IBP HDM99 User Manual

HDM99

User Guide

Preface

The information contained in this is subject to change without notice. IBP Instruments GmbH, its distributors and subsidiaries take no responsibility for any errors or omissions in this document. The contained software is being delivered on the basis of a general licence contract or in single license. Use or reproduction of the software is allowed only in agreement with the contractual arrangements. Whoever transfers this software and/or this manual on magnetic tape, diskette or any other media, except for the purpose of own use, without written authorization of the IBP Instruments GmbH, is liable to prosecution.

Publishers: IBP Instruments GmbH IBP Medical Inc Sutelstr. 7a 3853 E Edna Ave D 30659 Hannover Phoenix, AZ 85032 Germany USA

Phone: +49 511 651647 1-888-338-8742 Fax: +49 511 652283 1-888-338-9838

Internet: http://www.ibpmt.com http://www.ibpmedical.com E-Mail: HDM-Support@ibpmt.com HDM-Support@ibpmedical.com

Manual author: Dipl. Ing. Werner Pfingstmann Christopher Weed

Rev 1 August 2002 Temperature Coefficient for B.Braun now 2.10%/°C Rev 2 September 2002 Temperature Coefficient for Gambro now 2,07%/°C

Specification: Temp. Accuracy 25 … 40°C ± 0.07 °C otherwise ± 0.1 °C

This user guide is only valid for software releases 3.6x (x = 0..9)

Conformity Declaration in accordance with Medical Product Law Flow Measuring extended Window Entrance Test added

Safety Instructions

For your own safety, and the safety of your patients, follow these important safety

instructions as well as other safety instructions noted throughout this User Guide.

• Please read the User Guide in its entirety before using the HDM99.

• Keep away the device from unauthorized persons.

• Never use the HDM99 on a dialysis machine to which a patient is connected.

• Never use the HDM99 on a dialysis machine with a connected battery charger.

• Never use the HDM99 in place of the hemodialysis machine’s primary sensors.

• Operate the instrument only in a dry environment, and do not touch it with damp

hands.

• Ensure that no fluids intrude into the interior of the device or into the sockets at

the front.

• Apply a clean Transducer Protector to the nozzle for the pressure measurement.

• Verify accurate function of the meter before taking measurements or whenever

inaccurate readings are suspected.

• Avoid a discharge of static electricity over the sockets. It could lead to the

destruction of your instrument. Before touching the sockets and lines that are connected with them, dissipate any static electric charge that may be present in your body.

• Only calibrate the HDM99 if you have understood the consequences to their full

extent. Use only the recommended standards later in this manual.

• Do not use abrasive cleaning agents and/or full strength bleach or acid to clean

HDM99 or the electrodes as this will cause damages.

• Voltages above 40 V can be dangerous. Take extreme care while working with

higher voltages.

• To avoid electrical shocks, and/or damage to your measuring system, do not apply

excess voltages above 40 V to the instrument.

• Do not open the device.

• To avoid current loops use the RS232-Interface only with notebooks which are not

connected with the battery charger.

• Federal law restricts the use of this device to sale by or on the order of a

physician.

1 Table of Content

Introduction.....................................................................................................................3

Applications for use........................................................................................................3

EC Declaration of Conformity.........................................................................................4

Delivery Content ............................................................................................................5

Warranty.........................................................................................................................7

Product Overview...........................................................................................................9

Measuring Channels ...................................................................................................9

Battery Charger.........................................................................................................10

Use of the Flow Through Adapter ............................................................................11

Switching on the unit.................................................................................................12

Main Menu.................................................................................................................12

Installation....................................................................................................................14

Language ..................................................................................................................14

Switch-off time...........................................................................................................14

Adjust-reset...............................................................................................................15

System Error Message.................................................................................................16

#1 MEM – Memory Error...........................................................................................16

#2 ADC - AD-Converter Error....................................................................................16

#3 ADJ – Cecksum Error...........................................................................................17

#4 SYS - Watchdog Error..........................................................................................17

MC, ECT – Additional Information.............................................................................17

Measurement ...............................................................................................................18

Temperature measurement.......................................................................................19

Conductivity measurement........................................................................................20

Temperature Coefficients..........................................................................................21

Pressure measurement.............................................................................................24

Further possible measurements................................................................................25

pH Measurement.......................................................................................................26

Flow measuring.........................................................................................................30

Frequency – Period time – Counter ..........................................................................32

Pool menu.................................................................................................................33

Voltage measurement - plotter..................................................................................34

Voltage measurement – oscilloscope........................................................................36

Battery voltage .............................................................................................................38

Table of content 2

Calibration and Verification ..........................................................................................39

Handling of Standard Solutions.................................................................................40

Calibration of the HDM99..........................................................................................40

Temperature Calibration............................................................................................42

Conductivity Calibration.............................................................................................43

Pressure Calibration..................................................................................................48

pH Calibration............................................................................................................50

Flow Calibration.........................................................................................................53

Voltage Calibration....................................................................................................55

Maintenance and Care.................................................................................................56

Specifications...............................................................................................................60

PC-Interface.................................................................................................................62

RS-232-Interface.......................................................................................................62

Interface from PC to HDM.........................................................................................62

Data transfer..............................................................................................................63

Format of Data ..........................................................................................................64

HDMView .....................................................................................................................65

Main Window.............................................................................................................66

Alarm Window...........................................................................................................68

Chart Window............................................................................................................69

Analysis Window.......................................................................................................72

3 Introduction

Introduction

The HDM99 is a self-contained hemodialysis test instrument designed for the measurement of

Conductivity Temperature

Pressure

Flow

Voltage

Frequency

Period time

Pulses..

This innovative device has been designed to be user-friendly, reliable, and rugged enough for the demanding needs of hemodialysis technicians. In addition, the HDM99 may also be used for environmental measurement and other non-medical applications.

The measured values are displayed numerically on the instrument’s large screen. The instrument also may be connected to a computer, and using the supplied software, displayed, stored and analyzed.

Please take a few moments upon initial receipt of your shipment to ensure that all the items listed below have been included. In the event of a discrepancy, contact your supplier immediately. Be sure to read this User Guide in its entirety before first using the product.

Applications for use

The HDM99 may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems. The HDM99 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications. The HDM99 may also be used to test the voltage and alternating signals in hemodialysis delivering systems.

Introduction 4

EC Declaration of Conformity

according to the Council Directive 93/42/EEC

concerning medical devices

IBP Instruments GmbH

Sutelstraße 7A

30659 Hannover

declare under our sole responsibility that the product:

HDM99, Art.-Nr.: 31.0006.

meet the provisions of the Council Directive 93/42/EEC concerning medical devices which apply to them.

CE – certified by : Medcert GmbH Hamburg, Germany Nr.: 0482

Date of issue: 09.08.02

Authorized person : Dipl. Ing. Werner Pfingstmann (Managing director)

5 Introduction

Delivery Content

Introduction 6

Pos. Standard Option

1 HDM99 x 2 Conductivity/Temperature Probe (CTP) x 3 Flow Through Adapter for CTP x 4 Battery Charger with country specific adapter x 5 Tube inc. Male Connector for Pressure Measurement x 6 13,63 or 14.00 mS/cm Conductivity Standard Solution x 7 User Manual x 8 Interface Lead Voltage x

9 Interface Lead Frequency/Period Time/Pulses x 10 Test prod x 11 Case x 12 Flow Probe x 13 pH Probe with Reference Solution x 14 HDMView Software and RS232 Interface Cable x

7 Introduction

Warranty

IBP Instruments GmbH warrants that it will repair or replace, at its option, any defective or malfunctioning part without charge for the terms listed below. Parts used for repair or replacement are warranted for the remaining warranty period only.

The user must deliver, at its own expense, the product to IBP Instruments Inc., USA, from any country in America or IBP Instruments GmbH, Germany from all other countries.

Parts Warranty Terms* Conditions

HDM99 60 months Annual calibration through IBP** Conductivity/Temperature Probe 24 months Annual calibration through IBP** HDM99 36 months No Conductivity/Temperature Probe 12 months No

* from date original purchase of original purchaser ** Calibration service must be performed by IBP Instruments every year (maximal plus 2 months of the first calibration) without interruption

The warranty does not cover:

• Disposable parts as battery or pH electrode

• Annually calibration

• Cell cleaning

• Defects caused by:

1. Modification, alteration, repair or service of the product by anyone other than IBP Instruments or an authorized service center

2. misuse due to negligence or accident

3. operation or maintenance of the product in a manner contrary to IBP instructions

Any express warranty not provided herein, and any remedy for breach of contract that but for this provision might arise by implication or operation of law, is hereby excluded and disclaimed. The implied warranties of merchantability and of fitness for any particular purpose are expressly limited to the terms mentioned above. Some states do not allow limitations on the duration of an implied warranty, so the above limitation may not apply to you.

Under no circumstances shall IBP Instruments GmbH be liable to the original purchaser or to any other person for any special or consequential damages, whether arising out of breach of warranty, breach of contract, or otherwise. Some states do not allow the exclusion or limitation of special or consequential damages, so the above exclusion or limitation may not apply to you.

Introduction 8

This warranty gives you specific legal rights, and you may also have other rights that vary from state to state.

For further warranty information, contact IBP Instruments GmbH.

9 Introduction

Product Overview

Voltage Connecto

Flow/Alternating Signal Connector

Conductivity/Temperature Connector

Measuring Channels

Pressure Inle

pH Connector

Only use accessories provided with the HDM99. Use of other devices may damage the instrument and will void the warranty.

Conductivity/Temperature Transducer

The Conductivity/Temperature probe is a quadropole design for greater accuracy and longevity than other designs. Take care to properly align the pins in the connector when attaching the transducer.

Pressure

To avoid damage or inaccurate measurement, ensure that no fluids enter the instrument. We recommend the use of a Transducer Protector for this purpose.

The input connector is designed exclusively for pH electrodes. Use of other devices may destroy the instrument.

Introduction 10

Flow

The connection is to be found at the right side of the device. (8 pol. connector)

Frequency, Periodicity and Events

The connection on the right side of the device is also used for the measuring of the flow. The incoming voltage range is +5...+24 V. The form of the signal should be of a rectangular form and has to be positive.

Voltage

The sockets are intended only for AC and DC voltages up to ± 40 V. They are protected up to ± 80 V.

Battery Charger

The HDM99 is equipped with an internal NiMH battery for extended run times when not connected to the external charger. The charger provides a 12V/500mA charge to the battery. A message appears on the display when the battery requires charging. For further details, consult the Maintenance section of this User Guide.

11 Introduction

Use of the Flow Through Adapter

The Conductivity/Temperature Transducer may be used in two ways. In the Flow-Through Mode (illustrated at left) the user may measure pressure, temperature and conductivity with the included Flow Through Adapter. The preferred position of the Hansen connector is vertical, the axial supply is show at the bottom of the illustration. In the Flow-Through Mode the axial supply is used as input and the radial supply as output. The pressure probe in the HDM99 is fastened to the radial connection above the input. Before any measurements you must shake the connector to assure that any air within the system escapes.

In the Dip Mode temperature and conductivity can be measured. For this mode open the screw cap at the upper end of the connector and extract the combined electrode. You must not remove the tube covering the probe carrier. Dip the electrode into the media up to a level above the holes in the covering tube. By moving the electrode you assure that the trapped air can escape and the temperature is well balanced.

NOTE: Do not touch the surface of the electrode with

your fingers.

Introduction 12

Switching on the unit

The unit is switched on and off with the keys marked I for on and O for off. The unit also switches itself off automatically when the switch-off time after the last key activation is over or the battery is fully discharged.

Main Menu

After switching on the device you receive an information menu for approx. two seconds. After that the system goes back to the last setting. In some cases you will receive the following main menu.

Activation of the function keys leads to

display of the info-menu

display of the measuring menu

display of the calibration menu

display of the installation menu

13 Introduction

Info

From the root menu via info you receive the following information: There are device specific data like product name, software version and version date as well as the serial number of your HDM99.

Introduction 14

Installation

Language

By pressing the function key beside the menu point language you will reach the language choice. With the keys beside the arrows you can select the desired language for your work with HDM99. The selection is shown inverted. With activation of ok you will return to the installation menu. After altering the language the entire menu leadership and display appears in the chosen language.

Switch-off time

The switch-off time is the time after the last key activation. At the end of this time the device switches off automatically. The activation of the function switch-off leads to a selection of times which can be selected with the arrow-keys. The chosen time is shown inverted and taken over with ok as new switch-off time in the installation menu. If >--< is chosen, the automatic power shutoff is cleared, the device remains active until it is switched off manually with the key >OFF<.

15 Introduction

Adjust-reset

With the adjust-reset the calibration values for all measuring channels can be set to basic values. These basic values are the calibration values of the company conducted calibration. Operate the function key beside this menu point. You will have to enter a code via the numeric keyboard. This code is 1704. When you confirm your input with >enter< you will receive the following images:

With the function keys beside the individual measuring channels you can decide on which calibration values this function should be applied. The calibration values will be reset to basic values.

If for individual parameters the function adjust reset was used, then a new verification is necessary for these parameter.

The reset of the flow measurement only resets the parameters of the flow sensors 1....7. The

possibly existing calibration values of own sensors remain unchanged.

Introduction 16

System Error Message

When the HDM99 is switched on, an internal check is initiated. If the check shows no errors the HDM99 is started using the menu which was last in use. If the check reveals an error, following error message (window) is displayed:

Example: AD-Converter Error

An" OK" error display shows that the internal test routine has been completed with no errors found. An "ERR" in the display shows that a problem has occurred during the check. When this error report is displayed, please contact IBP.

#1 MEM – Memory Error

This error is displayed when an internal memory check shows that a problem has occurred. The unit is need of repair.

#2 ADC - AD-Converter Error

This error display is shown when a defect is fount in the Analog/Digital-Converter. The unit is need of repair.

17 Introduction

#3 ADJ – Cecksum Error

The calibration values are saved to memory together with an internal check sum. This check sum is used each time the system is started to verify that all memory data remains unchanged. The aforementioned text is displayed when an error occurs during system start-up; the unit cannot function while the error is displayed and a renewed calibration is mandatory.

#4 SYS - Watchdog Error

This message is displayed when the unit is restarted after a system crash. To delete the message, switch the unit off and then on again. If this error occurs at regular intervals, please contact IBP for support.

MC, ECT – Additional Information

The entry on the display following the MC and ECT are IBP error messages facilitating problem analysis. When contacting IBP to report an error, please report the messages describing the system error.

Measurement 18

Measurement

From the main menu over measuring you will receive the following menu:

Examples for measurement displays

Activation of the function keys F5 leads to the menu for the

arameter setting

F6 leads back to the main menu

The handling of all menus corresponds to the already explained operating instructions. The individual menus and submenus are presented and explained below.

19 Measurement

Temperature measurement

Time range

By activation of the function key param. you will receive a menu which allows to change the time range, in which the course graphic will run through horizontally once. Long term

measurements up to twelve hours are possible. Since you do not have all possible times presented simultaneously, a black beam on the right side shows that above, or - like in the example - further options hide themselves below. The selected time range is shown inverted. To change the time range, operate the function keys beside the arrows upward or downward. When you have selected the suitable time range for your application, return to the temperature measurement with the activation of ok. The length of the horizontal axis of the graph now corresponds to the chosen time range.

Measurement 20

Conductivity measurement

After activation of the function key param. you will get to the menu which allows you to change the time range (horizontal axis of the graph) or the y-range (vertical axis) and also the temperature coefficient. By activation of the function key for the range to be changed you see the selection menus. At the time range long term measurements up to twelve hours are possible. Since you do not have all possible times presented simultaneously, a black beam on the right side shows that above, or - like in the example -, further options hide themselves below. The selected time range is shown inverted. To change the time range, operate the function keys beside the arrows upward or downward. When you have selected the suitable time range for your application, return to the temperature measurement with the activation of ok. The length of the horizontal axis of the graph now corresponds to the chosen time range. After the choice of the field y-range four fixed measuring ranges can be selected in the already explained way with the function keys beside the arrows. If you choose > auto <, the HDM99 automatically adjusts the measuring range so that an optimal graphic representation of the running measurement is assured.

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