3851-0020 5100 Operation Manual Rev E · All Distek 5100 heaters have thermostatic protection. In the event of a malfunction (or if no liquid in vessel), the heater will cut off at

Operation Manual

Premiere 5100 Dissolution Test System

About This Manual

Operation Manual: Model 5100 i

Distek Premiere 5100 Dissolution Test System

Operation Manual

Document # 3851-0020

Distek, Inc.121 North Center Dr. • North Brunswick, NJ 08902

Phone 732.422.7585 • Fax 732.422.7310http://www.distekinc.com

About This Manual

Operation Manual: Model 5100 ii

Notice This document contains proprietary information. All rights are reserved. No part of this document may be photocopied, reproduced or translated without the prior written consent of DISTEK Incorporated.

DISTEK, INC. 121 North Center Drive North Brunswick, NJ 08902-4905 Tel. (732) 422-7585 Fax. (732) 422-7310 Website: http://www.distekinc.com

“Dow Corning” is a registered trademark of Dow Corning Corporation, USA.

IBM and IBM PC are registered trademarks of IBM Corp.

CenterChek, HeightChek, RPMChek, ShaftChek, and TempChek are trademarks of DISTEK, Inc.

The DISTEK logo is a registered trademark of DISTEK, Inc.

All other company and product names are trademarks or registered trademarks of their respective holders.

Document Revision History Rev Date Document Notes

A September 1996 3851-0020

B March 1997 3851-0020

C December 1997 3851-0020

D June 2002 3851-0020

E August 2003 3851-0020 See Distek Change Notice 0381

About This Manual

Operation Manual: Model 5100 iii

Contents

About this Manual .............................................................................vi

Purpose ......................................................................................... vii Audience........................................................................................ vii Contents ........................................................................................ vii Prerequisites .................................................................................. viii Documentation ............................................................................... viii Conventions ................................................................................... viii

1 Introduction...........................................................................1-1

Specification .................................................................................. 1-2 Overview....................................................................................... 1-3

2 Installation ............................................................................2-1

Unpacking ..................................................................................... 2-2 To remove packing....................................................................... 2-2

Leveling: Model 5100 ........................................................................ 2-3 To level unit on bench .................................................................. 2-3

Positioning the Vessels ...................................................................... 2-6 To install vessels in vessel plate....................................................... 2-6

Paddles and Baskets ......................................................................... 2-6 To install paddle blades................................................................. 2-6 To install baskets ........................................................................ 2-6 Checking paddles, baskets and shafts for straightness ............................ 2-8 Checking shaft centering ............................................................... 2-8

Installing the Calibration Probe............................................................ 2-8 To install calibration probe ............................................................ 2-8

About This Manual

Operation Manual: Model 5100 iv

Adjusting the Paddle (or Basket) Height ................................................. 2-9 To set height of paddle or basket ................................................... 2-11

Installation Checkout ...................................................................... 2-12 RPM Control ............................................................................. 2-12 Test Duration ........................................................................... 2-12 Temperature Control .................................................................. 2-12 Time and Date .......................................................................... 2-13

3 Operation..............................................................................3-1

To Run a Pre-programmed Automatic Test .......................................... 3-5 Control Keypad ............................................................................... 3-7

Stir Key .................................................................................... 3-7 Arrow Keys ................................................................................ 3-7 Enter Keys ................................................................................. 3-7 Clear Key .................................................................................. 3-7 START Key................................................................................. 3-7 Sleep Key (System Standby) ............................................................ 3-8

Display and Control Screens ................................................................ 3-8 Display Screens ........................................................................... 3-9 For Method History Information ..................................................... 3-12

Automatic Testing Methods............................................................... 3-13 Select Method .......................................................................... 3-13 Edit Test Method ....................................................................... 3-14 Pre-Test Initialization ................................................................. 3-18 START Test Using Paddles ............................................................ 3-19 Program New Auto Test ............................................................... 3-23 Delete Test Method.................................................................... 3-24 Basket Testing .......................................................................... 3-24

Manual Operation .......................................................................... 3-25 Set RPM .................................................................................. 3-26 Controlling Vessel Individually ....................................................... 3-26 Controlling All Vessels Together ..................................................... 3-27

System Setup and Calibration ............................................................ 3-29 Introduction............................................................................. 3-29 Calibrate Using 5100 Calibration Probe ............................................ 3-30 Calibrating Using TempChek Digital Thermometer ............................... 3-36 Calibrating Using NIST Traceable Reference Thermometer..................... 3-44 Advanced Setup Options .............................................................. 3-53

Printouts ..................................................................................... 3-54 Serial Port Control of 5100 ............................................................... 3-57

RS-232 Port.............................................................................. 3-57 Serial RS-485 Address and Beep Mode .................................................. 3-61

4 Maintenance ..........................................................................4-1

General Care and Maintenance of Model 5100 .......................................... 4-2

About This Manual

Operation Manual: Model 5100 v

5 Troubleshooting & Service..........................................................5-1

Troubleshooting Chart....................................................................... 5-3 Model 5100 System Initialize Procedure................................................ 5-19 Clearing the Dallas Chip................................................................... 5-21 Replacing Chip Number U13 .............................................................. 5-21 Function Check and Initialize Instrument .............................................. 5-22 Initialize Unit ............................................................................... 5-22 Service ....................................................................................... 5-24 Appendix A: Spare Parts and Accessories ................................................A-1 Appendix B: Preventive Maintenance Checklist .........................................B-1 Appendix C: Pre-Installation Considerations: Electrical Power Supply ..............C-1 Appendix D: CE Declaration of Conformity ..............................................D-1 Appendix E: Certificate of Compliance................................................... E-1 Appendix F: Sample Printouts from Parallel Printer.................................... F-1

About This Manual

Operation Manual: Model 5100 vi

About this Manual

About This Manual includes information about what is contained in this manual and the conventions used. Purpose ......................................................................................... vii Audience........................................................................................ vii Contents ........................................................................................ vii Prerequisites .................................................................................. viii Documentation ............................................................................... viii Conventions ................................................................................... viii

About This Manual

Operation Manual: Model 5100 vii

Purpose This manual covers the installation, routine operation, maintenance and repair of your Model 5100 Dissolution Test System. It contains information regarding the commands, menus, indicators and controls. Chapter 1 provides an overview of the 5100. Chapter 2 covers unpacking, installation, and qualification of the system. Chapter 3 contains operation and programming information. Chapters 4 and 5 cover maintenance and troubleshooting. Please read Chapters 1, 2 and 3 before proceeding.

Audience This manual is written for any person responsible for maintaining, operating or troubleshooting the Distek Premiere 5100 Dissolution Test System.

Contents This manual is divided into chapters. The pages of the manual are numbered providing easy navigation to assist in finding information quickly. The following list describes the material covered in each chapter:

Table 1: Chapter Descriptions

Chapter 1 - Introduction Provided a general overview and warnings about the instrument.

Chapter 2 - Installation Describes how to unpack and properly install the unit.

Chapter 3 - Operation Describes how the functionalities of the system and how to run the unit.

Chapter 4 - Maintenance Explains the steps necessary to maintain the unit.

Chapter 5 – Troubleshooting & Service Provides and troubleshooting chart and description of error messages to assist the user is a problem should arise.

Appendix A – Spare Parts and Accessories

Provides a table of recommended and optional spare parts.

Appendix B - Preventive Maintenance Checklist

Provides a checklist of preventive maintenance actions.

Appendix C - Pre-Installation Recommendation information

About This Manual

Operation Manual: Model 5100 viii

Considerations: Electrical Power Supply

pertaining to electrical power supply.

Appendix D - CE Declaration of Conformity

CE Declaration of Conformity certificate.

Appendix E - Certificate of Compliance Certificate of Compliance Appendix F - Sample Printouts from Parallel Printer

Sample printouts for a parallel printer.

Prerequisites This manual assumes that you understand the principles of dissolution testing.

Documentation This manual contains important information regarding the safe operation, maintenance and repair of your Distek Premiere 5100 Dissolution Test System. We urge you to read Sections 1, 2, and 3 before proceeding.

Conventions The following table lists conventions and terms used throughout this manual:

Table 2: Conventions

“WARNING” statements are used in this manual to prevent injury to personnel.

“CAUTION” statements are used to prevent damage to equipment.

“NOTES” contain helpful information.

REQUIRED

ACTION

Used where necessary to distinguish the action needed from the Warnings, Cautions and Notes.

Chapter 1: Introduction

Operation Manual: Model 5100 1-1

1 Introduction The Distek Premiere 5100 Dissolution Test System is a state of the art instrument. This chapter will introduce the user to the unit. Specification .................................................................................. 1-2 Warnings and Notes .......................................................................... 1-3



Specification The Distek Premiere 5100 dissolution system utilizes state of the art electronics, solid state components, and advanced materials to provide the fastest, cleanest, and most cost effective dissolution testing solution available today. The 5100 has intelligent programming features that allow individual vessel control of heating profile, remote programming and control, and comprehensive method reporting, documentation, and validation.

Table 3: System Specifications

Dissolution Vessels: 7 built-in vessel positions Volume: 500mL to 1000mL, programmable

Heating Time (20-37ºC) Approximately 15-20 minutes, 0.3º C maximum overshoot

RPM Control Range: 25-300 RPM, digitally controlled, closed loop

Resolution: 0.1 RPM Accuracy: +/- 0.2 RPM from 50-150 RPM

Display: 0.75” (19mm) high output four-digit LED Motor: High Torque, Permanent Magnet

Vessel Temperature

Control: Each individual vessel is continuously

monitored and controlled. Display Resolution: 0.01º C

Accuracy: +/- 0.25º C Calibration: Built-in Calibration Probe

Shaft Wobble: Less than 0.010” (0.254mm) TIR

Program Modes: Manual (individual vessel control)

Automatic (30 pre-programmed methods) External (ProduKey memory device)

Interface Ports: RS-232 (1), RS-485 (2), Parallel Printer

Construction Materials: Cast Aluminum, Stainless Steel, Acid resistant solid state heating elements, Engineered Plastics

Dimensions: 27”(W) x 37”(H) x 19”(D) (68.6 x 94.0 x 48.3cm Deep)

Weight: 150 lb. (68kg) Electrical Power: 115V 50/60Hz 15A or 220V 50/60Hz 8A

(Operating voltage pre-set at factory)



Warnings and Notes

Improper servicing or adjustment practice can cause equipment failure or serious physical injury. This equipment must be adjusted and serviced by qualified electrical maintenance personnel who are familiar with the construction and operation of the equipment and the hazards involved. Take diligent care during adjustment. All exposed points on the control circuit boards are electrically hot with respect to earth ground.

HIGH VOLTAGE IS EXPOSED WHEN THE LOWER REAR PANEL IS OPENED ON THE 5100. Dangerous voltages exist on the circuit boards when powered. Disconnect AC power from the 5100 while troubleshooting. Be alert. High voltage can cause serious or fatal injury.

The Model 5100 is supplied with proper heaters and settings for the specified operating voltage (see label for information). Do not attempt to convert unit to another power supply without contacting the factory first!

Take care when removing or replacing vessel heaters. Turn off unit and disconnect power from 5100. Do not use metal tools or sharp objects to mount heater. Heater failure and/or injury could result.

Heater surfaces may be HOT. Do not touch vessel heater assemblies, when 5100 is in operation. Injury may result.

Take proper precautions when handling dissolution media. Liquid in vessel may be HOT. Wear protection from splash to avoid exposure to scalding, acidic, caustic, or pharmaceutical hazards. Bacteria have been shown to thrive in certain media, especially at test temperatures.

Improper remote PC control of 5100 may lead to unexpected motor and/or heater operation. Make sure personnel are clear before issuing PC commands.



To avoid damaging the instrument:

• Do not operate heaters with less than 500ml liquid in each vessel.

• The stirring element (paddle or basket) must be immersed into the liquid and rotating when heaters are operating.

• Use only glass vessels supplied for the model 5100 by Distek.

• Connect this unit to the specified AC supply. Observe proper grounding.

• Failure to observe these precautions may damage the heater assemblies and/or vessels.

To avoid glass breakage and injury: ♦ Do not heat vessels empty. ♦ Do not clean with materials that scratch. ♦ Do not bump. ♦ Discard vessels if cracked, scratched, or heated empty.

All Distek 5100 heaters have thermostatic protection. In the event of a malfunction (or if no liquid in vessel), the heater will cut off at approximately 150ºC. Thermostat automatically resets after cooling down.

The 5100 incorporates a height sensor to stop rotation and heating whenever the drive unit is raised well above operating position. This feature helps to prevent overheating and addresses safety issues. To resume rotation and heating, return drive unit to operating position and press START key.

External cables (excluding power cable) are limited to less than 3 meters length in order to maintain electromagnetic compliance.

Some forms of electromagnetic interference may cause unexpected operation. If this occurs, the unit will return to normal operation once the interference is removed.

Chapter 2: Installation


2 Installation This chapter describes the steps necessary to properly unpack and install the instrument. Unpacking ..................................................................................... 2-2

To remove packing....................................................................... 2-2 Leveling: Model 5100 ........................................................................ 2-3

To level unit on bench .................................................................. 2-3 Positioning the Vessels ...................................................................... 2-6

To install vessels in vessel plate....................................................... 2-6 Paddles and Baskets ......................................................................... 2-6

To install paddle blades................................................................. 2-6 To install baskets ........................................................................ 2-6 Checking paddles, baskets and shafts for straightness ............................ 2-8 Checking shaft centering ............................................................... 2-8

Installing the Calibration Probe............................................................ 2-8 To install calibration probe ............................................................ 2-8

Quick Change Height Adjustment Knob................................................... 2-9 To set height of paddle or basket ..................................................... 2-9

Adjusting the Paddle (or Basket) Height ............................................... 2-11 To set height of paddle or basket ................................................... 2-11

Installation Checkout ...................................................................... 2-12 RPM Control ............................................................................. 2-12 Test Duration ........................................................................... 2-12 Temperature Control .................................................................. 2-12 Time and Date .......................................................................... 2-13



Unpacking

To avoid injury, two people should remove 5100 from carton.

Do not bump or disturb built-in paddle shafts as this may affect shaft runout.

The drive unit is locked in place during shipping.

Please take a few moments when unpacking unit to check for all items indicated on packing list. Notify DISTEK or your shipper immediately of any discrepancies or damage to cartons or contents in transit.

Packing must be removed before operating this instrument.

To remove packing 1. Cut through tape at top of carton. Open four top flaps. 2. Carefully remove packing inserts and lift instrument from shipping carton.

See warning and cautions above. 3. If drive unit is locked in place, tie-wraps are visible from the front of the

unit, above the bearings (see item 1 below). 4. Identify & cut the tie-wraps on the guide rods above the bearings and

remove split tubing (see item 2 below). 5. Remove split washer (item 3) from top of each bearing. 6. Press brake release key (see Figure 2-3) and gently raise or lower drive unit. 7. Let go of brake release key to set drive unit at desired height.



Figure 2-1: Rear View – Inside

The power cord is shipped in a separate carton from the main unit. Connect power cord supplied to 5100 below power switch (see Figure 2-3). Locate proper outlet for 5100. See Appendix C for electrical power requirements.

Leveling: Model 5100 To level unit on bench 1. Trained personnel should lift unit onto bench and slide it into position. 2. Make certain the two stabilizers under rear of base are not touching bench. 3. Loosen locking nuts on front leveling feet, using the appropriate (1/2”)

wrench. 4. Observe permanently mounted circular level on vessel support plate. 5. Level unit from front to back and side to side by adjusting front two leveling

feet under instrument base (see Figure 2-3).

Do not loosen rear leveling foot. Level unit by adjusting front leveling feet.



6. Required Action: Tighten locking nut on each foot at this time. 7. After leveling, adjust two stabilizers under rear of instrument base so that

they just touch bench. 8. Mark location of leveling feet on bench, to prevent changes in level due to

moving unit. 9. Check the level after completing installation, or after moving the Model

5100 to a new location. Verify accuracy of built-in circular level by placing 6-9” carpenter’s level on vessel plate leveling bosses (see Figure 2-2). Check from front to back and side to side.

Connect this unit to the specified ac supply. Observe proper grounding.

10. Plug Model 5100 into proper electrical outlet provided.

Figure 2-2: Leveling Model 5100



1. Drive Unit 6. Glass Vessel 11. Spindle Assembly 2. Brake Release 7. Leveling Feet 12. Front LCD Display 3. Height Adjustment Knob 8. Heater Assembly 13. Shaft Handle 4. Power Switch 9. Vessel Support Plate 14. Top LED Display 5. Base Plate 10. Paddle Blade

Figure 2-3: Model 5100 Installation



Positioning the Vessels To install vessels in vessel plate

1. Raise drive unit.

2. Insert a vessel in each position on vessel plate.

3. Slide vessel through vessel clips until it can go no further.

Top of at least one vessel clip should contact bottom of vessel flange.

DISTEK supplies highly uniform vessels that fit properly into the 5100 heater assemblies. Use of vessels other than those supplied by DISTEK for the 5100 may result in unsatisfactory operation or heater damage and void the warranty.

Paddles and Baskets To install paddle blades

Carefully screw a paddle blade onto bottom of each shaft. Assemble finger-tight.

Do not grasp basket by mesh screen when installing or removing. ALWAYS GRASP BASKETS BY KNURLED UPPER RIM. Proper handling will prevent basket distortion and RESULTING wobble.

To install baskets

1. Carefully screw a basket adapter onto bottom of each shaft. Assemble finger-tight (see Figure 2-4).

2. Vessel pre-heat to be performed at 250 RPM with basket adapter only. Baskets are not installed during pre-heat.



3. Always place tablet or capsule into a dry, empty basket before test.

4. When vessel stabilizes at test temperature, lift shaft out of vessel.

5. Place basket, open end up, in palm with thumb and fingers grasping knurled grip (see Caution above.)

6. Raise basket until inside of knurled ring just contacts the O-ring shown in Figure 2-4.

7. Twist and push basket onto adapter.

8. When removing basket, grasp only on the knurled grip. Pull down and twist.

Upon completion of each test, rinse baskets and shafts thoroughly with distilled water. DO NOT ALLOW ACIDS OR BUFFERS TO DRY ON THE METAL SURFACES.

Figure 2-4: Installing Basket on Shaft

Handle paddle blades and optional baskets carefully to avoid bending or damage. Store carefully in original container to prevent damage.



Checking paddles, baskets and shafts for straightness

Use instruments such as Distek’s Wobble Meter, ShaftChek, or other means to verify straightness of stirring shafts, blades, and baskets. Check shaft wobble near bottom end of shaft. Check basket wobble at bottom rim of basket. Record values at 25 and 250 RPM.

Checking shaft centering

Use DISTEK CenterChek or other means to verify shaft centering with respect to vessels. Follow instructions included with Center-CHEK for accurate results.

“Basket” refers to USP Dissolution Apparatus 1. “Paddle” refers to USP Dissolution Apparatus 2.

Installing the Calibration Probe To install calibration probe

1. Make sure serial number of hand-held calibration probe matches serial number of 5100.

2. Plug in calibration probe at rear of drive unit.

3. Place probe in holder (see Figure 2-5).

Figure 2-5: Drive Unit (Rear View)

1. Calibration Probe 2. Holder with Probe 3. Upper Serial Port

(TempCheck Connection to Instrument)



Quick Change Height Adjustment Knob After completing the following setup procedure, it should not be necessary to move the shaft collars when switching back and forth from baskets to paddles. Just rotate the knob as shown. The extension block compensates for the difference in height paddles and baskets.

Handle baskets only by top ring. Undue pressure on wire mesh can bend basket out of shape, which could affect test results.

Figure 2-6: Horizontal Figure 2-7: Paddles Figure 2-8: Baskets

To set height of paddle or basket

1. Press brake release button and raise drive unit.

2. Install extension block in knob hole as shown (see Figure 2-8).

3. Turn height adjustment knob to either horizontal position (see Figure 2-6).

4. Loosen shaft locking collars so they slide freely on shafts. Use 7/64” Allen (hex) wrench.

5. Raise shafts slightly by pulling up on handles.

PADDLES

B A S K E T S Knob

Extension Block



6. IMPORTANT: Install paddle blades first on all shafts, even if baskets will be used for test. Paddle blades must be used to set shaft collars.

7. Lower drive unit slowly to lowest position.

8. While applying slight downward pressure on drive unit, let go of brake release button to lock drive unit in place. Make sure drive plate extension touches height adjustment knob.

9. Lower shafts until paddles just touch the bottom of each vessel.

10. Lock each shaft collar using 7/64” Allen wrench.

11. Raise the drive unit approximately six inches.

12. Turn the height adjustment knob to “PADDLES” position, as seen from front of unit (see Figure 2-7).

13. Lower drive unit gently until it comes to rest on height adjustment knob. Release brake button.

14. Check paddle height using DISTEK Height-CHEK™ or other means. Record distance from bottom of each paddle to bottom of vessel.

DO NOT CHANGE THE POSITION OF THE SHAFT COLLARS.

15. To switch to baskets, raise the drive unit and install baskets on shafts.

16. Turn the knob to “BASKETS” position (see Figure 2-8).

17. Lower drive unit gently until it comes to rest on height knob.

18. Release brake button.

19. Check basket height using DISTEK HeightChek or other means. Record distance from bottom of each basket to bottom of vessel.



Adjusting the Paddle (or Basket) Height

Handle baskets only by knurled top ring. Undue pressure on wire mesh can bend basket out of cylindrical shape, which could affect test results.

To set height of paddle or basket

1. Press brake release key and raise drive unit.

2. Turn height adjustment knob (Figure 2-3) to either horizontal position.

3. Loosen shaft locking collars so they slide freely on shafts. Use 7/64” Allen (hex) wrench.

4. Raise shafts slightly by pulling up on shaft handles (see Figure 2-3). There are no chucks to loosen.

5. Lower drive unit slowly to lowest position, so drive plate extension rests on height adjustment knob.

6. While applying slight downward pressure on drive unit, let go of brake release key to lock drive unit in place.

7. Lower shafts gently until paddle blades (or baskets) just touch the bottom of each vessel. Do not put undue pressure on baskets.

8. Lock each shaft collar using 7/64” Allen wrench.

9. Raise the drive unit approximately six inches.

10. Turn the height adjustment knob to “PADDLES” position, as seen from front of unit (Figure 2-3).

11. If baskets are used, turn the knob to “BASKETS” position instead.

12. Lower drive unit gently until it comes to rest on height adjustment knob.

13. Release brake key.

14. Check paddle or basket height using DISTEK HeightChek or other means. Verify and record distance from bottom of each paddle or basket to bottom of vessel.

If shafts do not slide up smoothly, a very thin film of lubricant may be applied to shaft, only to area just below spindle. Wipe off any excess grease. Move shaft up and down gently to distribute lubricant. If necessary, DISTEK recommends Dow Corning High Vacuum Grease. Do not use a lubricant which may affect your test results.



Installation Checkout Your instrument has been tested thoroughly before shipment. To detect any problems caused by shipping and handling, Distek recommends a careful check of all crucial operating parameters after complete installation of the dissolution system. This check should include, as a minimum, those steps outlined in Appendix B: Preventive Maintenance Checklist.

RPM Control

Check and record RPM display accuracy at 50, 100, 150 and 250 RPM using a calibrated tachometer such as DISTEK RPMChek.

Test Duration

Check and record timing accuracy at test RPM using a calibrated stopwatch. Test over range of expected usage: If your test durations and sample times range from 15 minutes to 12 hours, for example, you should measure Auto Test intervals of 10 minutes, 1 hour, and 24 hours.

Temperature Control

1. Install paddle blades.

2. Set shaft collars in place.

3. Raise drive assembly.

4. Fill each vessel with 900ml of DI water at 18-22°C.

5. Turn height adjust knob to “Paddles” position.

6. Lower drive assembly and paddles fully.

7. Set rotation to 150RPM (see Set RPM on page 3-26).

8. Cover all vessels with vessel covers provided.

9. Place a calibrated reference temperature probe, such as DISTEK TempChek, in one of front center vessels.

10. Record vessel temperature and time.

11. Set operating temperature and press START.

12. Monitor temperature and time until vessel temperature stabilizes.

13. Adjust temperature set-point so that vessel temperature stabilizes at required vessel temperature (such as 37.0°C).

14. Record set-point required to achieve required vessel temperature.

15. Press START to turn off heaters.

16. Verify & record temperature calibration of calibration probe and each vessel probe using external reference thermometer at approximately 37°C.



Time and Date

Press SLEEP key twice to check system time and date settings. See Sleep Key (System Standby) on page 3-8 to adjust if needed.

Chapter 3: Operation


3 Operation The chapter describes the user interface screens and system administrator for the instrument. It also provides step-by-step instructions to perform many of the common tasks. Control Keypad ............................................................................... 3-7

Stir Key .................................................................................... 3-7 Arrow Keys ................................................................................ 3-7 Enter Keys ................................................................................. 3-7 Clear Key .................................................................................. 3-7 START Key................................................................................. 3-7

For Manual Test Mode ...............................................................3-7 For Automatic Test Mode ...........................................................3-8

Sleep Key (System Standby) ............................................................ 3-8 Display and Control Screens ................................................................ 3-8

Display Screens ........................................................................... 3-9 For Method History Information ..................................................... 3-12

Automatic Testing Methods............................................................... 3-13 Select Method .......................................................................... 3-13

To Select and Edit Auto Test..................................................... 3-13 Edit Test Method ....................................................................... 3-14

To Set Vessel Temperatures...................................................... 3-14 To Set Stirring Speed and Duration ............................................. 3-14 To Select Paddle or Basket and Set Volume ................................... 3-15 To Print Method Settings ......................................................... 3-16 Writing Test to ProduKey Memory............................................... 3-17 To Write Automatic Test Settings to ProduKey ............................... 3-17



Reading Test from ProduKey Memory........................................... 3-17 To Read Automatic Test Settings from ProduKey............................. 3-18

Pre-Test Initialization ................................................................. 3-18 For Automatic Printout of Test Data at End of Test.......................... 3-19

START Test Using Paddles ............................................................ 3-19 To Drop Dosage Forms and Start Test .......................................... 3-20

Introducing Dosage Forms ............................................................ 3-20 Method A ............................................................................ 3-20 Method B ............................................................................ 3-21 For Staggered Drop of Dosage Forms ........................................... 3-21 To Monitor or Terminate Test.................................................... 3-22

Program New Auto Test ............................................................... 3-23 To Enter Name of New Test ...................................................... 3-23

Delete Test Method.................................................................... 3-24 Basket Testing .......................................................................... 3-24

To Set Basket Height .............................................................. 3-24 To Run Basket Test ................................................................ 3-25

Manual Operation .......................................................................... 3-25 For Manual Control ................................................................ 3-25

Set RPM .................................................................................. 3-26 To Set RPM in Manual Mode ...................................................... 3-26

Controlling Vessel Individually ....................................................... 3-26 To Check or Edit Individual Vessel Settings.................................... 3-27

Controlling All Vessels Together ..................................................... 3-27 To Check or Edit Settings for All Seven Vessels ............................... 3-28

System Setup and Calibration ............................................................ 3-29 Introduction............................................................................. 3-29 Calibrate Using 5100 Calibration Probe ............................................ 3-30

Lo-Calibration Procedure Using Probe.......................................... 3-30 Calibration Verification ........................................................... 3-33 Hi-Calibration Procedure Using Probe .......................................... 3-34

Calibrating Using TempChek Digital Thermometer ............................... 3-36 Lo-Calibration Procedure Using TempChek .................................... 3-37 Calibration Verification ........................................................... 3-40 Hi-Calibration Procedure Using TempChek .................................... 3-41

Calibrating Using NIST Traceable Reference Thermometer..................... 3-44 Lo-Calibration Procedure Using Reference Thermometer................... 3-44 Calibration Verification ........................................................... 3-47 Hi-Calibration Procedure Using Reference Thermometer ................... 3-49

Advanced Setup Options .............................................................. 3-53 CalKey ............................................................................... 3-53 To read from or write to CalKey................................................. 3-53 Printer Calibration Settings ...................................................... 3-54 To print calibration settings ..................................................... 3-54 To leave calibration and advanced setup screens ............................ 3-54



Printouts ..................................................................................... 3-54 To generate “Instaprint” ......................................................... 3-54

Serial Port Control of 5100 ............................................................... 3-57 RS-232 Port.............................................................................. 3-57

Serial RS-485 Address and Beep Mode .................................................. 3-61 Setting RS-485 address and Beep mode ........................................ 3-62



To avoid damaging the instrument:

• Do not operate heaters with less than 500ml liquid in each vessel.

• The stirring element (paddle or basket) must be immersed into the liquid and rotating when heaters are operating.

• Use only glass vessels supplied for the model 5100 by Distek.

• Connect this unit to the specified AC supply. Observe proper grounding.

• Failure to observe these precautions may damage the heater assemblies and/or vessels.

DISTEK recommends leaving vessels in the instrument filled with

water when not in use. This reduces chance of damage due to inadvertently turning on heaters with no liquid in vessel. As a

precautionary step always keep vessel 7 filled with water, even if not used as a test position

After switching instrument off, wait ten seconds before switching on power again.



Figure 3-1 shows vessel locations on model 5100:

VESSEL LOCATIONS

FRONT OF VESSEL PLATE

2 3 4 5

1 7 6

Figure 3-1: Location of Vessels #1-7

To Run a Pre-programmed Automatic Test

1. Gently pour media test volume into vessels.

2. Lower drive unit to operating position.

3. Turn on instrument power.

Power switch is located at back right side of instrument, above power cord (Figure 2-3). Unit performs brief power-on self-test and displays Firmware Revision number. LCD display on front cover will read “DISTEK 5100” after self-test.

4. Use RIGHT ARROW key at front of drive unit to select Automatic Test screens

(see Automatic Testing Methods on page 3-13), Display screens (see Display Screens on page 3-9), or Manual Test screens (see Manual Operation on page 3-25).

5. To edit settings, follow Automatic Test screen prompts.

6. To save settings and return, highlight SAVE SETTINGS and press ENTER.

7. To return to Automatic Test screen without saving changes, press CLEAR.

8. Press START to begin pre-programmed Auto Test sequence shown on screen.



Front display and controls are shown in Figure 3-2:

Figure 3-2: Front Display and Controls

1. Front LCD Display 2. Control Keypad 3. ProduKey Port

Figure 3-3: Control Keypad and Indicators



Control Keypad Stir Key This key starts and stops rotation in manual mode. The green “Stir” LED shows motor status. If the heaters are operating, stopping rotation will also stop heating. STIR key is disabled when editing certain settings.

Arrow Keys The ARROW keys are used to navigate through the user menus and displays.

Enter Keys The ENTER key locks in menu selections and settings made with the ARROW keys. ENTER is also used to reset the MAX and MIN values when displaying the vessel temperature and RPM data. Pressing ENTER when displaying the vessel temperature graphic while in manual mode will produce a printout of the vessel temperatures and RPM. This is called the “INSTAPRINT”.

Clear Key The CLEAR key returns 5100 from edit mode.

START Key The START key starts heaters and stirring. START key is disabled when editing certain settings. See the following steps for Manual or Automatic Test mode.

Heaters should not be operated without stirring.

1. Enable vessel heaters desired (see Automatic Testing Methods on page 3-13).

For Manual Test Mode

2. To start heating and stirring, press START key.

The “Heat” LED shows that all enabled heaters have been turned on. The “Stir” LED shows motor is on.

3. To stop heating, press START again.

Heaters and “Heat” LED turn off. Stirring continues until STIR key is pressed.



1. Use ARROW keys at front of drive unit to select Auto Test screen desired (see Display and Control Screens on page 3-8).

2. To edit settings, follow on-screen prompts.

3. Save settings, or press CLEAR to return without saving.

For Automatic Test Mode

4. Press START to start pre-test initialization.

The “Heat” LED will light up, even if all heaters are disabled (see Display and Control Screens on page 3-8).

Sleep Key (System Standby) The SLEEP key turns off rotation, heating, and displays from Manual mode. “Sleep” LED shows instrument power switch is on, but no other functions operate. Some PC commands may still function through serial port. SLEEP key is disabled when editing certain settings. Press the SLEEP key to return from Sleep (System Standby) mode.

Display and Control Screens The following will appear on front LCD display after power-on self-test:

Figure 3-4: Initial Display at Power-Up

distek 5100 DISSOLUTION SYSTEM

S/N – 5111111 FW – Rev 3.25

07-07-03 BEEP – ON 9:57:07



Date and time are shown, along with unit serial number, firmware revision, and beep status (see Serial Port Control of 5100 on page 3-57). Use LEFT or RIGHT ARROW key to access Automatic Test screens, Display screens, and Manual Test screens. A quick reference chart called “DISPLAY AND CONTROL SCREENS: MODEL 5100 DISSOLUTION SYSTEM” appears at the back of this manual.

Display Screens All Display screens are accessible while in Manual Mode or Auto Test Mode. Use up or DOWN ARROW key to scroll through the various Display screens as shown below:

Figure 3-5: Vessel Temperature Display Screen (Vessel Graphics)

♦ Figure 3-5 shows temperatures (Celsius) in vessels 1 through 7.

♦ The indication at lower left of screen (i.e., “Prednisone 10mg” above) shows name of automatic test now running. This will indicate “manual mode” when there is no automatic test running.

♦ The “pre-heating” at lower right of screen shows 5100 in Pre-Test Initialization.

♦ INSTAPRINT: When in manual mode, pressing ENTER while displaying this screen (see Figure 3-5) will produce a printout of vessel temperatures and RPM.



Use DOWN ARROW key to access Temperature and RPM Monitor:

Figure 3-6: Temperature and RPM Monitor Screen (#1-4)

♦ Figure 3-6 shows temperatures in vessels 1-4, and RPM. The “LAST” column shows the current value, and “Set” column indicates the setpoint.

♦ The “MAX” and “MIN” columns record the temperature and RPM range during a test, and “DEL” is short for delta, the difference between MAX and MIN.

♦ To reset all DEL values to zero in Manual mode, press ENTER. This also resets all MAX and MIN values to the current temperature and RPM. The elapsed time indicator on the top LED display will be reset to zero.

Use DOWN ARROW key to access next screen:

Figure 3-7: Temperature and RPM Monitor (#5-8)



♦ In Figure 3-6 and Figure 3-7, the asterisk to the left of vessel number indicates vessel heater is enabled. The above two screens show vessels 1 through 7 are enabled. Temperature probe # 8 is the built-in calibration probe.

♦ MAX, MIN, and DEL values can be reset from this screen also in the same manner as above.

♦ When in manual mode, the LEFT ARROW and RIGHT ARROW keys can be used to move from the Display screens to Auto Test or Manual Test screens. This is indicated by the “ < ” and “ > ” symbols at the top of the screen. Note that the Vessel Temperature screen, shown in Figure 3-5 with “PREDNISONE 10MG” Auto Test running, does not have these “ < ” and “ > ” symbols. Only the UP ARROW and DOWN ARROW keys may be used during Auto Test mode, to scroll through the various Display screens.

Use down ARROW key to access next screen:

Figure 3-8: Current Method Details

The display screen in Figure 3-8 summarizes the settings in use for the current Auto Test method. Vessels 1-7 are enabled. Test temperature is set to 37.0°C and stirring is currently at 100 RPM (“RPM: Running”).



Use down ARROW key to access next screen:

M E T H O D H I S T O R Y ( L a s t 5 T e s t s )N A M E C O M P L E T E DP R E D N I S O N E 1 0 M G D D : M M H H : M M

P R E D N I S O N E 1 0 M G D D : M M H H : M M

S A L I C Y L A C I D 3 0 0 D D : M M H H : M M

S A L I C Y L A C I D 3 0 0 - - A B O R T E D - -

S A L I C Y L A C I D 3 0 0 D D : M M H H : M M

Figure 3-9: Method History

Figure 3-9 lists the last five Automatic Tests completed, with date and time. Tests which were aborted are listed as shown above (see “SALICYL ACID300”).

For Method History Information

1. To print out test summary, connect parallel printer (optional) to 5100 printer port and follow steps below:

2. To view test results in Method History screen, press ENTER.

3. Use UP ARROW or DOWN ARROW key to select desired test.

4. Press ENTER again to view a summary of test results. Data is sent to printer port.



Automatic Testing Methods Automatic Test mode allows easy pre-programmed control of test temperature, RPM and duration. From Manual Mode, press LEFT ARROW or RIGHT ARROW keys to reach Auto Test screen. Name of test appears at top of LCD display:

Figure 3-10: Auto Test Screen

The LCD display shows a summary of the settings for test temperature, test RPM, test duration at selected RPM, stirring element, vessels enabled, and test volume as shown in Figure 3-10. The above example shows test at 100 RPM for 2 hours and 30 minutes, followed by IRPM (“Infinity RPM”) at 250 RPM for 1 hour. The test temperature is 37.0°C, stirring element is Paddle, and volume of test media is 1000ml.

Select Method

1. Use up or down ARROW key to choose Automatic Test Method desired.

To Select and Edit Auto Test

2. Press ENTER to edit settings (see Figure 3-11).

Press CLEAR to return without changes.



Edit Test Method

P R E D N I S O N E 1 0 M G T e s t T e m p e r a t u r e : 37 . 0 C V e s s e l s E n b . : * 1 * 2 * 3 * 4 * 5 * 6 * 7 T e s t R P M = 1 0 0 D u r a t I o n : H H : M M I N F R P M = 2 5 0 D u r a t I o n : H H : M M S t i r E l e m : P A D D L E V O L : 1 0 0 0 m l

M O R E O P T I O N S S A V E S E T T I N G S

Figure 3-11: Test Edit Screen

1. Use ARROW keys to highlight test temperature.

2. Press ENTER.

3. Use up or down ARROW key to change test temperature.

4. Press ENTER to lock in temperature.

5. Highlight vessel number.

To Set Vessel Temperatures

6. Press ENTER to enable or disable vessel heater. (✴ = Enabled).

1. Highlight Test RPM and press ENTER.

2. Use up or down ARROW key to adjust test RPM.

3. Press ENTER to lock in RPM.

4. Highlight and adjust RPM Duration.

To Set Stirring Speed and Duration

5. Highlight and adjust “Infinity” RPM (INF RPM) and duration.

“Infinity RPM” may be used at the end of certain tests to complete the dissolution of any remaining dosage forms.



The 5100 adds one or two minutes to the set RPM duration to allow time for the operator to withdraw the last sample at regular test RPM. Then the “Infinity RPM” is run for the regular time as set. For example, if the test duration is set to 60 minutes at 100 RPM, and the IRPM is set to 5 minutes at 250 RPM, the actual test will run about 62 minutes at 100 RPM and then 5 minutes at 250 RPM.

1. Highlight stir element.

2. Press ENTER to toggle Paddle/Basket.

3. Highlight Volume and press ENTER.

4. Use UP or DOWN ARROW key to adjust test volume in 25 ml steps.

5. Press ENTER to lock in volume.

6. If settings are correct, highlight “Save Settings”.

7. Press ENTER to lock in settings. Display returns to Auto Test screen.

To Select Paddle or Basket and Set Volume

8. Highlight “More Options” and press ENTER to reach Advanced Test Options (Figure 3-12).

Figure 3-12: Advanced Test Options

If a Sample Interval is set, unit prompts operator to withdraw samples at fixed intervals. The 5100 beeps to alert the operator for sampling time. The LCD screen counts down the last 15 seconds or so, and flashes the vessel graphic during the last 10 seconds to let the operator know which vessel to withdraw the sample from. In the above example, prompts are



every 15 minutes. The top LED display (Figure 3-14, page 3-22) shows time until next sample. The LCD vessel graphics screen gives prompts for sampling. Setting Delayed Drop Interval provides for staggered drop of dosage forms. Unit prompts operator to drop dosage form into each vessel at pre-set intervals. If sample interval is also set, unit prompts operator to withdraw samples at staggered sampling times. See Start Test Using Paddles on page 3-19 for explanation of staggered drop. “Interval Printing: ON” automatically prints actual temperature, RPM and time. Data is sent to 5100 printer port at START of test, at each sample interval, and at end of pre-programmed Automatic Test. Set “Interval Printing: OFF” for no Interval Printout. If Infinity RPM, Sample Interval or Delayed Drop Interval is not used for this test, set unused parameters to zero.

IMPORTANT NOTE: If using both Sample Interval and Delayed Drop Interval (“Staggered Drop”), a sample interval of at least 15 times the delayed drop interval is recommended (see example in Figure 3-12). This allows operator sufficient time to complete tablet drops. If all tablet drops are not completed well before the first sample time occurs, the test may not run properly.

1. Connect parallel printer to 5100 printer port.

2. Use UP or DOWN ARROW key to select Auto Test desired.

3. Make sure settings are correct. Go to “Save Settings” and press ENTER.

4. Go to Advanced Test Options screen (Figure 3-12).

5. Select “Print Method Settings”. Press ENTER for printout.

To Print Method Settings

6. To exit this screen, press CLEAR.



Writing Test to ProduKey Memory

The 5100 can write test parameters to the ProduKey memory device supplied with the unit. Additional ProduKey’s are available from DISTEK. Any existing test settings on the ProduKey will be deleted and replaced by the new settings when this is done.

A test written to the ProduKey must have a different name from the previous test stored on that key.

1. Insert pre-programmed ProduKey into slot to the right of

control keypad. Turn clockwise ¼ turn. Unit should beep.

2. Use UP or DOWN ARROW key to select Auto Test desired.

3. Go to Advanced Test Options screen (Figure 3-12).

4. Select “Write Method to ProduKey”.

5. Press ENTER and follow on-screen prompts.

To Write Automatic Test Settings to ProduKey

6. To remove ProduKey, turn counterclockwise and remove.

Reading Test from ProduKey Memory

The 5100 can read stored test parameters from the ProduKey memory device supplied with the unit. Additional ProduKey’s are available from DISTEK.



1. Turn on 5100.

2. Press CLEAR.

3. Insert pre-programmed ProduKey into slot to the right of control keypad. Turn clockwise ¼ turn. Unit should beep.

4. Test from ProduKey appears on LCD display.

5. Press START to begin test shown on screen.

To Read Automatic Test Settings from ProduKey

6. To remove ProduKey, turn counterclockwise and remove. Test will continue to run even after ProduKey is removed.

Pre-Test Initialization Make sure all heaters in use for this test have been enabled in the Method Program chosen. The pre-programmed test can only activate those heaters previously enabled. Even when the “Heat” LED lights up on the front display, any heaters which are not enabled will not operate (see Automatic Testing Methods on page 3-13).

Figure 3-13: Auto Test Screen



1. Connect parallel printer to 5100 printer port before starting test. Check print function using Method History printout (Figure 3-9).

For Automatic Printout of Test Data at End of Test

2. If the above settings are correct, you can start pre-Test

Initialization from the Auto Test Screen (see Figure 3-13). Press START.

When START is pressed while in Auto Test screen, the instrument will automatically start paddle or basket rotation and temperature regulation (heater operation), according to the settings last saved in the Method Program chosen. The front LCD display will show current vessel temperatures. The top LED display will cycle through all enabled vessel temperatures.

Heater surfaces may be HOT. Do not touch vessel heater assemblies when 5100 is in operation. Injury may result.

The 5100 incorporates a height sensor to stop rotation and heating whenever the drive unit is raised well above operating position. This feature helps prevent overheating and addresses safety issues. To resume rotation and heating, return drive unit to operating position. Return to Auto Test screen and press START key.

After the temperature setpoint is reached, the 5100 will wait for about 1-2 minutes to ensure a stable temperature and then signal readiness to start the pre-programmed test. The 5100 will “beep” to alert the operator, and display will show status message. Stirring and temperature regulation will continue.

START Test Using Paddles At end of Pre-Test Initialization, the 5100 will “beep” to alert operator, and display will show “System Ready for Start of Test. Drop Dosage Form and Continue?” Stirring and temperature regulation will continue.



1. Press STIR key to stop rotation while dropping in dosage forms.

2. Drop dosage forms into vessels.

3. Press STIR key to start rotation.

4. After introducing dosage forms, use LEFT ARROW key to choose “YES”.

To Drop Dosage Forms and Start Test

5. Press ENTER.

The instrument will record actual test duration, temperature and RPM data starting now. Once the test begins, the front LCD display monitors temperatures in all seven vessels. The “Staggered Drop” procedure has been modified in the 5100 firmware, revision 2.9. This feature provides operator prompts for staggered drop (also called delayed drop) of dosage forms into the vessel. This is only available during an Automatic Test. There are two alternative methods available for stopping rotation while dropping the tablets. Please check with Test Supervisor to determine whether Method A or Method B (below) is required for your dissolution test.

Introducing Dosage Forms

One approach to the staggered drop method is to follow exactly the on-screen prompts from the 5100. After the vessels are pre-heated to the required temperature, the display shows:

S T A G G E R E D D R O P Vessel set Temp. reached Prepare for start of test Press START to continue

Method A

When you are ready with dosage forms, press the START key to continue. The 5100 display shows:

S T A G G E R E D D R O P Hold Shaft # 1 Drop tablet and release shaft Then press START to continue



When this prompt appears you can either (A) manually hold the stirring shaft and follow the on-screen instructions exactly, or (B) use the method shown below.

Method B At the time for dropping the tablet, the 5100 Operation Manual instructs the operator to: use the STIR key to stop rotation while dropping tablet into vessel. Then press the STIR key again to resume rotation, and press START to begin timing the test (see “For Staggered Drop of Dosage Forms” Below).

Make sure the press STIR the second time to resume rotation after each tablet drop. Otherwise, without stirring, the dissolution test results will not be valid.

1. If staggered drops required, press START key when prompted by unit.

2. Use STIR key to stop rotation while dropping in dosage form.

3. Drop dosage form into vessel.

4. After introducing each dosage form, press STIR key again to resume stirring.

5. Press START.

For Staggered Drop of Dosage Forms

6. Repeat steps 2-5 above after each delayed drop interval.

“Staggered Drop” refers to a procedure in which the operator drops each dosage form into vessel, after a fixed pause between vessels called the “delayed drop interval” (see Figure 3-12 on page 3-15).



1. Use up or down ARROW key to monitor test data on front LCD display.

2. Pre-test initialization or automatic test mode may be terminated as follows: Press ENTER key; LCD display shows “DO YOU WISH TO ABORT? YES...NO” Select with ARROW key and press ENTER.

3. At end of test, the instrument beeps to alert the operator, and a summary of test data is automatically sent to 5100 printer port.

To Monitor or Terminate Test

4. Automatic Test settings are displayed on screen.

To view or print test data from last 5 Automatic Tests, see Figure 3-9 on page 3-12.

The top LED display (Figure 3-14) monitors temperatures in those vessels which are enabled. Elapsed Time is measured from start of test. RPM is displayed continuously. If Sample Interval is set, display counts down time until Next Sample.

Figure 3-14: Top LED Display



Program New Auto Test From Auto Test screen (Figure 3-10), use UP or DOWN ARROW key to access Figure 3-15 (below). Follow on-screen prompts.

Figure 3-15: New Product Screen

Press ENTER to access Name of New Product or Test screen:

Figure 3-16: Name of New Product or Test

1. Follow on-screen prompts to enter characters for name of new test.

2. Highlight “SAVE” and press ENTER when finished.

To Enter Name of New Test

3. See Automatic Testing Methods section to change test parameters as needed.

Make sure each test name is different. Two tests with same name cannot be stored. Make clear distinctions to avoid operator confusion.

Use “SP” to signify “space”, when no letter or number is desired.

Use “BK” for “backspace” to delete an incorrect letter or number.

Use up to 15 characters and spaces for test name.



Delete Test Method To delete a test method that is no longer used, choose the Auto Test screen for that method. Press CLEAR key. A message will appear asking if user wants to delete. Highlight ‘YES’ and press ENTER to delete test method from 5100 memory.

Test methods cannot be deleted from ProduKey. To write a new test onto ProduKey, see Figure 3-12 on page 3-15.

Basket Testing When Auto Test stirring element is set to BASKETS, Pre-Test Initialization will run at 250 RPM. This allows rapid heat-up and precise temperature control, even with the reduced stirring action of baskets.

Handle baskets only by knurled top ring. Undue pressure on wire mesh can bend basket out of cylindrical shape, which could affect test results.

1. Attach basket adapters and baskets to stirring shafts.

2. Set basket height using “Basket” position of height adjust

knob (see

3. Installation Checkout on page 2-12).

4. Remove baskets. Leave basket adapters on stirring shafts.

5. Fill vessels with dissolution media.

6. Lower shafts and adapters into vessels.

To Set Basket Height

7. Install vessel covers.



1. Set stirring element in Auto Test screen to “Baskets”.

2. Check all Auto Test parameters.

3. Press START to begin Pre-Test Initialization.

4. Place dosage forms in dry baskets.

5. Follow on-screen prompts to raise shafts out of vessels.

6. Mount baskets on shafts.

To Run Basket Test

7. Lower shafts, and press START.

Vessel probe in stirring shaft may cool when lifted out of vessel. “Maintenance” heat will keep all vessels at or close to set temperature during this time. When baskets are lowered into vessels and START is pressed, LCD display flashes temperature setpoint for a short time, while vessel probe temperature reaches media temperature. Top LED display also shows setpoint for a short time.

Manual Operation Use LEFT OR RIGHT ARROW key to reach Manual Test screens. The following screens can be used to set shaft RPM and vessel temperature.

1. Follow on-screen prompts to edit settings. For Manual Control

2. Press START to start stirring and heating in manual mode.

Elapsed time LED display starts when START key is pressed. Basket Test should not be used in manual mode.



Figure 3-17: Manual Operation - Set RPM

Set RPM

1. Use ARROW keys to access Manual Operation - SET RPM screen.

2. Press ENTER once so that the RPM setting flashes.

3. Use up or down ARROW key to change RPM setting.

4. Press ENTER to lock in RPM setting.

To Set RPM in Manual Mode

5. Press CLEAR when done to leave edit mode.

Pressing an ARROW key briefly will raise or lower the setting by 1 RPM. Holding down an ARROW key for two seconds or more causes the setpoint to change rapidly.

Controlling Vessel Individually Use DOWN ARROW key to access Figure 3-18:

Figure 3-18: Manual Operation - Set Vessel Temperature



1. Press ENTER to edit settings.

2. Highlight the vessel number and press Enter to flash value.

3. Use UP or DOWN Arrow key to choose vessel. Press ENTER to lock in value.

4. Highlight parameter to be changed.

5. Press ENTER and use ARROW key to change temperature or volume.

6. Press ENTER to lock in value.

7. Highlight and press ENTER to toggle vessel enable ON or OFF.

8. Highlight and press ENTER to toggle stir element Paddle/Basket.

To Check or Edit Individual Vessel Settings

9. Press CLEAR to leave edit mode. Set vessel #8 to OFF (disabled).

Controlling All Vessels Together Use DOWN ARROW key to access Figure 3-19:

Figure 3-19: Set Temperature in Vessels #1-7

Use the screen above to set parameters for all 7 vessels at once.

Baskets are not recommended for use in manual mode.



1. Press ENTER to edit settings.

2. Highlight parameter to be changed.

3. Press ENTER and use ARROW key to change temperature or volume.

4. Press ENTER to lock in value.

5. Highlight and press ENTER to toggle vessel enable ON or OFF.

To Check or Edit Settings for All Seven Vessels

6. Highlight and press ENTER to toggle stir element, Paddle or Basket.

Baskets are not recommended for use in manual mode.

7. Press CLEAR to leave edit mode. The 5100 incorporates a height sensor to stop rotation and heating whenever drive unit is raised well above operating position. This feature helps to prevent overheating and addresses safety issues. To resume rotation and heating, return drive unit to operating position and press START key to reset MAX, MIN, DEL, and elapsed time values, go to Temperature & RPM Monitor screen and press ENTER.



System Setup and Calibration Introduction ♦ Accurate calibration of the temperature probes is essential for proper

operation of the DISTEK 5100 dissolution system. Factory calibration provides accuracy within 0.1ºC. Care must be taken when re-calibrating in the field, in order to realize the full accuracy and range of the temperature sensing system.

♦ All installed temperature probes are factory-calibrated using an NIST-traceable digital reference thermometer, the DISTEK TempChek. DISTEK recommends a 6-month calibration cycle, during which each probe is checked and adjusted by this method to the specified accuracy. Only qualified personnel should adjust the 5100 calibration.

Interim temperature checks can be made in two ways:

A. The calibration probe supplied with the 5100 can be compared using TempChek, or any calibrated glass thermometer with acceptable accuracy. Each vessel temperature probe can then be checked (and re-calibrated if needed) using the calibration probe.

B. Alternatively, each vessel probe can be checked and re-calibrated with TempChek, or any calibrated thermometer of sufficient accuracy.

The 5100 will automatically detect whether a High-Temperature Calibration or a Low-Temperature Calibration will be performed based on the temperature of the probe. If the temperature of the probe is below 25 °C a Lo-Cal will be performed. If the temperature of the probe is above 35 °C a Hi-Cal will be performed. Use 900ml water in each vessel. Use cool water between below 22 º C to perform Low-Temperature Calibration. Use warm water between 38º and 42º C to perform High-Temperature Calibration. There must be a difference of at least 15° between the Lo-Cal temperature and the Hi-Cal temperature in order for the calibration procedure to work properly. For accurate calibration use PADDLES. Basket stirring is not adequate for precise calibration. Calibration settings are saved in non-volatile memory and are retained after the unit is powered down.

Verify accuracy of low temperature calibration (18-22º C) before performing High-Temperature Calibration.



Heaters turn off automatically when the Calibration screen is accessed. This will occur even when passing through briefly to access Advanced Setup screen. The reason is to stabilize vessel temperature during the calibration procedure, by preventing the high-powered heaters from raising temperatures rapidly.

Calibrate Using 5100 Calibration Probe

Check 5100 calibration probe against a calibrated reference before performing this procedure. Check at low and high temperatures. Probe is factory-calibrated.

Each original probe, including the calibration probe, was factory calibrated before your 5100 was shipped. Low-Temperature Calibration is only needed if the calibration values are deleted, or a new probe is installed. Otherwise, proceed to High-Temperature Calibration.

1. Install 7 vessels with 900 mL of water. The water temperature should be below 22 °C.

2. Install all Paddle blades.

3. Lower shafts into vessels and install vessel covers.

4. Turn instrument on.

Lo-Calibration Procedure Using Probe

5. Place Calibration Probe in vessel #1.

N E W P R O D U C T P r e s s : E N T E R T o P r o g r a m ∧ o r ∨ F o r N e x t P r o d u c t

Figure 3-20: New Product Screen



6. Press LEFT ARROW key once, ‘New Product’ screen should now be displayed. If the ‘New Product” screen is not displayed, press UP/DOWN ARROW key to scroll through stored methods until the “New Product’ Screen is found.

7. Press CLEAR key twice, then LEFT ARROW key. Display heading should now read ‘Calibrate Vessel with Probe.’

8. Press ENTER key. Vessel # should highlight (see Figure 3-21, item 1).

9. Press ENTER key again. Vessel # should begin flashing.

10. Press DOWN ARROW key to change vessel # to 1 then, press ENTER key. Verify vessel temperature is below 22 °C (see Figure 3-21, item 3).

C A L I B R A T E W I T H P r o b e

V e s s e l # 8 P r o b e t e m p : 2 0 . 0 5 V e s s e l T e m p : 2 0 . 0 5

L o - C a l o n M M : D D : Y Y a t 2 0 . 0 5 C H i - C a l o n M M : D D : Y Y a t 3 8 . 2 5 C

P r e s s : E N T E R t o s e l e c t v e s s e l S T A R T t o C a l i b r a t e

Figure 3-21: Calibrate with Probe Screen

11. Press START key. Display should give a warning (see

Figure 3-22).

12. Press LEFT arrow key, ‘YES’ should now be highlighted. Press ENTER key to calibrate.

Lo-cal date should change to current date (see Figure 3-21, item 4).

13. Vessel and Probe temperature readings should now match within 0.04 °C. If readings do not match within specifications, repeat steps 1 and 2, otherwise move on to next step.

1

4

2

3



14. Press ENTER key. Vessel # will begin flashing. Change to vessel # 2 using UP/DOWN ARROW key then, press ENTER key.

W A R N I N G : A b o u t t o d o a L 0 - C a l

C h e c k M a n u a l i f u n s u r e S e l e c t Y e s a n d E N T E R t o C a l. Y E S N O

Figure 3-22: Lo-Cal Warning Screen

15. Move Probe to vessel #2 then press ENTER key. Vessel # should begin flashing.

16. Using UP/DOWN ARROW key change to #2, then press ENTER key.

17. Wait approximately 30-45 seconds for Probe reading to stabilize.

18. Press START key. Display should give a warning (see Figure 3-22).

19. Press LEFT arrow key. ‘YES’ should now be highlighted. Press ENTER key to calibrate.

Note: Lo-cal date should change to current date (see Figure 3-21, item 4).

20. Vessel and Probe temperature readings should now match within 0.04 °C. If readings do not match within specifications repeat step 8 and 9, otherwise move on to next step.

21. Repeat steps 14 – 20 for all remaining vessels.



1. Return Probe to vessel #1, then press ENTER key. Vessel # will begin flashing.

2. Using UP/DOWN ARROW key change to #1.

3. Vessel #1 reading should match Probe reading within 0.05 °C.

4. Move Probe to vessel #2, then press UP ARROW key. Wait approximately 30-45 seconds for Probe reading to stabilize.

5. Verify vessel #2 reading matches to within 0.05 °C of Probe reading.

Calibration Verification

6. Repeat steps 4 and 5 for all remaining vessels.

If any of the readings do not match to within specifications, repeat the necessary steps to re-calibrate.

7. Press ENTER key, then CLEAR key. Lo-Calibration is now complete.

8. Exit calibration mode by pressing LEFT ARROW key.

M A N U A L O P E R A T I O N

R P M : 1 0 0

P r e s s : E N T E R T o S e t N e w R P M S T I R T o C o n t r o l ^ o r v T o S e t T e m p

Figure 3-23: RPM Screen


V E S S E L S # 1

T

O 7

T e m p : 4 0 . 0 0

O

N V o l u m e : 9 0 0 m l s E l e m e n t : P A D D L E P r e s s : E N T E R T o S e t N e w V a l u e s S T A R T T o A c t i v a t e h e a t

Figure 3-24: Manual Operation Vessels 1-7 Screen

4

3

1

2



1. Set RPM to 100 as seen in Figure 3-23:, then press UP ARROW key.

2. Change all settings to read as shown in Figure 3-24, items 1 to 4. Press CLEAR to save all settings when finished.

3. Press LEFT arrow key. This should display the screen as shown in Figure 3-25. If it does not, press the UP/DOWN ARROW key until it is displayed.

Hi-Calibration Procedure Using Probe

4. Press HEAT key. Wait for instrument to reach the set temperature.

VESSEL TEMPERATURES (deg. C) 39.9 40.1 40.0

40.0 39.9 40.1 40.0

MANUAL OPERATION Figure 3-25: Temperature Monitoring Vessels 1-7 Screen

W A R N I N G : A b o u t t o d o a H i - C a l


Figure 3-26: Hi-Cal Warning Screen



< C A L I B R A T E W I T H P r o b e >

V e s s e l # 8 P r o b e t e m p : 4 0 . 0 0 V e s s e l T e m p : 4 0 . 0 0



Figure 3-27: Calibrate Vessel with Probe Screen

5. Press RIGHT ARROW key twice. ‘New Product’ screen should now be displayed. If it is not press the UP/DOWN ARROW key to scroll until the ‘New Product’ screen is found.



8. Press ENTER key. Vessel # should begin flashing.

9. Press DOWN ARROW key to change vessel # to 1 then, press ENTER key. Verify vessel temperature is above 36.00 °C (see Figure 3-27, item 3).


11. Press LEFT ARROW key, ‘YES’ should now be highlighted. Press ENTER key to calibrate

Hi-cal date should change to current date (see Figure 3-27, item 2).

12. Vessel and Probe temperature readings should now match within 0.04 °C. If readings do not match within specifications repeat step 10 and 11, otherwise move on to next step.

13. Move Probe to vessel #2 then press ENTER key. Vessel # should begin flashing.

1

2

4

3



14. Repeat steps 9 to 18 for all remaining vessels.

15. Repeat the Calibration verification steps.

16. Temperature calibration is now complete. Save calibration data to Cal. Key if one is available.

Figure 3-28: Calibrate Vessel With Probe

Calibrating Using TempChek Digital Thermometer


Use PADDLES for accurate calibration. Use cool water between 18º and 22º C to perform Low-Temperature Calibration. Use warm water between 38º and 42º C to perform High-Temperature Calibration. There must be a difference of at least 15° between the Lo-Cal temperature and the Hi-Cal temperature in order for the calibration procedure to work properly.



1. Install 7 vessels with 900 ml of water. The water temperature should be below 22 °C.


3. Connect one end of RS-232 cable to RS-232 port adjacent to Cal probe connection on the 5100.

4. Connect other end of RS-232 cable to TempChek then turn on the TempChek.



7. Place Cal probe and TempChek probe into vessel #1.

8. Press LEFT ARROW key once, ‘NEW PRODUCT’ screen should now be displayed. If the “New Product” screen is not displayed, press UP/DOWN ARROW key to scroll through stored methods until the “New Product” Screen is found.


Lo-Calibration Procedure Using TempChek

10. Press DOWN ARROW key once. Display heading should now read ‘Calibrate Vessel with TempChek’ (see Figure 3-29).

TempChek reading on 5100 display should match the TempChek display (see Figure 3-29, item 2).






C A L I B R A T E W I T H T e m p - C h e k

V e s s e l # 8 T e m p - C h e k : 2 0 . 0 5 V e s s e l T e m p : 2 0 . 0 5



Figure 3-29: Calibrate Vessel with TempChek Screen


15. Press LEFT ARROW key, ‘YES’ should now be highlighted. Press ENTER key to calibrate.


16. Vessel and TempChek temperature readings should now match within 0.04°C. If readings do not match within specifications, repeat steps 14 and 15, otherwise move on to next step.



19. Press LEFT ARROW key. ‘YES’ should now be highlighted. Press ENTER key to calibrate.


1

4

2

3






20. Vessel and TempChek temperature readings should now match within 0.04 °C. If readings do not match within specifications, repeat step 18 and 19, otherwise move on to next step.

21. Move TempChek to vessel #2 then press ENTER key. Vessel # should begin flashing.

22. Using UP/DOWN ARROW key change to #2, then press ENTER key.

23. Wait approximately 30-45 seconds for TempChek reading to stabilize.




26. Vessel and TempChek temperature readings should now match within 0.04°C. If readings do not match within specifications repeat step 24 and 25, otherwise move on to next step.




1. Return TempChek probe to vessel #1, then press ENTER key. Vessel # will begin flashing.

2. Using UP/DOWN ARROW key change to #8.

3. Vessel #8 reading should match TempChek reading within 0.05 °C.

4. Press UP ARROW key. Verify vessel # 1 reading matches to within 0.05 °C of TempChek reading.

5. Move TempChek probe to vessel #2, then press UP ARROW key. Wait approximately 30-45 seconds for TempChek reading to stabilize.

6. Verify vessel #2 reading matches to within 0.05 °C of TempChek reading.



If any of the readings do not match to within specifications, repeat the necessary steps to re-calibrate.

8. Press ENTER key, then CLEAR key. Calibration is now complete.

9. Exit calibration mode by pressing UP/DOWN ARROW key until the screen ‘Calibrate vessel with Prob’ is found, then press LEFT ARROW key.




R P M : 1 0 0




V E S S E L S # 1

T

O 7

T e m p : 4 0 . 0 0

O



1. Set RPM to 100 as seen in Figure 3-31, then press UP ARROW key. Display should now read as in Figure 3-32.


3. Press LEFT ARROW key. This should display the screen as shown in Figure 3-33. If it does not, press the UP/DOWN ARROW key until it is displayed.

Hi-Calibration Procedure Using TempChek



40.0 39.9 40.1 40.0


4

3

1

2






C A L I B R A T E W I T H T e m p - C h e k

V e s s e l # 8 T e m p - C h e k : 4 0 . 0 0 V e s s e l T e m p : 4 0 . 0 0



Figure 3-35: Calibrate Vessel with TempChek Screen

5. Press RIGHT ARROW key twice. New Product screen

should now be displayed. If it is not press the UP/DOWN ARROW key to scroll until the ‘NEW PRODUCT’ screen is found.


7. Press DOWN ARROW key once. Display heading should now read ‘Calibrate Vessel with TempChek’.

TempChek reading on 5100 display should match the TempChek (see Figure 3-35).



10. Press DOWN ARROW key to change vessel # to 8 then, press ENTER key. Verify vessel temperature is above 36.00 °C (see Figure 3-35, item 3).

1

2

4

3





Note: Hi-cal date should change to current date (see Figure 3-35, item 2).

13. Vessel and TempChek temperature readings should now match within 0.04 °C. If readings do not match within specifications repeat step 11 and 12, otherwise move on to next step.





17. Vessel and TempChek temperature readings should now match within 0.04°C. If readings do not match within specifications repeat step 15 and 16, otherwise move on to next step.

18. Move TempChek to vessel #2 then press ENTER key. Vessel # should begin flashing.

19. Repeat steps 14 to 18 for all remaining vessels.

20. Repeat the Cal. verification steps.

21. Save calibration data to Cal. Key if one is available.



Calibrating Using NIST Traceable Reference Thermometer


Use PADDLES for accurate calibration. Use cool water between 18º and 22º C to perform Low-Temperature Calibration. Use warm water between 38º and 42º C to perform High-Temperature Calibration. There must be a difference of at least 15° between the Lo-Cal temperature and the Hi-Cal temperature in order for the calibration procedure to work properly.

1. Install 7 vessels with 900 mL of water. The water temperature should be below 22 °C.




5. Place Cal. Probe and Reference probe into vessel # 1.

6. Press LEFT ARROW key once, ‘New Product’ screen should now be displayed. If the ‘New Product’ screen is not displayed, press UP/DOWN ARROW key to scroll through stored methods until the “New Product” Screen is found.


8. Press DOWN ARROW key twice. Display heading should now read ‘Calibrate Vessel with Reference’ (see Figure 3-36).

Lo-Calibration Procedure Using Reference Thermometer






C A L I B R A T E W I T H R E F E R E N C E

V e s s e l # 8 R e f . T e m p : 2 0 . 0 5 V e s s e l T e m p : 2 0 . 0 5



Figure 3-36: Calibrate Vessel with Reference

12. Press DOWN ARROW key. Highlight should move to Ref. Temp. (see Figure 3-36, item 2).

13. Press ENTER key. Ref. Temp should begin flashing. Using UP/DOWN ARROW key match this reading with the Reference reading, then press ENTER key.




16. Vessel # 8 (Cal. Probe) and Reference temperature readings should now match within 0.05 °C. If readings do not match within specifications, repeat steps 13 thru 15, otherwise move on to next step.

17. Press DOWN ARROW key. Highlight should move to vessel # (see Figure 3-36, item 1).

1

4

2

3




Change to vessel # 1 using UP/DOWN arrow key then, press ENTER key.

19. Press DOWN ARROW key. Highlight should move to Ref. Temp (see Figure 3-36, item 2).

20. Press ENTER key. Ref. Temp should begin flashing. Using UP/DOWN arrow key match this reading with the Reference reading, then press ENTER key.







23. Vessel # 1 and Reference temperature readings should now match within 0.05 °C. If readings do not match within specifications repeat step 20 thru 22, otherwise move on to next step.

24. Move Reference probe to vessel # 2 then press DOWN ARROW key. Vessel # should highlight.



25. Press ENTER key. Vessel # should begin flashing. Change to vessel # 2 using UP/DOWN ARROW key then, press ENTER key.

26. Wait approximately 30-45 seconds for Reference probe reading to stabilize.

27. Press DOWN ARROW key. Highlight should move to Ref. Temp. (See Figure 3-36, item 2)

28. Press ENTER key. Ref. Temp should begin flashing. Using UP/DOWN arrow key match this reading with the Reference reading, then press ENTER key.




31. Vessel # 2 and Reference temperature readings should now match within 0.05 °C. If readings do not match within specifications repeat step 28 thru 30, otherwise move on to next step.


33. Lo Calibration is now complete. Move on to verification.

1. Return Reference probe to vessel #1, then press DOWN ARROW key. Vessel # should highlight.

2. Wait approximately 30-45 seconds for Reference probe reading to stabilize.


3. Press ENTER key. Vessel # should begin flashing. Change to vessel # 8 using UP/DOWN ARROW key then, press ENTER key.



4. Vessel # 8 (Cal Probe) reading should match Reference reading within 0.06 °C.

5. Press ENTER key then UP ARROW key to change vessel # to 1. Verify vessel # 1 reading matches to within 0.06 °C of Reference reading.

6. Move Reference probe to vessel # 2 then press UP ARROW key. Wait approximately 30-45 seconds for Reference probe reading to stabilize.

7. Verify vessel # 2 reading matches to within 0.06 °C of Reference reading.


If any of the reading do not match to within specifications, repeat the necessary steps to re-calibrate.

9. Press ENTER key, then CLEAR key. Lo Calibration is now complete.

10. Exit calibration mode by pressing UP/DOWN ARROW key until the screen ‘Calibrate Vessel with Probe’ is found, then press LEFT ARROW key.


R P M : 1 0 0




V E S S E L S # 1

T

O 7

T e m p : 4 0 . 0 0

O



4

3

1

2



1. Set RPM to 100 as shown in Figure 3-38, then press UP ARROW key. Display should now read as in Figure 3-39.


3. Press LEFT ARROW key. This should display the screen as shown in Figure 3-40. If it does not, press the UP/DOWN ARROW key until it is displayed.

Hi-Calibration Procedure Using Reference Thermometer



40.0 39.9 40.1 40.0





C A L I B R A T E W I T H R E F E R E N C E

V e s s e l # 8 R e f . T e m p : 4 0 . 0 0 V e s s e l T e m p : 4 0 . 0 0



Figure 3-42: Calibrate Vessel with Reference

1

2

4

3



5. Press RIGHT ARROW key twice. New Product screen should now be displayed. If it is not, press the UP/DOWN ARROW key to scroll until the ‘New Product’ screen is found.

6. Press CLEAR key twice, then LEFT arrow key. Display heading should now read ‘Calibrate Vessel with Probe.’

7. Press DOWN ARROW key twice. Display heading should now read ‘Calibrate Vessel with Reference’.

8. Press ENTER key. Vessel # should highlight (see Figure 3-42, item 1). Then press ENTER key. Vessel # should begin flashing. Change it to 8 by pressing UP/DOWN ARROW key then press ENTER key.

9. Press DOWN ARROW key. Highlight will move from vessel # to Ref. Temp. Press ENTER key. Highlight should begin flashing.

10. Press UP/DOWN ARROW key to match reading with Reference probe reading then press ENTER key (see Figure 3-42, item 3).


12. Press LEFT ARROW key, ‘YES’ should now be highlighted. Press ENTER key to calibrate


13. Vessel # 8 (Cal. Probe) and Reference temperature readings should now match within 0.05 °C. If reading does not match within specifications repeat step 9 thru 12, otherwise move on to next step.

14. Press DOWN ARROW key. Highlight should move to vessel #.




16. Press DOWN arrow key. Highlight should move to Ref. Temp reading, and then press ENTER. Highlight should begin flashing.




20. Vessel # 1 and Reference temperature readings should now match within 0.05°C. If readings do not match within specifications repeat step 17 thru 19, otherwise move on to next step.


21. Move Reference probe to vessel # 2 then press DOWN arrow key. Vessel # should highlight, then press ENTER key. Highlight should begin flashing.

22. Press UP/DOWN ARROW key to change to # 2, then press ENTER key.

23. Press DOWN ARROW key. Highlight should move to Ref. Temp. Now press ENTER key. Highlight should begin flashing.







27. Repeat steps 21 thru 26 for all remaining vessels.

28. Repeat the Cal. verification steps.

29. Save calibration data to Cal. Key if one is available.

30. Calibration procedure is now complete.



Advanced Setup Options

Check 5100 calibration probe carefully against a calibrated reference before performing these procedures. Check at low and high temperatures. Probe is factory-calibrated.

Use DOWN ARROW key to access next screen

Figure 3-43: Advanced Setup Options

Press ENTER to access Advanced Setup mode.

When 5100 reads calibration data from CalKey, or resets all calibration settings, all high- and low-temperature calibration constants stored in 5100 are deleted and replaced! This occurs for vessels 1 through 7 and calibration probe. Contact Distek before reading or resetting calibration data.

CalKey The 5100 can read stored calibration data from, or write to a CalKey memory device. Additional CalKey’s are available from DISTEK for storing calibration updates. The original factory calibration settings can be restored by reading from the CalKey which came with your 5100.

1. Insert CalKey into slot to the right of control keypad. Turn clockwise 1/4 turn. Unit should beep.

2. Select option and press ENTER. Follow on-screen prompts.

To read from or write to CalKey

3. To remove CalKey, turn counterclockwise and remove.



Printer Calibration Settings The Calibration Settings printout shows internal calibration constants for temperature probes. This information can be used by DISTEK, if necessary, to troubleshoot the temperature measurement system. It is recommended that this printout be generated after each time the 5100 is calibrated.

1. Connect parallel printer (optional) to 5100 printer port.

2. Select “Print All Cal Settings” (Figure 3-43) and press ENTER for printout.

To print calibration settings

3. Press CLEAR to leave Advanced Setup mode.

1. Press up or DOWN ARROW key to reach Calibration With Probe screen (Figure 3-28).

To leave calibration and advanced setup screens 2. Press right or LEFT ARROW key when done.

Printouts The 5100 printer port sends output in standard ASCII line printer format. Virtually any printer that is set to this format (Epson LQ emulation mode) can be used. The left side column of the 5100 has a DB-25 female connector which is similar to a standard PC printer port. A standard IBM PC-compatible parallel printer cable can be used to connect to a printer with a 36-pin Centronics parallel port.

1. Connect optional printer to parallel Printer port (Figure 3-44).

2. In manual mode, go to vessel graphics screen (below) and press ENTER.

To generate “Instaprint”

3. The 5100 will beep when data has been sent to the Printer port.



Figure 3-44: Left Side View

Figure 3-45: Vessel Temperature Display Screen (Vessel Graphics)

♦ The Method Printout shows pre-programmed method settings (see

♦ Figure 3-12).

♦ The INSTAPRINT shows temperature and RPM data. Go to vessel graphics

screen and press ENTER (see

♦ Figure 3-5).

♦ The Test Printout automatically lists actual temperature, RPM and time data at end of each pre-programmed test.

♦ The Interval Printout automatically lists actual temperature, RPM and time data at each sample interval during pre-programmed test. Set “Interval Printing: OFF” for no Interval Printout.



♦ The Test Summary Printout, from Method History screen, shows actual temperature, RPM and time data from selected pre-programmed test (Figure 3-9).

♦ The Calibration Printout shows internal calibration constants for temperature probes. This information can be used by DISTEK if necessary, to troubleshoot temperature measurement system. It is recommended that this printout be generated after each time 5100 is calibrated (see Figure 3-43).

♦ See Appendix for sample printouts. Actual printouts may vary from samples shown.

Set BJ-30 printer to LQ mode. For other parallel printers, set DIP switches to:

Line Feed = Carriage Return + Line Feed.

(Consult printer manual.)



Serial Port Control of 5100 For PC control, monitoring and reporting, the 5100 has a serial RS-232 port. There is also a dual RS-485 port provided. These are located below the Printer port (see Figure 3-44 above).

RS-232 Port

The 5100 Motor Board has a nine-pin DB-9 serial RS-232 port connector, for communications and control using a PC. This lower port, located below the printer port, is configured as Data Communications Equipment (DCE) at 9600 baud rate. Settings are: No parity, 8 data bits, and 1 stop bit (N, 8, 1). The lower RS-232 connector has the following pinout:

Table 4: RS-232 Pin Assignments

Direction Circuit Abbreviation

Circuit Name and Description Contact Number

5100 Output RXD Received data: The data signals generated by the DCE are transferred on this circuit to the DTE.

2

5100 Input TXD Transmitted data: The data signals originated by the DTE are transferred on this circuit to the DCE.

3

5100 Input RFR Ready for receiving: This circuit indicates whether the DTE is ready to accept data on RXD.

7

5100 Output CTS Ready for sending: this circuit indicates to the DTE whether the DCE is prepared to accept data signals on TXD.

8

-- GND Signal ground or common return. 5



Figure 3-46: RS-232 Pinout Diagram, From Side View of 5100

A second RS-232 port, located next to the calibration probe port, is configured as Data Terminal Equipment (DTE). This upper port is only available for temperature calibration using the DISTEK Tem-CHEK. The upper port will not respond to PC commands.

Test commands carefully. Improper PC control of remote instruments may lead to unexpected operation.

Table 5: 5100 Serial Command Reference

Command Response Function [MEAS:RPM] [XXXX] Measures the current

RPM Responds with RPM*10

[MEAS:RPM:MAX] [XXXX] Measures the Max RPM Responds with MAXRPM*10

[MEAS:RPM:MIN] [XXXX] Measures the Min RPM Responds with MINRPM*10

[CONT:MOTO:SET?] [XXX] Reports the set RPM Responds with the set RPM

[CONT:MOTO:STAT?] [ON] or [OFF] Reports the state of the Motor Responds with [ON] or [OFF]

[SYST:DATE?] [YY,MM,DD] Reports the current date

[SYST:TIME?] [hh,mm,ss] Reports the current time



Command Response Function [CONT:VESL:ELEM?_x] [PADDLE] or [BASKET] Reports the vessel

element, where x is the vessel number.

[CONT:VESL:TEMP?_x] [XXX] Reports the vessel setpoint temperature, where x is the vessel number, and XXX is the temperature in deg C * 10

[CONT:VESL:VOL?_x] [XXXX] Reports the vessel volume , where x is the vessel number, and XXXX is the volume in ml.

[MEAS:TEMP:CUR_x] [XXXX] Reports the current temperature of the vessel, where x is the vessel number, and XXXX is deg C * 100

[MEAS:TEMP:AVG] [XXXX] Reports the average temperature of all vessels enabled.

[HCOP:IMM] [!] if successful [??] if failed.

Prints immediately the current readings to the 5100 printer.

[*IDN?] [5100,xxxxxxx,MRevm.mm,SRevs.ss]

Responds with the serial number xxxxxx, and rom revisions m.mm and s.ss

[MEAS:TEMP:MAX_x] [XXXX] Responds with the MAX temp of vessel x.

[MEAS:TEMP:MIN_x] [XXXX] Responds with the MIN temp of vessel x.

[SYST:ETIME?] [hh,mm] Responds with the elapsed time as hours and minutes.

[SYST:CAL?] [iiii,ssss,………,iiii,ssss] Responds with the cal settings namely intercept iiii, and slope ssss of each and every vessel.

[CONT:MOTO:SET_XXX] [XXX] Sets the current RPM to XXX

[CONT:MOTO:STAT_ON] [ON] WARNING: Turns the motor on.



Command Response Function [CONT:MOTO:STAT_OFF] [OFF] Turns the motor off.

[SYST:DATE_YYyy,MM,DD] [yy,MM,DD] Sets the system date

[SYST:TIME_HH,MM,SS] [HH,MM,SS] Sets the system time

[CONT:VESL:TEMP_x,nnn] [x,nnn] Sets the temperature setpoint for vessel x to nnn = deg C*10

[CONT:VESL:ELEM_x,’type’] [x,’type’] Sets the vessel element type for vessel x to ‘type’, where ‘type’ = P for paddle or B for basket

[CONT:VESL:VOL_x,XXXX] [x,XXXX] Sets the volume for vessel x to XXXX mls.

[CONT:HEAT:STAT_ON] [ON] WARNING: Turns the heater relay on.

[CONT:HEAT:STAT_OFF] [OFF] Turns the heater relay off

[CONT:VESL:STAT_x,ON] [x,ON] Enables vessel x

[CONT:VESL:STAT_x,OFF] [x,OFF] Disables vessel x

[SYST:PANEL:STAT_ON] [ON] Enables front panel; keys and datakey become active.

[SYST:PANEL:STAT_OFF] [OFF] WARNING: Disables front panel; keys become inactive. Disables datakey while in Auto Test mode.

[SYST:SLEEP] [!] WARNING: Puts the system in SLEEP mode. Displays turn off, but PC controller can still oper-ate motor and heaters.

[CONT:TEST:ABORT] [!] Aborts the current test.

[SYST:ADDR?] [aa] Returns the address of the unit.

If any command is not understood, the 5100 responds with [??].



Serial RS-485 Address and Beep Mode To find out what address the 5100 is set to, connect serial port of a PC to lower RS-232 port of 5100. Use a terminal program to send [SYST:ADDR?] command from PC (see Table 5). Unit should respond with [XX], where XX is address between 00 and 31.

Front LCD display shows Beep status (off or on) after 5100 is turned on.

Figure 3-47 below shows location of DIP switch SW1 on motor control PC board 5103. This board is located behind hinged panel at lower rear of the unit.

Turn off unit and disconnect power before opening panel. Improper servicing or adjustment practice can cause equipment failure or serious physical injury. All exposed points on the control circuit board are electrically hot with respect to earth ground.

Figure 3-47: 5103 PC Board DIP Switch Settings



Setting RS-485 address and Beep mode

DIP switch positions one through five are used to set RS-485 address of the unit. Switch six sets BEEP mode ON or OFF. Disabling BEEP mode eliminates audible operator prompts from unit, but still provides verification beep whenever any key is pressed. DIP switch functions are shown in Table 6.

Table 6: DIP Switch Functions, 5100

* = Default Settings

♦ In certain modes the command address field is optional or unnecessary. The address field is only shown in Table 7 example as “[aa_”.

♦ The underscore character “_” is used in the command format to indicate the need for a blank space in the command line.

Table 7: Command Example

Command Function Format Response Format

Device Identification “[aa_*IDN?]” “[5100,serial#,revision]”

Chapter 4: Maintenance


4 Maintenance This chapter describes the steps necessary to properly maintain the Premiere 5100. General Care and Maintenance of Model 5100 .......................................... 4-2

Chapter 4: Maintenance


General Care and Maintenance of Model 5100

1. Unit should be cleaned periodically by wiping with a slightly damp cloth. Do not use any harsh chemicals or detergents.

2. Electronics require no customer attention. In the event of a malfunction, please call the factory before attempting any repairs.

3. ** Turn off unit and unplug power cord. Remove drive cover. Apply small amount of Dow Corning High Vacuum Grease to top and bottom of both drive belts. (This should be done every 6 months.) Replace cover. Drive motor and bearings are permanently lubricated. Belt tension is factory adjusted.

4. ** Clean guide posts every three months with alcohol and wipe dry with clean cloth or paper towel. Do not lubricate posts (see Figure 2-3).

5. Temperature calibration probe should be cleaned off and stored in holder on rear left side of drive unit when not in use.

6. ** Vessel support plate requires extra care. Do not allow acids or buffers to remain on the plate for extended periods of time. WIPE THE PLATE CLEAN AFTER USE. DO NOT SCRATCH OR SCORE PAINTED SURFACE.

7. See Appendix A: Preventive Maintenance Checklist for additional information.

Do not clean plastic and rubber parts with organic solvents.

Items marked ** require periodic attention.

Chapter 5: Troubleshooting & Service


5 Troubleshooting & Service This chapter provides troubleshooting information to identify the most common problems and their solution. Troubleshooting Chart....................................................................... 5-2 Model 5100 System Initialize Procedure................................................ 5-19 Clearing the Dallas Chip................................................................... 5-21 Replacing Chip Number U13 .............................................................. 5-21 Function Check and Initialize Instrument .............................................. 5-22 Initialize Unit ............................................................................... 5-22 Service ....................................................................................... 5-24



Before performing any procedure in this section, please disconnect AC power from the 5100.

Improper servicing or adjustment practice can cause equipment failure or serious physical injury. This equipment must be adjusted and serviced by qualified electrical maintenance personnel who are familiar with the construction and operation of the equipment and the hazards involved. Take diligent care during adjustment. All exposed points on the control circuit boards are electrically hot with respect to earth ground.

HIGH VOLTAGE IS EXPOSED WHEN THE LOWER REAR PANEL IS OPENED ON THE 5100. Dangerous voltages exist on the circuit boards when powered. Disconnect AC power from the 5100 while troubleshooting. Be alert. High voltage can cause serious or fatal injury.

The Model 5100 is supplied with proper heaters and settings for the specified operating voltage (see label for information). Do not attempt to convert unit to another power supply without contacting the factory first!



Troubleshooting Chart Display/Keypad PROBLEM POSSIBLE SOLUTION LCD DISPLAY Blurred display Adjust display

contrast Locate and adjust by turning the multi-turn potentiometer on the stage board.

Display cable Check the ribbon cable that goes from the LCD connector to the stage board from any loose wires or crimps.

LCD display Make sure that the display assembly is mounted securely on the bezel. Replace the LCD display.

Stage board Check that all socketed chips are inserted properly. Remove the RAM chip U10 (Dallas DS1244Y)-wait one minute then plug it back on. Note: Make sure you do not bend the leads when removing and reinstalling the chip.

Horizontal line across the LCD display

Display contrast Locate and adjust by turning the multi-turn potentiometer on the stage board.

Display cable Check the ribbon cable that goes from the LCD connector to the stage board from any loose wires and crimps.


No display Display contrast Locate and adjust by turning the multi-turn potentiometer on the stage board.

Display Cable Check the ribbon cable that goes from the LCD connector to the stage board from any loose wires or crimps.


Stage board Check that all socketed chips are inserted properly. Remove the RAM chip U10 (Dallas DS1244y) wait 1 minute then plug it back it in. Note: Make sure you do not bend the leads when removing and reinstalling the chip. Replace the stage board if necessary.



PROBLEM POSSIBLE SOLUTION LCD DISPLAY (cont.)

Scrambled LCD screen

Power Supply Cycle the main power off for at least 1 minute then turn it on again. This step will reset and initialize the microprocessor.

LCD display Check the ribbon cable that goes from the LCD connector to the stage board. Make sure that the display assembly is mounted securely on the bezel.

Stage board Check that all socketed chips are inserted properly. Remove the RAM chip U10 (Dallas DS1244y) - wait 1 minute then plug it back in. Note: Make sure you do not need the leads when removing and reinstalling the chip.

LCD display/Power supply PCB

Check if capacitor is installed at the C1 location of the 3651-5109 PCB (display power supply mounted top left of the LCD display).

Shaft not rotating-unit heats properly

Fuse Check if the 0.5 amp fuse located on the 5103 PCB (see figure 3 location F5) is blown. Replace is needed.

Cable connectors

Check drive motor connection on 5103 PCB at location “J6” (see figure 3) for loose wire connection or damage pins. Repair as necessary. Check motor drive connection on the drive motor itself for loose wire connection or damaged pins.

Shaft rotate-not heating properly

Initialize unit See instructions for “Model 5100 System Initialize Procedure” on page 5-21.

Re-cycle power Turn instrument off. Wait approximately 2 minutes and restart unit.

RAM corrupted Clear RAM (Dallas chip) using the “Clear 0” chip (see instructions for “Dallas (RAM) Chip Clearing” on page 5-22. Replace Dallas chip.




PROBLEM POSSIBLE SOLUTION LCD DISPLAY (cont.)

Stage board Check that all socketed chips are inserted properly. Remove the RAM chip U10 (Dallas DS1244Y) wait 1 minute then plug it back on. Note: Make sure you do not bend the leads when removing and reinstalling the chip. Replace the stage board if necessary.

LED DISPLAY LED display not scrolling/locks up

LED display cable

Check the LED cable going from the motor/heater board (5103) to the LED board (5104) for any loose wires on the crimp connector.

LED board Replace the 5104 LED board display. Stage board Replace the 5101-stage board that

causes the LED board not to function. No LED

display LED display cable

Check the ribbon cable that goes from the LED connector to the motor board from any loose wires or crimps.

LED display (seven segment)

Check for any loose or shorted connection on the LED display board.

LED display board

Replace the LED display board.

Stage board Replace the stage board. Some LED

display digits missing

LED display cable

Check the LED cable going from the motor/heater board (5103) to the LED board (5104) fro any loose wires on the crimped connector.

LED display Replace the LED seven-segment display if necessary.

LED board Replace the 5104 LED board display. Stage board Replace the 5101 stage board that

causes the LED board not to function properly.

KEYPAD Not heat light indicator

LED indicator Defective LED. Replace the keypad overlay.

Not responding

Keypad connection

Check that the keypad connector is securely inserted into stage board J11 connector and that orientation of the cable is plug right.

Stage board Replace the 5101-stage board that causes the keypad to malfunction.

Keypad Replace the keypad membrane for probable short on the circuit.

No stir light indicator when pressed

LED indicator Defective LED. Replace the keypad overlay.



Power Supply PROBLEM POSSIBLE SOLUTION AC SUPPLY Main circuit

keeps tripping

Short circuit on the unit

Check the unit for any shortages starting from the power switch, in-line filter, transformer, wiring and the system circuit boards.

No main power

Underrated main circuit

Check that the circuit breaker for that particular line outlet is not underrated as specified.

Main circuit breaker

Check that the circuit breaker for that particular line outlet is turned on.

Main outlet Check that the unit is plugged in a regular outlet without ground fault interrupters (this will cause the outlet to trip during heating due to overload). Check with an electrician.

No low voltage ac (secondary) from the transformer

No power Measure if there is input voltage coming into the transformer primaries (115v or 2202v).

I/O board voltage selector

Check that the transformer wirings are securely fastened into the I/O connector J4.

Power switch keeps tripping

Short circuit on the unit

Check the unit for any shorts starting from the power switch, in-line filter, transformer, wiring and the system circuit boards.

Underrated power switch

Check that the power switch is rated for that particular 5100 (115v=16A, 220v=10A).

DC SUPPLY No +5v Transformer secondary

Measure if there is output voltage coming out of the transformer secondary. If there is no AC voltage coming out of the secondary replace the transformer if necessary.

Wiring harness Check that the transformer wiring is securely soldered into the transformer terminals. Also, check the connector that supplies the motor/heater board for any loose connections.



PROBLEM POSSIBLE SOLUTION DC SUPPLY (cont.)

Voltage regulator

Replace the defective +5v regulator if there is no dc voltage measured across TP4 (GND) and TP5 (+5) of the motor/heater board.

Motor/heater board

Replace the defective motor/heater (5103).

No +6v Transformer secondary

Measure if there is output voltage coming out the transformer secondary. If there is no ac voltage coming out of the secondary replace the transformer.

Wiring harness Check that the transformer wiring is securely soldered into the transformer terminals.

Voltage regulator

Replace the defective +6v regulator if there is no dc voltage measured across TP4 (GND) and TP2 (+6) of the motor/heater board.

Motor/heater board

Replace the defective motor/heater board (5103).

No +12v Transformer secondary

Measure if there is output voltage coming out of the transformer secondary. If there is no ac voltage coming out of the secondary replace the transformer.

Wiring harness Check that the transformer wiring is securely soldered into the transformer terminals. Also check the connector that supplies the motor/heater board for any loose connections.

Voltage regulator

Replace the defective +12v regulator (U30) if there is no dc voltage measured across pin2 (GND) and pin3 (+12) of the +12v regulator.

Motor/heater board


No -5v Transformer secondary

Measure if there is output voltage coming out the transformer secondary. If there is no ac voltage coming out of the secondary replace the transformer.

Wiring harness Check that the transformer wiring is securely soldered into the transformer terminals.



PROBLEM POSSIBLE SOLUTION DC SUPPLY (cont.)

Also, check the connector that supplies the motor/heater board for any loose connections.

Voltage regulator

Replace the defective -5v regulator (U34) if there is no dc voltage measured across TP4 (GND) and TP3 (-5v).

Motor/heater board

Replace the defective motor/heater board

No high voltage (HV)

Transformer secondary

Measure if there is output voltage coming out the transformer secondary. If there is no AC voltage coming out of the secondary replace the transformer.

Wiring harness Check that the transformer wiring is securely soldered into the transformer terminals. Also check the connector that supplies the motor/heater board for any connections.

Motor/heater board




Heating/Speed PROBLEM POSSIBLE SOLUTION HEATERS “Abnormal

Heating Profile”

Triacs Check for any defective triacs that stays off all the time when heaters are enabled.

Heaters Check for heater unplugged or any loose wiring from the heater especially where the connectors meet. Check the resistance of the heater(s) is not infinite or open.

Calibration Check and verify the calibration of the unit. Check the low calibration at room temperature and the high calibration between 37 to 40 degrees centigrade. Perform calibration if necessary.

Volume settings Check that a specific vessel position(s) is set to the right volume setting (this can be done through manual parameter settings or auto test).

Motor/heater board


Vessels Vessel is empty; cool & fill with liquid.

Stirring element

Stirring element is out of vessel; lower and stir.

Probe Vessel probe may have failed; test and replace.

Power Turn off 5100 main power switch, wait 10 seconds and turn back on to reset.

“CRITICAL ERROR”

Abnormal Heating in Vessel: ___ Temp read at : ___

Calibration probe unplugged; plug in and press ENTER. Temperature too hot in vessel. Indicated probe # may have failed; test and replace if necessary.

“HIGH TEMPERATURE ERROR”

Vessel Temp Vessel temperature exceeds approx. 60 ºC, causing safety to automatically cut power to all heaters. If this occurs, ensure vessel temperature setpoint is less than 55 ºC. Turn off 5100 and disconnect power from instrument. Contact Distek for further information.

No heat Triacs Check for any defective triac(s) that stays off all the time when heaters are enabled. Replace the defective triac(s) if found faulty.



PROBLEM POSSIBLE SOLUTION HEATERS (cont.)

Heaters Check for heater unplugged or any loose wiring from the heater especially where the connectors meet. Check that the resistance of the heater(s) is not infinite or open.

Program disabled heater

Check that a specific vessel position(s) is enabled (this is done through manual parameter settings or auto test). Note: An asterisk symbol next to vessel number (*1) means vessel #1 is on.

Motor/heater board


Slow heating on one or more vessel position

Triacs Check for any defective triacs that stays off all the time when heaters are enabled.

Heaters Check for any loose wirings from the heaters harness especially where the connectors meet. Check that the resistance of the heaters(s) is not infinite or open.

Programmed volume settings

Check that a specific vessel position(s) is set to the right volume setting (with 500mls settings only the lower part of the heater will be enabled). Change the volume settings through manual parameter settings or auto test.

Motor/heater board

Replace the defective motor/heater board (5103) if necessary.

When heat/start key pressed-heat indicator lights up momentarily-heater will not turn on

Height switch Check that the height switch is engaged when the drive head is lowered. Adjust the switch position until it triggers the switch with the cylinder of the gas spring.

Wiring Check that the wiring of the height switch is intact and the connector end is plugged into J5 of the motor/heater board.



PROBLEM POSSIBLE SOLUTION

DRIVE MOTOR No stirring Motor fuse Check that the fuse (F5) for the motor on the motor/heater board is not faulty. Replace if found faulty.

Height switch Check that the height switch is engaged when the drive head is lowered. Check that the wiring of the height switch is intact and the connector end is plugged into J5 of the motor/heater board.

Motor cable wiring harness

Check that the cable is intact and make sure all connectors are plugged into their respective mates from the drive motor to the 5103 board.

Defective drive motor

Check that the drive motor for any shorts and faulty wiring. When the drive motor is turned by hand the rotation should be smooth and without binding.

No high voltage supply

Refer to problem “No high voltage”.

Motor board Replace the defective motor/heater board (5103).

Speed goes to maximum speed

Motor cable wiring harness

Check that the cable is intact and make sure all connectors are plugged into their respective mates.

Magnetic pick up gap

Check that the distance between the magnetic pick-up and the rotating gear is at 0.001 inch.

Magnetic pick up

Check that the magnetic pick-up is securely fastened with the bracket. Check the magnetic pick-up shorts or faulty wiring. Replace if found defective.

Motor/heater board


Stir key pressed-indicator lights up momentarily-drive motor will not turn on.

Height switch Check that the height switch is engaged when the drive head is lowered. Adjust the switch position until it touches the cylinder of the gas spring.

Wiring Check that the wiring of the height switch is intact and the connector end is plugged into J5 of the motor/heater board.



*I/O Communication PROBLEM POSSIBLE SOLUTION PRINTER No printout I/O cable Check the cable for any faulty

connections. Replace the cable if necessary.

Printer cable Check the IEEE printer cable for any faulty connections especially with bent pins.

Printer Make sure that the printer is on and has enough paper. Set the printer’s carriage return to enable. This can be done through the printer’s software.

Program setting

Under “More Options” make sure that the printer setting is on.

I/O board Check the board for any faulty or short connections. Replace the I/O board if necessary.

Motor/heater board


RS232 No communication (handshaking)

I/O cable Check the cable for any faulty connections.

RS232 cable Check the RS232 cable for any faulty connections especially bent pins.

Systems address

Make sure that the system address is set right. This can be done through the motor/heater board SW1 address settings.

PC or Master controller

Make sure that the setting of the controller matches the systems protocol. Use COM1-COM4 at 9600-baud rate.

I/O board Check the board for any faulty connections. Replace the I/O board if necessary.

Motor/heater board


RS485 No communication

I/O cable Check the cable for any faulty connections.

RS485 Check the RS485 cable for any faulty connections especially bent pins.



PROBLEM POSSIBLE SOLUTION RS485 (cont.) No

communication System address

Make sure that the system address is set right. (This can be done through the motor/heater board SW1 settings) Note: Follow the protocol when hooking up different models (5100 to 2100B)

RS485 terminator

Plug in the RS485 termination accordingly.

PC or master controller

Make sure that the setting of the controller meets the systems protocol. Use COM1-COM4 at 9600-baud rate.

I/O board Check the board for any faulty connections. Replace the I/O board if necessary.

Motor/heater board




Temperature, abnormal display PROBLEM POSSIBLE SOLUTION DISPLAY Temperature

seems locked/not changing

+6 volts dc not present

Refer to no +6 volts dc.

-5 volts dc not present

Refer to no -5 volts dc.

RTD wiring harness

Check the harness for any faulty wiring and connections.

A/D board Replace the A/D board. RTDs/CalProbe Abnormal

display reading

RTD shaft connection

Check the slip ring connection of the suspected RTD.

RTD Check the RTD(s) for any shorts or higher resistance readings.

RTD cable harness

Check the harness for any faulty connections.

A/D board Replace the A/D board.



Calibration PROBLEM POSSIBLE SOLUTION PROBE No response from

calibration probe Cal Probe Check the calibration probe for any

shorts.

RTD wiring harness

Check the harness for any faulty connections.

A/D board Replace the A/D board.



Mechanical PROBLEM POSSIBLE SOLUTION BATH LEVEL Level Leveling feet By using the bubble level as a

guide, level the unit from front to back and side to side by adjusting front leveling feet under instrument base.

Rear stabilizers

Adjust rear stabilizers so they just barely touch the bench.

SHAFT WOBBLE/RUNOUT

RTD shafts RTD shafts With the 5100 at its operating position (paddles or baskets) use a run out gauge to validate the shaft wobble. Mount the gauge base with a clamp on the vessel support plate (next to the shaft to be checked). Move the tip of the gauge until it contacts the shaft tolerably. Raise the drive head until the tip of the gauge is just less than 1 inch above the apparatus. Rotate a spindle that is not under test manually until you reach the high-end deflection of the gauge’s readout. Gradually push the shaft with your thumb near the meter shaft, away from the gauges adjustable tip. Start stirring at 25 rpm and check the shaft wobble. Do this until you meet the specifications.

SHAFT CENTERING Spindles Spacers and Inserts

Check the spacers and inserts for defects. Replace if necessary.

Adjustments Attach CenterChek as per instruction on the position in question. Rotate a spindle that is not under test manually. Note the whole deflection of the CenterChek.



PROBLEM POSSIBLE SOLUTION SHAFT CENTERING (cont.)

Rotate the gauge until you reach the high-end deflection of the gauge’s pointer (counter clockwise movement) then stop the rotation.

Open the drive assembly cover. Loosen the screws (big) slightly

until you get a slight movement of the spindle in question. Loosen or tighten one of the setscrews until you can set the pointer of the gauge between the low and high deflection of the meter. Carefully start tightening the big screws making sure that the pointer of the gauge only moves slightly.

Shaft wobble/run out

Shaft Refer to “Shaft wobble/run out”.

Vessels Non-DISTEK 5100 vessels

Replace non-DISTEK 5100 vessels (5100 vessels have tighter inside diameter tolerance).

Vessel centering arm assembly

Mounting Check the installation of the centering arm making sure that the plastic nylon post is flush with the arm.

Centering arm

Replace if centering arm is broken or has defects.

APPARATUS HEIGHT ADJUSTMENT

Paddle and basket height

Height block Refer to manual for “How to adjust paddle or basket height”.

Shaft collars Locking collars

Make sure that when locking the shaft collars the shaft does not move (slightly push down the shaft while locking the collars).

Vessels Non-DISTEK 5100 vessels

Replace non-DISTEK 5100 vessels (5100 vessels have tighter inside diameter tolerance).



PROBLEM POSSIBLE SOLUTION

DRIVE HEAD MOVEMENT DIFFICLUT TO RAISE AND LOWER

Brake tension

Tension Adjust the tension of the brake assembly.

Drive posts Guide posts Clean drive post. Use cloth dampened with alcohol and wipe dry.

Gas Spring Gas Spring Replace if gas spring is found defective (pressure leakage).

NOISE IN DRIVE ASSEMBLY

Drive belts Drive belts tension Check for drive belts tension. Adjust if necessary.

Drive motor

Brushes Check the drive motor’s conductive brushes for wear. Replace the brushes if necessary.

Idler wheels

Idler wheels Inspect the idler wheels especially the bearings for any sign of wear. Lubricate the bearings if necessary. Replace the idler wheel assembly.

Pulleys Pulleys Inspect the pulleys for any cracks that may cause the setscrews to loosen up. This will cause the pulley to rotate around the spindle shaft.

EXCESS VIBRATION Drive belts Drive belts tension Check drive belts tension. Adjust if necessary.

Lubrication Lubricate the drive belts with vacuum grease.

Drive belts Replace the drive belts if necessary. Drive

motor Brushes Check the drive motor’s conductive

brushes for wear. Replace the brushes if necessary.

Idler wheels

Idler wheels Inspect idler wheels especially bearings for any sign of wear. Lubricate bearings if necessary. Replace idler wheel assembly.

EXCESS VIBRATION (cont.)

Other equipment

Instruments and equipment

Make sure that there are no units that can produce excessive vibration when they are turned on (filtration systems, shakers, etc.).

Pulleys Pulleys Inspect the pulleys for any cracks that may cause the setscrews to loosen up (this will cause the pulley to rotate around the spindle shaft). Replace cracked or defective pulleys.



Model 5100 System Initialize Procedure

This procedure should be performed whenever the “Dallas” chip is changed or heating irregularities are experienced.

Install all vessels with at least 900mL of water in them, then follow the steps below. 1. Turn the instrument off, unplug it, wait approximately 2 minutes then

plug it in and turn it on.

2. Press the LEFT key twice. This should bring you to the Manual Operation, RPM settings screen. Press ENTER. The RPM should begin flashing, change it to 100 using the UP or DOWN key, then press ENTER again. Press the UP key. This should get you to the ‘Vessels 1 to 7’ settings.

3. Press ENTER. The temperature setting should then be highlighted. If the current temperature setting is 37.0 °C press the DOWN key and go to step 5, otherwise move on to the next step.

4. Press ENTER. The temperature setting should begin flashing. Press the UP or DOWN key to adjust the temperature as necessary to 37.0 °C. Press ENTER when finished, then the DOWN key.

5. The word ‘ON’ or ‘OFF’ should now be flashing. Press ENTER to set as ‘ON’ if it is not so, then press the DOWN key.

6. The volume setting should now be highlighted. If it is currently set at 900mL press the DOWN key then go to step 8, otherwise move on to next step.

7. Press ENTER. The volume setting should begin flashing. Use the UP or DOWN key to adjust the volume to 900ml. Press ENTER when finished, then the DOWN key.

8. The stirring element setting should begin flashing. Press ENTER until ‘BASKET’ is flashing. Then press clear to save all settings.

9. Press the UP key. (This screen allows you to set individual vessels). Press ENTER. The vessel # will highlight. If # 8 is the current setting press the DOWN key then go to step 11, otherwise move on to the next step.

10. Press ENTER. The vessel # should begin flashing. Use the UP or DOWN key to select vessel # 8. Press ENTER when finished, then the DOWN key.

11. The temperature setting should now be highlighted. If the current temperature setting is 37.0 °C press the DOWN key then go to step 13, otherwise move on to the next step.



12. Press ENTER. The temperature setting should begin flashing. Use the UP or DOWN key to adjust the temperature as necessary to 37.0°C. Press ENTER when finished, then the DOWN key.

13. The word “ON” or “OFF” should begin flashing. Press ENTER to set as “ON” if it is not so, then press the DOWN key.

14. The volume setting should now be highlighted. If it is currently at 900ml press the DOWN key and go to step 16, otherwise move on to the next step.

15. Press ENTER. The volume setting should begin flashing. Use the UP or DOWN key to adjust the volume to 900mL. Press ENTER then the DOWN key.

16. The element setting should begin flashing. Press ENTER to change this setting to BASKETS if it is not so. Then press clear to save all settings.

17. Press start. Let the instrument heat for approximately 10 to 15 seconds then press start again to stop the heating.

Only the heating will stop, not the Shaft rotation.

18. Press ENTER. The element setting will begin flashing. Press the UP key twice. ‘ON’ should begin flashing. Press ENTER to change it to ‘OFF’ then press clear to save the setting.

19. Procedure is now complete.

Vessel # 8 (Cal. Probe) setting should remain as last set in step 18 for proper operation of the instrument.

Run a short test for approximately 30 minutes to verify the instrument is functioning correctly.



Clearing the Dallas Chip

Before attempting this step, make sure a “clear 0” chip has been supplied. Not all upgrades require this step. Performing this step will clear the instrument’s memory. All methods and calibration data will be lost. A full calibration sequence should be performed once this procedure is completed.

1. Once the U13 EPROM has been removed, orient, then install the “Clear

0” chip in the U13 socket.

Remember to orient new Clear 0 chip with notch in same direction as the socket. Carefully align all pins with socket before final insertion.

2. Connect and plug in the power cord. Turn on the instrument. Wait about six to ten seconds, then turn off the instrument.

3. Unplug the power cord. Remove the “Clear 0”chip and store for future use.

Replacing Chip Number U13 1. Gently insert the new EPROM chip or replace the existing EPROM chip

into the U13 socket. 2. Carefully align all pins with socket before final insertion.

Remember to orient the chip with the notch in the same direction as before.

3. Check that all pins have been properly inserted. If no other chips will be replaced on this PCB, go to step 6.



Function Check and Initialize Instrument The unit is now ready to be powered on.

1. Re-connect all cables and close up front control cover.

2. Plug in unit.

3. Turn on power.

4. Unit should perform power-on self-test, shown on front LCD display.

5. If no response at power-on, switch off unit quickly.

6. Unplug unit.

7. Make sure EPROM chips were inserted correctly, with notch oriented as before.

8. If problem still occurs, call Distek.

9. After power-on self-test, see Operation Manual for information on resetting the calibration before performing the following steps if the “clear 0” chip was used at any time during this procedure.

Perform the following initialization steps, in the order shown, before operating heaters.

Initialize Unit

The following steps should be performed whenever the “Dallas” chip is changed or heating irregularities are experienced.

1. Turn off the instrument, unplug it and wait about 2 minutes, then plug it in again.

2. Go to the Manual Operation Screen (RPM) then press the UP key. This should bring you to the screen name Manual Operation (Vessels # 1 - 7)

3. At this screen set as follows: Temp. = 37.0 °C; ON; Volume = 900mL; Element = BASKET. Press the CLEAR key to save all settings when finished.

4. Press the UP key to move to the screen name Manual Operation (Vessel # 1). At this screen set as follows: Vessel # = 8; Temp. = 37.0 °C; ON; Volume = 900mL; Element = BASKET. Press the CLEAR key to save all settings when finished.



5. Press the START key. The ‘Stir and Heat’ led should turn on. The

instrument should also begin running and heating. Allow this to continue for about 10 to 15 seconds, then press the START key again to stop the heating.

Only the heating will stop, not the Shaft rotation.

6. Once step 5 is completed change the setting for Vessel # 8 as follows:

Vessel # = 8; Temp. = 37.0 °C; OFF; Volume = 900mL; Element = BASKET. Press the CLEAR key to save all settings when finished.

7. Press the DOWN key. This brings you back to Manual Operation (Vessels 1 – 7) Screen. Set as follows: Temp. = 37.0 °C; ON; Volume = 900mL; Element = PADDLES. Press the CLEAR key to save all settings when finished.

8. Procedure complete. Run a test to check if the problem has been resolved.



Service If you have a problem with the instrument or need parts information, contact the Distek Service Department by e-mail at [email protected] or call our toll-free number (888)234-7835. Items returned for repair or exchange require an R.A. #. Please contact the Distek Service Department to obtain an R.A. Please send the return or repair to: Distek, Inc. Service Department 121 North Center Drive North Brunswick, NJ 08902 Attention: R.A. # ___________

Appendix A

Operation Manual: Model 5100 A-1

Appendix A : Spare Parts and Accessories Baskets 2821-0160 SN 10 Mesh Basket Serialized 2821-0160 10 Mesh Basket, 2821-0160 G 10 Mesh Basket, Gold Coat 2821-0160 H 10 Mesh Basket, Hard Coat 2821-0159 20 Mesh Basket 2821-0159 G 20 Mesh Basket, Gold Coat 2821-0159 H 20 Mesh Basket, Hard Coat 2821-0072 40 Mesh Basket 2821-0072 G 40 Mesh Basket, Gold Coat 2821-0072 H 40 Mesh Basket, Hard-Coat 2821-0072 SN 40 Mesh Basket, Serialized 2821-0072-SN 40 Mesh Basket, Serialized (set of 7) 2851-0138 40 Mesh Basket and Adapter (No Shaft ) 2800-0032 40 Mesh Basket, without Knurled Ring 2800-0004 100 Mesh Basket 2800-0004 G 100 Mesh Basket, Gold Coat 2800-0004 H 100 Mesh Basket, Hard Coat 2821-0444 150 Mesh Basket, 2821-0444 H 150 Mesh Basket, Hard Coat 2821-0342 250 Mesh Basket 2821-0342 H 250 Mesh Basket, Hard Coat 2821-0471 300 Mesh Basket 2821-0472 400 Mesh Basket 3250-0445 Basket for Suppository Test Basket Adapters & Clips 2851-1052 Adapter for Standard Basket 3200-0038 Adapter for Basket without Knurled Ring (Can only be used with basket, p/n 2800-

0032)

3100-0017 Detachable Snap-on Basket Clip Capsule Sinkers 0500-0467 Basket with Clip on Lid, 316SS (Large) 0500-0468 Basket with Clip on Lid, 316SS 0500-0473 6 Turn Spiral, Magnetic Sinker, Epoxy Coated 0500-0474 6 Turn Spiral, 316 SS 0500-0475 Sinker, XL, Teflon Coated

Appendix A


0500-0476 "S" Shaped Sinker, 316 SS 0500-0477 5 Turn, 316 SS 0500-0478 4 Turn, SS, Inert Coated 0500-0479 5 Turn, SS, Inert Coated 5000-0011 3 Prong Black Plastic Sinker 5000-0012 3 Prong Metallic Core Encased in Inert Plastic Sinker, Magnetic

Cables & Cords 4952-0013 Cable, RS-232, 12 Ft. Long, Male to Female 4952-0012 Cable, RS-232, 6 Ft. Long, Male to Female 2400-0004 Cable, RS-485 4955-0001 Power Cord, 6 Ft., 13 Amps, 125V, For 5100 4955-0002 Power Cord, 6 Ft., 15 Amps, 125V, For 5100 Filter Disks 5720-0203 Filter Disks, 10 Micron, 1000 per pack 5720-0275 Filter Disks, 45 Micron, 1000 per pack Fittings & Connectors 5720-1009 Coupling, 1/4 x 28 Thread 5720-9074 Elbow , Male to Female 5720-9059 Luer Adapter, Female 5720-9060 Luer Adapter, Male Kits & Accessories 2800-0066 1 Intrinsic Dissolution Apparatus - Paddle Over Stationary Disk. Includes 1 each of

the following: Flat bottom glass vessel 1L, acculign ring, punch, die/plunger/cap assembly, wrench, and surface plate for pellet pressing.

2800-0066 6 Intrinsic Dissolution Apparatus - Paddle Over Stationary Disk. Includes 6 each of the following: Flat bottom glass vessel 1L, acculign ring, punch, die/plunger/cap assembly, and 1 ea. wrench and surface plate for pellet pressing.

4960-0001 E-Z Press Hydraulic Lab Press, 12 Ton Featuring built-in Polycarbonate Safety Shields and Lightweight, Ergonomic Design (weighs only 51 lbs.)

2421-0173 Back Light Kit

3011-0001 VisiChek for Enhanced Visual Perspective and Observation of Tablets for 5100. 3851-0020 Manual, Operation for 5100 3851-1090 Quick Start Instructions for 5100

Appendix A


Paddle Blades 3251-1051 Paddle Blade, 3251-1051 SN Paddle Blade, Serialized 2800-0077 Paddle Blade, Hard Coat 3251-1084 Paddle Blade, Plastic 2800-0073 Paddle Blade, Teflon Coat Printer & Printer Cables 2600-0061 Printer Cable 4000-0337 Printer Cable, Parallel Port, 10ft 2651-0001 Printer Sharing Box for Model 5100

Allows up to 4 Model 5100's to print to one printer. Includes; printer sharing box with 1ea 6" interface cable, 10' printer cable, and ribbon cable, and HP InkJet printer.

6687-0015 Printer, HP InkJet - requires printer cable p/n 4000-0337 2651-0002 Cable Pair for Printer Sharing Box (2651-0001).

Includes interface cable for Model 5100 to printer sharing box and modified ribbon cable. Requires 1 hour of labor for field upgrades.

Pulleys 3251-1079 Pulley, 1/2" ID 3221-0039 Pulley, 5/8" ID Black Sampling Probes 2910-0250 250mL Sampling Probe 2910-0500 500mL Sampling Probe 2910-0504 500mL Sampling Probe, for use with 2L Vessel 2821-0265 500mL Sampling Probe, Hard Coat 2910-0502 500mL Sampling Probe, Lower Portion, 2910-0506 500mL Sampling Probe, Solid Housing 2910-0750 750mL Sampling Probe 2910-0754 750mL Sampling Probe, for use with 2L Vessel 2910-0752 750mL Sampling Probe, Lower Portion Only 2910-0756 750mL Sampling Probe, Solid Housing 2910-0900 900mL Sampling Probe 2821-0205 900mL Sampling Probe, Hard Coat 2910-0904 900ml Sampling Probe, for use with 2L Vessel 2821-0205 6 900mL Sampling Probe, Hard Coat, set of 6 2910-0902 900mL Sampling Probe, Lower Portion Only 2910-0906 900mL Sampling Probe, Solid Housing 2910-1000 1000mL Sampling Probe 2910-1004 1000mL Sampling Probe, for use with 2L Vessel 2910-1002 1000mL Sampling Probe, Lower Portion Only

Appendix A


5570-8032 O-ring for Sampling Probe 2910-0003 Probe Plug with O-ring 2910-0001 Return probe Service Parts 0707-0665 Adjustable Leveling Foot 0707-6011 Hinge with screw for vessel cover 2451-5101 PC Board 5101 2451-5103 PC Board 5103 2451-5104 Top LED Display Board 2600-0012 ProduKey for 5100 2600-0013 CalKey for 5100 2821-0290 Idler Assembly 2851-0015 Heater Enclosure Assembly for 5100, 110V 2851-0016 Vessel Centering Arm Assembly 2851-0024 Heater Enclosure Assembly, 220V 3250-0019 Block for Vessel Cover with O-ring 3250-0102 Extension Block for Quick-change Height Adjustment Knob, 5100 and 2100C 3251-1056 Height Knob for 5100 and 2100C 3251-1109 Spring, Extension for Heater Jacket 3500-0001 Temperature Calibration Probe for 5100 4500-0001 Motor Fuse (F5) for PC Board 5103 ().5A, 250V, Fast Acting) 4500-0008 Heater Fuse (F1-F4) for PC Board 5103 (^Am 250VAC, Fast Acting) 4810-1004 Magnetic Pickup & Gear 5351-8047 Drive Belt - Short (Motor to Seventh Position) 5351-9033 Drive Belt - Long 5531-6061 Ball Used on 5100 Cover/Door, SS, Pack of 4 5570-8003 O-ring for Center Cap of Vessel Cover 5570-8007 O-Ring for Basket Adapter 5720-8019 Rubber Grommet Used on 5100 Calibration Probe Holster

Shafts & Paddles 2651-0023 Shaft Assembly, Includes bearing for 5100 2651-0123 Shaft Assembly for 5100, Teflon Coated, Includes bearing 2651-0124 Shaft Assembly for 5100, Hard Coating Coated, Includes bearing Shaft Collars 5570-6077 Shaft Collar with Allen Key Locking Validation Tools 0500-0281 CenterChek Model 170 5000-0013 Flat Tip Adapter for Wobble Meter Runout Gauge 0500-4078 Height Adjustment Ball 2.5cm

Appendix A


0500-0300 HeightChek Model 180 6220-0004 Reflective Stickers for Use with Optical Tachometer, Price Per Foot 0500-0301 ShaftChek 0500-1044 Tachometer, Contact 0500-1045 Tachometer, Optical 0500-0298 TempChek 3250-0046 Tip, Nylon for CenterChek 8100-0001 Validation Kit: Includes Contact Tachometer, CenterChek, HeightChek, and

Wobblemeter 8100-0602 Validation Kit: Includes Optical Tachometer, CenterChek, HeightChek, and

Wobblemeter 0500-0299 VesselChek 0500-0319 VibraChek 0500-0273 Wobblemeter Runout Gauge Vessels 3010-0096 Vessel, Premiere, Serialized, 1L Clear Glass 3010-0023 Vessel, Amber, 1L 3010-0023 6 Vessel, Amber, 1L set of 6 3010-0022 Vessel for Intrinsic Dissolution Apparatus, Flat Bottom Vessel Covers 3250-0089 Vessel Cover, Clear Acrylic with 3 Probe Holes, Small Center Hole 3250-0089 6 Vessel Cover, Clear Acrylic with 3 Probe Holes, Small Center Hole, Set of 6 3250-0070 Vessel Cover, Clear Acrylic with Three Probe Holes and Large Center Hole for

Basket and Shaft. Includes Center Cap and O-ring

3250-0070 6 Vessel Cover, Clear Acrylic with Three Probe Holes and Large Center Hole for Basket and Shaft. Includes Center Cap and O-ring, Set of 6

3250-0254 Vessel Cover, Black Polypropoylene 3250-0254 6 Vessel Cover, Black Polypropoylene Set of 6 5720-4037 Vessel Cover Hole Plug

Appendix B

Operation Manual: Model 5100 B-1

Appendix B : Preventive Maintenance Checklist Company: Date:

Location: Serial #:

Performed By:

NOTE: Distek recommends the following steps after every six (6) months

of operation, prior to process calibration.

1. Check instrument level. Place 6-9” carpenter’s level on vessel plate leveling bosses. Note any adjustments required for front-to-back or side-to-side leveling. Verify accuracy of built-in level on vessel plate.

2. Check all vessel retainer clips & screws.

3. Turn off unit and unplug power cord. Remove drive cover. Apply small amount of Dow Corning High Vacuum Grease to top and bottom of both drive belts. Replace cover.

4. Clean drive posts. Use cloth dampened with alcohol & wipe dry. (This should be done every 3 months.)

5. Verify & record RPM using external tachometer at following speeds:

(a) 25 RPM; (b) 50 RPM; (c) 100 RPM; (d) 150 RPM; (e) 250 RPM.

6. Verify & record temperature calibration of calibration probe and each vessel probe using external reference thermometer at following temperature: 37°C. (See note below.)

Set paddles to 150 RPM, 37.0°C, reach stable temp., turn off all heaters, then compare vessel readings to reference for accurate calibration. (See SYSTEM SETUP AND CALIBRATION section in 5100 Operation Manual if adjustment required).

7. Measure & record run-out (wobble) for each shaft.

8. Verify & record height of each stirring element from bottom of vessel.

Appendix C

Operation Manual: Model 5100 C-1

Appendix C : Pre-Installation Considerations: Electrical Power Supply

ELECTRICAL POWER SUPPLY 1

1. Locations using 115V, 60-cycle AC should provide a separate 20-A circuit for each Distek Model 5100 Dissolution System that they intend to install. In cases where additional modules (sampling, monitoring, printing) are being installed, separate 20-A circuits are necessary.

2. Similarly if 220V, 50 cycle AC systems are being installed, each system should be wired to a separate 15-A circuit.

3. Because of the extensive use of microprocessor technology, it is recommended, where possible, that 12-gauge stranded-copper wiring be used for all circuit wiring. In cases where the distance from the circuit breaker sub-panel to the outlet exceeds 500 feet (150m), 12-gauge wire is the minimum that should be used. The use of larger diameter wiring reduces the voltage drop in the wiring, helps reduce power consumption, and increases the inductive impedance of the circuit which helps smooth voltage fluctuations.

4. In addition, if possible, an isolated ground wire should be used and the site should be wired in a 3-phase, 4-wire configuration with an approximate load balancing among the phases. In sites where many systems are being installed, the number of systems wired to each phase should be balanced as much as possible.

5. To minimize the risk of damage to a system from electrical system problems:

5.1 Verify that the power wiring configuration is proper.

5.2 Verify that the mains voltage (“supply” to “neutral”) is within 7% of the nominal supply voltage.

5.3 Verify that the common-mode voltage between “neutral” and “ground” is: less than 3.0V AC in 115V installations or less than 3.0V in 220V installations.

5.4 If possible, verify the current dissipation capacity of the “ground” and the “neutral” lines in the circuit wiring.

5.5 Building mains should be protected with “lightning suppressors” and, ideally, each circuit should be terminated by the appropriate “surge protection” receptacle. (In the United States, suitable receptacles are supplied by Hubbell, Inc. Alternately, a sized computer-grade surge-suppression accessory with the appropriate current rating can be added to existing circuits.)

5.6 For those users who require protection from voltage drop-outs, short term power interruptions, and supply voltage reductions, a suitable standby Uninterruptible Power Supply (UPS) should be installed between the supply and the dissolution system.

Appendix C

Operation Manual: Model 5100 C-2

5.7 For those sites whose power quality is compromised either by the nature of the generation source or imposed fluctuations and pulses, an isolation transformer or an on-line UPS may be needed.

1 Although the Distek Model 5100 is designed with internal surge protection, failure to follow these recommendations may compromise the operation of the system and, should the system be damaged by power surges, lightning or other significant power fluctuations, such system damage is not covered by Distek’s warranty

Appendix D

Operation Manual: Model 5100 D-1

Appendix D : CE Declaration of Conformity

CE DECLARATION OF CONFORMITY

NOT TRANSFERABLE

CERTIFICATE NO: CE-5100-01 RESPONSIBLE COMPANY: DISTEK INC. NORTH BRUNSWICK NJ, USA REPRESENTED BY: DISTEK INC., European Head Office 36 Brunswick Road, Gloucester GL1 1JJ, UK EQUIPMENT TYPE & MODEL (s): Distek Dissolution System Model 5100 with Distek 4600 Calibration Meter and BJ-30 Printer Options. EQUIPMENT CLASSIFICATION: Light Industrial DECLARED COMPLIANCE: Council Directives 73/23/EEC and 89/336/EEC via (or other codes as applicable) Standards EN 60 950, EN 55 022 and EN 50 082-1

August 16, 1996

Appendix E

Operation Manual: Model 5100 E-1

Appendix E : Certificate of Compliance

Certificate of Compliance

This is to certify that DISTEK Dissolution Test Systems 2100A, 2100B, 2100C, 5100, 6100 and 6300, paddles, baskets, accessories and calibration tools are designed and manufactured to meet or exceed the specifications described in: USP 26, current USP supplements under the heading of “Dissolution”, Section 711 for USP Methods I and II; and comparable sections of the EP. All systems undergo rigorous testing and verification prior A to shipment.

DISTEK, INC. 121 North Center Drive

North Brunswick, New Jersey 08902

Appendix F

Operation Manual: Model 5100 F-1

Appendix F : Sample Printouts from Parallel Printer SAMPLE PRINTOUTS FROM 5100 PARALLEL PRINTER (OPTIONAL)

Note: Actual printouts may vary from samples shown.

Method Printout

DISTEK 5100 PREMIERE Dissolution System METHOD PRINTOUT

--------------------

Serial Number:

Lot Number: Batch Number:

Date: 03-18-97

Time: 10:46:39

Test Method Name: DISTEK TEST 3HR

Test Settings -------------

RPM: 75 IRPM: 250 Temp: 37.0 deg C

RPM Duration: 3:00 IRPM Duration: 0:30

Stirrer Type: BASKET Vessels Enabled: 1 2 3 4 5 6 7

Vessel Volume: 900 mls

Staggered Drop Interval: 0 seconds

Sample Interval: 30 minutes

Interval Printing: Enabled

------------------------------------------------------

Appendix F


Test Summary Printout

DISTEK 5100 PREMIERE Dissolution System

TEST SUMMARY PRINTOUT ---------------------

Serial Number: Lot Number: Batch Number:

START Date : 01:24p 03-18-97 End Date : 04:55p 03-18-97

Test Method Name: DISTEK TEST 3HR ------------------------------------------------------

Test Settings -------------

RPM: 75 IRPM: 250 Temp: 37.0 deg C Stirrer Type: BASKET Vessels Enabled: 1 2 3 4 5 6 7 Vessel Volume: 900 mls Staggered Drop Interval: 0 seconds Sample Interval: 30 minutes Interval Printing: Enabled ------------------------------------------------------

RPM Results -----------

Last Max Min Delta(Max-Min)

RPM 74.9 75.0 74.9 0.1

IRPM 249.9 250.1 249.5 0.2 ------------------------------------------------------

Temperature Profiles ---------------------

Vessel Number Max Temp. Min Temp. Delta(Max-Min) ------------- --------- --------- ------------- 1 37.08 36.82 .26 2 37.11 36.87 .24 3 37.07 36.84 .23 4 37.12 36.79 .33 5 37.10 36.76 .34 6 37.07 36.77 .30 7 37.08 36.87 .21

Appendix F


InstaPrint

DISTEK 5100 PREMIERE Dissolution System

InstaPrint ---------------------

Serial Number: 4321 Lot Number: Batch Number: Operator ID: Date : 02-18-98 Time : 04:55p

Temperature Profiles ---------------------

Vessel # Set Last Temp. Max. Min. Max-Min -------- --- ---------- ---- ---- ------- 1 37.0 37.02 37.08 36.82 .26 2 37.0 37.01 37.09 36.84 .25 3 37.0 36.98 37.11 36.91 .20 4 37.0 37.04 37.08 36.83 .25 5 37.0 37.05 37.08 36.82 .26 6 37.0 36.97 37.05 36.82 .23 7 37.0 37.01 37.12 36.83 .29 8 20.0 37.03 37.09 36.81 .28 -----------------------------------------------------------

Last Max Min Delta(Max-Min)

RPM 74.9 75.0 74.9 0.1

-----------------------------------------------------------

Note: “Vessel # 8”above is hand-held 5100 calibration probe

Documents

3851-0020 5100 Operation Manual Rev E · All Distek 5100 heaters have thermostatic protection. In the event of a malfunction (or if no liquid in vessel), the heater will cut off at