CALIBRATION CERTIFICATE

Product catalog summary

Calibration Certificate Overview
This document is a calibration certificate issued by HE Instruments LLC for the calibration of a TechPatient Cardio V4 ECG Simulator, serial number TPC9939, belonging to Biomedical Corporation.

Calibration Conditions
The calibration was conducted under controlled conditions with a temperature of 73 ± 1 ºF and relative humidity of 42 ± 3% HR. The standards used included an Agilent 34410A with serial number MY53001287, last calibrated on May 24, 2018.

Calibration Procedure
The calibration followed procedure SP02EN, involving direct measurement against standards.

Test Results
The equipment was tested and confirmed to conform to the manufacturer's specifications. Key measurements included:

DC Voltage for various leads with combined uncertainty of ± 0.000006 V.
Pulse intervals for BPM settings of 60, 80, and 100 with respective uncertainties of ± 0.0005 s, ± 0.0004 s, and ± 0.0003 s.

Traceability and Conformity
The combined uncertainty was calculated with a coverage factor k=2, indicating a 95% confidence level. The results are traceable to NIST standards. The certificate cannot be duplicated without written approval from HE Instruments LLC.

Certification
The certificate was certified on December 23, 2017.

Catalog excerpts

CALIBRATION CERTIFICATE CERTIFICATE NUMBER: CTPC-A7F3 HE INSTRUMENTS LLC 3677 23rd Ave S. Suite C-107 Lake Worth, FL (33461) United States +1-866-921-4971 +1-561-899-7791 BIOMEDICAL CORPORATION HE INSTRUMENTS TECHPATIENT CARDIO V4 ECG SIMULATOR 31 SPOONER STREET QUAHOG (02802) RHODE ISLAND UNITED STATES STANDARDS USED FOR CALIBRATION CALIBRATION CONDITIONS Temperature Relative Humidity Calibration Date Calibration to standards by direct measurement according to specific procedure SP02EN. TEST RESULTS We hereby confirm that the above equipment has been tested and calibrated, and conforms to the manufacturer’s specifications on the calibrated values, as listed on the Operator’s Manual. SELECTED %DC MEASURED VALUE

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CALIBRATION CERTIFICATE CERTIFICATE NUMBER: CTPC-A7F3 HE INSTRUMENTS LLC TEST RESULTS (CONT.) SELECTED BPM PULSE INTERVAL MEASURED VALUE TRACEABILITY AND CONFORMITY Combined uncertainty was calculated using a coverage factor k=2 corresponding to an approximate confidence level of 95% considering a normal distribution. It includes terms that consider the measurement method and the instrument behavior during calibration. No terms evaluating long term behavior are included. The test results on this Certificate refer to the moment and conditions when the measurements took place. HE Instruments LLC...

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