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Description

The QRS Universal SmartECG and Spiro Package (#790009-00) includes the Universal SmartECG (#Z-7000-0500), Orbit Portable Spirometer (#Z-7000-0101), a box of 100 mouthpieces, and the Office Medic Software.

Warranty: 3 Years - Free from Defects in Material and Workmanship.

When it comes with diagnosing heart disease, it's vital that caregivers have access to accurate ECG testing. The Universal ECG can help diagnose and monitor patients with cardiovascular issues so caregivers can better treat them. The device maintains accuracy by using the Louvaine algorithm, which had the most accuracy when compared to nine other algorithms by cardiologists.

This ECG device is also battery-free, as it draws power from the attached PC via USB port. The Office Medic Software is easy to use and intuitive. It allows caregivers to store diagnostic data for review, and create printouts in PDF, JPEG, and TIFF formats compatible with EMR.

Specifications

QRS Universal SmartECG and Spiro Package Specifications

Universal SmartECG Specifications

  • Hub Weight: 250 - 335 grams.
  • Hub Dimensions: 85 mm x 91 mm x 20 mm.
  • Patient Leads Length:
    • Limb: 1 meter.
    • Chest: 0.6 meter.
  • PC Connection Length: 1.8 meters (USB Type A connector).
  • Case Material: ABS Plastic.
  • Electrode Connection: 4 mm Banana plug with "snap" or "tab" connectors.
  • Gain Sensitivity: 5, 10, 20 mm/mV.
  • Speed: 12.5, 25, and 50 mm/s.
  • Input Range: ± 6 mV.
  • Acquisition Sample Rate: 1000 samples/sec.
  • Heart Rate Range: 20 - 170 bpm.
  • Frequency Response: 0.05 - 175 Hz ± 3dB.
  • Defibrillation Protection: Patient leads are isolated from system and operator, with 4kV protection.
  • Common Mode Rejection: - 60 dB (minimum).
  • Safety Standards: Complies with AAMI EC11, EN60601-1, EN60601-2, EN60601-2-25.
  • Leads Off Indicators: Connection status for each lead is shown on Acquisition screen.
  • Power Source: PC, powered from USB interface.
  • Supply Voltage: 4 - 16 V DC.
  • Supply Current: Less than 17 mA DC.
  • Permanent Filters:
    • High Pass: 0.05 Hz 1st order; Low Pass: 170 Hz 1st order.
    • Baseline Wander: Baseline reset by adaptive zeroing algorithm.
  • Notch Filter (Mains Noise Rejection):
    • 50 Hz 4th order Butterworth, 49.1 Hz - 50.9 Hz.
    • 60 Hz 4th order Butterworth, 59.1 Hz - 60.9 Hz
  • Low Pass (Muscle Artifact Filter): 35 Hz 4th Order.
  • Report Capabilities: User Selectable Report Formats - (1) 3 x 4 Simultaneous; (2) 3 x 4 Sequential; (3) 6 x 2 ECG; (4) 6 x 1 ECG; (5) Averaged Complexes ECG; (6) ECG Measurements Report; (7) Avg. Zoom Report; (8) Zoom Report.
  • Interpretation: Rhythm, Morphology.
  • Environmental Conditions:
    • Operating Temperature: 0 to 40 °C.
    • Storage Conditions: -20 to 70 °C.
    • Humidity: 85% Max. (non-condensing).

Orbit Spirometer Specifications

  • Weight: 0.5 lb (226.8 grams).
  • Dimensions: 4.3" x 3.7" x 1.7" (109.2 mm x 94 mm x 43.2 mm).
  • Communication Port: USB (2.0 or higher).
  • Software Compatibility: Office Medic Version 5.5 (or later).
  • Environmental Conditions:
    • Ambient Temperature: -15 to 50 °C.
    • Relative Humidity: 90% Maximum (non-condensing).
    • Atmospheric Pressure: 700 to 1060 hPa.
  • Power Supply: Internal: 5 Vdc, ± 5% 100 mA or less from the host PC USB Port.
  • Measurement Method: FLOW: Mouthpiece (US Patent #4,905,709).
  • Range (BTPS):
    • FLOW: ± 14 liters/second.
    • VOLUME: 0.5 - 8 liters.
  • Accuracy (BTPS):
    • FLOW: FEF25-75: ± 5% of indication or ± 200 ml/sec, whichever is greater; PEF: ± 10% of indication or ± 300 ml/sec, whichever is greater.
    • VOLUME: FVC and FEV1: ± 3% of indication or ± 50 ml, whichever is greater; MVV: ± 10% of indication or ± 15 L/min, whichever is greater.
  • Precision (BTPS):
    • FLOW: PEF: ± 5% of indication or 150 ml/sec, whichever is greater.
    • VOLUME: FVC and FEV1: ± 3% of indication or 50 ml, whichever is greater.
  • Calibration: ATS 3-speed or standard calibration check.
  • Measuring Time:
    • FVC: 60 seconds.
    • SVC: 60 seconds.
    • MVV: 15 seconds.
  • Sampling Rate: 125 Hz.
  • Safety:
    • IEC/EN 60601-1.
    • IEC/EN 60601-1-2.
  • Printed Scale:
    • Flow Volume: (vertical) 5 mm/L/S, (horizontal) 10 mm/L.
    • Volume Time: (vertical) 10 mm/L, (horizontal) 10 mm/S.
  • Parameters Measured: FVC, FEV0.5, FEV1, FEV6, FEV1/FEV6, FEV3, FEV1/FVC, FEV3/FVC, PEFR, PEFT, FEF25%, FEF50%, FEF75%, FEF25-75%, FIVC, FIV0.5, FIV1, FIV3, FIV1/FIVC, FIV3/FIVC, PIFR, FIF50%, FIF25-75%, FIF.2-1.2, FVC/FIVC, Extrapolated Volume (Ext. Vol.), EOTV, FET, MVV, RR, MTV, SVC.
  • Languages Available: English, Spanish, French, German, Japanese, Italian, Portuguese.

Frequently asked questions

What are the benefits of this diagnostic package?

The QRS Universal SmartECG and Spiro Package provides a comprehensive, all-in-one solution for both cardiovascular and pulmonary diagnostics, streamlining patient testing and data management.

Key advantages include:

  • Comprehensive Diagnostics: The package bundles the Universal SmartECG, the Orbit Portable Spirometer, Office Medic Software, and 100 disposable mouthpieces, offering complete testing capability out of the box.
  • High ECG Accuracy: The SmartECG utilizes the highly reliable Louvaine algorithm, recognized by cardiologists for superior accuracy in ECG interpretation.
  • Battery-Free Operation: The SmartECG draws power directly from the connected PC via USB, eliminating the need for batteries and reducing maintenance complexity.
  • EMR Compatibility: The Office Medic Software facilitates easy storage and allows reports to be generated in EMR-compatible formats (PDF, JPEG, and TIFF) for simple integration with existing medical records systems.
  • Safety and Quality: The ECG components comply with stringent safety standards, including AAMI EC11, EN60601-1, EN60601-2, and EN60601-2-25.
Is the Universal SmartECG highly accurate?

Yes, the Universal SmartECG provides high accuracy for cardiac diagnosis.

It utilizes the Louvaine algorithm, which is specifically recognized by cardiologists as having superior accuracy compared to nine other interpretation algorithms.

Furthermore, the ECG components comply with rigorous safety and quality standards, including AAMI EC11, EN60601-1, EN60601-2, and EN60601-2-25.

Does this diagnostic package integrate easily with EMR?

Yes, the QRS Universal SmartECG and Spiro Package is designed for easy integration into Electronic Medical Records (EMR) systems.

Integration is managed by the included Office Medic Software, which supports:

  • Data Archival: Secure storage for both ECG and Spirometry diagnostic data.
  • EMR-Ready Reporting: Generation of patient reports and printouts in widely compatible formats, including PDF, JPEG, and TIFF.

The PC-based operation, where the SmartECG is powered directly via USB (battery-free), further contributes to a simplified and streamlined clinical workflow.

How compact are the ECG and spirometer components?

The components are designed for portability and flexibility, making them highly compact for use in various clinical settings. Both devices are powered directly via the USB connection to a host PC, eliminating the need for bulky batteries.

Here are the size and weight specifications:

Component Weight Dimensions (L x W x H)
Universal SmartECG Hub 250 – 335 grams 85 mm x 91 mm x 20 mm
Orbit Portable Spirometer 0.5 lb (226.8 grams) 4.3” x 3.7” x 1.7” (109.2 mm x 94 mm x 43.2 mm)
What pulmonary function parameters are supported?

The Orbit Portable Spirometer supports a very comprehensive list of pulmonary function parameters. This ensures thorough assessment for respiratory diagnostics.

Supported parameters include:

  • Volume & Flow Ratios: FVC, FEV0.5, FEV1, FEV3, FEV6, FEV1/FVC, FEV3/FVC, FEV1/FEV6, FVC/FIVC
  • Expiratory Flows: PEFR, PEFT, FEF25%, FEF50%, FEF75%, FEF25-75%
  • Inspiratory Volumes & Flows: FIVC, FIV0.5, FIV1, FIV3, FIV1/FIVC, FIV3/FIVC, PIFR, FIF50%, FIF25-75%, FIF.2-1.2
  • Time & Volume Metrics: MVV (Maximum Voluntary Ventilation), SVC (Slow Vital Capacity), RR (Respiratory Rate), MTV (Minute Tidal Volume)
  • Other Metrics: Extrapolated Volume (Ext. Vol.), EOTV (End of Test Volume), FET (Forced Expiratory Time)
Is the diagnostic data compatible with EMR systems?

Yes, the included Office Medic Software is designed to ensure seamless integration with Electronic Medical Record (EMR) systems. It allows users to store diagnostic data and generate printouts in formats compatible with EMR platforms, specifically:

  • PDF
  • JPEG
  • TIFF

This functionality enables easy transfer of both ECG and spirometry results into the patient’s digital record.

Is the SmartECG fully safety compliant?

Yes, the Universal SmartECG component is designed to meet rigorous international safety and performance standards, ensuring patient and operator protection.

The SmartECG specifically complies with the following safety certifications:

  • AAMI EC11
  • EN60601-1
  • EN60601-2
  • EN60601-2-25

For enhanced patient safety, the SmartECG features leads that are isolated from the system and provides 4kV defibrillation protection.

What is included in this comprehensive package?

The QRS Universal SmartECG and Spiro Package provides an integrated solution for cardiovascular and pulmonary function testing. The complete package contains all the necessary components for clinical use:

  • Universal SmartECG Unit: This battery-free ECG device operates by drawing power directly from the host PC via USB. It features the Louvaine algorithm, which is noted for its superior accuracy in cardiovascular diagnosis.
  • Orbit Portable Spirometer: A highly accurate device designed to measure a broad spectrum of pulmonary function parameters (e.g., FVC, FEV1, PEF).
  • Office Medic Software: The central application for data management, analysis, and report generation. It facilitates compatibility with EMR systems by creating printouts in formats like PDF, JPEG, and TIFF.
  • Patient Leads: Includes all required Limb and Chest leads for the ECG unit.
  • 100 Mouthpieces: A supply of disposable mouthpieces for hygienic spirometry testing.
What is the warranty period for the QRS Universal SmartECG and Spiro Package?

The QRS Universal SmartECG and Spiro Package comes with a 3-year warranty covering defects in material and workmanship.

Is the SmartECG battery-free?

The Universal SmartECG is conveniently powered directly from a PC via a USB interface, eliminating the need for batteries and ensuring consistent, reliable performance.