Hach HIAC 9705 User manual

HIAC 9705

LIquId PArtICLe CountIng SyStem

Operator Manual

9705

KSS - March 2006 - Edition 1

Operator Manual

9705 - Table of Contents 3 of 82

KSS - March 2006 - Edition 1

HIAC Operator Manual

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

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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9705 - Manual Overview 7 of 82

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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

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.

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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 factory-

authorized 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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9705 - Introduction 11 of 82

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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.

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.

Fig 1-1 : Model 9705 Liquid Particle Counting System

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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.

Fig 2-1 : 9705 Particle Counting System

touch screen

printer

bottle dock

syringe access

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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.

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.

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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.

Fig 2-2 : Rear View of 9705

drain USB service power

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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.

Fig 2-3 : 9705 Right Side View

Syringe access

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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

®

door on the right of the 9705 upward to open it and gain

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

®

fitting at the bottom

of the syringe drive.

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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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.

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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.

Fig 2-4 : Door Open Error Message

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9) From the Main Screen, select the Setup icon to invoke the Setup screen, shown in

Figure 2-6.

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.

Fig 2-5 : Main Screen

Fig 2-6 : Setup Screen

Run Flush Swirl Setup Diagnostics Print Security

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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.

Fig 2-7 : Syringe Settings Screen

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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:

Fig 2-8 : 9705 Left Side View

• Automatically printing runs, described in “Automatically Printing

Results” on page 58

• Manually printing the displayed record, described in “Manually

Printing Results” on page 59

Printer

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