Kimberly-Clark Baylis PMG-115 Скачать руководство пользователя страница 46 | Manualshive

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025-0169-311 Revision: B

Page 44 of 52

8.14

IEC Electrical Safety and EMC Specifications

Table 8-1 IEC Electrical Safety Specifications

Device Description

Class I, Defibrillation proof Type CF Equipment, IPX0, not AP/APG
Mode of Operation: Continuous

Electrical Isolation

•

Leakage current conforms to
IEC 60601-1

•

Dielectric withstanding
voltage conforms to IEC
60601-1

EMC Emissions and Susceptibility: The Baylis Pain Management System has been tested and found to
comply with the limits for medical devices to the IEC 60601-1-2:2004. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation. This system generates,
uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instruction
given below, may cause harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation.

Table 8-2 IEC EMC Specifications (Emissions)

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Baylis Pain Management System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Baylis Pain Management System should assure that it is used in such
an environment.

Emissions Test

Compliance Electromagnetic Environment – Guidance

RF emissions

CISPR 11

Group 1

The Baylis Pain Management System must emit
electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.

RF emissions

CISPR 11

Class A

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions

IEC 61000-3-3

Complies

The Baylis Pain Management System is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.

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Содержание Baylis PMG-115

Страница 1: ...alth Care has acquired the back pain management assets from Baylis Medical Company All references to Baylis Medical in this manual will now refer to Kimberly Clark Please contact your Kimberly Clark sales representative for the warranty and other product information For product service please contact Kimberly Clark at Email InterventionalPain KCHC kcc com In the USA call 1 800 KCHELPS Internationa...

Страница 2: ...aylis Medical Company Inc 5959 Trans Canada Highway Montreal Quebec Canada H4T 1A1 Telephone 514 488 9801 800 850 9801 Facsimile 514 488 7209 EU Authorized Representative Quality First International 20 Eversley Road Bexhill on Sea East Sussex TN40 1HE United Kingdom Telephone 44 20 8 522 1937 Facsimile 44 20 8 522 1937 ...

Страница 3: ...INGS State _______________________________ 32 7 7 2 ADVANCED SETTINGS Mode LESION SETTINGS State______________________________________ 33 7 7 3 ADVANCED SETTINGS Mode COOLED RF SETTINGS State _________________________________ 34 7 7 4 ADVANCED SETTINGS Mode TRANSDISCAL SETTINGS State ______________________________ 35 7 7 5 ADVANCED SETTINGS Mode RFA SETTINGS State _________________________________...

Страница 4: ...ecifications 41 8 8 Environmental Specifications 41 8 9 Fuses 41 8 10 Line Input Ratings 41 8 11 Footswitch Specifications 41 8 12 Rated Accessory Voltage for Associated Equipment and Active Accessories 42 8 13 Output Power Graphs 42 8 14 IEC Electrical Safety and EMC Specifications 44 9 Standard RF Lesion Size 49 10 Labeling Symbols 50 11 Warranty 52 ...

Страница 5: ...gure 7 15 COOLED RF AUTO TEMP ON Display 26 Figure 7 16 TRANSDISCAL TREATMENT ON Display 26 Figure 7 17 RFA Mode TREATMENT ON Display 27 Figure 7 18 IDL Mode ON Display Secondary Thermocouple Enabled 27 Figure 7 19 Save Settings Display 32 Figure 7 20 ADVANCED SETTINGS Mode STIMULATION SETTINGS Display 33 Figure 7 21 ADVANCED SETTINGS Mode LESION SETTINGS Display 34 Figure 7 22 ADVANCED SETTINGS M...

Страница 6: ...E that comprise the machine steps necessary to complete a procedure The modes for this Generator include Current Stimulation Voltage Stimulation Auto Temp Lesion Manual Power Lesion Auto Pulsed Lesion Manual Pulsed Lesion Cooled RF TransDiscal RFA and IDL ON State of the Generator when RF energy is applied to the probes and dispersive return electrode if applicable PDT A The Peripheral Disc Temper...

Страница 7: ...n A feature that will maintain the time at the Set Temperature and generate a notification if probes are in a configuration that prevents the set temperature from being reached in the specified Ramp Time Y Cable Any of TDX Y TSW TDP TransDiscal Y Cable PMX Y RSW RFA RFA Y Cable or PMX Y BAY ORA IDL Y Cable resembling the characteristic shape of the letter Y 2 Indicated Use Baylis Pain Management G...

Страница 8: ... the available contact quality monitor Risk of RF burns to the patient Unless a compatible Monitoring Dispersive Electrode is used with a Contact Quality Monitor loss of safe contact between the Dispersive Electrode and the patient will not result in an auditory alarm Risk of RF burns to the patient Skin to skin contact for example between the arms and body of the PATIENT should be avoided for exa...

Страница 9: ...Operating non essential equipment in the vicinity of the PMG should be avoided if possible The PMG should not be used adjacent to or stacked with other equipment If the PMG must be operated adjacent to or stacked with other equipment the PMG should be observed to verify normal operation in that configuration Use of accessories transducers and cables other than those specifically approved by Baylis...

Страница 10: ...en you open a box you will find o Generator o Power Cord o User Manual 4 5 Generator Maintenance Schedule The Generator verifies calibration integrity during the Power On Self Test POST maintenance is not required For Cleaning and Disinfection Instructions refer to 4 3 Generator Cleaning And Disinfection Instructions 4 6 Compatible Accessories The Baylis PMG has been approved for use with all Bayl...

Страница 11: ... highlight to indicate the current operating mode If no label is present the associated button is not used in the present mode 3 Mode Function Keys These keys select and change the state of operation For Baylis Pain Management Thermocouple RF probes STIMULATION or LESION states are selected with a single press In RFA mode PLACEMENT or TREATMENT states are selected with a single press In COOLED RF ...

Страница 12: ...e system must be cycled off on to attempt recovery from a system fault 10 MEASUREMENTS Window Measured values for elapsed TIME probe TEMPERATURE S RF POWER RF VOLTAGE and or IMPEDANCE are displayed during and after RF output in both STIMULATION and LESION states and during treatment states for COOLED RF TRANSDISCAL RFA and IDL modes During all READY states prior to RF output TEMPERATURE and IMPEDA...

Страница 13: ...or each voltage setting the proper corresponding fuses must be used as indicated in the rear panel labeling 5 AC CONFIGURATION SWITCH The orientation of this switch in conjunction with the Fuse Drawer determines the AC input voltage range 100 120V or 220 240V Do not change the position of the voltage selector while the system is plugged in 6 Equipotential Ground Connection This connector is attach...

Страница 14: ... 75 s Multi RF TRUE TX MAX RAMP TIME EXTENSION DISABLE 5 120 s with 5 s interval 30 s TEMP LIMIT 38 95 C 80 C TIME 15 600 s 75 s MANUAL POWER LESION SET POWER 0 50 W 0 W SET TEMP 38 95 C 42 C TIME 10 900 s 120 s PULSE DUR 10 100 ms with 10 ms interval 20 ms AUTO PULSED LESION PULSE RATE 1 10 Hz 2 Hz WARNING TEMP 38 95 C 42 C TIME 10 900 s 120 s PULSE DUR 10 100 ms with 10 ms interval 20 ms MANUAL ...

Страница 15: ...te is initiated when the system is turned on and it lasts about 40 seconds Figure 7 1 System Initialization State Display The POST state is initiated after System Initialization is completed It lasts about 30 seconds Figure 7 2 POST State Display The STANDBY state is initiated upon successful completion of the POST state Figure 7 3 STANDBY Display ...

Страница 16: ...ystem Initialization OFF RF audio output is not generated during Initialization OFF Impedance related audio output is not generated during Initialization Power On Self Test POST ON POST tone A tone sounds for approximately 2 s to indicate that the system is active and is performing self tests The tone also serves as a test of the audio output N A STANDBY None N A None No parameters are graphed dur...

Страница 17: ...TREATMENT READY states The PLACEMENT state cannot be accessed during the STIMULATION ON or TREATMENT ON states When in the PLACEMENT state MEASURING TDP A is the default screen when the switching cable is set to Probe A or when a TransDiscal Y Connecting Cable is used MEASURING TDP B is the default screen when the switching cable is set to Probe B and two probes are enabled for use in the TRANSDIS...

Страница 18: ... selectable In the TDP A Placement state Treatment mode is available If the position of the switch on the Switching Cable changes to TDP B the Generator changes to the TDP B Placement state and the Treatment mode key is not selectable and the mode select key is greyed out In the RFA Placement state Treatment mode is available if the position of the switch on the Switching Cable concurs or if only ...

Страница 19: ...tinuous audio output is generated for placement Frequency of output is related to active impedance measurement No audible tone if selected probe is an open circuit replace with warning message This feature can be disabled in the AUDIO SETTINGS state accessible from the ADVANCED SETTINGS mode PLACEMENT MEASUREMENT Indicates the system is measuring the selected probe impedance Impedance Related Audi...

Страница 20: ...state VOLTAGE STIMULATION During the ON state Voltage must be greater than 0 0 V for Stimulus pulses to be delivered CURRENT STIMULATION Stimulus pulses are not delivered during the READY state During the ON state Current must be greater than 0 0 mA for Stimulus pulses to be delivered TRANSDISCAL AND COOLED RF TREATMENT When Output ON OFF is pressed the Generator will enter the PRE TREATMENT COOLI...

Страница 21: ... changes to treatment TIME The dashed line denoting SET TEMP TEMP LIMIT WARNING TEMP will move according to changes made to the SET TEMP TEMP LIMIT WARNING TEMP value TRANSDISCAL AND COOLED RF TREATMENT Pump Status is displayed at the top of the Graph Window Graph Window STIMULATION READY display Indicates the system is ready to generate stimulus pulses Status Window None N A Impedance Related Aud...

Страница 22: ... the SAVE SETTINGS function is used VOLTAGE STIMULATION CURRENT STIMULATION ON Impedance measurements are displayed VOLTAGE STIMULATION CURRENT STIMULATION AUTO TEMP MANUAL POWER AUTO PULSED MANUAL PULSED SAVE SETTINGS While in the READY state other operating modes for Baylis Pain Management Thermocouple probes are available When a different mode is selected the Generator will enter the READY stat...

Страница 23: ...nt 1 ºC SET TEMP Default 42 ºC Range 10 900 s Increment 1 s TIME Default 120 s Range 10 100 ms Increment 10 ms PULSE DUR Default 20 ms Range 1 10 Hz Increment 1 Hz AUTO PULSED LESION ON Temperature and Impedance measurements are displayed while Time and Power are not displayed dashed lines replace values In Multi RF the maximum impedance is displayed according to range Rrms 25Ω LOW 25Ω Rrms 3000Ω ...

Страница 24: ...isplayed while Time and Power are not displayed dashed lines replace values In Multi RF the maximum impedance is displayed according to range Rrms 25Ω LOW 25Ω Rrms 3000Ω OK Rrms 3000Ω HIGH VOLTAGE STIMULATION CURRENT STIMULATION AUTO TEMP MANUAL POWER AUTO PULSED MANUAL PULSED SAVE SETTINGS While in the READY state other operating modes for Baylis Pain Management Thermocouple probes are available ...

Страница 25: ...emperature is displayed in the PERIPHERAL DISC TEMP box If two TransDiscal probes are used the maximum temperature of the two probe locations is displayed in the TRANSDISCAL TEMP box while the maximum peripheral disc temperature of the two probe locations is displayed in the PERIPHERAL DISC TEMP box Impedance measurement between TransDiscal probes is displayed Time and Power are not displayed dash...

Страница 26: ...ashed lines replace values If the Thermocouple Probe is disabled via IDL SETTINGS state accessible from the ADVANCED SETTINGS mode that measurement is greyed out and the value replaced with dashed lines SAVE SETTINGS While in the READY state other operating modes are not available The present SETTINGS can be saved as defaults by holding down the SAVE SETTINGS key TIME Default 16 30 min Defaults ar...

Страница 27: ... Figure 7 7 VOLTAGE STIMULATION ON Display Figure 7 8 CURRENT STIMULATION ON Display Figure 7 9 AUTO TEMP LESION ON Display Figure 7 10 MANUAL POWER LESION ON Display Figure 7 11 AUTO PULSED LESION ON Display Figure 7 12 MANUAL PULSED LESION ON Display ...

Страница 28: ...igure 7 14 Multi RF AUTO PULSED ON Display COOLED RF AUTO TEMP AND TRANSDISCAL TREATMENT states consist of PRE TREATMENT COOLING TREATMENT ON and POST TREATMENT COOLING if enabled from ADVANCED SETTINGS Figure 7 15 COOLED RF AUTO TEMP ON Display Figure 7 16 TRANSDISCAL TREATMENT ON Display ...

Страница 29: ...ND TRANSDISCAL RF power is delivered during the TREATMENT ON state If the procedure is stopped while in TREATMENT ON state the Generator enters POST TREATMENT COOLING state if enabled in ADVANCED SETTINGS mode FAULT Indicator OFF The FAULT indicator is used only in the POST and SYSTEM FAULT states RF Stimulus Output ON OFF Indicator ON The indicator is illuminated during Stimulus pulse RF power de...

Страница 30: ...ED RF graphed temperatures should be the maximum Cooled RF probe temperature Pump Status is displayed at the top of the Graph Window TRANSDISCAL graphed temperatures should be the maximum TransDiscal temperature and the maximum peripheral disc temperature unless modified in TRANSDISCAL SETTINGS state accessible from the ADVANCED SETTINGS mode Pump Status is displayed at the top of the Graph Window...

Страница 31: ...ge 15 600 s AUTO TEMP LESION TIME Increment 1 s Range 38 95 ºC TEMP LIMIT Increment 1 ºC Range 15 600 s TIME Increment 1 s Range N A MANUAL POWER LESION POWER LIMIT Increment N A Range 38 95 ºC SET TEMP Increment 1 ºC Range 10 900 s TIME Increment 1 s Range 10 100 ms PULSE DUR Increment 10 ms Range 1 10 Hz AUTO PULSED LESION PULSE RATE Increment 1 Hz Range 0 55 V VOLTAGE Increment 5 V between 0 an...

Страница 32: ... the ADVANCED SETTINGS mode the measurement is greyed out and the value replaced with dashed lines TIME Increment 30 s Range 40 95 ºC SET TEMP Increment 1 ºC Range 30 s 20 min IDL MODE ON All measurements are displayed During ON state SET TEMP should not be decreased below INITIAL TEMP in ADVANCED SETTINGS During ON state SET TIME should not be decreased below INITIAL TIME in ADVANCED SETTINGS Non...

Страница 33: ...E SETTINGS is replaced with HOLD DISPLAY which has the function of holding the display If selected the HOLD DISPLAY button will read RELEASE DISPLAY and the button will flash If the flashing RELEASE DISPLAY button is selected the system shall return to the READY state If the HOLD DISPLAY button is not selected the system defaults to the ready state in 5 seconds Settings are not adjustable while in...

Страница 34: ...g the settings Defaults are factory set and are overwritten when the SAVE SETTINGS function is used 7 7 1 ADVANCED SETTINGS Mode STIMULATION SETTINGS State When the ADVANCED SETTINGS mode is accessed the Generator displays the default STIMULATION SETTINGS screen Settings on this screen apply to both VOLTAGE and CURRENT STIMULATION This mode allows the user to limit the quantity of selectable value...

Страница 35: ...pulses are delivered 1 Shot 2 5 10 20 50 75 100 150 180 and 200 Hz 50 Hz PULSE DUR 1 ms 1 0 ms STIMULATION Modes PULSE DUR 2 ms Duration of pulses delivered 0 1 0 2 0 5 and 1 0 ms 0 1 ms STIMULATION Modes refers to both VOLTAGE AND CURRENT STIMULATION Modes 7 7 2 ADVANCED SETTINGS Mode LESION SETTINGS State The following screen appears when LESION SETTINGS is selected from the ADVANCED SETTINGS Mo...

Страница 36: ...N Maximum allowable duration for extension of ramp time If all probes have not reached Set Temperature within this time an error notification will be generated DISABLE 5 120 s 30 s 5 s 7 7 3 ADVANCED SETTINGS Mode COOLED RF SETTINGS State The following screen appears when COOLED RF SETTINGS is selected from the ADVANCED SETTINGS Mode This screen allows adjustment of the RAMP RATE used by the COOLE...

Страница 37: ...n appears when TRANSDISCAL SETTINGS is selected from the ADVANCED SETTINGS Mode This screen allows adjustment of the warning temperature threshold for the Peripheral Disc Temperature PDT by adjusting PERIPHERAL DISC WARNING TEMP The Peripheral Disc Warning Temperature can be used as an aid during treatment If either PDT A or PDT B exceeds the Peripheral Disc Warning Temperature the rate of the Out...

Страница 38: ...NABLE DISABLE ENABLE Stimulation Mode Placement Mode Treatment Mode NUMBER OF PROBES Number of TransDiscal Probes used 1 2 2 N A Treatment Mode POWER LIMIT Maximum power available for temperature control 1 50 W 15 W 1 W 7 7 5 ADVANCED SETTINGS Mode RFA SETTINGS State The following screen appears when RFA SETTINGS is selected from the ADVANCED SETTINGS Mode This screen allows the option of disablin...

Страница 39: ...d POWER LIMIT are adjustable in this state Changes to the INITIAL TIME and RAMP RATE affect the portion of the total TIME spent at the SET TEMP Lowering the INITIAL TIME causes the Generator to attempt to reach the INITIAL TEMP more rapidly Figure 7 25 ADVANCED SETTINGS Mode IDL SETTINGS Display Settings Affected Mode Parameter DESCRIPTION Range Units Default Value Increment SECONDARY THERMOCOUPLE...

Страница 40: ...ble audio output in Stimulation modes ENABLE All Modes except IDL IMPEDANCE AUDIO Enable Disable audio output in all Ready States EXCEPT IDL READY STATE ENABLE DISABLE DISABLE N A 7 7 8 ADVANCED SETTINGS Mode LANGUAGE SETTINGS State The following screen appears when LANGUAGE SETTINGS is selected from the ADVANCED SETTINGS Mode The language selected applies to all text displayed on the Generator sc...

Страница 41: ... previous READY mode If the probe and cable have been detached the Generator returns to the STANDBY state Recoverable Error measurement values are shown and settings are greyed out 7 8 2 Non Recoverable Faults Figure 7 29 AUTO TEMP Mode Non Recoverable Fault Pop Up Display 7 8 2 1 Display Red error indicator will display on screen System Fault code will display in the center of the screen within t...

Страница 42: ...usoidal Maximum power 50 W available into an impedance range of 60 Ω 520 Ω resistive Outside this range the Generator reduces available power to comply with specified voltage and current limits Applied part of patient circuit is not referenced to earth at high frequency The maximum output of 50 W is restricted by o Maximum voltage o Maximum current o Maximum peak voltage 160 Vrms 0 9 Arms 254 V un...

Страница 43: ...IEC601 8 8 Environmental Specifications Operational temperature 10 C to 40 C Storage Transportation temperature 40 C to 70 C Operation Storage Transportation Humidity 20 to 95 non condensing 8 9 Fuses 100 120 V 60 Hz configuration Replace mains fuses as marked 4A 250V T lag 5x20mm 220 240 V 50 Hz configuration Replace mains fuses as marked 2A 250V T lag 5x20mm When replacing fuses ensure the integ...

Страница 44: ...etting 0 10 20 30 40 50 60 0 500 1000 1500 2000 2500 3000 Load Impedance Ω Ω Ω Ω Power Output Watts Power vs Load At 25 Watt Setting 0 5 10 15 20 25 30 0 500 1000 1500 2000 2500 3000 Load Impedance Ω Ω Ω Ω Output Power Watts Peak Voltage vs Power Setting 0 50 100 150 200 250 300 0 10 20 30 40 50 Power Setting Watts Peak Voltage Volts Figure 8 1 Power vs Load and Peak Voltage ...

Страница 45: ...n B Page 43 of 52 0 10 20 30 40 50 60 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 Set Power Watts Power Output Watts Output Minimum Output Maximum 0 25 Watts 5 Figure 8 2 Set Power vs Output Power ...

Страница 46: ...s in the vicinity However there is no guarantee that interference will not occur in a particular installation Table 8 2 IEC EMC Specifications Emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions The Baylis Pain Management System is intended for use in the electromagnetic environment specified below The customer or the user of the Baylis Pain Management System should assure ...

Страница 47: ...rge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for ...

Страница 48: ...g cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P d 17 1 MHz to 800 MHz P d 17 1 MHz to 800 MHz P d 33 2 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters ...

Страница 49: ...ctromagnetic site survey should be considered If the measured field strength in the location in which the Baylis Pain Management System or any of its components are used exceeds the applicable RF compliance level above the Baylis Pain Management System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or reloc...

Страница 50: ...nications equipment Separation distance according to frequency of transmitter M Rated maximum output power of transmitter W 150 kHz to 80 MHz P V d 5 3 1 80 MHz to 800 MHz P E d 5 3 1 800 MHz to 2 5 GHz P E d 7 1 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 50 8 25 8 25 16 50 For transmitters rated at a maximum output power not listed above the recommended separation d...

Страница 51: ...valid for active tip lengths of up to 5 mm Eg based on Active tip 5 mm 0 197 Major axis 10mm 0 394 Minor axis 6 7mm 0 263 For active tip lengths in excess of 5 mm the active tip diameter will primarily dictate the minor axis dimension of the lesion The maximum minor axis dimension will not typically exceed 8 mm for 18 to 22 gauge cannulae Note In Multi RF Auto Temp mode maintain a minimum distance...

Страница 52: ...mber REF Connector Cable connection Consult Instructions for Use Dangerous Voltage Defibrillator proof Patient Isolated connections Isolated Patient Circuit Dispersive Return Electrode connection Up Down Earth Ground Federal law U S A restricts this device to sale by or on the order of a physician Footswitch Fuses Manufacturer Measured Temperature Non Ionizing Radiation Output OFF F ...

Страница 53: ... 0169 311 Revision B Page 51 of 52 Output ON Power OFF Power ON Pump Module Interface Connector Serial Number SN Time Please contact your distributor or the device manufacturer for recycling of this device ...

Страница 54: ...repaired under Baylis standard repair program will be issued a thirty day warranty against defects in both materials and workmanship provided the original warranty period has passed Instruments submitted due to defects in materials and workmanship during the warranty period will be repaired at no charge to the customer The warranty set forth herein is exclusive and in lieu of all other warranties ...

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