
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
Instructions for Use Manual Soniquence RF Generator 2 The generator enhanced capability Radiosurgery Devices are a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with controls to prevent operation when an error code is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered. This device is designed to comply with international safety standards. The atraumatic nature of electrosection provides a noteworthy advantage. The lack of trauma results in tissue healing without fibrous contractile scar tissue, which characterizes the healing of wounds created by manual cutting. Read Instructions for Use in details before use. The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. SYMBOL DEFINITIONS The following symbols are used on the equipment and/or labels 1.1.1 Classification Class IIb, according to European Council Directive 93/42/EEC concerning medical devices. Classification = Class I, according to the type of protection against electric shock as per IEC 60601-1. Nominal Line Voltage: 100V - 240V AC Line Frequency: 60Hz/50Hz Power Consumption at max output power: 360 VA Input current at max output power: 100V - 240V, 2.3A Rating of two fuses in the main supply power: F4.0 (250V) T4.0A (250V) optional 1.1.2 Supply Input Power = 100V AC - 240V AC ~ 50/60 Hz 1.1.3 Alternating current 1.1.4 Defribrilation-Proof Type CF applied part 1.1.5 MR Unsafe - Device should not enter the MRI Scanner room 1.1.5 Refer to Instruction Manual/Booklet 1.1.6 Protective earth (ground) 1.1.7 Neutral electrode referenced to ground 1.1.8 Neutral plate 1.1.9 Fingerswitch control 1.1.10 Footswitch 1.1.11 Bipolar 1.1.12 Volume control 1.1.13 Non-ionizing radiation 1.1.14 UL Mark E504261 ELECTROSURGICAL GENERATOR AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1-2:, IEC 60601-2-2. LIST OF AUTHORIZED ACCESSORIES BY PRODUCT FAMILY Bayonet Tip, Malleable Tip, Microincision Tip, SP-Tips, SP-Kit, Fiber Tip, Tip Set, Neutral Plates, Suction Coagulator, Footswitch, Fingerswitch Wand, Bipolar Cable, RF Cobb Tip, and Bipolar Wand E504261 For technical information, refer to Service Manual (item # IN S0004). The information provided in instruction manual does not replace the information provided in service manual (item # IN S0004). 1.1 1.2 1. INTRODUCTION INDICATIONS FOR USE Mode/Character CUT BLEND HEMO BIPOLAR BIPOLAR TURBO Output Waveform 4.0 MHz Square Wave Envelope 4.0 MHz Square Wave Envelope 4.0 MHz Square Wave Envelope 1.7 MHz Square Wave Envelope 1.7 MHz Square Wave Envelope Activation via footswitch or via fingerswitch via footswitch or via fingerswitch via footswitch or via fingerswitch via footswitch via footswitch Output Power ± 20% 120W 120W @ 500 Ω 90W @ 500 Ω 60W @ 500 Ω 40W @ 200 Ω 120W @ 200 Ω 170W 150W @ 500 Ω 110W @ 500 Ω 60W @ 500 Ω 40W @ 200 Ω 170W @ 200 Ω Max Output Power 2.3A 2.3A 2.3A 2.3A 2.3A II. TECHNICAL INFORMATION 2.1 OUTPUT CHARACTERISTICS 3 2.2 DUTY CYCLE The supplier suggested operational duty cycle is 10 seconds ON / 30 seconds OFF.The yellow CUTTING MODE Activation Indicator will be ON when CUTTING MODE circuit is energized. The blue COAGULATION MODE Activation Indicator will be ON when COAGULATION MODE circuit is energized. A continuous tone will alert user of activation. After 55 seconds of continuous applied power (at any power level, in any mode), the tone will change and energy will cease 5 seconds after. The tone continues to alert of footswitch depression even though energy will not be emitted. 2.3 CLASSIFICATION 2.3.1 According to the type of protection against electric shock: the equipment is energized from an external electrical power source and is Class I equipment 2.3.2 According to the type of protection against electric shock: DEFIBRILLATION-PROOF TYPE CF APPLIED PART 2.3.3 Degree of protection against harmful ingress of water: ordinary equipment, or IPX0 according to IEC 60529. 2.3.4 Cleaning and Disinfection of the Unit Before Each Use: Cleaning and disinfection of the unit should only be done with non-flammable and non-explosive agents. Make sure that no moisture or detergents enter the unit. If cleaning or disinfection of the unit with flammable or explosive agents is unavoidable, these must be completely evaporated from the radiosurgical generator before it is switched on. 2.3.5 The mode of operation is continuous operation with intermittent loading, duty cycle 10 seconds ON / 30 seconds OFF. 2.3.6 The permissible operational environment conditions: Ambient temperature range ------ +10°C ~ +40°C Relative humidity range ------ 30% ~ 75% 2.3.7 The following specifications are applicable to the extent called out herein: EN IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. EN IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility. EN IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for safety of high frequency surgical equipment. ELECTROSURGICAL GENERATOR WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R)2012, CSA C…
Text truncated - open the document above for the full version.
Instructions for Use Manual Soniquence RF Generator ® 2 The generator enhanced capability Radiosurgery Devices are a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with controls to prevent operation when an error code is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered. This device is designed to comply with international safety standards. The atraumatic nature of electrosection provides a noteworthy advantage. The lack of trauma results in tissue healing without fibrous contractile scar tissue, which characterizes the healing of wounds created by manual cutting. Read Instructions for Use in details before use. The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. SYMBOL DEFINITIONS The following symbols are used on the equipment and/or labels 1.1.1 Classification Class IIb, according to European Council Directive 93/42/EEC concerning medical devices. Classification = Class I, according to the type of protection against electric shock as per IEC 60601-1. Nominal Line Voltage: 100V - 240V AC Line Frequency: 60Hz/50Hz Power Consumption at max output power: 360 VA Input current at max output power: 100V - 240V, 2.3A Rating of two fuses in the main supply power: F4.0 (250V) T4.0A (250V) optional 1.1.2 Supply Input Power = 100V AC - 240V AC ~ 50/60 Hz 1.1.3 Alternating current 1.1.4 Defribrilation-Proof Type CF applied part 1.1.5 MR Unsafe - Device should not enter the MRI Scanner room 1.1.5 Refer to Instruction Manual/Booklet 1.1.6 Protective earth (ground) 1.1.7 Neutral electrode referenced to ground 1.1.8 Neutral plate 1.1.9 Fingerswitch control 1.1.10 Footswitch 1.1.11 Bipolar 1.1.12 Volume control 1.1.13 Non-ionizing radiation 1.1.14 UL Mark E504261 ELECTROSURGICAL GENERATOR AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1-2:, IEC 60601-2-2. E504261 For technical information, refer to Service Manual (item # IN S0006). The information provided in instruction manual does not replace the information provided in service manual (item # IN S0006). 1.1 1. INTRODUCTION INDICATIONS FOR USE Mode/Character CUT BLEND HEMO BIPOLAR BIPOLAR TURBO Output Waveform 4.0 MHz Square Wave Envelope 4.0 MHz Square Wave Envelope 4.0 MHz Square Wave Envelope 1.7 MHz Square Wave Envelope 1.7 MHz Square Wave Envelope Activation via footswitch or via fingerswitch via footswitch or via fingerswitch via footswitch or via fingerswitch via footswitch via footswitch Output Power ± 20% 120W 120W @ 500 Ω 90W @ 500 Ω 60W @ 500 Ω 40W @ 200 Ω 120W @ 200 Ω 170W 150W @ 500 Ω 110W @ 500 Ω 60W @ 500 Ω 40W @ 200 Ω 170W @ 200 Ω Max Output Power 2.3A 2.3A 2.3A 2.3A 2.3A II. TECHNICAL INFORMATION 2.1 OUTPUT CHARACTERISTICS LIST OF AUTHORIZED ACCESSORIES BY PRODUCT FAMILY Bayonet Tip, Malleable Tip, Microincision Tip, SP-Tips, SP-Kit, Fiber Tip, Tip Set, Neutral Plates, Suction Coagulator, Footswitch, Fingerswitch Wand, Bipolar Cable, RF Cobb Tip, and Bipolar Wand 1.2 3 2.2 DUTY CYCLE The supplier suggested operational duty cycle is 10 seconds ON / 30 seconds OFF. The yellow CUTTING MODE Activation Indicator will be ON when CUTTING MODE circuit is energized. The blue COAGULATION MODE Activation Indicator will be ON when COAGULATION MODE circuit is energized. A continuous tone will alert user of activation. After 55 seconds of continuous applied power (at any power level, in any mode), the tone will change and energy will cease 5 seconds after. The tone continues to alert of footswitch depression even though energy will not be emitted. 2.3 CLASSIFICATION 2.3.1 According to the type of protection against electric shock: the equipment is energized from an external electrical power source and is Class I equipment 2.3.2 According to the type of protection against electric shock: DEFIBRILLATION-PROOF TYPE CF APPLIED PART 2.3.3 Degree of protection against harmful ingress of water: ordinary equipment, or IPX0 according to IEC 60529. 2.3.4 Cleaning and Disinfection of the Unit Before Each Use: Cleaning and disinfection of the unit should only be done with non-flammable and non-explosive agents. Make sure that no moisture or detergents enter the unit. If cleaning or disinfection of the unit with flammable or explosive agents is unavoidable, these must be completely evaporated from the radiosurgical generator before it is switched on. 2.3.5 The mode of operation is continuous operation with intermittent loading, duty cycle 10 seconds ON / 30 seconds OFF. 2.3.6 The permissible operational environment conditions: Ambient temperature range ------ +10°C ~ +40°C Relative humidity range ------ 30% ~ 75% 2.3.7 The following specifications are applicable to the extent called out herein: EN IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. EN IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility. EN IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for safety of high frequency surgical equipment. ELECTROSURGICAL GENERATOR WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R)2012, CS…
Text truncated - open the document above for the full version.
Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com Thursday, April 9, 2020 UL LLC 12 Laboratory Dr RTP, NC 27709, USA To whom it may concern: I, the undersigned, hereby authorize UL LLC to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL LLC on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL LLC as our agent, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use our product certification in such a manner as to bring UL LLC into disrepute and not make any statement regarding our product certification which UL LLC may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by UL LLC; Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com f) use certification only to indicate the products are certified as being in conformity with specified standards; g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of UL LLC; i) keep a record of all complaints made known to the us relating to the product’s compliance with requirements of the relevant standard and to make these records available to UL LLC when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, (Alfredo Micalizzi, Electrical Engineering Manager) (Soniquence, LLC) (04/09/20) REMARK: 1. This authorization letter will be sent along with your application when filing with UL LLC. 2. Please follow the format and type it on company letterhead and send original to us. 3. Authorized signature must be in agreement with grantee code contact in FCC database.
Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: 2AV4P-0270412 To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §§ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Antenna Specification Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04- 1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant short-term confidentiality request on the following attachments until November 1, 2020. External Photos Internal Photos Test Setup Photos User Manual Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and that information will be available for public review once the grant of equipment authorization is issued. Best Regards (Alfredo Micalizzi) (Electrical Engineer Manager) (Soniquence, LLC) (04/09/20)
To whom it may concern, There is no difference between Soniquence (IEC6-IESU170) and Soniquence (IEC6-IESV170) (Other than the metal housing). Also, both models Soniquence (IEC6-IESU170) and Soniquence (IEC6-IESV170) have been evaluated for the worst-case test data on test report and passed IEC 60601 3 rd and 4 th edition (UL) Underwriters Lab testing. Thank you Alfredo Micalizzi Electrical Engineering Manager Soniquence LLC 2477 Grand Ave Baldwin, NY 11580
I I -� Mll�� .. ·O(lt,,� foni9uence-
NVLAP Lab code: 200246-0 CERTIFICATION TEST REPORT Report Number: R13105073-E1 Applicant : SONIQUENCE LLC 2477 GRAND AVE BALDWIN, NY 11510-3556 Model : Soniquence Generator FCC ID : 2AV4P-0270412 EUT Description : MEDICAL DEVICE WITH RFID RADIO Test Standard(s) : FCC 47 CFR PART 15 SUBPART C ISED CANADA RSS-210 ISSUE 10 Date Of Issue: June 12, 2020 Prepared by: UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 U.S.A. TEL: (919) 549-1400 REPORT NO: R13105073-E1 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 2 of 37 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC REPORT REVISION HISTORY Rev. Issue Date Revisions Revised By V1 2020-05-29 Initial Issue Cristian Melara V2 2020-06-03 - Revised applicant address Cristian Melara V3 2020-06-12 - Revised model name - Revised test methodology and references Cristian Melara REPORT NO: R13105073-E1 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 3 of 37 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC TABLE OF CONTENTS REPORT REVISION HISTORY .................................................................................................... 2 TABLE OF CONTENTS ............................................................................................................... 3 1. ATTESTATION OF TEST RESULTS .................................................................................... 4 2. TEST METHODOLOGY ........................................................................................................ 6 3. FACILITIES AND ACCREDITATION .................................................................................... 6 4. CALIBRATION AND UNCERTAINTY .................................................................................. 7 4.1. MEASURING INSTRUMENT CALIBRATION ................................................................ 7 4.2. SAMPLE CALCULATION ............................................................................................... 7 4.3. MEASUREMENT UNCERTAINTY ................................................................................. 7 5. EQUIPMENT UNDER TEST ................................................................................................. 8 5.1. EUT DESCRIPTION ....................................................................................................... 8 5.2. MAXIUMUM FIELD STRENGTH .................................................................................... 8 5.3. SOFTWARE AND FIRMWARE ...................................................................................... 8 5.4. WORST-CASE CONFIGURATION AND MODE ............................................................ 8 5.5. DESCRIPTION OF TEST SETUP .................................................................................. 9 6. MEASUREMENT METHOD ................................................................................................ 10 7. TEST AND MEASUREMENT EQUIPMENT ....................................................................... 11 8. OCCUPIED BANDWIDTH AND 20dB BANDWIDTH ......................................................... 13 8.1. 99% BANDWIDTH PLOT ............................................................................................. 14 8.2. 20dB BANDWIDTH PLOT ............................................................................................ 15 9. FREQUENCY STABILITY ................................................................................................... 16 10. RADIATED TEST RESULTS .............................................................................................. 17 10.1. LIMITS AND PROCEDURE ......................................................................................... 17 10.2. TRANSMISSION SPURIOUS EMISSIONS .................................................................. 19 10.2.1. TAG ................................................................................................................... 20 10.2.2. WITHOUT TAG .................................................................................................. 26 11. AC POWER LINE CONDUCTED EMISSIONS ................................................................... 32 11.1. RFID ............................................................................................................................. 33 11.1.1. NORMAL OPERATION ..................................................................................... 33 11.1.2. ANTENNAS TERMINATED ............................................................................... 35 12. SETUP PHOTOS ................................................................................................................. 37 REPORT NO: R13105073-E1 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 4 of 37 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC 1. ATTESTATION OF TEST RESULTS COMPANY NAME: SONIQUENCE LLC 2477 GRAND AVE BALDWIN, NY 11510-3556 EUT DESCRIPTION: MEDICAL DEVICE WITH RFID RADIO MODEL: Soniquence Generator SERIAL NUMBER: 1S130008 DATE TESTED: 2020-03-05 to 2020-04-03 APPLICABLE STANDARDS STANDARD TEST RESULTS CFR 47 Part 15 Subpart C Complies ISED CANADA RSS-210 Issue 10, Annex B.6 Complies ISED CANADA RSS-GEN Issue 5 Complies UL LLC tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. It is the manufacturer's responsibility to assure…
Text truncated - open the document above for the full version.
NVLAP Lab code: 200246-0 CERTIFICATION TEST REPORT Report Number. : R13105073-E2 Applicant : SONIQUENCE LLC 2477 GRAND AVE BALDWIN, NY 11510-3556 Model : Soniquence Generator FCC ID : 2AV4P-0270412 EUT Description : MEDICAL DEVICE WITH RFID RADIO Test Standard(s) : FCC 47 CFR PART 15 SUBPART C ISED CANADA RSS-210 ISSUE 10 Date Of Issue: June 12, 2020 Prepared by: UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 U.S.A. TEL: (919) 549-1400 REPORT NO: R13105073-E2 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 2 of 41 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC . REPORT REVISION HISTORY Rev. Issue Date Revisions Revised By V1 2020-05-29 Initial Issue Cristian Melara V2 2020-06-03 - Added calibration notes - Revised model name - Revised applicant address Cristian Melara V3 2020-06-12 - Revised test methodology and references Cristian Melara REPORT NO: R13105073-E2 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 3 of 41 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC . TABLE OF CONTENTS REPORT REVISION HISTORY .................................................................................................... 2 TABLE OF CONTENTS ............................................................................................................... 3 1. ATTESTATION OF TEST RESULTS .................................................................................... 4 2. TEST METHODOLOGY ........................................................................................................ 6 3. FACILITIES AND ACCREDITATION .................................................................................... 6 4. DECISION RULES AND MEASUREMENT UNCERTAINTY ................................................ 7 4.1. MEASURING INSTRUMENT CALIBRATION ................................................................ 7 4.2. MEASUREMENT UNCERTAINTY ................................................................................. 7 4.3. SAMPLE CALCULATION ............................................................................................... 7 5. EQUIPMENT UNDER TEST ................................................................................................. 8 5.1. EUT DESCRIPTION ....................................................................................................... 8 5.2. MAXIMUM FIELD STENGTH ....................................................................................... 8 5.3. SOFTWARE AND FIRMWARE ..................................................................................... 8 5.4. WORST-CASE CONFIGURATION AND MODE ............................................................ 8 5.5. DESCRIPTION OF TEST SETUP .................................................................................. 9 6. MEASUREMENT METHOD ................................................................................................ 10 7. TEST AND MEASUREMENT EQUIPMENT ....................................................................... 11 8. OCCUPIED BANDWIDTH AND 20dB BANDWIDTH ......................................................... 15 8.1. 99% BANDWIDTH PLOT ............................................................................................. 16 8.2. 20dB BANDWIDTH PLOT ............................................................................................ 17 9. FREQUENCY STABILITY ................................................................................................... 18 10. RADIATED TEST RESULTS .............................................................................................. 19 10.1. LIMITS AND PROCEDURE ...................................................................................... 19 10.1. TRANSMISSION SPURIOUS EMISSIONS .............................................................. 21 10.1.1. TAG ................................................................................................................... 22 10.1.2. WITHOUT TAG .................................................................................................. 28 11. AC POWER LINE CONDUCTED EMISSIONS ................................................................... 34 11.1. RFID .......................................................................................................................... 35 11.1.1. NORMAL OPERATION WITH TAGS ................................................................ 35 11.1.2. NORMAL OPERATION WITHOUT TAGS ......................................................... 37 11.1.3. NORMAL OPERATION WITH ANTENNAS TERMINATED .............................. 39 12. SETUP PHOTOS ................................................................................................................. 41 REPORT NO: R13105073-E2 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 4 of 41 UL LLC FORM NO: CCSUP4701I 12 Laboratory Dr., RTP, NC 27709; USA TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC . 1. ATTESTATION OF TEST RESULTS COMPANY NAME: SONIQUENCE LLC 2477 GRAND AVE BALDWIN, NY 11510-3556 EUT DESCRIPTION: MEDICAL DEVICE WITH RFID RADIO MODEL: Soniquence Generator SERIAL NUMBER: 1S130001 1S1300025 DATE TESTED: 2020-03-04 to 2020-05-20 APPLICABLE STANDARDS STANDARD TEST RESULTS CFR 47 Part 15 Subpart C Complies ISED CANADA RSS-210 Issue 10, Annex B.6 Complies ISED CANADA RSS-GEN Issue 5 Complies UL LLC tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. The results documented in this report apply only to the tested sample, under the conditions and modes of oper…
Text truncated - open the document above for the full version.
NVLAP Lab code: 200246-0 SETUP PHOTOS EXHIBIT Report Number: R13105073-EP1 Applicant : SONIQUENCE LLC 2477 GRAND AVE BALDWIN, NY 11510-3556 Model : Soniquence Generator FCC ID : 2AV4P-0270412 EUT Description : MEDICAL DEVICE WITH RFID RADIO Test Standard(s) : FCC 47 CFR PART 15 SUBPART C ISED CANADA RSS-210 ISSUE 10 Date Of Issue: June 12, 2020 Prepared by: UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 U.S.A. TEL: (919) 549-1400 REPORT NO: R13105073-EP1 DATE: 2020-06-12 FCC ID: 2AV4P-0270412 Page 2 of 10…
Text truncated - open the document above for the full version.
12 Laboratory Drive · RTP, North Carolina · United States
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 13.56 MHz - 13.56 MHz | - |