Spacelabs Healthcare employs state-of-the-art 12-lead electrocardiographs and 12-lead Holter monitors manufactured by Mortara Instruments. Because we are a Mortara Certified Partner, our data processing ensures seamless intergration into the FDA E-scribe ECG Warehouse.

12-lead ECG

Spacelabs Healthcare uses the Mortara ELI 250 Rx ECG. A full-service electrocardiograph designed specifically for use in clinical trials, the ELI 250 Rx includes:

• 1000 Hz sampling rates
• Simplified demographic entry with full keypad
• One-touch buttons for ECG acquisition and transmission
• Interpretation and measurements using Mortara's Veritas™ analysis algorithm
• Printing of full-sized ECG tracings
• Bi-directional data throughput via phone modem, LAN or wireless LAN
• Backlit LCD display for high-resolution, real-time preview and post-acquisition review of 12-lead ECGs

Holter Monitoring

In addition to standard rate and rhythm analysis, the Mortara H12+ 12-lead Holter can be used in the Phase I setting for Thorough QT trials. This Holter monitor offers:

• State-of-the-art digital data acquisition for both QT measurements and rate and rhythm analysis
• Either 3 channels or 12 leads and 1000 Hz of high-fidelity data
• 24 to 48 hours of continuous Holter monitoring data
• LCD display for real-time preview of all 12 leads, to ensure quality recording
• Event markers
• Lightweight, compact, 4 oz (125 gm) design for greater patient comfort

Ambulatory Blood Pressure Monitors

Spacelabs Healthcare offers the Spacelabs 90207 ambulatory blood pressure monitor (ABPM), recognized as the industry gold standard, and the exclusive Spacelabs Healthcare PDA-based proprietary ABP Controller. This combination features:

• Oscillometric determination of blood pressure
• Compact and lightweight design to ensure patient comfort
• Handheld PDA system for easier collection, analysis and reporting of ambulatory blood pressure data
• Handheld PDA controller that stores demographic data throughout the term of the trial to reduce discrepancies and optimize site workflow efficiencies
• Handheld PDA controller to support real-time evaluation of ambulatory blood pressure data for protocol-specific criteria and technical success

Information Technologies

All Spacelabs Healthcare technology supports the retention and reporting of records in accordance with established standards and regulatory requirements (e.g., FDA aECG, CDISC). Spacelabs Healthcare uses the
E-Scribe Rx-Data Management System for ELI 12-Lead ECG and the H-Scribe Rx-Data Management System for continuous Holter monitoring.

As a designated Mortara certified partner, Spacelabs Healthcare ensures your data will seamlessly integrate into the FDA Escribe ECG Warehouse. The ECG Warehouse was developed by Mortara Instruments in partnership with the FDA and under a Coperative Research and Development Agreement (CRADA). It was established as part of the Critical Path Initiative to promote collaboration between government, industry, academia and patient groups.

Designed to accelerate the drug approval process and cardiac safety evaluation for new drug therapies, the ECG Warehouse is the primary pathway for submission of digital ECG data for FDA review.

E-Scribe Rx -Data Management System for ELI 12-Lead ECG.

• Meets 21 CRF Part 11 Compliance for electronic records
• Offers controlled access to ECG records
• Provides onscreen interval measurement and annotation of ECG records
• Includes study-specific, customizable demographic fields

H-Scribe Rx-Data Management System for continuous Holter monitoring data enables:

• Review for rate and rhythm analysis
• Serial timepoint extraction of 12-lead ECG for QT analysis
• Study-specific, customizable demographic fields