product overview hda10 - ibp medical home overview key features ... ability to test integrity of...

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Product Overview Key Features ................................................. Operation in accordance with DIN EN 1283 standard for Hemodialysers Easily adaptable to user requirements Protocol print facility CE certified Ability to test integrity of filter housing and membrane UFR measurement may be conducted using defined TMP or defined filtration Automatic sample preparation for clearance and sieving coefficient measurement Over pressure test function Cleaning and disinfection cycle function Service and maintenance , , , , , , , , , , Standard Routines HDA10 The production of dialyser filters require the utmost reliability Advanced Software Quality The HDA10 Dialyser Filter Analyser provides the user with the best system to test hemodialysis filters in accordance with DIN-EN1283 standard. The device was developed in cooperation with a leading hemodialyser fiber manufacturer in order to control the fiber and dialyser production on a daily basis. The device was designed with the busy laboratory in mind, therefore after entering test parameters the machine will run standard routines automatically. Procedure status is clearly indicated on the screen allowing the user to both monitor and control the whole test. Upon test completion all results and commentaries may be printed. The device’s Advanced Software Technology provides the user with the ability to easily adapt procedures to user needs. The user interface is programmed with Labview, a graphical software development environment. Test sequence parameters are stored in an Excel-Table, which allows for easy accessibility and modification. The HDA10 has been developed to and is produced under certified medical device quality management system ISO 13485. I B P nnovation rings erformance www.ibpmedical.com For complete details on IBP products visit: IBP Medical GmbH Ikarusalle 15 30179 Hannover Germany Phone: +49 511 651647 Fax: +49 511 652284 eMail: [email protected] IBP Medical, Inc. 4113 W. St. Charles Ave. Phoenix, AZ 85041 U.S.A. Phone: Fax: 1-866-243-0187 eMail: [email protected] 1-865-686-8650 IBP Medical GmbH reserves the right to make changes in the specifications of their products without prior notice. © Copyright 2012 IBP Medical GmbH PHDA120101 Reference Meter for Hemodialysis Machines HDV-Sensors EXCO-Modules Customer specific product development IBP is the industry-leading manufacturer of high quality reference meters used in the calibration of hemodialysis machines worldwide. Intelligent Sensor family utilizing the RS485-Bus. The product family was designed with biomedical devices and laboratory applications in mind. LABView-Driver allows for rapid application development. A range of OEM-Modules are also available for extracorporal blood circuits including: blood pump, infusion pump, syringe pump, blood- leakdetector, air-detector, pressure sensors and blood line clamp The IBP team has 30 years of extensive experience in designing biomedical and medical devices ................................................... ................................................. ................................................... ................................................. ................................................... ................................................. Temperature Conductivity pH Pressure Flow , , , , , , Our expertise includes Mechanical and electronic hardware Fluid handling Software development Human Machine Interface Design Regulatory affairs for medical devices , , , , , Hemodialyser Analyser

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Product Overview

Key Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operation in accordance with DIN EN1283 standard for Hemodialysers

Easily adaptable to user requirements

Protocol print facility

CE certified

Ability to test integrity of filterhousing and membrane

UFR measurement may be conductedusing defined TMP or defined filtration

Automatic sample preparation forclearance and sieving coefficientmeasurement

Over pressure test function

Cleaning and disinfection cyclefunction

Service and maintenance

,

,

,

,

,

,

,

,

,

,

Standard Routines

HDA10

The production of dialyser filters require the utmost reliability

Advanced Software

Quality

The HDA10 Dialyser Filter Analyser provides the user with the best system to

test hemodialysis filters in accordance with DIN-EN1283 standard. The

device was developed in cooperation with a leading hemodialyser fiber

manufacturer in order to control the fiber and dialyser production on a

daily basis.

The device was designed with the busy laboratory in mind, therefore after

entering test parameters the machine will run standard routines

automatically. Procedure status is clearly indicated on the screen

allowing the user to both monitor and control the whole test. Upon test

completion all results and commentaries may be printed.

The device’s Advanced Software Technology provides the user with the

ability to easily adapt procedures to user needs. The user interface is

programmed with Labview, a graphical software development

environment. Test sequence parameters are stored in an Excel-Table,

which allows for easy accessibility and modification.

The HDA10 has been developed to and is produced under certified

medical device quality management system ISO 13485.

I B Pnnovation rings erformance

www.ibpmedical.com

For complete details on IBP products visit:

IBP Medical GmbH

Ikarusalle 15

30179 Hannover

Germany

Phone: +49 511 651647

Fax: +49 511 652284

eMail: [email protected]

IBP Medical, Inc.

4113 W. St. Charles Ave.

Phoenix, AZ 85041

U.S.A.

Phone:

Fax: 1-866-243-0187

eMail: [email protected]

1-865-686-8650IBP Medical GmbH reserves the right to make changes in thespecifications of their products without prior notice.

© Copyright 2012 IBP Medical GmbH PHDA120101

Reference Meter for Hemodialysis Machines

HDV-Sensors

EXCO-Modules

Customer specific product development

IBP is the industry-leading manufacturer of high quality referencemeters used in the calibration of hemodialysis machines worldwide.

Intelligent Sensor family utilizing the RS485-Bus. The product familywas designed with biomedical devices and laboratory applicationsin mind.

LABView-Driver allows for

rapid application development.

A range of OEM-Modules are also available for extracorporal blood

circuits including: blood pump, infusion pump, syringe pump, blood-

leak detector, air-detector, pressure sensors and blood line clamp

The IBP team has 30 years of extensive experience in designing

biomedical and medical devices

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Temperature

Conductivity

pH

Pressure

Flow

,

,

,

,

,

,

Our expertise includes

Mechanical and electronic hardware

Fluid handling

Software development

Human Machine Interface Design

Regulatory affairs for medical devices

,

,

,

,

,

Hemodialyser Analyser

Easy operationThe operation of the machine was designed with the

busy laboratory in mind. The application windows are

clear and easily understandable.

All entries are checked for plausibility. After entering the

test parameters the machine runs the standard routines

automatically. At every step, the status of any current

procedure is clearly indicated on the screen, allowing

the user to monitor at any time.

Upon test completion, the protocol can be printed

(including all results and commentaries). All data is

stored in a database for later analysis or reprint.

Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

H a r dwa r e

Standard Routines

Software

Advanced Technology

,

,

,

,

,

,

,

,

,

,

,

,

,

,

,

,

Robust design assuring years of reliable use

Highly effective degassing of measuring solution

Highly accurate measuring of pressure and flow

Easily accessible electronics and hydraulics allowing straight

forward maintenance

Filter housing and membrane integrity tests

Conducts UFR measurement with defined transmembrane

pressure or defined filtration

Automatic sample preparation for clearance and sieving

coefficient measurement

Over pressure test function

Cleaning and disinfection cycle function

The Human Machine Interface was designed every step of the

way with ease of use for laboratory professionals in mind

All operating modes will display at any time details such as

‘remaining time’

User hints and errors messages give the user additional helpful

information

Operating procedures are easily adaptable to user

requirements

Test parameters may be easily adapted to user measuring

requirements

All measuring data is stored in a database allowing structured

and easy access

Measuring data can be printed using templates

Advanced electronic and hydraulic technology,

combined with highly developed well thought out

software, results in a completely new type of measuring

instrument that keeps user convenience in mind. This

coupled with special features and an accuracy level not

achievable with other units assures that you are using the

most advanced reliable technology.

Specifications

Water preparation

Blood and dialysate side

Temperature

Pressure

Flow

Interface

Power supply

Dimensions

Weight

Delivery 600 ml/min

Degassing Combination of heat

and negative pressure

Air content less than 9.8 % O2

Range 30 … 40°C

Accuracy +/- 0.1°C

Range -700 …3420 mmHg (4.5 Bar)

Accuracy 0 … 600 mmHg +/- 1 mmHg

Otherwise +/- 2 mmHg

Range 10 … 600 ml/min

Resolution 1 ml/min

Accuracy +/- 2 % of MBE

Range 5 … 500 ml/min

Resolution 0,5 ml/min

Accuracy +/- 1,0 % of measured value

USB 2.0 for Printer

LAN

230 V 50/60 Hz, other upon request

3500 Watt

DialyserMeasuring fluid

Dialyser In/Out - Blood/Dialysate

Blood/Dialysate Flow

UFR-Measurement

145 x 80 x 66 cm

92 Kg

HDA10Hemodialyser Analyser Always clearly informed

The current operating mode along with all status

information is displayed in the top left window.

System error messages and user information are

displayed on the right.

Connection of the measuring solution

bottle to the machine has been kept

simple, thus allowing quick and easy

measuring of clearance and sieving

coefficients.

For the photometric determination of

clearance and sieving coefficients,

the device allows automatic sample

collection on the blood and dialysate

side, each at the inlet and outlet.

Service friendlyMaintenance and Service can be expensive in the

lifecycle of machines. Therefore, we have designed the

hydraulic and electronic compartments to be separate,

allowing easier access to all parts. Calibration

procedures are guided by detailed onscreen handling

instructions.

I B Pnnovation rings erformance

Hydraulic Electronic compartmentcompartment