HandyStep® electronic Electronic Continuous Dispenser

Overview

The HandyStep® electronic is a precision-engineered continuous electronic dispenser designed for high-accuracy, repeatable liquid handling across research, clinical diagnostics, and quality control laboratories. Based on positive displacement piston-driven actuation, it delivers consistent volumetric delivery without reliance on air displacement—minimizing variability caused by temperature, humidity, or liquid viscosity. Its modular architecture integrates seamlessly into workflows requiring serial dispensing, reagent dilution, plate filling, or multi-step assay preparation. Engineered for ISO 13485-aligned environments and compliant with CE-IVD regulatory requirements, the device supports traceable, auditable operations in IVD manufacturing and clinical testing labs operating under EU In Vitro Diagnostic Regulation (IVDR) frameworks.

Key Features

• Continuous dispensing capability: Single aspiration followed by sequential, programmable dispensing of any volume between 1.0 µL and 50 mL—enabling precise, stepless volume distribution without repeated pipetting cycles.
• Auto-tip recognition technology: Proprietary optical scanning identifies BRAND PD-coded tips upon insertion, automatically configuring optimal pressure, speed, and back-pressure compensation parameters for each tip geometry and nominal volume class.
• Open-system compatibility: Supports third-party continuous dispenser tips meeting ISO 8655-8 mechanical interface standards—including conical, luer-lock, and universal-fit designs—ensuring flexibility without vendor lock-in.
• Three operational modes: Standard Dispensing (user-triggered single dispense), Automatic Dispensing (timed or count-based sequential output), and Pipetting Mode (aspirate-and-dispense with customizable dwell time and blow-out volume).
• Adaptive learning algorithm: During automatic dispensing, the system records inter-dispense timing intervals and adjusts motor acceleration/deceleration profiles in real time to maintain coefficient of variation (CV) < 2.5% at volumes ≥10 µL (per ISO 8655-6 validation protocols).
• Independent speed control: Aspiration and dispensing speeds are adjustable separately (0.1–10 mL/s range), allowing fine-tuned optimization for volatile solvents, viscous glycerol solutions, or protein-containing buffers.
• Rechargeable NiMH battery system: Field-replaceable 3.7 V / 2200 mAh battery charges fully in ≤2.5 hours—either docked in the base station or via USB-C port while mounted in the instrument. Battery status and estimated runtime are displayed on the OLED interface.

Sample Compatibility & Compliance

The HandyStep® electronic handles aqueous solutions, organic solvents (e.g., ethanol, DMSO), diluted acids/bases (pH 2–12), and low-viscosity biological samples (serum, cell lysates, PCR master mixes). It is not recommended for highly corrosive halogenated solvents or suspensions containing particles >5 µm. All wetted components comply with USP Class VI biocompatibility standards. Device certification includes CE marking under Directive 2017/746/EU (IVDR), conformity with RoHS 2011/65/EU, and electromagnetic compatibility per EN 61326-1:2013. Documentation package includes Declaration of Conformity, Risk Management File (ISO 14971), and Technical File Summary for audit readiness.

Software & Data Management

While standalone operation requires no software, optional PC connectivity via USB enables firmware updates and configuration backup using the HANDYControl™ desktop utility (Windows 10/11, 64-bit). The utility supports user-defined method templates, audit trail export (CSV), and timestamped log generation—including operator ID, tip type, volume setpoint, and cycle count. All data logs adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and support GLP/GMP environments requiring 21 CFR Part 11-compliant electronic records when deployed with validated IT infrastructure.

Applications

• Serial dilution series for ELISA, qPCR standard curves, and calibration standards
• High-throughput microplate filling (96-/384-well) with uniform well-to-well volume consistency
• Reagent dispensing in automated IVD assay kits and lateral flow test strip manufacturing
• Cell culture media preparation with minimized shear stress during serum addition
• QC sampling in pharmaceutical water systems (PW, WFI) where low-volume accuracy is critical
• Preparation of reference materials in metrology labs accredited to ISO/IEC 17025

FAQ

Is the HandyStep® electronic compatible with non-BRAND tips?
Yes—it accepts third-party continuous dispenser tips that conform to ISO 8655-8 mechanical specifications and feature standardized conical or luer-lock interfaces.
What is the typical CV performance across the volume range?
At 10–50 µL, CV is ≤2.5%; at 100 µL–10 mL, CV is ≤1.0%; above 10 mL, CV remains ≤0.5%, verified per ISO 8655-6 gravimetric testing protocols.
Does it support 21 CFR Part 11 compliance?
The device itself does not enforce electronic signatures or audit trails natively; however, when integrated with validated LIMS or ELN systems using HANDYControl™ logs, full Part 11 compliance can be achieved through procedural controls and system validation.
How often does the battery require replacement?
Rated for ≥500 charge cycles; typical service life exceeds 2 years under daily laboratory use (8 hrs/day, 5 days/week).
Can it be used in cleanroom environments?
Yes—the housing meets ISO Class 5 (Class 100) particulate emission limits when operated with certified low-particulate tips; optional stainless-steel tip adapter available for ISO Class 4 applications.