DOD A-A-54948-1994 SUCTION APPARATUS SURGICAL《外科吸力器械》.pdf

1、, A-A-54948 = 7779774 O363702 297 O 1 INCH-POUND 1 A-A-54948 29 April 1994 COMMERCIAL ITEM DESCRIPTION SUCTION APPARATUS, SURGICAL (Gastrointestinal Abdominal Drainage) (Programmable, Battery or AC Operated) The General Services Administration has authorized the use of this Commercial Item Descripti

2、on. This Commercial Item Description covers three types of programmable, intermittent suction apparatuses for use during surgery. Salient Characteristics: The apparatus shall be in conformance with ASTM F 960 as applicable to surgical and ONT (Oral, Nasal, Tracheal) and gastrointestinal abdominal dr

3、ainage suction apparatus. Basic unit for Types I, II, and III. The unit shall be a programmable, intermittent suction apparatus for oral, nasal, and tracheal suctioning during surgery and post operative drainage. multiple power sources including a component battery. O The apparatus shall be capable

4、of operating from The suction apparatus shall consist of at least a programmable, intermittent suction system including battery, charger circuit, controls, luminous indicators, a vacuum gauge, a suitable clear patient suction tube at least 5 feet long by 1/4 inch ID, two operators manuals, two servi

5、ce manuals, two spare fuses for DC circuit (if fuse is used, otherwise a circuit breaker shall be incorporated into the DC circuit), one spare fuse for AC circuit (if fuse is used, otherwise a circuit breaker shall be incorporated into the AC circuit), and a disposable hydrophobic bacterial filter.

6、AMSC/NA FSC 6515 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. O Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54948 9999974 0363703 I123 . A-A-5 4 94 8 The suction apparatus shall be capable of operating usi

7、ng the following power sources: O component battery O external 12 VDC O 115/230 volt, 50/60 Hz AC The suction apparatus shall be capable of operating from any of the specified AC power sources while the internal battery is being charged via the component battery charging circuit. The power cord shal

8、l be a minimum of 6 feet long. The suction apparatus shall provide for a low and high range of vacuum. In the low range of vacuum, the unit shall be capable of being user programmed to provide any of at least 144 intermittent timing cycles. The selection of ON time periods shall be from 5 seconds th

9、rough 60 seconds in increments of 5 seconds. The OFF time period selection shall be the same as selection of ON time periods. The ON and OFF settings shall be independent of each other. When set to high range of vacuum, the unit shall provide the selected vacuum continuously. The ON/OFF timers shall

10、 be electronic. The apparatus shall be so designed that it shall be capable of being operated a minimum of 300 hours over a time period of 6 months without requiring calibration. The suction system shall provide for at least: Controls: O O O O O O O O O O Master power switch Power mode switch(s) Vac

11、uum mode switch Vacuum range switch Vacuum level switch ON time selector OFF time selector DC voltage protector AC voltage protector Safety lockout external/internal/charge intermittent/constant 1 ow / high OFF through highest setting 5 through 60 sec. 5 sec. incr. 5 through 60 sec. 5 sec. incr. fus

12、e or circuit breaker fuse or circuit breaker no intermittent in high range 2 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5494 = 9999974 0363704 ObT A-A-5 4 9 4 8 Switches may be electronic controls incorporating luminous indication of mode/po

13、sition. a Indicators: O Master power lamp * O External electrical power and recharge lamp * O Intermittent suction mode lamp * O Low vacuum ON lamp * O Vacuum gauge, dual scale, metric and English * * A lamp may be an electronic read-out of condition or otherwise luminous indication of condition. Mi

14、nimum capabilities with patient tube and either the specified component collection system or the specified compatible canister system in place: O Shall have a vacuum range of: 1. Operating on AC power, vacuum level range, selective from O to at least: a. High range, continuous vacuum, 550 mm Hg. b.

15、Low range, continuous and intermittent, 200 mm Hg. a 2. Operating on DC power, vacuum level range, selective from O to at least: a. High range, continuous vacuum, 550 mm Hg. b. Low range, continuous and intermittent, 120 mm Hg. O High range free air flow, patient end of 5 ft. x 1/4 in. ID tube, sele

16、ctive range from O Lpm to at least: 1. With the hydrophobic bacterial filter in place: a. 18 Lpm when operated on AC power. b. 16 Lprn when operated on DC power. 2. Without the filter attached: a. 30 Lpm when operated on AC power. b. 25 Lpm when operated on DC power. 3. Low range, free air flow, pat

17、ient end of 5 ft. x 1/4 in. ID tube, AC or DC power, with or without filter, selective within 10 percent, from 4 Lpm to 10 Lpm. Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-54948 9999974 0163705 TTb A-A- 5 4 9 4 8 O Battery operating time, 1 H

18、r., high range, 550 mm Hg O Depleted battery charge time, max. 16 hr., 22 deg. C plus O Intermittent low range provide at least 144 settings O Compatible with collection system defined in Type I O Compatible with mobile cart defined in Type II The basic unit shall be housed in a suitable case which

19、shall not be larger then 0.85 cubic feet and the combined weight shall not exceed 28 pounds. The case shall be corrosion- resistant or treated for corrosion resistance. Any painted surfaces shall have at least one coat of commercial paint over a suitably prepared surface. The finish shall be free of

20、 gaps, scratches, chips, and other imperfections. The enclosure for electrical circuitry, including attachment of controls and indicators shall be drip proof in accordance with Underwriters Laboratories, Inc. (UL) 50, Type 5. or minus 1 deg. Type I. Type I shall include a collection system. The coll

21、ection system shall include two collection canisters, a wall-mounting bracket system, and all required interconnecting tubing between canisters and the suction apparatus. The design of the unit shall allow easy removal and installation of the internal battery without extensive dismantling of the uni

22、t. The time required for the procedure to remove or install the battery(ies) by a person experienced at this operation shall not exceed 5 minutes. The procedure shall start and end with a completely assembled unit (less battery(ies) as appropriate). The procedure shall not include disconnection/remo

23、val of mechanical/electromechanical components or disconnection of electrical circuits other than plug type connection for the battery(ies). The operating manual shall provide instructions for removing and installing the battery(ies). The canisters shall have a volume of at least 1800 cc with a usab

24、le capacity of at least 1500 cc, capable of being autoclaved repeatedly at 250F, and shall be clear glass or clear plastic. The canisters shall be graduated in increments of not more than 100 cc/ml from zero to, at least, 1500 cc/ml. 4 Provided by IHSNot for ResaleNo reproduction or networking permi

25、tted without license from IHS-,-,-A-A-54948 9999974 0363706 932 A-A- 5 4 9 4 8 The design of the mounting bracket and collection canisters shall allow easy removal of canisters for emptying. The bracket system shall be compatible with the disposable canister assembly described in Commercial Item Des

26、cription (CID) A-A-51602 (latest issue as of date of this solicitation). In addition, the mounting bracket and collection system shall be compatible with the mobile cart described in Type II allowing attachment and detachment to/from the cart and alternately be attached to a wall. Tubing shall inclu

27、de a 10 foot length by 3/8 inch ID tube between the suction pump and the filter, and interconnecting tubes of appropriate length by, at least 1/4 inch ID. When the collection system is connected to the basic suction apparatus, the combined unit shall be a complete operating system for oral, nasal an

28、d tracheal suctioning. The combined weight of the suction apparatus and collection system shall not exceed 50 pounds. Type II. The Type II unit shall include a castered cart with a detachable mounting bracket system to secure the non- component collection system as described in Type I above. The mou

29、nting bracket system shall be compatible with the disposable canister system described in Commercial Item Description (CID) A-A-51602 (latest issue as of date of this solicitation). The mounting bracket system shall be capable of being detached and wall mounted. The bracket shall be compatible with

30、both the reusable collection system described in Type I and the disposable canister assembly described in CID A-A-51602. The cart shall include, at least, 4 swivel casters, two of which shall be lockable. The casters shall be, at least, 4 inches OD. The combined system of the basic suction apparatus

31、 and cart with mounting bracket shall be ready for mounting and connecting the collection system described in Type I or CID A-A-51602. The combined height shall be 40 inches (plus/minus 4 inches) and shall require a floor space of 18 inches (plus/minus 2 inches) by 18 inches (plus/minus 2 inches). T

32、he combined weight of the basic suction unit and cart with mounting bracket shall not exceed 67 pounds. 5 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A- 54 9 4 8 Type III. The Type III unit shall include a collection system as defined in Type I

33、 and a cart as defined in Type II except only one mounting bracket system is required to secure either of the collection systems. The combined weight shall not exceed 77 pounds. Workmanship. The suction apparatus shall be free from defects which detract from its appearance or impair its serviceabili

34、ty. Unit. Each (EA). One suction apparatus, as specified, constitutes one unit. The battery shall he packaged separately. Ouality Assurance Provisions. Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of al

35、l inspection requirements as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves

36、 the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements. Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contrac

37、tor and made available to the Government upon the Governments request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate. Inspection. Inspection, as used herein, is defined as both exa

38、mination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item. Samplinq for examination. Sampling for examination shall be conducted in accordance with

39、MIL-STD-105, with an AQL of 1.0 (percent defective) and an inspection level of I. The unit of product for examination purposes shall be one suction apparatus. Samplinq for tests. Sampling for tests, including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 1.0 (pe

40、rcent defective) and an inspection level of I. shall be one suction apparatus. The unit of product for test purposes 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5 4 94 8 Tests. Tests shall be conducted to determine compliance with specifica

41、tion requirements. Where feasib specification requirem shall be used for the determination of two or more test characteristics. Tests shall include, but shall not be limited to, the applicable tests in ASTM F960. O Metric products. Products manufactured to metric dimensions will be considered on an

42、equal basis with those manufactured using inch-pound units, providing they fall within the tolerances specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements of this document are met. If a product is manufactured to metric dimensions and

43、 those dimensions exceed the tolerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the product is acceptable. The contracting officer has the option of accepting or rejecting the product. Contractor certification. maintain substantiating ev

44、idence that the product offered meets the salient characteristics of this Medical Procurement Item Description, and that the product conforms to the producers own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conforma

45、nce prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. Requlatory requirements. The contractor shalP certify and Federal Food, Druq and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Admin

46、istration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor sh

47、all comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Federal

48、 Acquisition Regulation Subpart 23.4 to the maximum extent practical. 7 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A-A-5494 9999974 0163709 b41 A-A-54 9 4 8 Preservation, packaqinq, p ackinq, labelins, and markinq. Unless otherwise specified, pr

49、eservation, packaging, and packing shall be to a degree of protection to preclude damage to containers and/or contents thereof under normal shipping conditions, handling, etc:, involving shipment from the supply source to the receiving activity, plus reshipment from receiving activity, and shall conform to applicable carriers rules and regulations. Intermediate and exterior package quantities and labeling and marking shall be as specified in