BACKGROUND:
Notice is hereby given by the University of Ottawa of the intent to enter into a contract with Novus Medical Inc. to procure an automated metabolic gas analysis system with a combined 12-lead electrocardiogram (ECG) measurement system
PROCESS;
Suppliers who consider their equipment functional, successfully tested, readily available and fully compliant to the ACAN minimum requirements may submit in writing a statement of specifications to the contact person identified in this Notice, on or before the closing date of this Notice. In the statement of specifications, the supplier must unequivocally demonstrate how their equipment, at minimum, equals or exceeds the stated requirements.
If no other supplier submits a statement of specifications, on or before the closing date of this Notice, the competitive requirements of the University of Ottawa will be considered to have been met.
Following notification to suppliers not successful in unequivocally demonstrating that their statement of specifications equals or exceeds the requirements set out in this Notice, the contract may then be awarded to the pre-identified supplier.
Date of issue: January 11, 2023
Closing Date: January 26, 2023, at 3:00:00 P.M. Eastern Standard Time
INTENDED USE:
The system will be used to perform customized cardiopulmonary exercise tests integrating a 12-lead electrocardiogram assessment for patient screening. The system is also used to conduct customized measurements of metabolic heat production during rest and exercise conducted in the world’s only air calorimeter (device the provides the gold standard measure of the heat dissipated and stored by the human body).
FUNCTIONALITY:
The equipment must conform to the following Minimum Requirements:
- breath-by-breath automated pulmonary gas exchange measurement
- 12-lead electrocardiogram (ECG) measurement system with real-time display employing a single software platform to obtain continuous real-time output of gas exchange and ECG measurements.
- software platform to control ergometers (Lode) for cardiorespiratory exercise stress testing
- pulmonary function (spirometry) capabilities
- nutritional assessment platform
- customized, flexible patient analysis and display, data reporting and report-generating software
- flow sensor technology comparable to preVent®
- yearly on-site system calibration and maintenance including replacement of oxygens sensor and 3-L fixed volume calibration syringe.
- urgent on-site support (72 hours)
- color laser-printer
Other specific requirements:
- system must use a flow sensor that is low cost with no electrical wiring/cable for simple accurate operation
- system must use a flow sensor that is either cleanable or disposable
- system must not require re-calibration after a flow sensor is changed to facilitate rapid multiple tests
- system must store all test data in a SQL database, either on the computer hard drive or a network drive, and have the ability to review all leads after the patient has completed testing. Note: SQL database must be truly open (i.e. can be opened by an off the shelf program such as “My SQL” or SQL Server Express
- system must measure and display all ventilatory and gas exchange parameters on a true breath-by-breath basis (without mixing chamber), using automatic phase alignment of gas signals with expiratory flow. A mixing chamber can however be simulated by system through averaging method selection.
- flow transducers must measure flow over a range of ±18 liters/second.
- flow and volume measurements must meet or exceed ATS/ERS Standards for spirometry.
- system must have an integrated drying sample line.
- system must continuously sample inspired and expired patient gas at a flow rate not exceeding 120-130 milliliters per minute.
- real-time measurements of breath-by-breath FIO2 and non-zero FICO2 must be incorporated into the calculations of oxygen uptake and carbon dioxide output.
- oxygen analyzer must have a measurement range of 0% to 100% Oxygen in breath-by-breath mode with accuracy of ±0.1%.
- carbon Dioxide analyzer must have a measurement range of 0% to10% Carbon Dioxide in breath-by-breath mode with accuracy of up to ±0.1%.
- physiologic waveforms, including air flow, CO2 and O2 waveforms must be displayed in real-time and available in hardcopy form.
- data collection, graphic and tabular presentations must be configurable and must support user-defined limits and warnings.
- system must provide automatic V-slope detection of anaerobic threshold with the ability for manual adjustment. Additionally, the software must provide the point of respiratory compensation after anaerobic threshold is achieved.
- system must control optional treadmill or electronically braked cycle ergometer (Lode) to support ramping, incremental, or user-defined protocols.
- system must provide "windowing" capability to select several intervals from a test for appropriate determination of steady state.
- system must provide software filtering of non-physiologic gas exchange events, for data rejection at the discretion of the system operator.
- system must provide a "replay" function to recalculate and display stored ventilatory and gas exchange data following dead space verification and entry of environmental conditions.
- relevant auxiliary data, including blood gases and blood chemistry, blood pressures, rating of perceived exertion, heart rate, and free-text comments must be able to be directly entered into the patient file during testing for instantaneous alignment and calculation of related variables.
- complete system can be a desktop or standing configuration, with all essential components (not including printer) housed within a single system design.
- system must provide user-configurable predicted values for pediatric, adult, and geriatric subjects.
- system must provide capability of performing full spirometry including flow-volume loops with both inspiratory and expiratory efforts.
- system must provide full-disclosure recording of Exercise Flow Volume Loops with iso-volume alignment at FRC with analysis of flow limitation.
- system must provide the capability of computerized interpretation and editing of exercise test results.
- system must provide the capability of computerized exercise prescription.
- system must offer capability to measure REE on elevated FiO2 (> 60%) using REE CO2 variable.
- system must offer capability to operate in either a stand-alone environment or on a network in a client-server configuration
- system must offer a set of database tools to perform database functions such as patient and staff maintenance and patient database backups.
- system must offer LAN and WAN networking capabilities.
- system must support configurable data outputs of ASCII, HTML, PDF, SNP, TXT.
- system must have capability of database query option for trending subject data and laboratory quality control.
- system and software must have the ability to calibrate gas analyzers with calibration gas and room air.
- oxygen and carbon dioxide gas analyzers inside the system must be field replaceable.
- system must calibrate the gas analyzers from the sample line.
- the software must allow for scheduling of automatic system warm-up and standby functions.
- system must have the ability to be field upgradable in order to perform exercise ECG testing.
For Pulmonary function:
- the system must provide quick and easy decontamination between patient testing to minimize cross contamination without requiring barrier filters, recalibration, or warm-up.
- for infection control purposes, the entire breathing circuit, including the flow transducer and mouthpiece must be easily removed and cleaned or disposed of between patients.
- flow transducer may be replaced between tests without requiring recalibration or stabilization (warm-up).
- system must provide for the capabilities of the following measurements: All spirometric values, flow volume loops, lung volume determination through Nitrogen Washout, single breath diffusion capacity (transfer factor), closing volume, maximal inspiratory/expiratory pressures and distribution of ventilation measurement.
- patient database must be based upon a non-proprietary platform (Microsoft SQL) and provide for direct import/export of test data into Microsoft Office Professional Suite including Excel and Access.
- user configurable calculation methodologies for lung subdivisions.
- operator override of automatic valve sequencing for diffusing capacity and FRC measurements to permit testing of difficult patients.
- the system software must provide full disclosure of all patient test efforts and data in textual and graphical formats.
- test data must be saved to hard disk storage after each individual effort.
- system software must include the capability for complete multi-level review of all test data separate from the data collection software either at the testing station or remotely via a network connection.
- flow measurement must meet the following criteria:
- flow transducer must measure over a clinical range of ±18 liters/second with a resolution of 8 ml/second.
- measurement of flow and volume must meet or exceed ATS/ERS standards for Spirometry and Diffusing Capacity.
- flow transducer may be replaced between tests without requiring recalibration or stabilization (warm-up).
- single Breath Diffusion methods must meet the following criteria:
- analysis by infra-red analyzer (MultiGas Sensor) via Real Time Diffusion permits testing of patients with vital capacities of less than one liter.
- user selectable timing methodologies
- system must provide for operator control of breath hold and sample collection volume.
- user selectable predicteds with corrections for hemoglobin, hematocrit, and carboxyhemoglobin must be present.
- gas analysis is independent of inhaled or exhaled flow rates.
- each individual system is certified to have passed the Hans Rudolph DLco Simulator.
- RTD MultiGas Sensor must be solid state technology with no moving parts.
- RTD MultiGas Sensor should have a response time less than 200 msec.
- software will display a pressure meter to notify the operator if the subject is performing a Valsalva or Muller maneuver during lockout.
- system must offer hardware/software to calculate maximal expiratory pressure, maximal inspiratory pressure.
- system software must be easy to learn and operate with extensive use of on-line context-sensitive help screens, step-by-step on-screen instructions, and clear documentation.
- graphics and tabular presentation of data must include predicted normal comparisons for adult and pediatric, males and females.
- system software must provide the option to allow input of user-defined predicted formulas.
- system must provide ability to reduce to hard copy any display appearing on screen (screen print) during testing or effort review.
- system must have a drying sample line to remove water vapor from the sample gas.
- gas analyzers must be insensitive to airway pressures up to 20 cm H20.
- oxygen analyzer must have a measurement range of 0% to 100% Oxygen in breath-by-breath mode with accuracy of ±1%.
- system must provide automatic gas analyzer calibration that displays calibration results in real-time on screen and hardcopy form. System will offer manual calibration override capability.
- all system calibration results must be stored in SQL database by date and time.
- complete system must be mobile, with all essential components (not including printer) housed within a single system design.
- system must offer a set of database tools to perform database functions such as patient and staff maintenance and patient database backups.
- system must have capability of database query option for trending subject data and laboratory quality control.
- system pulmonary function head must have a built-in locking mechanism to secure flow sensor.
Justification of Pre-Selected Supplier:
Supplier: Novus Medical Inc.
Justification:
The system must provide a seamless transition from our existing system, which employs a custom recording, monitoring and report software platform provided by the company. Further, because of the high level of precision required for the measurement of metabolic heat production in our worlds only air calorimeter, we must rely upon a comparable sensor technology for the calibration and measurement of gas exchange. We must also have the capability of extracting or transferring existing patient files (~6000+ files), including the capacity to conduct secondary analysis of these files. Due to the high volume of testing, which includes the assessment of out-of-town patients, we require expedited on-site maintenance support within a 72-hour period.
University Contact:
ALopes
Ana Lopes
Approvisionneur principal, recherche | Senior Procurement Officer, Research
Strategic Project Management Group (SPMG) | Procurement Services
Université d'Ottawa | University of Ottawa
1 Nicholas (303)
Ottawa, ON K1N 7B7
alopes@uottawa.ca
613-562-5800 (2312)
