Return Procedures” on page 71 before shipping a unit to a
service center for repair or re-calibration.
WARNING
Use of controls or adjustments, or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
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WARNING
Only factory certified personnel should perform service of the 9705. Attempts by untrained
personnel to disassemble, alter, modify or adjust the electronics and/or hydraulics may result
in personal injury and damage to the 9705.
This instrument has been tested and found to comply with:
• EN 61326 Electro Magnetic Compatibility (EMC) EN 61010-1 Safety Requirement for
Electrical Equipment for Measurement, Control and Laboratory Use.
• Low Voltage Directive EN 60825-1 Safety of Laser Products
• FDA Laser Safety 21 CFR, Chapter 1, Sub-Chapter J
WARNING
The following DANGER label is clearly visible on the body of the laser sensor inside the unit.
Do not disassemble or attempt to service due to the possibility of eye damage.
Although the 9705 is designed for rugged use, it is still an instrument that should be cared for
and maintained as described in this manual. Following proper safety and handling instructions
will promote accident free operation and prolong product life.
Warranty
Hach Ultra warrants that this instrument will be free of defects in materials and workmanship
for a period of one (1) year from the shipping date. If any instrument covered under this
warranty proves defective during this period, Hach Ultra will, at its option, either repair the
defective product without charge for parts and labor, or provide an equivalent replacement in
exchange for the defective product.
To obtain service under this warranty, the customer must notify the nearest Hach Ultra service
support center on or before the expiration of the warranty period and follow their instructions for
return of the defective instrument. The customer is responsible for all costs associated with
packaging and transporting the defective unit to the service support center, and must prepay
all shipping charges. Hach Ultra will pay for return shipping if the shipment is to a location within
the same country as the service support center.
This warranty shall not apply to any defect failure or damage caused by improper use or
maintenance or by inadequate maintenance or care. This warranty shall not apply to damage
resulting from attempts by personnel other than Hach Ultra representatives, or factoryauthorized and trained personnel, to install, repair or service the instrument; to damage
resulting from improper use or connection to incompatible equipment; or to instruments that
have been modified or integrated with other products when the effect of such modification or
integration materially increases the time or difficulty of servicing the instrument.
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THIS WARRANTY IS GIVEN BY HACH ULTRA ANALYTICS WITH RESPECT TO THIS
INSTRUMENT IN LIEU OF ANY OTHER WARRANTIES, EXPRESSED OR IMPLIED. HACH
ULTRA ANALYTICS AND ITS VENDORS DISCLAIM ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR NON-CONTRACTUAL PURPOSE.
HACH ULTRA ANALYTICS’ RESPONSIBILITY TO REPAIR OR REPLACE DEFECTIVE
PRODUCTS IS THE SOLE AND EXCLUSIVE REMEDY PROVIDED TO THE CUSTOMER
FOR BREACH OF THIS WARRANTY. HACH ULTRA ANALYTICS AND ITS VENDORS WILL
NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES EVEN IF HACH ULTRA ANALYTICS OR ITS VENDORS HAS BEEN GIVEN
ADVANCED NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
Acknowledgements
• Accu-Swirl is a trademark or registered trademark of Hach Ultra Analytics, Inc.
• Cavro is a trademark or registered trademark of Tecan Systems, Inc.
• Plexiglas is a registered trademark of Rohm and Haas Company Corporation.
• Teflon is a registered trademark of E.I. du Pont de Nemours and Company.
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1 Introduction
This guide helps the operator begin using the HIAC Model 9705 Liquid Particle Counting
System productively with minimal up-front instruction. The guide contains the information most
essential to running the 9705.
WARNING
The operator should always wear proper safety equipment and clothing when operating any
fluid system. The operator should also ensure that all connections are tight.
1.1 Product Overview
The Model 9705 Liquid Particle Counting System combines proven technology and application
knowledge in a compact syringe sampler. This instrument precisely measures particles from
small and large volume parenterals as well as fluid used for cleaning medical devices or
precision parts and water for injection (WFI) systems.
Fig 1-1 : Model 9705 Liquid Particle Counting System
The 9705 offers the Accu-Swirl™ built-in stirring mechanism to agitate the entire sample bottle
to distribute particles uniformly, thus increasing the sample’s accuracy. No separate stirring
mechanism is necessary. When used with PharmSpec 2.1, the 9705 supports FDA 21 CFR
Part 11 compliance.
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The 9705 can also be used with a Large Volume Adapter to sample from vessels greater than
125 mL. The adjustable height stand and stainless steel tube intake accommodate IV bags and
Large Volume Injectables (LVIs) and adds 0.054 mL tare volume per inch of tubing.
1.2 Operation Conventions
While the 9705 is most commonly used with PharmSpec to conduct compendial tests, some
9705 setup and display information is accessed by use of a TFT color touch screen located on
the front panel of the unit, shown in Figure 1-1. All commands may be executed through the
touch screen.
Items on the screen that need to be touched or pressed to invoke actions appear in bold text.
Buttons or tab names that should be pressed in sequence appear like this:
1) Press Settings icon > System icon to invoke the System screen.
Screen items commonly referred to in this manual include:
• A screen is a window of the Graphical User Interface (GUI) which takes all up all visible
space on the touch screen and can only be exited by pressing a button.
• A tab is a subdivision the GUI easily accessed by touching the tab at the top of the
screen.
• A button is an area of the touch screen that should be touched to invoke another screen
or execute an action (such as performing a sample run or clearing the buffer).
• A field indicates an area of the screen where strings of text and/or numbers may be
entered. To enter information in a field, touch the field. Depending on the nature of the
field (alphanumeric versus numeric), a keypad will appear on the touch screen to allow
text or numeric entries. Touch OK to complete the entry.
• A checkbox allows functions to be toggled on or off. Touch the box to make a checkmark
appear and enable the function. Touch the box a second time to make a checkmark
disappear and disable the function.
• A dropdown menu allows operators to choose from a set list of values. Dropdown menus
can be identified by the arrow on the right side of the field. To use a dropdown menu,
touch the arrow to show the list, drag a finger down the list to show all items, then
highlight the desired item to select it.
• A pop-up box is a warning or note to make sure actions are taken as intended. Click OK
or Yes to continue or Cancel to stop.
1.3 Accessories
Several accessories are available which can be ordered from a local Hach Ultra representative
or from the factory by calling either a local representative or the factory at 800.866.7889 or
+1 541.472.6500 during the week from 6:00 a.m. to 4:30 p.m. PT.
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2 Initialization
This section contains information on unpacking and setting up the Model 9705 Liquid Particle
Counting System so it is ready for use.
CAUTION:
Do not attempt to operate or set up the 9705 without reading and following the procedures
described in this section.
2.1 Inspection and Unpacking
The 9705, shown in Figure 2-1, is shipped in a single carton. Visually inspect the outside of the
carton for signs of damage (dents, tears, etc.) that may have occurred during shipping and
bring the damage to the attention of the shipper. Save this carton for reshipping the 9705.
Inspect the interior of the carton for damage to the contents. Compare the contents of the
carton to the shipping papers to assure all items are present. If any items are missing, contact
the factory at 800.866.7889 or +1-541.472.6500 or a local Hach Ultra representative.
WARNING
Never reach inside the bottle dock. There is a sharp needle inside the bottle dock; personal
injury may occur.
touch screen
syringe access
printer
bottle dock
Fig 2-1 : 9705 Particle Counting System
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2.2 9705 Components
Figure 2-2 shows the locations of connectors on the back panel of the 9705.
Place the particle counter on a dry, level surface. Do not power up any instruments until all
electrical and communications connections are complete.
drain USB service power
Fig 2-2 : Rear View of 9705
2.3 Fluid Connections
2.3.1 Connecting the Drain Line
1) Attach the drain line to the back of the unit.
2) Be sure the connection is secure before powering on the unit.
3) Place the other end of the drain line in a suitable waste-fluid receptacle.
e:
The sensor cleaning port is located on the left side of the unit below the printer. For more
information, refer to “Sensor Port Cleaning” on page 62.
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2.4 Electrical Connections
2.4.1 USB Communications
On the back of the 9705, shown in Figure 2-2, connect a computer or data device using the
following connectors:
• USB Client
• USB Host (for services updates only, not data transfer)
2.4.2 Power Cable
Connect the end of the power cord to the male socket on the rear panel of the 9705. Plug the
power cord into an appropriately rated AC line.
Attach the AC power cable supplied with the unit to the AC power socket. Do not turn the power
on until installation is complete.
CAUTION:
The round connection slot left of the AC power is for use by service personnel only. Do not
operate the unit with this cover removed.
2.5 Syringe Installation
The syringe is located on the right side of the 9705 as shown in Figure 2-3.
Syringe access
Fig 2-3 : 9705 Right Side View
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CAUTION:
The 9705 ships with the syringe drive positioned for loading a syringe. Load the syringe prior
to initially powering the 9705.
A syringe may be loaded or unloaded with the syringe drive plunger bolt set at its top travel
point.
Each syringe has the same plunger travel distance, so this procedure allows changing to
different volume syringes. The 9705 uses syringes in these volumes:
•1 mL
•10 mL
•25 mL
To load a syringe into the syringe drive:
1) Make sure the 9705 has been flushed of all fluids and the unit power is off. Make sure
the syringe drive plunger bolt is positioned at its top travel point.
2) Gently push the Plexiglas
access to the syringe cavity.
3) Be certain that the syringe is of an appropriate size. Remove the drive bolt from the
syringe drive mechanism.
4) Fasten the syringe to the drive by bolting the drive bolt through the syringe plunger.
5) Pull up on the syringe until the lower fitting mates with the Teflon
of the syringe drive.
®
door on the right of the 9705 upward to open it and gain
®
fitting at the bottom
CAUTION:
Do not overtighten the connection! Overtightening may cause Teflon extrusion and connector
degradation.
6) Twist the syringe until the connection is secure. Try to tighten so that the numbers on
the syringe face outward.
CAUTION:
When loading or removing a syringe, twist the syringe into and out of the fitting. Repeated
lateral movement of the syringe may cause damage to the Teflon syringe fitting.
7) Close the door. An error message will appear and an alarm will sound if a run is
initiated without closing the door.
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Fig 2-4 : Door Open Error Message
WARNING
The 9705 will not operate with the syringe door open. Attempts to operate the 9705 with the
door open may result in personal injury and/or damage to the 9705. Do not tamper with the
door interlock. Do not attempt to operate the 9705 with the door open.
e:
When changing syringe sizes, adjust the 9705’s settings to make sure the syringe installed
matches the syringe size setting. This procedure is described briefly here but is explored in
more detail in “Changing the Syringe Size” on page 49.
8) Turn the unit on. The Main Screen should appear, similar to the one shown in Figure 2-
5.
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Run Flush Swirl Setup Diagnostics Print Security
Fig 2-5 : Main Screen
9) From the Main Screen, select the Setup icon to invoke the Setup screen, shown in
Figure 2-6.
Fig 2-6 : Setup Screen
10) From the Setup screen, select the Syringe icon to invoke the Syringe Settings
screen, shown in Figure 2-7.
11) Check that the syringe size listed matches the one installed.
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Fig 2-7 : Syringe Settings Screen
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If the syringe sizes do not match, refer to “Changing the Syringe Size” on page 49 to adjust the
system settings.
12) Touch the Return icon to exit the Syringe Settings screen and return to the Setup
screen, then press Return again to return to the Main Screen.
2.6 Loading Printer Paper
The 9705 features an internal printer located on the left side of the unit for easy printing of
records, shown in Figure 2-8. Print procedures are described in detail in “Setting Print Results”
on page 38.
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Printer
Fig 2-8 : 9705 Left Side View
CAUTION:
The printer should not be operated without paper as damage may occur to the print head. If
the particle counter must be operated without paper in the printer, be sure to set the Print
Mode to None as described in “Automatically Printing Results” on page 58.
CAUTION:
Paper used in this printer is temperature-sensitive on one side and must go into the printer as
explained in the instructions. Do not substitute other types of paper.
To load printer paper:
1) Locate the printer on the left of the unit, shown in Figure 2-8.
2) Pull up the green handle in the center of the paper cover until a click is heard.
3) Fold the door down and remove the cardboard tube from the previous roll, if present.
4) Load the new paper roll so the paper feeds over the top of the roll. Position the end of
the paper on the black roller at the end of the printer feed door.
5) Push the printer door back until it clicks into place.
6) The printer is now ready to print. Print options include:
• Automatically printing runs, described in “Automatically Printing
Results” on page 58
• Manually printing the displayed record, described in “Manually
Printing Results” on page 59
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e:
If the paper does not feed out or no image appears on the paper after a print command has
been sent, double-check paper direction.
2.7 Initial Power On
Once the unit is powered on, the screen appears like the one shown in Figure 2-9.
Fig 2-9 : Main Screen
• Refer to “Operating the 9705” on page 55 for more information on operating the unit.
• Refer to “System Setup” on page 23 for information on system configuration.
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3 System Setup
3.1 Settings Overview
The 9705’s functions are accessed via an icon bar, shown in Figure 3-1.
Run Flush Swirl Setup Diagnostics Print Security
Fig 3-1 : 9705 Icon Bar
Many of the 9705’s settings are accessed via the Setup icon shown in Figure 3-1. Touching the
Setup icon invokes the Setup screen, shown in Figure 3-2.
Fig 3-2 : Setup Screen
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These functions are listed in Table 3-1.
Table 3-1 : Settings Button Functions
Icon Name Functions Relevant Sections
Sample Set sample parameters, including:
• Number of runs
• Sample Volume
•Tare
• Multi-Stroke Tare
• Dilution Factor
• Stir speed
System • Change date and time
• Setting the backlight timeout
• Changing the display language
Syringe • Changing syringe size
• Changing flow rate
Display Setting these parameters:
• Count display
• Scaling
• Number of runs to display
Printer • Configuring automated print com-
mands
• Manually feeding paper out of the
printer
“Changing Sample Parameters” on page 49
• “Changing the Date and Time” on page 26
• “Setting Backlight Timeout” on page 29
• “Changing the Syringe Size” on page 49
• “Setting Flow Rate” on page 28
“Display Settings” on page 25
• “Automatically Printing Results” on page 58
• “Loading Printer Paper” on page 19
Sizes • Adding size channel to monitor
• Editing existing size channel
• Deleting size channel
Security • Enabling or disabling password
protection
• Changing the password
Sound • Setting sound effects for actions
and errors
• Setting system volume
Load Defaults Loads the default settings for the
9705
Save Defaults Saves the current settings as the
default settings
3.2 Changing the Language
1) From the Main Screen, select the Setup icon > System icon to invoke the System
Settings screen, shown in Figure 3-3.
• “Adding a Size” on page 27
• “Editing a Size” on page 28
• “Deleting a Size” on page 28
“Password Protection” on page 52
“Configuring Sounds” on page 31
N/A
N/A
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Fig 3-3 : System Settings Screen
2) To change the language, touch the Language field to invoke a keypad entry screen.
3) Select the language from the dropdown menu.
4) A warning message will appear to ask for confirmation that the language will change. If
the language selected is correct, press OK.
5) Press Return to save changes and exit.
3.3 Display Settings
1) From the Main Screen, select the Setup icon > Display icon to invoke the Display
screen, shown in Figure 3-4.
Fig 3-4 : Display Settings Tab
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The Display Settings screen allows modification to the type of count displayed, scaling, and
number of runs displayed. These fields are described in Table 3-2.
Table 3-2 : Display Settings Fields
Field Name Description Valid Entries
Count display Select whether data will be displayed in
cumulative or differential mode
Count scaling Select whether or not data will be scaled on
the display
Runs To Display The number of runs displayed in a data
record
2) Make changes by touching a field to invoke a dropdown menu, touching the desired
choice to highlight it.
3) Press Return to exit the Display Settings screen.
3.4 Changing the Date and Time
1) From the Main Screen, select the Setup icon > System icon to invoke the System
Settings screen, shown in Figure 3-5.
• Cumulative
• Differential
•Raw
• Counts/mL
1 through 5
• Counts/100mL
• Counts/L
Fig 3-5 : System Settings Screen
2) To change the date, touch the Date field to invoke a keypad entry screen.
3) Enter the current date by pressing the number keys in YYYY/MM/DD format. Be sure to
add any leading zeroes; for example, December 1, 2006, should be entered 2006/12/
01.
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