Partners in medicaldevice manufacturing

Tecnoideal’s P-TEST series is the new generation of electro-pneumatic testing equipment for leak testing of medical

devices such as blood lines, infusion and transfusion sets, bags, filters, oxygenators and many other disposable

products. The operational conditions can be programmed in a wide range of pressures and times. The P-TEST technical

features, along with the new operative interface, makes its use even simpler. Not only it can be used for validation and

qualification purposes on Q.A. and R&D Departments, but mainly in production lines for routine controls of finished

products.

P-TESTLeak Testers

TECHNICAL SPECIFICATIONS

P-TEST Plus 500 P-TEST Plus 15 P-TEST Plus 60

Range of test pressure

Type of tests

Power supply

Electrical protection

Maximum Pneumatic Supply

Pneumatic supply

Accuracy

Decay resolution

Pressure resolution

Pressurization time (T1p)

Stabilization time (T1s)

Test time (T2)

Discharge time (T3)

Serial Ports

PLC interface

Foot pedal connector

Display languages

Pressure units

Password

Memory

Test counter

Acoustic signal

Clock / Calendar

Display

Keyboard

Construction material

Protection

Operating conditions

Dimensions

Weight

Product codes

International Standards

10.0-500.0 hPa(1.00-50.00kPa/7.5-375.0

mmHg/102-5098

mmH2O/0.146-7.252PSI)

30-1500 hPa(3.00-150.00 kPa/23-1125.0

mmHg/310-15300

mmH2O/0.44-21.76 PSI)

120-6000 hPa(12.00-600.00kPa/90-4500

mmHg/1220-61180

mmH2O/1.74-87.05 PSI)

115-230V, 50-60 Hz, 40 VA

Electromagnetic interference filter and 2 1AT fuses

Leak test Leak test Leak test

5 bar 8 bar 10 bar

Dry and filtered air, max. 5µm

0.25%of the full scale

0.01 hPa 0.05 hPa 0.1 hPa

1 hPa0.2 hPa0.1 hPa

1.0 - 999 seconds

1.0 - 999 seconds

1.0 - 999 seconds

1.0 - 999 seconds

No. 1 RS232 + No. 1 RS232/485 optoisolated

PNP, isolated, 10-30 Vdc; 8-pin connector (start/stop/passed/failed)

Different tones and programmable duration, for positive and negative results

3-pin connector

English, Italian, German, French

HPa(=mBar), kPa, mmHg, mmH2O, PSI

8-digit, alfanumeric, programmable on 4 protection levels

Up to 100 test programs, with date/time and alfanumeric 16-digit code

Up to 99,999 )(for goods, rejects for leak, reject for pressure drop, total tests

To set time, date and calibration date

20 numeric (including 4 functions) keys, touch-sensitive

Graphic 128x64 pixels, blue and white, with display of 5 different fonts

Plastic and aluminium external body

Ip40

Temperature from 10 to 40° , relative room humidity max. 80%

16x20x13 cm

2.7 Kg

2006/42/CE, 2004/108/CE, 2006/95/CE

4-digit, alfanumeric, programmable on 4 protection levels

98167 98168 98169

LEAK TEST

SINGLE OBSTRUCTION TEST

MULTIPLE OBSTRUCTION TEST

(ALL MODELS)

(P-TEST ONE and NINE)

(P-TEST ONE and NINE)

P-TEST series are testing equipment for leak testing of

medical devices such as blood lines, infusion and

transfusion sets, bags, filters, oxygenators and many

other disposable products.

The device to be tested is connected to the test port of

the equipment and is pressurized at the preset value.

P-TEST checks the leak by measuring the pressure decay

in the test time.

The equipment can detect obstructions in medical

devices by blowing air through the part to test and

measuring if the pressure given by the flow resistance is

below a preset value.

In devices where many different pathways have to be

detected for the obstruction.

P-Test ONE and NINE can perform multiple obstruction

tests in sequence.

At the end of the multiple obstruction test the

equipment performs a leak test with the preset

conditions.

115-230V, 50-60 Hz, 40 VA

Electromagnetic interference filter and 2 1AT fuses

Leak test, multiple and single obstruction tests

Dry and filtered air, max. 5µm

1.0 - 999 seconds

1.0 - 999 seconds

1.0 - 999 seconds

1.0 - 999 seconds N.A. N.A.

PNP, isolated, 10-30 Vdc; 8-pin connector (start/stop/passed/failed)

Different tones and programmable duration, for positive and negative results

3-pin connector

Plastic and aluminium external body

Ip40

Temperature from 10 to 40° , relative room humidity max. 80%

16x20x13 cm

2006/42/CE, 2004/108/CE, 2006/95/CE

P-TEST ONE P-TEST NINE

50-1013 hPa(38-760 mmHg/0.72-14.70 PSI)

250-9000 hPa(190-6750 mmHg/3.7-130.5

PSI)

8 bar 13 bar

0.5% of the full scale 2.5% of the full scale

0.2 hPa 0.2 hPa

1 hPa1 hPa

No. 1 RS232/485 optoisolated

English

HPa(=mBar), mmHg, PSI

4-digit, alfanumeric, programmable on 4 protection levels

Up to 50,000 )(for goods, rejects, total tests

Up to 10 test programs

Alfanumeric 16 characters, LED backlight

To set calibration date

7 keys, touch-sensitive

2.0 Kg

98155 98175

Manufactured by:

Via Lea Cazzuoli, 43 - I-41037 Mirandola (MO) Italy -Tel.: 0039 0535 23653 - Fax: 0039 0535 27443

Home page: www.tecnoidealsrl.com - e-mail: sales@tecnoidealsrl.com

Marketed in USA, CANADA, MEXICO

Marketed in SOUTH AMERICA by:

Begonienstraße 1 D-90542 Eckental - Brand

Tel. 0049 09126 2948 0 Fax. 0049 09126 294828

home page: www.modenplast.de - E-mail: international@modenplast.de

São Paulo - SP - Brasil

Tel. 0055 011 37172006

home page: www.alvimed.com.br - E-mail: info@alvimed.com.br

Unit C, Bulding 3, 112 Medical Village Drive, Wallace,NC 28466 - USA

Tel. 001 910 285 5003 - Fax 001 910 285 5021

Home page: www.technomedinc.com - E-mail: technomed@ix.netcom.com

Marketed in GERMANY, POLAND, SERBIA, AUSTRIA, CZECH REPUBLIC, HUNGARY and SLOVAKIA by:

Testing of medical plastic bags requires the use of dedicated

holders to contain the plastic deformation due to the test

pressure.

The use of holders is also recommended :

to reduce the test volume;

to increase the test pressure for easier identification of the

leak.

Holders are available in two surface versions:

Flat testing surface: for testing simple bags. Surfase contact is

100% : this is indicated to test the welding perimeter.

Knurled testing surface: designed to test bags in which a leak

on the film can be easily detected because the air escape is not

blocked. Surface contact is 25%.

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HOLDERS FOR BAG TEST

OPTIONALS - HOW TO ORDER

Holder 300x400 mm, flat test surface 98085

Holder 400x500 mm, flat test surface 98086

Holder 300x400 mm, knurled test surface 98172

Holder 400x500 mm, knurled test surface 98087

Foot switch for P-TEST T70239

USB-RS232 serial adapter for P-TEST ONE/Plus T89106

PTestOneSys (data extraction software) T78076

PtestPlusSys (data extraction software) T78077

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