CERTIFICATE OF ACCREDITATION

The ANSI National Accreditation Board

Hereby attests that

Sistagrosa S.A.
Cdla Guayaquil, Av. Victor H. Sicuret P. Mz11,
S4; Entre Emilio Soro Lenti y Enma E. Ortiz Bermeo
Guayaquil, Ecuador
Fulfills the requirements of

ISO/IEC 17025:2017
In the field of

CALIBRATION
This certificate is valid only when accompanied by a current scope of accreditation document.
The current scope of accreditation can be verified at www.anab.org.

______________________________
R. Douglas Leonard Jr., VP, PILR SBU
Expiry Date: 02 October 2022
Certificate Number: AC-2622

This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory
quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017

SISTAGROSA S.A.
Cdla Guayaquil, Av. Victor H. Sicuret P. Mz11, S4; Entre Emilio Soro
Lenti y Enma E. Ortiz Bermeo
Guayaquil, Ecuador
Víctor Ernesto Pineda Gonzalez Phone: (011) 59 34 2 269 2375
sistagrosa@sistagrosa.com www.sistagrosa.com

CALIBRATION
Valid to: October 2, 2022 Certificate Number: AC-2622

Electrical – DC/Low Frequency

Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Defibrillator/AED Tester,
Energy Monophasic
(15 to 360) J (0.013X+ 0.31) J External Pacer Analyzer
/Defibrillator1
Fluke Impulse 7000DP
Defibrillator/AED Tester,
Energy Biphasic
(15 to 175) J (0.018X + 0.4) J External Pacer Analyzer
/Defibrillator1
Fluke Impulse 7000DP
(5 to 300) W
at 200 Ω (0.053X + 1.2) W
Electrosurgery Analyzer
Power/ Electrosurgical 1
at 300 Ω (0.053X + 1.1) W
Fluke QA ES II
at 400 Ω (0.053X + 1.3) W
at 500 Ω (0.053X + 1.3) W

Mass and Mass Related

Parameter/Equipment
Flow/Infusion Pump1
Pressure/
blood pressure cuff1
Reference Standard,
Expanded Uncertainty of
Range Method, and/or
Measurement (+/-)
Equipment
Infusion Pump Analyzer
(16 to 200) ml/h (0.009 1X + 1.6) ml/h
IDA 4 Plus
Digital pressure gauge
ADDITEL ADT681-02-
(0 to 300) mmHg (0.002 2X + 0.65) mmHg GP5-PSI-N, Vital Signs
Patient Simulator Fluke
PROSIM 8

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Mass and Mass Related
Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Non-Invasive Blood Pressure Vital Signs Patient
/Multi-parameter Monitor (30 to 150) mmHg (0.007 4X + 0.5) mmHg Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Invasive Blood Pressure / Vital Signs Patient
Multi-parameter Monitor (0 to 120) mmHg (0.011X + 1.2) mmHg Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Airway Pressure/Pulmonary
Fluke VT900 Gas Flow
Ventilator-Anesthesia (-100 to 100) cmH2O (0.006 3X + 0.083) cmH2O
Analyzer
Machines1
Airway Flow/Pulmonary
Fluke VT900 Gas Flow
Ventilator- Anesthesia (0.5 to 100) l/min (0.02X + 0.008) l/min
Analyzer
Machines1

Thermodynamic
Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Temperature/ Incubator Analyzer
(25 to 40) ºC 0.77 ºC
Infant Incubator1 Fluke INCU

Time and Frequency

Reference Standard,
Expanded Uncertainty of
Parameter/Equipment Range Method, and/or
Measurement (+/-)
Equipment
Cardiac Rate ECG/Multi- Vital Signs Patient
parameter Monitor (40 to 300) BPM (0.011X + 0.022) BPM Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Cardiac Rate/Fetal Doppler Fetal Simulator
(90 to 180) BPM (0.008 9X + 0.6) BPM
(Electrical Simulation)1 Fluke PS 320
Respiration Rate-Multi- Vital Signs Patient
Parameter Monitor (20 to 60) BrPM (0.06X + 0.033) BrPM Simulator
(Electrical Simulation)1 Fluke PROSIM 8
Digital Caliper/
Cardiac Rate/
Vital Signs Patient
Electrocardiogram (Electrical (40 to 300) BPM (0.016X – 0.034) BPM
Simulator Fluke
Simulation)1
PROSIM 8

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Calibration and Measurement Capability (CMC) is expressed in terms of the measurement parameter, measurement range, expanded uncertainty of measurement and
reference standard, method, and/or equipment. The expanded uncertainty of measurement is expressed as the standard uncertainty of the measurement multiplied by a
coverage factor of 2 (k=2), corresponding to a confidence level of approximately 95%.
Notes:
1. On-site calibration service is available for this parameter, since on-site conditions are typically more variable than those in the laboratory, larger measurement
uncertainties are expected on-site than what is reported on the accredited scope.
2. X = reading of the unit under test.
3. This scope is formatted as part of a single document including Certificate of Accreditation No. AC-2622.

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