SOLICITATION NOTICE
65 -- Vital Signs Monitor System
- Notice Date
- 4/11/2006
- Notice Type
- Solicitation Notice
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264506RC20060
- Response Due
- 5/2/2006
- Archive Date
- 5/17/2006
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 6.302) with Welch Allyn Protocol, Inc., 8500 SW Creekside Place, Beaverton, OR 97008, as the only source that can provide an Encore 206 EL Vital Signs Monitor System. Specifically, the vital signs monitor shall conform to the following Salient Characteristics: (1) The unit is a small, lightweight, ultra-portable, battery and line-powered patient monitor, capable of monitoring ECG, heart rate, non-invasive and invasive blood pressure, pulse, temperature, air certified pulse oximetry; displaying selected parameters on EL screen and strip chart recorder. Shall include an expansion module, recorder, remote patient input device interface, and pulse oximeter. The monitor shall have flexibility to allow utilization as follows: (a) Individual bedside monitoring with capability to display at a central location. (b) Patient monitoring during emergency transport. (c) Patient monitoring in the operating room during surgery and/or the administration of anesthesia. (d) Patient monitoring after surgery, during transport to, and during recovery. (e) Patient monitoring during transport to and while doing special procedures. (f) Patient monitoring in hostile environments during transport while exposed to the outdoors. (g) Patient monitoring at stand-alone bedside or networked bedside care units. (2) Capable of providing an ECG through a shielded, three lead patient cable having a six pin connector, configured in accordance with AAMI ECG 5/83 Standard for ECG Connectors. (3) Front panel of the unit provided with a pushbutton lead selection switch for leads. (4) Monitor display shall use electroluminescent dot matrix technology. (5) User selectable sweep speed of 12.5, 25, and 50 millimeters per second and ECG gain selections of 0.2, 0.5, 1.0, 2.0, and 4.0 mV/cm. (6) Common Mode Rejection Ratio (CMRR). Output shall be less than 1 mV pk-pk RTI for input of 10 V RMS at 50/60 Hz from 200 pF source impedance with 51 K ohms paralled by .047 less than or equal to F of imbalance in lead source resistance, and 50 and 60 Hz filter off. (7) Frequency response of the ECG signal amplifier shall not be more than 3 dB down from 0.5 Hz to 40 Hz. (8) Noise level shall be less than 40 less than or equal to Vp-p RTI in any position of the lead select switch. (9) A one centimeter reference pulse shall be provided on the display to indicate 0.2, 0.5, 1.0, 2.0, and 4.0 less than or equal to V/cm, at all times ECG is being monitored. (10) An automatic trace reset shall be provided so that if the trace is deflected off the scale due to lead handling or lead selection, it shall return to the display within 3.0 seconds. (11) Withstand a defibrillator energy pulse of 360 joules into a 50 ohm load, with 400 ohms of series resistance between the 50 ohms load and the ECG leads, when used with supplied ECG cable. (12) ECG input impedance shall exceed 2.5 Megohms for frequencies up to 10 Hz. The unit shall operate with common mode input offsets of up to plus or minus 300 millivolts. (13) Protected from and suppress electrical signal interference during electrocautery. (14) Capable of displaying heart rate with an input from ECG electrodes or pulse rate from the non-invasive blood pressure. (15) Internally computed and digitally displayed heart rate with a range of 25 to 249 beats per minute. Shall count biphasic 0.2 mV to 5 mV "R" waves with no external sensitivity adjustment. (16) Digital display of the value of heart rates updated successively at intervals not to exceed 5-9 seconds. (17) Digital display capable of selectively providing the following physiological data: (a) Heart rate in beats per minute derived from ECG or pulse signal. (b) Temperature in degrees Centigrade or Fahrenheit. (c) Blood pressure in mmHg: systolic, diastolic, mean pressure. (18) Audible and visual alarm indicator for heart rates, pulse rates, systolic, diastolic, mean blood pressures, and temperature which violate chosen high and low limits. The audible alarm shall be able to be manually reset. A temporary alarm silence shall last no more than 90 seconds. (19) High and low alarm limits independently adjustable and read on the display, with a setting accuracy of plus or minus 1 BPM, 1 mm Hg, 0.1 degree Centigrade or Fahrenheit. All alarm parameters and limits shall have the capability of being set with one button activation. (20) ECG monitor show pacemaker pulses on the ECG waveform display, but not count the pacemaker pulse in computing the heart rate. Have the capability to display ECG sync pulses during cardioversion with a defibrillator. (21) Battery Operation. Allow for monitoring during power failures and emergency transport, the unit capable of operating from a battery pack to be included with the unit. (a) Battery Type: Rechargeable, sealed lead acid. (b) Battery Capacity: 6.5 hours of continuous monitoring from fully-charged condition. (c) Battery Display: Indicate voltage of batteries. (d) Battery Charge Indicator: Illuminate when batteries are charging. (e) Battery Charge Time: 8 hours maximum to full charge for each depleted battery. (f) The battery power source installed in the equipment, and in a condition which optimizes shelf-life and minimizes potential damage for the particular battery type. (g) When the battery voltage drops below 7.9 volts a low battery message is displayed on the monitor screen. (h) In addition to the requirements specified, include specific technical data on battery care and maintenance. (i) Charging shall occur while rated input power is supplied to the monitor, whether or not the unit is turned on. Batteries will have at least a 16 month shelf-life with 50%permanent loss in capacity if stored at 20 degrees Centigrade. (22) Blood Pressure: Contain a non-invasive channel and two invasive channels. The output shall be such that the pressure can be displayed on a direct writing recorder and simultaneous waveform display; processed to digitally display systolic, diastolic, and mean pressure (and heart rate if required). (a) Non-Invasive Blood Pressure Channel: Ranges - Systolic: 30 to 250 mmHg. Diastolic: 20 to 230 mmHg. Mean pressure range: 25 to 200 mmHg. Pulse range: 25 to 250 BPM. Indicate a pressure display accuracy of plus or minus 3 mmHg or 2% whichever is greater. Indicate pulse rate accuracy of 6 BPM or 6%, whichever is greater. Response time for determining blood pressure between 28 to 45 seconds with a maximum determination time of 3 minutes. Maximum cuff pressure shall be 260 mmHg with cuff over-pressure relief valve at 280 - 330 mmHg. Child, standard adult, large adult, and thigh blood pressure cuffs provided. (b) Invasive Blood Pressure Channels: Range for the waveform display and numeric readout of systolic, diastolic and mean blood pressure is -30 mmHg to 300 mmHg for each channel. HR/PR is displayed from 25 BPM to 250 BPM. Numeric display accuracy is plus or minus 2 mmHg or 2%, whichever is greater, plus transducer error. The pulse rate accuracy is plus or minus 3 BPM or 3%, whichever is greater. Include an auto zero feature or a zeroing control provided to compensate for any residual output voltage that may exist without any applied pressure. If a zero balance control is furnished it shall allow adjustment over a range of plus or minus 200 mmHg for 5.0 VDC excitation voltage. Recommended blood pressure transducers are those that comply with the "ANSI/AAMI Standard for Performance of Resistive Bridge Type Blood Pressure Transducers, BP23," Nov. 1986. (23) Temperature: (a) Input: Include 1 channel capable of sensing rectal, skin, or esophageal temperature measurement. Compatible with Yellow Springs Instrument Co., 400 and 700 series probes. (b) Range: Temperature measuring function (including probe) Cover the range of 17 degrees C to 50 degrees C (62 degrees F to 122 degrees F). (c) Accuracy: The temperature range digitally displayed with an accuracy of plus or minus 0.1 degrees C (0.2 degrees F). (24) For additional physiological monitoring functions, include an expansion module in order to provide one functional unit. Module not exceed a size of 3.5 by 8.5 by 2.5 inches (8.9 by 21.6 by 6.4 cm) and not weigh more than 4.2 pounds (1.9 Kg). (25) Include a recorder with the following characteristics: (a) Thermal hot dot type and allow for intermittent recording of up to three (3) continuous waveforms. Recorder capable of automatically recording the direct or delayed waveform signals when manually initiated or when an alarm condition occurs. (b) Standard paper speed of 25 mm per second provided with an accuracy of plus or minus 5%. (c) Recording paper of the thermal type and available from a number of commercial sources. Paper recording output suitable for inclusion in the patient's chart. Paper allow ball-point pen and pencil writing. Paper recording also provide clear copies after copying in a copying machine. Recording paper ruled with 5.0 mm divisions along both the time and voltage axis. 5.0 mm divisions not deviate more than plus or minus 2% from 5.0 mm in either axis. Ruled division span, along the voltage axis, at least 4 cm. Recordings be rectilinear. (d) Drift of the recording due to all causes not exceed 1.0 mm of vertical displacement per 10 mm of horizontal deflection. (e) Band width of the recorder 0.5 to 40 Hz. (f) Triggering of a monitor alarm will automatically initiate the direct paper charting of the alarmed patient's ECG, as a minimum. Recording contain a minimum of twelve seconds of information at 25 mm/sec. (g) User able to initiate a strip chart recording of the trace information displayed on the associated waveform display devices. (26) Provided with a remote patient input device interface, capable of providing serial communication between data collection and communications systems and ultra-portable vital sign monitors. (27) Provided with a pulse oximeter, capable of monitoring oxygen saturation of functional arterial hemoglobin. Meet the following characteristics: (a) Display the following patient data: (1) Numeric oxygen percentage saturation level. (2) Waveform (plethysmograph), representative of minimum to maximum detectable oxygen saturation levels. (3) Patient's pulse rate detectable from pulsatile waveform; pulse rate can be used as an alternate heart rate source to display current patient heart rate. (4) Pulse amplitude meter. (5) Trend display of the last five (5) hours of oxygen saturation of oxygen saturation of functional arterial hemoglobin. (b) Oxygen saturation measurement range shall be from 0 to 100%. (c) Capable of monitoring both adult, pediatric, and neonatal patients. (d) Compatible with disposable and reusable digit, nasal, and reflectable sensors. (e) Equipped with an 8 foot (2.4 meter) extension cable. (f) Able to lock to ECG signals detected through the patient monitor ECG parameter. (g) Measurement response time selectable in three ranges: 2 to 3 seconds, 5 to 7 seconds, or 10 to 15 seconds. (h) Able to accurately measure oximetry on patients being noninvasively monitored for blood pressure. (i) Upper and lower alarm limits independently settable on minimum and maximum oxygen saturation levels and have the capability to trigger audible and visual indicators for oxygen saturation measurements which violate chosen high and low limits. The audible alarm able to be manually reset with one button push. A temporary alarm silence last no more than 90 seconds. (j) A reference pulse appear next to the plethysmograph waveform. (k) Pulse rate measurement range from 25 to 250 BPM with accuracy of plus or minus 3 BPM. (l) Automatically re-calibrate when first turned on and at least every 15 minutes thereafter. (m) Measurement data (waveform and numerics) printable. (n) Control of the oximeter in accordance with the patient's monitor protocol through menus and pushbuttons. Control allow selection of waveform size, indication if oximetry sensor is attached to the same limb as the blood pressure cuff, the measurement response time and selection of locking to ECG signals detected through the monitor's ECG leads. (o) Weigh less than 0.7 pounds (0.3 Kg). (p) A warning and caution message displayed to warn the operator of possible oximetry monitoring problems. (q) Provided with, but not limited to, two (2) each disposable pulse oximetry sensors. (28) Provided with but not limited to the following accessories: (a) Two (2) each ECG patient cables, 10 feet (3.03 meter) minimum length. (b) Three (3) each pre-gelled electrodes. (c) One (1) each adult NIBP cuff and associated tubing. (d) Two (2) each spare batteries. (e) One (1) each power adapter 100-240 VAC, 50/60 Hz, and IEC power cord for specified country. (29) Meet the electrical characteristics as stated in the latest addition of specification MIL-D-42048 (includes requirement for 110/220 volt, 50/60 Hz electric motor). (30) Fully provisioned in accordance with the DEPMEDS provisioning code "E" to include: DI-ILSS-80865 Medical Support Kit Lists. (31) Unit of issue: Each. (32) Operational and Service Data Manuals shall be furnished as follows: (a) Information Content: Furnish manuals, handbooks, and/or brochures containing complete operation, installation, and service/maintenance instructions (including pictures of illustrations, as necessary) with complete schematics and wiring diagrams. All manuals, handbooks, and/or brochures will be written in the English, and all schematics brochures will be written in the English, and all schematics and wiring diagrams will use American electrical and electronics symbols. Manuals will include electrical data and connection diagrams for all applicable utilities. Instructions shall also contain a complete list of all replaceable parts showing part number, name, and quantity required. All service notes, service memos, etc., pertaining to the equipment and issued subsequent to the printing of the original instructions shall also be included. These instructions shall be, as a minimum, those furnished to service engineers (or servicemen) who normally install and service the equipment for the company or distributor. When the system being procured includes, or will operate ancillary equipment, the service data shall include complete instructions and drawings which show interfacing of all system components. (b) Quantities, Distribution and Schedules: Two (2) complete sets of the above information shall be packaged with each unit of the required equipment. Where multiple quantities of the same unit are to be delivered to the same ultimate consignee, then only a total of two (2) service manuals need to be supplied to each consignee. However, two (2) operation manuals still need to be supplied with each unit. (33) Warranty. Standard Commercial Warranty shall be as specified. (34) Potential Patient Movement Items (PMI) considered for usage aboard military aircraft shall have a Joint Airworthiness Certification (JAC) consisting of a safe-to-fly letter from the U.S. Air Force and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification Letter from the U.S. Army. The potential PMI shall comply with the following JAC requirements. Military standards shall be interpreted as though all units of PMI could be used aboard military aircraft, and should comply. (a) Baseline Performance Assessment (MIL-STD-1472). (b) Electrical Safety (ANSI/AAMI ES1-1999). (c) Vibration Testing (MIL-STD-810F). (d) Electromagnetic Interference Testing (EMI): EMI/EMC MIL-STD-461E. (e) Climatic: Environmental (MIL-STD-810F). (f) Altitude (MIL-STD-810F, Method 500.4). (g) Rapid Decompression Testing (MIL-STD-810F, Method 500.4, Procedure III). (h) Explosive Atmosphere (MIL-STD-810F, Method 511.4 with Change Notice 1). (i) Acceleration (MIL-STD-810F, Method 513.5, Procedure III). (j) Flight Testing (MIL-STD-1472G). (k) Testing results will be expressed as Risk Assessment Codes (RAC) according to MIL-STD-882D. (l) Any equipment upgrades/modifications after the initial certification (JAC), must be reviewed by testing agency for re-certification. Regulatory Requirements: The vital signs monitor and all of its components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. Each Unit (System) to include all of the following items: (1) P/N: ENCORE 206 EL Description: Vital Signs Monitor w/ SP02 Expansion Module, Printer, 1 NIBP Cuff (Adult), EKG (5-LEAD) (2) P/N: 009-0669-00 Description: Soft Protective Case for Encore w/ Expansion module (3) P/N: 008-0040-98 Description: Thermal Paper (10 Rolls/CS) (4) P/N: 008-0419-01 Description: General Purpose Temperature Probe (Reusable) (5) P/N: 008-0324-00 Description: Cuff Kit (6) P/N: 900-0021-00 Description: Pulse Oximeter Probe DS 100A (7) P/N: 008-0742-00 Description: Extension Cable (8) P/N: 810-0867-05 Description: Operator?s Manual (2 per unit) (9) P/N: 810-1084-01 Description: Service Manual (2 per unit) This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 334510 with a Small Business Size Standard of 500 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received within 15 business days after publication of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to James Suerdieck at jdsuerdieck@nmlc.med.navy.mil. Statements are due by COB 02 MAY 06. No phone calls accepted.
- Place of Performance
- Address: Naval Medical Logistics Command, 1681 Nelson Street, Ft. Detrick, MD
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN01025814-W 20060413/060411221048 (fbodaily.com)
- Source
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