Global Standards: FDA & CE Certified
🛡️ Uncompromising Safety & Compliance
In the rapidly evolving landscape of modern healthcare, reliability is not just an option—it is an absolute necessity. Our flagship Syringe Pump proudly bears both FDA (Food and Drug Administration) and CE (Conformité Européene) certifications. These prestigious marks are a testament to our relentless pursuit of medical excellence, rigorous clinical testing, and strict adherence to global safety protocols.
Achieving FDA and CE certifications means this medical device has undergone comprehensive evaluation for electrical safety, electromagnetic compatibility (EMC), software validation, and clinical efficacy. Whether deployed in a high-stakes ICU environment or a fast-paced emergency department, healthcare professionals can trust that our equipment meets the highest international regulatory standards, ensuring zero compromise on patient well-being.
Integrating AI-driven technological advancements, this open-system syringe pump represents the pinnacle of modern intravenous therapy, combining intelligent software compensation with robust hardware architecture.
Intelligent Syringe Pump Overview
💻 AI-Enhanced Classic Single Channel Design
The Syringe Pump is engineered with a classic single-channel design, optimized for intuitive operation and flawless performance. As a truly open system, it possesses the unique capability to accept and adapt to different syringe brands post-calibration. Utilizing advanced AI software compensation algorithms, the error margin is strictly controlled to be within ±2% after calibration, guaranteeing unprecedented accuracy in drug delivery.
- ✔️ Numeric Keypad: Designed for rapid, error-free data entry, mimicking a highly familiar ATM-like interface.
- ✔️ More Syringe Mode Optional: Unparalleled versatility for complex clinical requirements.
- ✔️ Accurate Injection: Micro-stepping motor technology ensures smooth and continuous infusion.
- ✔️ More User Friendly: Ergonomic design tailored for the demanding workflows of modern nurses and doctors.
Next-Generation Features & Capabilities
Equipped with dual-core processing and intelligent power management, this device redefines the standards of intravenous infusion. Explore the core technological features that make this FDA & CE approved pump a market leader.
Friendly UI Interface
Operating the pump is as simple as using a bank machine. The ATM-like interface displayed on a crisp 3.5' TFT color LCD allows healthcare providers to navigate complex settings with zero learning curve. Brightness is 10-level adjustable for optimal visibility in dark ICU rooms.
Strong Battery Backup
Never worry about power outages during critical patient transfers. The built-in high-capacity 3000mAh rechargeable lithium battery provides an astonishing operating time of ≥9 hours (at 5ml/h), ensuring uninterrupted life-saving therapy.
Advanced Injection Modes
Catering to diverse pharmacological needs, the system supports multiple modes including: Constant rate, Volume/Time mode, Drug weight mode, Micro-mode, Programmable mode, and an integrated Drug Library mode for maximum clinical flexibility.
Double CPU Architecture
Safety is hardwired into the system. The Double CPU design acts as a real-time fail-safe. One processor controls the motor while the other independently monitors parameters. If any discrepancy is detected, the system instantly triggers an alarm and halts infusion.
Adjustable Sensitivities
Highly customizable alert systems. Features include 8-level adjustable occlusion pressure (20Kpa-150Kpa) with dynamic pressure value display, adjustable alarm volume, and a pressure release function that automatically activates after an occlusion to prevent post-occlusion bolus.
Massive Event Log
Full traceability for medical audits and FDA/CE compliance. The internal memory securely stores over 10,000 event logs, recording every parameter change, alarm trigger, and operational history, which is crucial for incident analysis and quality assurance.
Technical Specifications & Parameters
Comprehensive data detailing the operational excellence of our Syringe Pump. *The specification is subject to change without prior notice, please refer to real products.
| System & Hardware Parameters | Specification Details |
|---|---|
| Syringe Management | Preset 20 syringe brands, can add or edit the brand, accept different brands after calibration. Auto-recognition of 5ml, 10ml, 20ml, 30ml, 50/60ml syringes. |
| Display & UI | 3.5’ TFT color LCD, 10 level brightness adjustable. Numeric keypad, 4 soft function keys, key lock function, sleeping function. |
| Power Supply & Battery | AC Power: 100V-240V, 50/60Hz, ≦45W. Rechargeable Lithium battery, DC11.1V, 3000mAh; operating time: ≥9h @5ml/h. |
| Classification & Dimension | Class II, Type CF; IPX4 rating. Size: 275mm × 145mm × 160mm | Weight: 2.1kg. Includes a 90º rotatable IV pole clamp. |
| Operation Environment | Temperature: +5℃ - +40℃ | Relative humidity: 20%-90% | Atmospheric pressure: 70 ‒ 106 Kpa. |
| Infusion & Clinical Parameters | Specification Details |
|---|---|
| Flow Rate Range |
5ml: 0.10 - 60.00 ml/h 10ml: 0.10 - 300.00 ml/h 20ml: 0.10 - 400.00 ml/h 30ml: 0.10 - 600.00 ml/h 50/60ml: 0.10 - 1200.00 ml/h Increment: 0.01ml/h |
| Accuracy & Volume | Accuracy: ≤±2% (±1% mechanical accuracy included). Preset Volume (VTBI): 0.10-9999.99ml & empty. Accumulated Volume: 0.00-9999.99ml. |
| Purge & Bolus Rate |
Purge: 5ml (30-60ml/h), 10ml (150-300ml/h), 20ml (200-400ml/h), 30ml (300-600ml/h), 50ml (600-1200ml/h). Bolus: Matches maximum flow rate per syringe size. |
| KVO & Occlusion | KVO (Keep Vein Open): 0.10 - 5.00ml/h adjustable. Occlusion Pressure: 8 level adjustable, 20Kpa-150Kpa, dynamically pressure value display with pressure release function. |
| Comprehensive Alarms | Finished, near finished, near empty, empty, occlusion, syringe disconnected, no operation, parameter error, syringe error, low battery, battery lost, battery ran out, AC power lost, abnormal injection, communication error, finished! KVO. Standard Medical Alarm Voice with Mute function, 8 levels adjustable. |
Wide Clinical Applications
Because of its strict adherence to FDA and CE guidelines, combined with micro-level precision, this syringe pump is widely trusted and heavily utilized across various demanding medical departments globally.
Beyond the critical care environments mentioned above, the pump's highly adaptable Intravenous injection capabilities make it an indispensable tool in pediatrics, internal medicine, obstetrics and gynecology, oncology, and outpatient infusion rooms. The ability to change parameters (like VTBI and flow rate) *during* injection without stopping the pump provides nurses with the dynamic control required in fast-paced clinical scenarios.
Design Details & Build Quality
Every curve, button, and screen has been meticulously designed to enhance the user experience and ensure patient safety. The build quality reflects the stringent requirements of CE and FDA manufacturing standards.
Sleek Profile
Robust Syringe Clamp
Friendly UI Interface
Like ATM interface. Intuitive, Fast, and Secure.
Frequently Asked Questions (FAQ)
Why are FDA and CE certifications important for a Syringe Pump?
FDA and CE certifications are globally recognized benchmarks for medical device safety and efficacy. They ensure that the syringe pump has passed rigorous testing for accurate fluid delivery, electrical safety, software reliability (like our Double CPU system), and biocompatibility. Using certified equipment drastically reduces clinical risks and ensures compliance with healthcare regulations.
How does the auto-recognition of syringe sizes work?
Our advanced sensor technology automatically detects the physical dimensions of the inserted syringe (5ml, 10ml, 20ml, 30ml, or 50/60ml). Once clamped, the system cross-references the size with the 20 pre-loaded syringe brands in its database, ensuring the injection volume and flow rate algorithms are perfectly calibrated to that specific syringe, achieving ≤±2% accuracy.
What happens during an occlusion (blockage)?
If the IV line gets blocked, the pump's dynamic pressure sensor detects the spike in pressure. Based on the 8-level adjustable occlusion setting (20Kpa-150Kpa), it will trigger an immediate visual and auditory alarm. Crucially, the Pressure Release Function automatically activates, withdrawing the plunger slightly to relieve pressure and prevent a dangerous bolus of medication from entering the patient once the blockage is cleared.
Can I change infusion parameters without stopping the pump?
Yes. Our system supports the dynamic changing of parameters such as VTBI (Volume To Be Infused) and flow rate directly during an active injection. This feature is particularly vital in ICU and OR environments where a patient's condition can change rapidly, requiring immediate titration of drugs like vasopressors or inotropes without interrupting the baseline infusion.