"URO-BIOFON" urogenital apparatus for IR-therapy

Specifications

1 Specifications.

1.1 The apparatus should comply with ÃÎÑÒ P 50444, these specifications requirements and the ÅÈ-Þ. 941527.001 set of documentation.

1.2 Basic parameters and dimensions

1.2.1 The apparatus should be operated from the internal power source with voltage 2,8 to 3,2V.

1.2.2 Amperage expendable by the apparatus should be not more than 100mA.

1.2.3 The apparatus weight should be not more than 0,5 kg.

1.2.4. Dimensions of the apparatus should be not more than 155x85x30mm.

1.2.5 The apparatus should contain the infrared radiation source with the spectrum range 0,8-h30 microns.

1.2.6 The radiated power at the angle (50±10)° should be within 0,1 to 1,0 mW.

1.2.7 Duration of a treatment session should be 24±1s.

1.2.8 The IR-radiation should be at the first 12±1s of a treatment session.

1.2.9 The average feed amperage of the light emitting diode is (8±1)A.

1.2.10 The apparatus should provide control and indication on the built-in sign indicator:

• treatment session duration;

• number of treatment sessions undertaken;

• power source discharge.

1.2.11 The apparatus should provide light indication of switching on, beginning and ending of a procedure, finishing of the radiation mode as well as sound signalling at the beginning and end of the procedure.

1.3 Characteristics

1.3.1 Time period to set up the operating mode of the apparatus after switching on should not be more than 1s.

1.3.2 The apparatus should provide for continuous operating mode until the batteries discharge.

1.3.3 Mounting of electrical components is according to ÐÄÒ 25-106.

1.3.4 Outer surfaces of the apparatus should withstand multiple disinfection (according to ÎÑÒ 42-21-2) with 3% solution of hydrogen peroxide (according to ÃÎÑÒ 177) with an addition of 0,5% detergent of the LOTUS type (according to ÃÎÑÒ 25644) or 1% solution of toluene sulphonchloramide (according to ÒÓ 6-01-4689387-16).

1.3.5 In operation the apparatus should be resistant to the effect of climatic factors according to ÃÎÑÒ 15150 and ÃÎÑÒ P 50444 for the products of the ÓÕË 4.2. climatic performance type.

1.3.6 At transportation the apparatus should resist the effect of climatic factors according to ÃÎÑÒ 15150 for the storage condition 5.

1.3.7 As to the stability against mechanical effects in operation the apparatus falls into group 2 according to ÃÎÑÒ P 50444.

1.3.8 The apparatus in the transportation package should be stable against mechanical effects in conditions of transportation according to ÃÎÑÒ P 50444.

1.3.9 Average time between failures should be not less than 2000 hours. Failure criterion is non-conformance to items 1.2.7., 1.2.9. As to failure results, the apparatus falls into grade B according to ÐÄ 50-707 and ÃÎÑÒ P 50444.

1.3.10 Average service life of the apparatus should be not less than 5 years at average operation rate of 8 hours per day. Criterion of limiting condition of the apparatus is impossibility or technological inexpediency of recovering the operable condition.

1.3.11 Maintainability of the apparatus should meet the requirements of ÐÄ 50-707. Average recovering period should be not more than 1 hour. The apparatus design should provide for easy access to fail-to-danger parts and assembly units.

1.4 Safety Requirements

1.4.1 On electrosafety the apparatus should meet the requirements of ÃÎÑÒ P 50267.0 for units with the internal B type power source.

1.5 Completeness

1.5.1. The complete set of delivery should comply with table 1.

Table 1

1.6 Marks

1.6.1 Marks according to ÃÎÑÒ P 50444, ÃÎÑÒ P 50267.0, taking into account the requirements of ÃÎÑÒ 26828.

1.6.2 In accordance with Design Documentation on each item there should be specified the following:

• the Manufacturers trade mark;

• the product description;

• the ES designation;

• the year of production;

• the product number;

• the type symbol.

1.6.3 Marks on the transportation box should comply with ÃÎÑÒ P 50444. The box should be marked with handle signs, as well as indication of storage conditions according to ÃÎÑÒ 15150.

1.7 Packaging

1.7.1 Packaging is according to ÃÎÑÒ 15150.

1.7.2 Each item should be packed in a separate container providing its safety at transportation and storage and consisting of a polyethylene pack, a cardboard box and amortisation gaskets.

1.7.3 The maintenance documentation should be enclosed with the apparatus in a pack of polyethylene film according to ÃÎÑÒ P 50444.

1.7.4 Packing list according to ÃÎÑÒ P 50444 should be enclosed in each separate place.

2 Acceptance Requirements

2.1 General

2.1.1 Acceptance requirements and testing according to ÃÎÑÒ P 50444 and in the safety part according to ÐÄ 50-707.

2.1.2 The apparatus should be subject to the following types of tests:

• acceptance tests;

• periodic tests;

• qualification tests (set series tests);

• standard tests;

• reliability audit tests;

• certification tests.

2.1.3 Tests on items 1.2.5. and 1.2.6. are carried out on the stage of qualification tests, and further with standard tests.

2.1.4 The apparatuses presented to the warehouse of finished products should be accepted by the Manufacturer on the items of acceptance tests.

2.2 Acceptance tests.

2.2.1 Acceptance tests are carried out in order to inspect the apparatus for compliance with the requirements of these ES.

2.2.2 Each apparatus should be subject to acceptance tests.

2.2.3 Scope and proper sequence of acceptance tests shall comply with those specified in table 2.

2.2.4 If non-conformance of the apparatus with at least one item of the requirements from table 2 is proved on acceptance testing, test data are considered to be unsatisfactory and the apparatus is disqualified. After defect elimination the product is subject to the second engineering inspection.

Depending on the defect mode it is allowed to carry out re-testing only on the non-conformance items and the items on which acceptance tests have not been performed.

If the apparatus is again, it is not subject to the third inspection. The question of using fit components of the apparatus is decided by the Manufacturer's management staff.

2.2.5 Records in the certificate or the operating manual should be done for the devices accepted by the respective service.

2.3 Periodic tests

2.3.1 Only those apparatuses passed acceptance tests and packed for shipment are subject to periodic tests.

2.3.2 Periodic tests are carried out once a year exclusive of testing the stability against climatic and mechanical effects in operation and operational capability in the required mode of working (items 1.3.2., 1.3.5., 1.3.7.) which are carried out 3 times a year, and testing the stability against climatic factors at transportation (items 1.3.6., 1.3.8.) which are carried out on samples from set series and on standard testing. If an average production is less than 30 items per year, it is allowed to carry out all types of periodic tests once in three years.

2.3.3 Minimum sample number for testing is according to ÃÎÑÒ P 50444.

2.3.4 Number and order of carrying out the periodic tests shall satisfy the requirements of table 2.

2.3.5 The results of periodic testing are considered to be satisfactory, if all the selected apparatuses satisfy the requirements of these ES given in table 2.

Single breakdowns of electrical components cannot be the cause for interrupting the tests. After carrying out fault analysis and, if this has not been caused by design and product arrangement defects, faulty components are replaced and testing is continued. If failures of the same electrical components are repeated, acceptance and shipment of the product is stopped until failure cause is proved and eliminated.

2.3.6 On obtaining unsatisfactory periodic testing results on at least one point of the requirements from table 2 the products are subject to repeated periodic tests on doubled sample number. Repeated testing is carried out only on the non-conformance items and the items on which testing has not been performed.

If on carrying out repeated periodic testing the product non-conformance to the ES requirements is proved, the periodic testing results are considered to be final and all non-shipped products shall be returned for repeated testing.

Prior to resuming the shipment new tests proving defect elimination and compliance with these ES requirements shall be undertaken.

2.3.7 The periodic testing results are recorded in the protocol in due order.

2.4 Reliability Testing

2.4.1 Infallibility testing (item1.3.18) are carried out within qualification tests and further not less than once in three years.

2.5 Infallibility control testing should be carried out with a single-stage control method for exponential failure law according to ÐÄ 50-707(by under-control operation).

2.5.1 Checkout of average time between failures.

Initial data for planning the tests are:

• the plan code B3-3

• the manufacturers risk α=0,2

• probability of accepting a bad product β=0,2

• rejection level of time between failures, h Ò_β= 2000

• acceptance level of time between failures, h T_α= 5570

• total testing duration, h t_max = 8550

• sample number, pc N = 9

• test time for each sample, h t₁ = 950

• limit number of failures n_lim = 3

2.5.2 Checkout of average life time (item 1.3.19) is carried out on batch production samples by under-control operation method not later than the first release year, and further at standard tests.

Initial data for planning the tests are:

• the manufacturer's risk α = 0,2

• probability of accepting a bad product β = 0,2

• rejection probability level, % P_β = 0,5

• acceptance probability level, % P_α = 0,85

• number of tested samples, pc N = 5

• test duration, years T_p = 5

• acceptance number C_α = 1

2.5.3 Checkout of average make-up time (item 1.3.20) is carried out on sample production phase.

Initial data for planning the tests are:

• the plan code B3-3

• rejection value of make-up time, h T_Hβ = 1

• acceptance value of make-up time, h T_Hα = 0.36

• max total make-up time, h t_∑ = 1,54

• limit number of make-ups, n_lim = 3

3 Test methods

3.1 All tests of the apparatus are carried out in standard climatic conditions according to ÃÎÑÒ 15150 and feed voltage (2,8 h 3.2) B, exclusive of those particularly specified in this section.

The list of equipment and instruments necessary for testing is given in Appendix B.

3.2 Inspection of the apparatus conformance to the set of engineering documentation (item 1.1.) is carried out at process control inspection in the way of comparison with the documentation and at receiving inspection of purchased products by checking compliance with the documentation requirements.

3.3 Checkout of completeness (item 1.5.), marking (item 1.6) and packaging (item 1.7.) is carried out by outer examination and checking the documentation.

3.4 Weight control (item 1.2.3) is performed by weighing on weights with a limit up to 1 kg with a value of division not more than 0,1 kg.

3.5 Inspection of dimensions (item 1.2.4) is carried out with the instrumentation with error not more than ±1 mm.

3.6 Control methods for mounting of electrical components (item 1.3.10) is according to ÐÄT 25-106.

3.7 Testing of electrosafety (item 1.4.1) is according to ÃÎÑÒ P 50267.0 for products with inner power source of type B.

3.8 Testing the stability of outer surfaces of the apparatus against disinfection (item 1.3.13) is carried out according to ÎÑÒ 42-21-2 by fivefold cleansing of outer surfaces with a gauze cloth wetted with a disinfecting agent specified in item 1.3.10. at intervals of 10 h 15 min. The cloth should be squeezed out.

Outer surface appearance after five testing runs shall not change.

3.9 Testing the time of setting the operating mode from the moment of switching on the apparatus (item 1.3.8.) is carried out with a mechanical stop watch of the 2nd category according to ÑÎÏð-2à-à-010 ÒÓ 25-1819-0021.

3.10 Testing the spectral range of radiation (item 1.2.5) is carried out by checking this ES requirements and the documentation for the IR-radiation source.

3.11 Testing the radiated power of light emitting diode (item 1.2.6) is carried out with a thermal radiation receiver of ÈÌÎ-2 type. The apparatus in assembly with the light emitting diode and the radiation receiver are located so that the meter receiving area is seen from the light emitting diode at the angle (50±10)° and the emitter optical axis goes through the centre of the receiver. A transparent glass plate is located in front of the receiving area to avoid heat convection to the receiver. Direct current (8 ±11) mA is transmitted through the light emitting diode during not less than 1 min and the radiation power is measured. It should be within the limits (0,09 +0,9) mW taking into account the 10% of glass plate reflection. It is allowed to perform the diode power measuring without the apparatus and with the similar power source.

3.12 Checkout of session duration (item 1.2.7) and radiating time of the light emitting diode(item 1.2.8) is carried out with a mechanical stop watch of the 2nd category according to ÑÎÏð-2à-à-010 ÒÓ 25-1819-0021. For this it is necessary to press the "ÑÅÀÍÑ" button and switch on the stop watch at the same time with the sound signal of the procedure beginning. Note the radiating time of the light emitting diode by intermediate indication and end-of-session time by the sound signal.

3.13 Testing the average feed amperage of the light emitting diode (item 1.2.9) is performed with a direct current milliammeter connected sequentially in the light diode feed circuit. It is allowed to carry out this measuring at in-process check.

3.14 Checkout of control and indication (item 1.2.10) on the light display is carried out by visual examination. This test is made together with a functional check of the apparatus on changing feed voltage (item 3.17.).

3.15 Checking the operation of light and sound signalling (item 1.2.11) is carried out by examination during testing according to item 3.12.

3.16 Operational capability in the required mode (item 1.3.2) is checked in the way of performing serial treatment sessions until the battery discharge symbol appears on the display. The test results are considered to be positive, if the product is operable in testing. This test can be carried out on any testing stage.

3.17 Operational capability of the apparatus on changing the voltage (item 1.2.1) is checked at the voltage values 2,8 and 3,2V. Voltage is tested with a direct current voltmeter of precision category not less than 1,5 according to ÃÎÑÒ 8711. The apparatus is checked for conformance to the requirements on items 1.2.7., 1.2.9.

3.18 Expendable amperage (item 1.2.2.) is checked at the voltage 3,0V with the direct current ammeter with the measuring range 0,1A and precision category not less than 1,5 according to ÃÎÑÒ 8711.

3.19 Methods of testing the resistance to the effect of climatic factors in operation (item 1.3.5.) are according to ÃÎÑÒ P 50444.

Time of keeping in the chamber after setting up the temperature is 2 hours. Conformance of the apparatus to items 1.2.7. and 1.2.9. is checked.

3.20 Methods of testing the stability against effect of climatic factors in transportation (item 1.3.6.) are according to ÃÎÑÒ P 50444.

Thermal stability and cold resistance are checked at temperatures +50 and -50°C, test duration is 2 h (after setting up the temperature).

Moisture resistance is checked on the cyclic mode (method 1).

After each type of tests the apparatus is kept for 12 hours in standard conditions and checked for conformance to the requirements of items 1.2.7. and 1.2.9.

3.21 Methods of testing the stability against mechanical effects in operation and transportation (item 1.3.7., 1.3.8.) are according to ÃÎÑÒ P 50444.

The testing results are considered to be satisfactory, if the apparatus meets the requirements of items 1.2.7. and 1.2.9. after testing and there are no mechanical defects.

3.22 Checking of reliability indices (item 1.3.9.) is carried out according to ÐÄ 50-707 and the plan given in item 2.5.1. of these Engineering Specifications.

Failure criteria control is carried out each 320 hours. The apparatus complies with the criteria, if r<3, and it does not, if r>3.

3.23 The apparatus durability (RAMD) control (item 1.3.10.) is carried out in the way of under-control operation according to the plans of item 2.5.2.

The apparatus meets the requirements, if r<1, and it does not, if r>1.

3.24 Checking the maintainability (QRM) requirements to the apparatus (item 1.3.11.) is carried out by the expert examination according to ÐÄ50-707.

Checkout of average make-up time is carried out according to the plan of item 2.5.3 of these Engineering Specifications.

Testing is carried on until getting 3 failures. A go decision is made, if the total make-up time is not more than 1,54 h.

4 Storage and transportation

4.1 Transportation of apparatuses in the manufacturer's packing can be performed by all types of covered transport, exclusive of not heated bays of aeroplanes and sea transport, in accordance with ÃÎÑÒ P 50444 and shipment regulations in force at all types of transport.

4.2 The apparatus transportation conditions are according to storage conditions 5 to ÃÎÑÒ 15150.

4.3 The apparatuses should be stored in the manufacturer's packing according to storage conditions 2 to ÃÎÑÒ 15150. Shelf-life without represervation is 1 year.

4.4 After keeping the apparatus at below-zero temperatures it should be kept in room temperature for an hour, and only after that it could be in use again.

5 Operation instructions

5.1 After transportation at the conditions of law temperatures the apparatus should be kept in the transportation packing at normal climatic conditions no less than 12 h.

5.2 The apparatus should be operated in accordance with the instructions given in the Operating Manual.

Appendix A

List of documents referred to in the Engineering Specifications (exclusive of those given in Appendix B).

Appendix B

List of materials and equipment necessary for the product control.