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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 31, 2015 FBO #4937
DOCUMENT

65 -- RADIO FREQUENCY GENERATOR - Attachment

Notice Date

5/29/2015
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25815Q0517
 

Response Due

6/12/2015
 

Archive Date

8/11/2015
 

Point of Contact

Johanne Gingras
 

E-Mail Address

ns
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) Neurotherm Radiofrequency Generators Contracting Officer fills out blue text. Contract Number:(completed by the CO at time of award) Task Order Number:(completed by the CO at time of award if a TO) IFCAP Tracking Number: Follow-on to Contract and Task Order Number:N/A 1.Contracting Officer's Representative (COR). Name: Section:Anesthesiology Service Address:1501 San Pedro SE, Albuquerque, NM 87108 Phone Number: Fax Number: E-Mail Address: 2. Contract Title. This is a request to purchase 2 Neurotherm Radiofrequency Generators 3. Background. Radiofrequency ablation (RFA) is a medical procedure in which part of the nervous system or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current (in the range of 350-500 kHz). RFA is generally conducted in the outpatient setting, using either local anesthesia or conscious sedation. Two important advantages of RFA current are that it does not directly stimulate nerves or heart muscle and therefore can often be used without the need for general anesthesia, and that it is very specific for treating the desired tissue without significant collateral damage. The Pain Service uses RFA on a daily basis and would need this/these units ASAP, as their schedule is full. 4. Scope. This is a request for 2 Neurotherm Radiofrequency Generators. The pain Service presently owns 2 Smith and Nephew RF generators. One of the generators is marginally functioning, with a failure rate of approx. 50%. It can't be determined if the unit will fail until it is placed used on a patient, requiring an invasive procedure on a sedated patient. Neither unit is not repairable should it fail. Biomed has researched a looked at the 2 units and determined that they are not serviceable. Brand Name or Equal: Neurotherm Radiofrequency Generators 5. Specific Tasks. a)Provide the NMVAHCS with "brand name or equal" acquisition of CCO Equipment. Additional information to include part number, order number and description is identified in the product information. b)Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting officer: 3 TECHNICAL DATA 3.1SPECIFICATION 3.1.1SIZE Width370 mm (14.5") Height320 mm (12.6") :jDepth430 mm (17.0").1Weight11.4 Kg(25.08 lbs.) 3.1.2ELECTRICAL 3.1.2.1VOLTAGE INPUT Europe210-260 Volt50Hz - 60Hz Fused 1 Amp on live and neutral USA/Canada90-125 Volt60Hz - 50Hz Fused 2 Amp on live and neutral Voltage Change.via rear connector 3.1.2.2POWER SUPPLY AND GROUNDING Power Consumption150 VA The power supply is built to Class 2 Standard. The mains transformer and all mains-related parts are double insulated from the main enclosure. The mains transformer has separate isolated bobbins for mains and low voltage windings. Poly switches are fitted into all primary and secondary windings. The enclosure and exposed parts are not connected to mains ground (class 2). 3.1.3STANDARDS This machine complies with: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1:1988 + A1 :1991 + A2:1995 IEC 60601-1-4: 1996 (First Ed.) + Am.1: 1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts 1 (1991) and 2 (1995) IEC 60601-1-6:2010 IEC 60601-1-6: 2004 IEC 60601-2-2: 2009 IEC 60601-2-2:2006 With respect to electrical shock, fire, and mechanical hazards only in accordance with UL 60601-1, IEC 60601-1, CAN/CSA C22.2 No. 601.1 and IEC 60601-2-2. 3.1.4IMPEDANCE Measuring Frequency460 KHz ( ± 3 %) Measuring PowerLess than 200 mW Measurement Display0-2000 O (1 O resolution) Accuracy20-199 0 ± 20%; 200-799 0 ±10% 800-2000 0 ±10% Features (a) Internal 200 0 Test Resistor (b) Impedance in all Lesion Modes and in Stimulation Standby Mode (c) Audible tone available in Cordotomy Stimulation Mode where frequency varies with impedance over full impedance range (20-2000 0). Audible tone is adjustable and mutable. 3.1.5STIMULATION MODE Signal ShapeBiphasic square wave with negative edge leading. This wave is available in a variety of frequencies and widths. Output Range Voltage: 0-5 V ± 3% for motor frequencies (2Hz and 5 Hz) 0-5 V ± 5% (default for all other frequencies) 0.5 V ± 5% Stimulation Load Regulation : ± 5% into 50-2000 0 Pulse RatesMotor: 2 or 5 Hz (default 2Hz) Sensory Pulse: 10, 20, 50, 75, 100, 150, 180, 200 Hz (default 50 Hz) Rate Accuracy: ± 3% Pulse Widths: 0.1, 0.2, 0.5, and 1.0 mS (default 1.0 mS) Pulse Width Accuracy: ± 3% 3.1.6STIMULATE FEATURES (a)Hardware and software lockout if voltage I current · not initially set to zero} (b)Warning on screen if stimulation control is not initially at zero (c)Flashing LED on front panel indicates machine is delivering stimulation pulses (d)Stimulation test socket is provided on front of machine to interface with the standard stimulation test kit (e)Various screen displays for displaying amplitude of each stimulation procedure 3.1.7LESION MODE RF Waveform460 KHz ± 3% sinusoidal Power Output (1-4 Electrodes): Continuously variable. Maximum power output SO W into 100 n. Maximum Power Output Limit: Maximum total power output (the sum of all the RF power entering the patient from all active electrodes) is hardware and software-limited to SO W total. This power is distributed as necessary to raise the electrodes to the desired set temperature. Depending on physiological conditions, different electrodes can have different power delivered to them. The only constraint is that the total power never exceeds 50W. Voltage Display on Screen:0-99 RF V (RMS) 80V Max Current Display on Screen:0-999 RF mA (RMS) Self Test:200ohm dummy load resistor built into machine LED Indicator:LED flashes when Lesion Power is being delivered Temperature Range:Selectable SO - 90 °C ±2 °C for Thermal Lesion (default 80 °C) and selectable in S °C steps in initial screen setups.Selectable in 1 °C steps when in Lesion Mode, using 'Temp Up' and 'Temp Down' buttons. (Output is disabled if temperature is above 98 °C.) Timer:Selectable 0-600 seconds (default 60 seconds) Selectable in 30-second steps in initial screen set-ups Selectable in 1-second steps when in Lesion Mode using 'Time Up' and 'Time Down' buttons Special Temperature Profiles:One preset profile - Default - is programmed into the generator. The user can also program nine custom profiles. Lesion StartLesion timer starts as soon as temperature is within 5deg c of desired temperature. 3.1.8PULSED RF MODE (1-4 ELECTRODES} Pulsed WaveformSinusoidal RF waves Pulse Widths5ms, 8ms, 20ms, 50 ms (default 20 ms) Pulse Rates1Hz, 2Hz, 5Hz, 10 Hz, (default 2 Hz) Temperature LimitSelectable 42-90 °C range ±2 °C (default 42 °C) TimeSelectable 0 to 600 seconds (default 240 seconds) Set Voltage RangePulsed RF can be carried out in Auto Mode at fixed voltages. Voltage range 30-75 V (default 45 V). 3.1.9CUSTOM PROFILE One Custom Profile and nine Programmable Profiles 3.1.10PULSED DOSE MODE (1-4 ELECTRODES} In Pulsed Dose Mode, the numbers of pulses of RF are counted until the full quantity of pulses have been delivered to the patient. Pulsed Dose Procedures are carried out in Auto Mode. Temperature Range:42-90 °C ± 2 °C (Default 42 °C) Pulse Counts120-960 count (Default 240 counts) Pulse Rates: 1Hz, 2Hz, 5Hz, 1OHz, (default 2Hz) Pulse Widths.5ms, 8 ms, 20 ms, 50 ms (default 20 ms) Set Voltage Range:Pulsed Dose RF can be carried out in Auto Mode at fixed voltages. Voltage range 30-75 Volts (default 45 Volts). Note:When the electrode reaches set temperature, the RF power is switched off and the count is stopped. When the temperature is below the set temperature, the counter will start and the RF power is switched on. This will ensure only full RF pulse bursts are delivered to the patient. The procedure will end when the total selected number of pulses is reached. 3.1.11SIMPLICITY IIAND SIMPLICITY Ill This algorithm is used with a two or three-electrode probe and can be used in Radiofrequency Lesion treatment to shape lesion sizes. For Simplicity II,the lesion sequence consists of a Dual electrode lesion between electrodes 1 and 2, a monopolar lesion between electrode 1 and the grounding pad, and a monopolar lesion between electrode 2 and the grounding pad. There is a short time delay between the Dual lesion to allow for a reduction in temperature in the lesion area. For Simplicity Ill, the lesion sequence consists of a Dual electrode lesion between electrodes 1 and 2, a Dual electrode lesion between electrodes 2 and 3, a monopolar lesion between electrode 1 and the grounding pad, a monopolar lesion between electrode 2 and the grounding pad, and lastly a monopolar lesion between electrode 3 and the grounding pad. There is a short time delay between the Dual lesions to allow for a reduction in temperature in the lesion area. Note: The NT2000iX will automatically disconnect the grounding pad from the patient during the Dual Electrode section of this procedure. 3.1.12MULTIPLE PROBES The NT2000iX can be operated with 1, 2, 3, or 4 probes. When in Stimulation Mode, each probe is selected by the operator for Stimulation. In RF Lesion, Pulse RF, or Pulsed Dose Mode, the generator energizes all connected probes with a control circuit to limit the total RF output to a maximum of 50 Watts. In multiple probe operation, all pulse rates are available. Features: (a) Hardware and Software lockout if RF Power Control not initially set to zero during Manual Mode (b) LED Flashes on front panel to indicate machine is delivering power {c) Four output sockets to accept a variety of probes {d) Hardware lockout if temperature exceeds 98 °C {e) Operation of the "Stop" button sets the generator to a safe state Note: Independent procedure settings are not settable on individual channels. 3.2 GROUND LEAKAGE Typical Maximum Allowable 1Enclosure Leakage Current 40 microamps 100 microamps Normal Reverse40 microamps100 microamps Single Fault Condition Normal40 microamps500 microamps Reverse40 microamps500 microamps 2Patient Leakage Current 5 microamps 100 microamps Normal (AC) Reverse (AC)4 microamps100 microamps Single Fault Condition Normal (AC)7 microamps500 microamps Reverse (AC)7 microamps500 microamps 3Patient Leakage Current 4 microamps 10 microamps Normal (DC) Reverse (DC)4 microamps10 microamps Single Fault Condition Normal (DC)4 microamps50 microamps Reverse (DC)4 microamps50 microamos 4Patient Auxiliary Leakage Current 4 microamps 100 microamps Normal (AC) Reverse (AC)4 microamps100 microamps Single Fault Condition Normal (AC)6 microamps500 microamps Reverse (AC)6 microamps500 microamps 5Patient Auxiliary Leakage Current 4 microamps 10 microamps Normal (DC) Reverse (DC)4 microamps10 microamps Single Fault Condition Normal (DC)4 microamps50 microamps Reverse (DC)4 microamps50 microamos 6Patient Leakage Floating Type 27 microamps 5000 microamps Normal Reverse27 microamps5000 microamps Single Fault Condition Normal36 microamps5000 microamps Reverse35 microamps5000 microamps Note: Leakage measurements must be made as is appropriate for Class II design. See Section 20.2 Electrode Connections for more information referring to how leakage measurements were attained. 3.3REQUIRED ENVIRONMENTAL CONDITIONS 1 Transport Temperature Humidity Pressure -10 °C to 70 °C 0-95% RH 140-760 mm Hg Non-Condensing (0-12,200 metres) (0-40,000 ft.) 2 Storage Temperature Humidity Pressure 10 °C to 60 °C 10 to 80% RH 520-760 mm Hg (0-3000 metres) (0-10,000 ft.) 3 Operating Temperature Humidity Pressure 10 °C to 40 °C 10 to 80% RH 520-760 mm Hg (0-3000 metres) (0-10,000 ft.) 3.4DUTY CYCLE RATINGS Maximum number of days use per year220 days Maximum average RF power output shall be 25W10 minute period Realistic maximum number of days use per year150 days Realistic maximum hours active use per day2 hours Realistic hours standby per day10 hours Minimum operating life5 years Product production life7 years Maximum Duty Cycle10 minutes ON, 10 minutes OFF c)Clearly describe any modifications the offer or plans to make a product to make it conform to the solicitation requirements None d)Provide brand name product referenced in the solicitation, unless it can clearly be shown by the vendor that the product being offered is "equal." 5.1 Task 1 - Enterprise Management Controls N/A Deliverables: N/A 5.2 Task 2. N/A 5.2.1 Subtask 1. N/A 5.2.2 Subtask 2. N/A Deliverables: N/A 6. Performance Monitoring The Contracting Officer Representative will work with Contracting Officer (CO) to ensure right equipment is procured through appropriate channels in accordance with the VAAR/FAR. 7. Security Requirements This contract will not require access to "VA sensitive information." Vendor personnel will not perform any functions requiring access to a VA system or VA sensitive information (e.g., system administrator privileged access to a VA system, or contractor systems or processes that utilize VA sensitive information). Any security violations or attempted violations shall be reported to the COR immediately upon detection. The Contractor shall adhere to applicable VA policies and procedures governing information security, especially those that pertain to certification and accreditation. The C&A requirements do not apply, and that a Security Accreditation Package is not required. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A 9. Other Pertinent Information or Special Considerations. a. Identification of Possible Follow-on Work. N/A b. Identification of Potential Conflicts of Interest (COI). N/A c. Identification of Non-Disclosure Requirements. N/A d. Packaging, Packing and Shipping Instructions. The equipment will need to be delivered to Bldg 46, Logistics/receiving Department e. Inspection and Acceptance Criteria. All items should be free of defects. The COR will oversee receipt, inspections and accountability for non-expendable equipment. 10. Risk Control The staff is trained in the equipment operational procedures. 11. Place of Performance. The Raymond G. Murphy VA Health Care Center ICUs/Anesthesiology Service 12. Period of Performance. N/A 13. Delivery Schedule. Request delivery ASAP
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815Q0517/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-Q-0517 VA258-15-Q-0517_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2077119&FileName=VA258-15-Q-0517-002.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2077119&FileName=VA258-15-Q-0517-002.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Veterans Health Administration;New Mexico VAHCS;1501 San Pedro Dr SE;Albuquerque, NM 87108

Zip Code: 87108
 

Record

SN03746686-W 20150531/150529234754-6cd5da5ede3be4852228525c835531f0 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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