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D550-Electronic Differential Leak Tester Medical Device Manufacturing

For medical device manufacturers requiring auditable seal integrity, Yuanzhi supplies the D550 electronic differential leak tester with 0.1Pa/s differential resolution and 0.15%F.S measurement accuracy. Its 4MPa-rated differential sensor handles both positive and negative pressure cycles, while 64 stored profiles support multi-product cleanroom lines. Every unit exports date-stamped records in Excel format for regulatory traceability. ISO9001-certified production backed by 10,000+ active installations.
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Overview of the D550 Electronic Leak Tester

The D550 Electronic Differential Leak Tester is a bench-top air leak detection instrument built for production-line quality control in medical device manufacturing. It operates on the differential pressure method: the instrument charges both a test part and a sealed reference volume to the same pressure, then measures the pressure difference that develops as air escapes from a leaking part. This method delivers a pressure-decay resolution of 0.1 Pa/s, allowing detection of small leaks in catheter hubs, syringe barrels, implant housings, and sterile packaging.

Pressure on the electronic model is regulated through internal digital proportional valves controlled via the touchscreen. The front panel contains no manual adjustment knobs; operators enter target pressure values numerically and save them to parameter recipes. The instrument supports both positive-pressure and vacuum test cycles across six selectable ranges, from -88 to +50 kPa up to -88 to +1000 kPa. Four differential measurement ranges are available: ±500 Pa, ±1000 Pa, ±2000 Pa, and ±5000 Pa.

D650 Mechanical Leak Tester

Key Features of the D550 Electronic Differential Leak Tester

The unit features a 5.6-inch color LCD industrial resistive touchscreen with 640×480 resolution, supporting Chinese and English operator interfaces. Up to 64 parameter channels can be stored, each holding an independent test recipe including fill time, stabilization time, test time, pressure limits, and leak-rate thresholds. This allows rapid changeover between product families on mixed production lines.

The instrument provides 16 opto-isolated input channels and 16 relay output channels for integration with PLC systems, fixture cylinders, and conveyor controls. Test initiation is available through three methods: on-screen touch, wired external signal input, or barcode scanner trigger. The D550 does not include wireless remote control; all external triggering is handled through the wired I/O interface.

Data management includes internal storage for the latest 50,000 test records, queryable by date or channel name. Records can be exported via USB, Ethernet, or RS485 in Excel-compatible format for batch traceability and quality audits. The unit also supports direct connection to label printers and specific barcode scanner models for QR code and linear barcode reading. A pressure-hold (bubble test) mode maintains output pressure while an operator applies soap solution for visual leak location, and a built-in product counter tracks production throughput. The system operates on DC 24 V at 1.5 A through an included 220 V-to-24 V adapter, with audible buzzer and on-screen visual alarms for pass and fail results.

Pressure Regulation of the D550 Electronic Leak Tester

The electronic model adjusts test pressure through internal digital valves commanded from the touchscreen interface. No rotary knobs are present on the front panel. Operators select a target pressure in 0.001 kPa increments, and the valve assembly holds the set point for the duration of the test cycle. Both positive-pressure and vacuum (negative-pressure) profiles are configurable within the selected pressure range. The differential pressure sensor carries a 4 MPa overpressure rating. Pressure repeatability is specified at ±0.5% F.S., and comprehensive pressure sensitivity is ±0.25% F.S. Pressure is displayed to three decimal places, with selectable units including kPa, bar, Pa, PSI, mmHg, mmH₂O, MPa, mbar, kgf/cm², and atm.

Applications of the D550 Leak Tester in Medical Device Manufacturing

In medical device production, verified seal integrity is directly tied to patient safety and regulatory compliance. The D550 electronic leak tester is deployed on assembly lines for intravenous catheters, pre-filled syringes, insulin pen components, surgical instrument housings, respiratory masks, and sterile barrier packaging. Electronic pressure regulation delivers consistent set-point repeatability across multi-shift operation, reducing operator-dependent variation that can affect pass/fail consistency. The 64-channel memory allows line technicians to switch between product families in seconds, while Excel-format data export supports batch traceability records required by quality management systems. The instrument uses clean compressed air or nitrogen meeting ISO 8573-1 or JIS B8392-1 grade as the test medium, avoiding contamination of medical-grade components during testing.

FAQ About the D550 Electronic Differential Leak Tester

What is the difference between electronic and mechanical pressure regulation on the D550?

The electronic model adjusts test pressure through internal digital valves controlled from the touchscreen, with no manual knobs on the front panel. The mechanical model uses two rotary knobs for vacuum and pressure adjustment. Electronic regulation provides higher set-point repeatability and supports digital recipe recall across 64 parameter channels.

Does the D550 electronic model include wireless remote control?

No. The D550 does not offer wireless remote control. Test start and channel switching can be triggered through wired external I/O signals, PLC connection, or barcode scanner input.

What leak rate can the D550 detect?

At a 1000 Pa test range, measurement accuracy is 0.15% F.S ±1 Pa; at 5000 Pa, it is 0.15% F.S ±10 Pa. The actual detectable leak rate depends on test pressure, part internal volume, and test cycle time.

How is test data stored and exported?

The instrument stores up to 50,000 test records internally, queryable by date or channel. Data can be exported through USB, Ethernet, or RS485 in Excel-compatible format for quality documentation and batch traceability.

Maximum working pressure(kPa)

-50/-98/20/50/100/200/500/700/1000/1600

voltage regulating mode

Mechanical/Electronic

Minimum operating pressure

Maximum pressure*5%

Ensure resistance to pressure

Maximum operating pressure*20%

Pressure repeatability accuracy

±0.5%F.S

Comprehensive sensitivity to pressure

±0.25%F.S

Pressure resolution

0.001kPa

Pressure indication

Three decimal places

Pressure unit

kpa,bar,Pa,PSI,mmHg,mmH2O,MPa,mbar,kgf/cm²,
atm,in3/d

DPsensor with high pressure resistance

4MPa

Test range:Pa

±5000,±2000,±1000 ±500

Measurement accuracy(standard
conditions)

0.15%F.S±1Pa(1000 Pa);0.15%F.S±3 Pa(2000 Pa);
0.15F.S±10 Pa(5000 Pa)

Test tolerancestandard conditions)

1%F.S±1Pa/s(1bar);1.5%F.S±2Pa/s(5bar);2%F.S±5Pa/s(10bar)

Pressure drop unit

Pa,Pa/s,Pa/min,KPa,KPa/s,mmHg,mmH2O,mbar,psi

Leakage value unit

ml/min,ml/s,ml/h,cc/min,cm3/min,sccm,SLM,L/S,L/min,
L/h,Pa.m3/s(1.69E-3)

The test results show

0.001Pa/0.001ml/min

CPU

Cortex M432位

RAM

64MB

Display mode

Color LCD Industrial Resistive Screen

Display

5.6inch

Screen display resolutio

640*480

Time Settings

0.1-9999.9s

Power supply voltage

DC24V 1.5A

Use gas

Clean compressed air/nitrogen/ISO8573-1 grade or JIS B8392-1 grade

Operating Mode

Local and Remote

Startup Method

Touch/Scan/Remote

Channel switching method

Manual/Relay/Network/485

Operating temperature

0-40℃

Use fluid temperature

0-50℃

Pipe connection diameter

Air inlet:8mm outer diameter,air outlet:8mm or 6mm

Protection circuit

Switch output reverse connection protection,switch output load short-
circuit protection

Humidity

80%RH,No condensation

Parameter Channel

64

Alarm method

Buzzer and touchscreen indicator light

Power Configuration

220V to 24V power supply adapter

Quality(Ontology)

5kg

Size

250*279*143mm(Excluding the height of the pressure relief valve knob)

Drive air source

0.3-0.7MPa

Test air source

Above the test pressure by 0.05 MPa,

Default operation mode

Touch

Language

Chinese/English (optional,Choose any one)

Data Output

USB/Ethernet/485

Communication method

Network,RS485

Auxiliary pneumatic interface

Optional

Scanner

Supports specific models of QR code and barcode scanning

LAN Port

Support

RS232

Support

USB port

1个

I/O Control Interface

16 inputs,16 outputs

485

Support

Save data

50,000 items

Channel Name Naming

Supports Chinese and English

The airtightness leak detector is mainly used to test the sealing performance of products or systems during the production process. It is widely applied in industries such as automobiles, electronics, healthcare, aerospace, etc.

1. The instrument will alarm when it enters into inflation or stabilizes.

answer:

  • Check whether the upper and lower pressure settings are set incorrectly. ,

  • Check whether there is leakage in the pipeline connection position or the connection workpiece position

  • Check if the product is substandard

  • Check whether the inflation parameters are unreasonable, because the inflation time is short, and the pressure cannot reach the lower limit of the standard pressure.

Exclude the above situation and cannot help you, please contact the sales staff of Yuanzhi Company, or send the instrument to Yuanzhi Company for overhaul.

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