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Test Limits

Appendix

Test Limits

BS EN 60601 (IEC601) Leakage

Type

Applied
Parts

Type

BF
Applied
Parts

Type

CF
Applied
Parts

Normal

SFC

Normal SFC

Earth
Leakage

0.5mA 1mA 0.5mA 1mA 0.5mA 1mA

Enclosure
Leakage

0.1mA

0.5mA 0.1mA 0.5mA 0.1mA 0.5mA

Patient
Leakage (dc)

0.01mA 0.05mA 0.01mA 0.05mA 0.01mA 0.05mA

Patient
Leakage (ac)

0.1mA 0.5mA 0.1mA 0.5mA 0.01mA 0.05mA

Patient
Leakage (F-Type)

---- ---- ---- 5mA

---- 0.05mA

Patient SIP/SOP
Leakage

---- 5mA

---- ---- ---- ----

Patient Auxiliary
Leakage (dc)

0.01mA 0.05mA 0.01mA 0.05mA 0.01mA 0.05mA

Patient Auxiliary
Leakage (ac)

0.1mA 0.5mA 0.1mA 0.5mA 0.01mA 0.05mA

Содержание Rigel 266 Plus

Страница 1: ...Rigel 266 Plus Compact Electrical Medical Safety Analyser Instruction Manual 350A555 Issue 1 0 February 2006 2006 Seaward Electronic Ltd Issue 1 0...

Страница 2: ......

Страница 3: ...ically mechanically by photocopying recording or in any manner without prior written consent from SEAWARD Electronic Limited This also applies to accompanying drawings and diagrams Due to a policy of...

Страница 4: ...nt Type 17 Earth Continuity Tests 17 Insulation Tests 18 Powered Tests 20 Load Test 20 Earth Leakage Test 22 Earth Leakage normal condition 23 Earth Leakage single fault supply open 23 Enclosure Leaka...

Страница 5: ...YSER 46 Cleaning the Analyser 46 User Maintenance 46 CHAPTER 6 ACCESSORIES 48 Standard Accessories 48 Optional Accessories 48 CHAPTER 7 SPECIFICATIONS 49 AC Earth Bond Test 49 Insulation Test 49 Earth...

Страница 6: ...onforms with Electromagnetic Compatibility Directive 89 336 EEC and Low Voltage Directive 73 23 EEC Standards used EN 60601 1 1990 Medical Electrical Equipment General Requirements for Safety EN 61010...

Страница 7: ...icate 2 Read the operating instructions fully before conducting any tests 3 Contact Rigel Medical if you require training on this Analyser or any other Rigel Medical product Courses can be arranged at...

Страница 8: ...he user is familiar with the instructions covering the capabilities and operation of this instrument The user should ensure that all reasonable safety precautions are followed and if any doubt exists...

Страница 9: ...is manual is read fully before proceeding with any tests Should the Analyser behave abnormally do not continue with the testing Disconnect immediately and contact Rigel Medical for servicing see Chapt...

Страница 10: ...e provided with innovative features to aid difficult test situations which allow testing of a wide variety of equipment The Analyser combines state of the art testability with the following innovative...

Страница 11: ...our compact medical safety analyser Item Number Part 1 Rigel 266 plus EMSA 2 Carrying case 3 Earth Bond Lead 4 Power cord Integral with the Rigel 266 plus 5 Applied Part Lead Set including Applied Par...

Страница 12: ...Keyboard Item Part 1 Rotary Test Selection Switch 2 Semiautomatic Mode Up Down Cursor keys Manual Mode UP SFC Neutral Open DOWN SFC Earth Open DOWN SFC Mains on AP 3 Semiautomatic Mode SELECT button...

Страница 13: ...he tester performs the SFC test automatically Manual Mode The User initiates the SFC tests Applied Part A part of the EUT that in normal use comes into contact with a patient SFC Single Fault Conditio...

Страница 14: ...rranged on the switch such that a clockwise rotation of the switch needed to perform a normal sequence of tests Arrow keys and allow for adjustment of test variables e g of the test time The Select ke...

Страница 15: ...on of the Analyser status a primary 4 digit 7 segment display along with a 4 digit secondary display and a 2 digit duration time display Test Icons Indicates the test selected Insulation Patient Auxil...

Страница 16: ...est sequence After a test this display compares the test result with standard limits During the leakage tests this displays the test being carried out in the test sequence This is indicated as a text...

Страница 17: ...Connecting the Analyser 15...

Страница 18: ...rent tests Earth Leakage Enclosure Leakage Patient Leakage Patient Leakage F Type Mains on AP Patient Leakage SIP SOP and Patient Auxiliary Current Rotate the switch to the appropriate leakage test Se...

Страница 19: ...ng the SELECT key will cause the equipment type to stop flashing indicating that the equipment class and type had been selected During tests where the equipment class and type is displayed the operato...

Страница 20: ...he mains supply plug and the earth bond test lead clip probe A high current is normally used to stress the connection under fault conditions The length of the test should be limited to prevent damage...

Страница 21: ...selected The Analyser displays the insulation resistance measured The Analyser can test either the EUT by itself or all the Applied Parts internally connected together Press the SELECT button and the...

Страница 22: ...sage appears allowing the user to continue This message will be displayed if a Live to Neutral short exists or the EUT mains current consumption is too high and if tests are continued the Analyser s f...

Страница 23: ...ets with the rated voltage of that socket The Analyser measures the power used by the appliance and displays the reading in kVA Power to the appliance can be set to remain on until the rotary switch i...

Страница 24: ...conditions neutral or earth open circuit is done automatically during the test The current test sequence step is shown on the lower display Should a test fail the Analyser will stop the automatic tes...

Страница 25: ...ion This test measures the earth leakage current under normal conditions The current is measured through the Measuring Device with S1 closed and S5 normal and then S5 reversed The maximum allowed valu...

Страница 26: ...uched the appliance This is based on the standard IEC601 body model The Analyser uses the earth bond probe to detect any current flowing on the appliance metalwork attached to an appropriate point on...

Страница 27: ...bond probe is used to make contact with all conductive non protectively earthed parts of the equipment Enclosure Leakage normal condition This test measures the enclosure leakage current under normal...

Страница 28: ...pen This test measures the enclosure leakage current with a single fault condition earth open The current is measured through the Measuring Device with S1 closed S8 open and S5 in normal and then S5 r...

Страница 29: ...detects any current flowing in the Applied Parts Lead The Analyser displays the result in milliamps mA To change the test duration press the SELECT key and then UP or DOWN keys The user can also sele...

Страница 30: ...type CF equipment the patient leakage current is measured from each part of the applied lead separately IEC601 1 amendment 2 specifies separate maximum allowed values for AC and DC current both of whi...

Страница 31: ...ss II n a n a n a Patient Leakage F Type Switch Position PATIENT F TYPE Test Icon Displayed Warning This test involves applying a current limited mains potential 110 of mains input voltage to the Appl...

Страница 32: ...user can toggle between different Patient Connections as required to take the individual measurements The selection of normal or reverse operation and single fault conditions neutral or earth open ci...

Страница 33: ...en conducting this test Current limiting is via a limiting resistor in series with the SIP SOP socket NOTE The Earth bond probe should not be used as part of these tests as this may affect the current...

Страница 34: ...nt the Single Fault Earth Open tests are skipped The test sequence is shown below Test Sequence Mains Single Fault 1 nS Normal Mains on SIP SOP Normal 2 nSr Normal Mains on SIP SOP Reversed 3 rS Rever...

Страница 35: ...hown dotted above The current is measured through the Measuring Device with S1 closed S8 closed and S5 and S9 normal and then S9 reversed The maximum allowed values are as follows Type B Type BF Type...

Страница 36: ...ient Connection or Applied Part prior to commencing the test When the test duration is set to UL unlimited the user can toggle between different Patient Connections as required to take the individual...

Страница 37: ...erated in unlimited test duration mode In this mode of operation the Start key must be pressed to stop the current test and pressed again to initiate the next test in the test sequence In this manner...

Страница 38: ...Device with S1 and S8 closed S5 normal and then S5 reversed The maximum allowed values are as follows Type B Type BF Type CF Class I DC 0 01 mA 0 01 mA 0 01 mA AC 0 1 mA 0 1 mA 0 01 mA Class II DC 0 0...

Страница 39: ...mA 0 05 mA 0 05 mA AC 0 5 mA 0 5 mA 0 05 mA Class II n a n a n a IEC Lead Polarity Test Switch Position POLARITY Test Icon Displayed Warning 40Va c test voltage applied to lead Plug the lead into the...

Страница 40: ...C mains polarity and AC DC parameter before initiating a test The user presses the START to begin the test Power is maintained to the EUT even when the user changes the SFC or when an Applied Part is...

Страница 41: ...on SIP SOP AP Earth Yes No No No No Enclosure Yes Yes No No No Patient Yes Yes No No Yes Patient F Type No No Yes No Yes Patient SIP SOP No No No Yes Yes Patient Auxiliary Yes Yes No No Yes The polar...

Страница 42: ...Operation 40...

Страница 43: ...rection of the fault If a voltage greater than 30V is detected on the neutral input line or the earth is missing then the following display will be seen L N REVERSED Err2 Check for incorrect wiring at...

Страница 44: ...Medical for repair Safety Tests During Operation The Analyser performs self tests during normal operation An internal earth bond test and a low voltage test are performed prior to applying mains power...

Страница 45: ...nents are not overheated High rates of testing may cause this situation especially with a series of long duration Earth Continuity tests Setting Earth Continuity test duration to 2 seconds will increa...

Страница 46: ...PC s will effect the reading of the Rigel 266 plus An option Blue Tooth RS 232 adaptor is allow for real time download to earthed peripherals ie Laptops PC s Please contact our sales department for f...

Страница 47: ...facing 45 Serial Port The serial port uses a standard 9 way D type connector Pin Description 1 N C 2 RX 3 TX 4 DTR 5 0V 6 N C 7 0V 8 N C 9 5V Baud Rate 9600 Start Bits 1 Data Bits 8 Stop Bits 2 Parity...

Страница 48: ...ll reduce both the life of the instrument and its reliability If the Analyser is subject to condensation allow the Analyser to completely dry before use Always check the Analyser and all test leads fo...

Страница 49: ...e department to obtain a Returns Number By obtaining a Returns Number your service request can be booked in advance thus reducing the down time of your equipment When asking for a Returns Number pleas...

Страница 50: ...nalyser The standard accessories are supplied with the Analyser Standard Accessories Accessory Part Number Earth Bond Test Lead 286A925 Mains Lead 270A025 Applied Part Adaptor Lead 286A950 Carry Bag 2...

Страница 51: ...gits Misc 4 wire measurement floating earth Insulation Test Test Voltage 500V d c nominal 0 5M load Short Circuit Current 2mA d c maximum Range 100k 100 M Resolution 0 01 M 100 M Accuracy 5 of reading...

Страница 52: ...ng Resistance Nominal 48K 230V Units Nominal 24K 110 120V Units SIP SOP Open Circuit Voltage 110 20 of Mains Input Voltage Patient F Type Test Input Impedance 1Mohm Frequency Response as per IEC 60601...

Страница 53: ...C non condensing Storage 10 C to 50 C non condensing Maximum R H 90 Supply Rating UK European Australian Versions 230V 10 50 60Hz US Version 115V 10 50 60Hz Power Rating 30VA Max EUT Output Current UK...

Страница 54: ...mA 1mA 0 5mA 1mA Enclosure Leakage 0 1mA 0 5mA 0 1mA 0 5mA 0 1mA 0 5mA Patient Leakage dc 0 01mA 0 05mA 0 01mA 0 05mA 0 01mA 0 05mA Patient Leakage ac 0 1mA 0 5mA 0 1mA 0 5mA 0 01mA 0 05mA Patient Lea...

Страница 55: ...BS3456 Household electrical appliances 0 1 R BS4533 Luminaires 0 5 BS2769 Hand held motor operated tools 0 1 R BS415 Mains operated electronic and related apparatus 0 5 R BSEN 60950 Information techno...

Страница 56: ...15 Mains operated electronic and related apparatus 0 5 1 0 BSEN 60950 Information technology equipment 0 5 1 0 Information technology equipment not constructed to BSEN 60950 May be damaged by insulati...

Страница 57: ...844 2 may be obtained from The Institution of Electrical Engineers P O Box 96 Stevenage Herts SG1 2SD England Copies of the Medical Devices Agency Checks and tests for newly delivered medical devices...

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