Attachment B - Cost and Pricing Schedule.pdf

Attachment B

RFQ: 36C24820Q1377

Line Item Description Quantity Unit of Measure

Unit Price

Total Price

1 Digital Noninvasive Ventilation and Oxygenation Monitoring (Transcutaneous Monitoring) System

5 EA

2 Sensor 5 EA

3 Roll Stand with Basket and Quick Connect

5 EA

4 Adapter Cable Universal 5 EA

Salient Characteristics:

Shall continually monitor for adverse breathing events with no interruptions

Shall correctly reflect hypo‐ and hyperventilation, even under supplemental oxygen

Shall have a system performance measured against the following requirements:

o For Transcutaneous Carbon Dioxide Partial Pressure (tcPCO2)1:

Shall have a measurement range of: 0–200 mmHg (0–26.7 kPa)

Shall have a resolution of: 0.1 mmHg (0.01 kPa) below 100 mmHg (10 kPa)/1 mmHg (0.1 kPa) above 100 mmHg (10 kPa)

Drift2 measurement shall be: typical of < 0.5%/hour

Response time (T90)2 shall be: typical of < 75 sec

Linearity2 measurement shall be: typical of < 1 mmHg (0.13 kPa)

Interferences from anesthetic gases shall be negligible

Stabilization/ artifact detection shall be after sensor application or occurrence of a tcPCO2 artifact, tcPCO2 is displayed in grey until it (re)stabilizes o Pulse Rate (PR)

Shall have a measurement range of: 30–250 bpm

Shall have a resolution of: 1 bpm

Accuracy shall be no less than: ± 3 bpm o Pulsation Index (PI)

Shall have a measurement range of: 0.1–10.0%

Shall have a resolution of: 0.1% o Oxygen Saturation (SpO2)

Shall have a measurement range of: 1 – 100%

Shall have a resolution of: 1%

Accuracy shall be no less than: ±2% (Arms over 70% to 100%)3

Shall have an Averaging Mode of: 2, 4, 6, 8, 12, 16, and 32 seconds

Approved sites for SpO2/ PR monitoring shall be:

Earlobe low on forehead cheek upper arm on scapula/shoulder blade o Sensor Heating Power (HP)

Shall have a measurement range of:

Absolute Heating Power (AHP): 0–999 mW

Relative Heating Power (RHP): ‐999–999 mW

Shall have a resolution of: 1 mW o Sensor Temperature

Shall have a measurement range of: 0.0 – 70.0 °C

Shall have a resolution of: 0.1 °C

Accuracy shall be no less than: ± 0.2 °C (over 37.0 to 45.0 °C)

Shall have a selectable sensor temperature range between:

o 37.0 and 44.5 °C (in steps of 0.5 °C with default range=40.0–44.0 °C).

o Default sensor temperature shall be: 42.0 °C in Adult Mode and 41.0 °C in Neonatal

Mode

Shall have an Alarm System that includes:

o Alarm signals shall have visual/ auditory alarm signals for high/ low tcPCO2, SpO2, PR, and technical alarms with facility‐selectable melodies o Alarm inhibition shall have auditory alarm signals which can be PAUSED or switched off permanently o Alarm system status indicators shall include:

Alarm Status Icon

AUDIO Status Icon

AUDIO PAUSED/ OFF Indicator

AUDIO OFF Reminder

Shall have a comprehensive data display with at minimum:

o Patient trend display area o Patient status numerical display area o Patient/Equipment status bar

Shall be easily transportable with at minimum the following physical characteristics o Weight shall be no greater than: 2.3 kg (5.1 lbs) – including gas cylinder o Size should be approximately: 10.2 cm x 27.0 cm x 23.0 cm (4.00’’ x 10.63’’ x 9.06’’) o Should have adjustable/flipping feet or equal to serve as carrying handle and/or to adjust angle for improved viewing capability on flat or tabletop surface o Shall have the ability to be mountable on rolling infusion stands, wall mounts, railings, transportable incubators, and other mobility devices found commonly in a hospital sleep lab setting.

Shall have multiple interfaces with minimum of:

o Shall have a serial output (RS‐/EIA‐232) with the following supported protocols:

SenTecLink

Philips VueLink/IntelliBridge

Spacelabs Flexport

Serial Printer

TCB

o Shall have a LAN port (Ethernet 10 BaseT) for remote monitoring o Shall have an Analog output (0–1V) for the following:

tcPCO2

SpO2

PR

Pleth Wave (with selectable ranges) o Shall have nurse‐call interface with open and close type relays

Shall have electrical requirements fitting:

o Instrument requirement shall be: AC Power: 100 – 240 V (50/60 Hz), max. 450 mA/

Electrical Safety (IEC 60601‐1): Class I, Type BF, Applied Part – Defibrillation Proof, IPX1.

o Internal battery requirement shall be:

Rechargeable

Sealed LiIon Battery/ Capacity (new fully charged battery):

up to 10 hours (if Sleep Mode=OFF, AUTO) up to 12 hours (if Sleep Mode=ON)

Charging time should be: approximately 7 hours

Shall be configurable to include:

o Patient Mode o Enabled Parameters o Severinghaus Correction Mode o Heating Power Mode o V‐Check Mode (currently using) o Parameter Display Color o PCO2/PO2 Unit o Ranges (time) for online trends o Sweep speed of Pleth wave o Sleep Mode o Brightness o Audio Settings o Menu Access o Profile Mode

Shall have preconfigured profiles to fit varying clinical settings

Shall be compatible with V‐Sign sensor which is currently used in facility

Shall have a single sensor to measure both tcPO2 and SpO2 and shall have the following characteristics:

o Preferred V‐Sign Sensor 2 (already being used) o Shall support the disconnection of the sensor for up to 30 minutes without losing the calibration status.

o Shall be Suitable for adult, pediatric, and neonatal patients o Shall be Reusable and waterproof o Shall have a measurement principle of Severinghaus‐type PCO2 sensor combined with reflectance 2‐wavelength pulse oximetry.

o Shall have an integrated opto‐electronic sensor head comprising micro pH‐electrode optical oximetry unit temperature sensors heating unit, all combined in a fully

High definition digitizer and pre‐processing in the sensor head

Low noise signals

Shall have the ability to digitally transmit to a SenTec Digital Monitor (SDM).

o Shall have sensor/sensor cable dimensions of approximately:

Diameter x Height of sensor head shall be: 14 mm x 9 mm (0.55’’ x 0.35’’)

Weight of sensor head shall be: < 2.9 g (0.1 oz)

Length of sensor cable shall be: Approx. 80 cm (31’’) [plus Digital Sensor

Adapter Cable of 150 cm (59’’), 250 cm (98’’), or 750 cm (295’’) length]

Sensor cable shall be: flexible, shielded cable with coating able to withstand cleaning and decontamination agents and irradiation commonly used in hospital environments

Shall be able to utilize disposable electrodes that are currently in stock at facility:

o Multi‐Site Attachment Ring EASY Mature/Intact Skin, Item Number: MARe‐MI

Shall meet or exceed all compliances stated: IEC 60601‐1, ANSI/ AAMI ES60601‐1, CAN/ CSA

C22.2 No. 60601‐1, IEC 60601‐1‐2, IEC 60601‐1‐8, IEC 60601‐2‐23, ISO 80601‐2‐61, ISO 10993, ISO 14971

Shall have an available 5‐year warranty

Shall have a Roll Stand with basket

Shall have a PSG Adapter Cable for each unit