
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
(Draft) Belos Family of Implantable Cardioverter Defibrillators Technical Manual X-ray Identification Belos DR, DR-T, VR and VR-T Implantable Cardioverter Defibrillator Inside the housing, top left-hand side: Year of manufacture X-Ray identification FA • CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. 2002 BIOTRONIK, Inc., all rights reserved. Belos Technical Manual i Contents 1. General...........................................................................1 1.1 System Description....................................................1 1.2 Indications and Usage...............................................2 1.3 Contraindications .......................................................3 1.4 Warnings and Precautions.........................................3 1.4.1 Sterilization, Storage, and Handling ..................4 1.4.2 Device Implantation and Programming..............4 1.4.3 Lead Evaluation and Connection.......................6 1.4.4 Follow-up Testing...............................................8 1.4.5 Pulse Generator Explant and Disposal..............8 1.4.6 Hospital and Medical Hazards ...........................8 1.4.7 Home and Occupational Hazards......................10 1.4.8 Cellular Phones..................................................10 1.4.9 Electronic Article Surveillance (EAS).................11 1.4.10 Home Appliances...............................................12 1.5 Adverse Events..........................................................13 1.5.1 Potential Adverse Events...................................13 1.5.2 Observed Adverse Events .................................14 1.6 Clinical Studies ..........................................................17 1.6.1 Tachos DR .........................................................17 1.6.2 Phylax AV...........................................................18 1.7 Patient Selection and Treatment ...............................21 1.7.1 Individualization of Treatment ............................21 1.7.2 Specific Patient Populations ..............................22 1.8 Patient Counseling Information .................................23 1.9 Evaluating Prospective ICD Patients .........................23 2. Device Features ............................................................25 2.1 Sensing ......................................................................25 2.1.1 Ventricular Sensitivity Settings ..........................25 2.1.2 Minimum Ventricular Threshold .........................28 2.1.3 Atrial Sensitivity Settings....................................28 2.1.4 Minimum Atrial Threshold ..................................29 2.1.5 Far Field Blanking ..............................................29 ii Belos Technical Manual 2.2 Ventricular Tachyarrhythmia Detection ......................30 2.2.1 VF Classifications ..............................................31 2.2.2 VT Interval Counters ..........................................31 2.2.3 VT Classification ................................................31 2.2.4 SMART Detection™...........................................32 2.2.5 Onset..................................................................33 2.2.6 Stability...............................................................33 2.2.7 Sustained VT Timer ...........................................34 2.3 Tachyarrhythmia Redetection ....................................34 2.3.1 VT Redetection ..................................................35 2.3.2 SMART Redetection..........................................35 2.3.3 VF Redetection ..................................................35 2.4 Tachyarrhythmia Termination.....................................35 2.5 Tachyarrhythmia Therapy ..........................................36 2.5.1 Therapy Options ................................................36 2.5.2 Anti-Tachycardia Pacing (ATP) .........................36 2.5.3 Shock Therapy...................................................39 2.5.4 Progressive Course of Therapy .........................41 2.6 Bradycardia Therapy.................................................42 2.6.1 Bradycardia Pacing Modes ................................43 2.6.2 Basic Rate..........................................................43 2.6.3 Night Rate ..........................................................44 2.6.4 Rate Hysteresis..................................................44 2.6.5 Dynamic AV Delay .............................................48 2.6.6 Upper Tracking Rate..........................................49 2.6.7 Mode Switching..................................................50 2.6.8 PMT Management .............................................51 2.6.9 Rate Adaptive Pacing ........................................51 2.6.10 Pulse Amplitude .................................................53 2.6.11 Pulse Width ........................................................53 2.6.12 Post Ventricular Atrial Refractory Period ...........53 2.6.13 PVARP Extension ..............................................53 2.6.14 Noise Response.................................................54 2.6.15 Post Shock Pacing.............................................54 2.7 EP Test Functions......................................................54 Belos Technical Manual iii 2.7.1 P and R-wave Amplitude Measurments ............54 2.7.2 Testing for Retrograde Conduction....................55 2.7.3 Pacing Threshold ...............................................56 2.7.4 Arrhythmia Induction Features...........................56 2.7.5 Manual Shock ....................................................57 2.7.6 Manual ATP .......................................................57 2.7.7 Test Shock .........................................................57 2.8 Special Features........................................................58 2.8.1 Detection and Therapy Status ...........................59 2.8.2 Home Monitoring (Belos…
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(Draft) Cardiac Airbag / Cardiac Airbag-T Family of Implantable Cardioverter Defibrillators and Software Cartridge for TMS 1000 PLUS and EPR 1000 PLUS Technical Manual X-ray Identification Cardiac Airbag/Cardiac Airbag-T Implantable Cardioverter Defibrillator Inside the housing, top left-hand side: Year of manufacture X-Ray identification EI • CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. 2003 BIOTRONIK, Inc., all rights reserved. Cardiac Airbag Technical Manual i Contents 1. General...........................................................................1 1.1 System Description....................................................1 1.2 Indications and Usage...............................................2 1.3 Contraindications .......................................................2 1.4 Warnings and Precautions.........................................3 1.4.1 Sterilization, Storage, and Handling ..................3 1.4.2 Device Implantation and Programming..............4 1.4.3 Lead Evaluation and Connection.......................6 1.4.4 Follow-up Testing...............................................7 1.4.5 Pulse Generator Explant and Disposal..............8 1.4.6 Hospital and Medical Hazards ...........................9 1.4.7 Home and Occupational Hazards......................11 1.4.8 Cellular Phones..................................................11 1.4.9 Electronic Article Surveillance (EAS).................12 1.4.10 Home Appliances...............................................12 1.5 Adverse Events..........................................................13 1.5.1 Potential Adverse Events...................................13 1.5.2 Observed Adverse Events .................................14 1.6 Clinical Studies ..........................................................17 1.6.1 Patients Studied .................................................17 1.6.2 Methods .............................................................18 1.6.3 Results ...............................................................18 1.7 Patient Selection and Treatment ...............................20 1.7.1 Individualization of Treatment ............................20 1.7.2 Specific Patient Populations ..............................20 1.8 Patient Counseling Information .................................20 1.9 Evaluating Prospective ICD Patients .........................21 2. Device Features ............................................................22 2.1 Sensing ......................................................................22 2.1.1 Ventricular Sensitivity Settings ..........................22 2.1.2 Minimum Ventricular Threshold .........................25 2.2 Ventricular Tachyarrhythmia Detection ......................25 2.2.1 VF Classifications ..............................................26 2.2.2 VT Interval Counters ..........................................26 2.2.3 VT Classification ................................................26 2.2.4 Onset and Stability .............................................27 ii Cardiac Airbag Technical Manual 2.3 Tachyarrhythmia Redetection ....................................28 2.3.1 VT Redetection ..................................................28 2.3.2 VF Redetection ..................................................28 2.3.3 Tachyarrhythmia Termination ............................28 2.4 Tachyarrhythmia Therapy ..........................................28 2.4.1 Shock Therapy...................................................29 2.5 Bradycardia Therapy.................................................31 2.5.1 Bradycardia Pacing Modes ................................31 2.5.2 Basic Rate..........................................................31 2.5.3 Rate Adaptation .................................................31 2.5.4 Gain and Threshold ...........................................32 2.5.5 Rate Increase / Decrease ..................................32 2.5.6 Maximum Sensor Rate ......................................32 2.5.7 Pulse Amplitude .................................................32 2.5.8 Pulse Width ........................................................33 2.5.9 Noise Response.................................................33 2.5.10 Post Shock Pacing.............................................33 2.6 Special Features........................................................33 2.6.1 Home Monitoring (Cardiac Airbag-T Only) ........33 2.6.2 Real-time IEGM Transmission ...........................37 2.6.3 Capacitor Reformation .......................................37 2.6.4 Patient and Implant Data ...................................38 2.6.5 System Status ....................................................39 2.6.6 Holter Memory...................................................40 2.6.7 Arrhythmia Induction Features...........................42 2.6.8 Manual Shock ....................................................43 2.6.9 Test Shock .........................................................43 3. Software Features.........................................................44 3.1 Follow-Up Assistant (FAST) Window.........................44 3.1.1 Interrogate ICD without Follow-up .....................45 3.2 Main Function Keys ...................................................45 3.3 Parameter Window....................................................47 4. Sterilization and Storage ..............................................50 5. Implant Procedure ........................................................52 5.1 Implant Preparation ...................................................52 5.2 Lead System Evaluation ............................................52 5.3 Opening the Sterile Container ...................................53 5.4 Pocket Preparation ....................................................53 5.5 Lead to Device Connection .......................................54 Cardiac Airbag Technical Manual iii 5.6 Blind Plug C…
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March 12, 2003 To whom it may concern; Re: Section 5301 (Anti-Drug Abuse) Certification This letter is to certify that neither Biotronik Inc., nor any party to the application, is 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). If you have any questions, please call me at (503) 387-2640, or fax (503) 387-2611. Thank you for your assistance. Sincerely, Jim Horton Senior Program Manager Biotronik, Inc.
March 06, 2003 Jim Horton Sr.Program Manager-Home Monitoring BIOTRONIK USA
March 12, 2003 Greg Kiemel Director of Engineering Northwest EMC, Inc. 22975 NW Evergreen Pkwy., #400 Hillsboro, Oregon 97124 Dear Greg, Included with this cover letter are the application files for our submission of the Belos-T family of Implantable Cardiac Defibrillator (ICD) devices. The submission covers three (3) devices built upon our 4085 substrate; The Belos DR-T, the Belos VR-T and the Cardiac Airbag-T. All three devices use our proprietary Home Monitoring technology. This submission is relevant to a bipolar-FSK transmitter used in the Belos-T series of ICD’s. We are seeking a type certification for this device. This type license is authorized under FCC Part 95 MICS. There is no other lab data other than that obtained from you (NWEMC). We have been assigned the FCC Registration Number (FRN) 0008602195. We will want to use the FCC ID# PG6BELOS-T for these products. If you have any questions, please call me at (503) 387-2640, or fax (503) 387-2611. Thank you for your assistance. Sincerely, Jim Horton Senior Program Manager Biotronik, Inc.
LAW OFFICES GOLDBERG, GODLES, WIENER & WRIGHT 1229 NINETEENTH STREET, N.W. WASHINGTON, D.C. 20036-2413 HENRY GOLDBERG JOSEPH A. GODLES JONATHAN L. WIENER MICHAEL A. McCOIN BRITA D. STRANDBERG HENRIETTA WRIGHT THOMAS G. GHERARDI, P.C. COUNSEL (202) 429-4900 TELECOPIER: (202) 429-4912 e-mail: [email protected] website: www.g2w2.com March 17, 2003 BY ELECTRONIC FILING Federal Communications Commission Office of Engineering and Technology Laboratory Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Re: Biotronik, Inc. (Grantee Code: PG6) Application for Equipment Authorization (Form 731) For the Belos VR-T and Belos DR-T Implantable Cardioverter Defibrillators and the Cardiac Airbag-T Medical Implant Devices Dear Sir or Madam: Submitted herewith on behalf of Biotronik, Inc. (“Biotronik”), is an application on FCC Form 731 for a new equipment authorization for the following medical implant devices: (1) the Belos VR-T implantable cardioverter defibrillator (“ICD”); (2) the Belos DR-T ICD; and (3) the Cardiac Airbag-T. These devices, all having identical RF transmission circuits, will operate pursuant to the Medical Implant Communications (“MICS”) service rules (Part 95, Subpart I) and will transmit operational, diagnostic, and therapeutic information associated with their use by cardiac patients to healthcare professionals via the cellular telephone network. The devices subject to the instant application offer a single mode of transmission for which authorization is sought. The devices transmit when certain cardiac and Mar. 17, 2003 Page 2 technical events are detected by the implant device itself, known as “event messaging.” 1 The Commission has determined that this mode of transmission is exempt from the frequency monitoring requirements contained in Section 90.628(a) of the MICS rules. 2 In addition, the devices subject to this application have the capability of offering regularly scheduled transmissions, which are preprogrammed by the implant patient’s physician. On February 25, 2003, the Commission issued an order finding that such preprogrammed, regularly scheduled transmissions on a single channel without prior frequency monitoring do not comport with the MICS rules. 3 The instant application, therefore, does not seek authorization to use the scheduled transmission features of the Belos VR-T, Belos DR-T, and Cardiac Airbag-T medical implant devices. This application, however, is being submitted without prejudice to any action Biotronik may take with respect to the Commission’s February 25, 2003 decision, or with respect to obtaining authorization for preprogrammed, regularly scheduled transmissions by the devices that are subject to this application or by any future Biotronik devices. Please direct questions concerning this application to Mr. James Horton, Senior Program Manager for Biotronik, by e-mail at [email protected] or by phone at (503) 387-2640. Respectfully submitted, Henry Goldberg Attorney for Biotronik, Inc. Attachments cc: Mr. Julius Knapp (w/o attachments) Mr. Bruce Romano (w/o attachments) 1 See Section 2.8.2.4 of Technical Manual for Belos Family of Implantable Cardioverter Defibrillators and Section 2.6.1.4 of the Technical Manual for the Cardiac Airbag-T, submitted herewith. 2 See Letter Order from Bruce A. Franca, Deputy Chief, Office of Engineering and Technology, FCC ID. No. PG6BA0T (Mar. 8, 2002) at 2 (“OET Letter Order”), aff’d, In re Biotronik, Inc., Equipment Authorization for the Medical Implant Communications Service, Memorandum Opinion and Order, FCC Identifier No. PG6BA0T, FCC 03-32, ¶11 (rel. Feb. 25, 2003). 3 See MO&O at ¶15. Mar. 17, 2003 Page 3 Mr. James Burtle (w/o attachments)
March 6, 2003 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To Whom It May Concern: Per the provision of 47 CFR 0.459, Biotronik would like to request that some of the information provided in our submission for a license for the RF transmitter embedded in our ICD product remain confidential. The confidential documents in this submission should include: Antenna description.pdf Frequency block diagram.pdf Modulation description.pdf Operational description.pdf Internal photos.pdf Schematics.pdf The reasons for requesting confidentiality of these items are that this transmitter circuitry and its performance are Biotronik proprietary designs. If disclosed, this information would result in substantial competitive harm. Utilizing RF communications in ICDs is a novel approach, which Biotronik seeks to exploit as a competitive advantage. Design and development efforts were substantial, and if provided to competitors would create an unfair market advantage to those gaining the information. Biotronik feels that this feature will provide first-to-market advantage that will provide financial gains of millions of dollars. These gains would be greatly diminished if such proprietary information was made publicly available to competitors. It is requested that this information remain proprietary for a period of at least two years, as this is the expected lifecycle of such products. It should also be noted that as this is a medical communications device, Biotronik has designed this implant communications system to meet the patient's privacy regulations provided by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Digital data transmitted with this system is encrypted using techniques to assure privacy of patient data. Specific information regarding the design of this system is revealed in the schematics, descriptions, and photographs. Disclosure of these documents may reduce the effectiveness of the designs for privacy that Biotronik has developed. If there are any further questions regarding the Biotronik request for confidentiality, please contact Jim Horton at (503) 387-2640 or [email protected]. Sincerely, Jim Horton Senior Project Manager Biotronik, Inc.
Northwest EMC Dear Application Examiner, Northwest EMC, Inc., is the agent for Biotronik, for their application for PG6BELOS-T. The form 731, which we submitted, did not have the correct information for the model notes to appear on the grant. We would like to modify the model notes for PG6BELOS- T. The model notes should be. “Belos DR-T, Belos VR-T, and Cardiac Airbag-T” Thank you for your assistance in this matter. David M. Tolman Quality Manager Northwest EMC, Inc.
External Photos
FCC ID Labeling Scheme Per 47 CFR 2.926 (e), “Where it is shown that a permanently affixed nameplate is not desirable or is not feasible, an alternative method of positively identifying the equipment may be used if approved by the Commission. The proposed alternative method of identification and the justification for its use must be included with the application for equipment authorization. Note: As an example, a device intended to be implanted within the body of a test animal or person would probably require an alternate method of identification.” Since the EUT is implanted in the human body, the FCC ID will not be applied to outside of the device. Instead, the applicant is proposing the following alternate method of applying the FCC ID number to two locations: 1. The FCC ID, along with the disclosure statement required by 95.1215(a), is in the User Manual (page 103 of the Belos, page 83 of the Cardiac Airbag – see excerpt below). 2. The FCC ID also appears on the package label (see examples below), which is affixed to outside of the shipping box for the EUT. Federal Communications Commission Disclosure The BA03 DDDR pacemaker is equipped with an RF transmitter for wireless communications. This transmitter is authorized by rule under the Medical Implant Communications Service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such aids, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Implant Communications Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. The FCC ID number for this device is: PG6BELOS-T. Belos DR-T Implantable Cardioverter Defibrillator Order No.: 338 171 DDDRD, 2 x IS-1/BI, 2 x DF-1 Serial No.: 12345678 Use Before: 99/99/9999 DESCRIPTION: One dual chamber active housing implantable cardioverter defibrillator with two IS-1 connector receptacles and two DF-1 connector receptacles. Belos DR-T contains Biotronik's Home Monitoring capabilities. Programmable Parameters* Factory Settings Bradycardia Mode OFF Tachycardia Detection OFF Home Monitoring OFF CAUTION: When Shipped, all tachycardia and bradycardia functions are inactive! *See technical manual for detailed specifications. STERILE: Cardioverter Defibrillator as identified and accessories NON-STERILE: Package inserts (documentation), refer to technical manual for additional information. STERILIZATION: This unit has been gas sterilized with ethylene oxide. Sterility cannot be guaranteed if the package has been damaged during transportation. Please examine the package carefully before opening. If it shows any evidence of damage or mishandling, it should be returned immediately to BIOTRONIK. Once the box seal has been broken, title passes to the hospital and a purchase order is required. CAUTION: Recommended Storage Temperature: 5° C - 55° C (41° F - 131° F). CAUTION: ICD and lead systems which do not expressly claim to agree with the IS-1 or DF-1 dimensions generally have to be regarded as incompatible with IS-1 or DF-1 connectors. Consult your BIOTRONIK representative regarding lead-generator compatibility prior to the implantation of an ICD system. CAUTION: Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. FCC Statement: Belos DR-T is equipped with an RF transmitter for wireless communications. This device must not interfere with stations operating in the 400.150 - 406.000 MHz band in the Meteorological Satellite or Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Made in Germany B1157-A 11/02 Device / No.: Belos DR-T / 338 171 Serial No.: 12345678 Manufacturer Name/No.: BIOTRONIK / 004 Device / No.: Belos DR-T / 338 171 Serial No.: 12345678 Manufacturer Name/No.: BIOTRONIK / 004 Device / No.: Belos DR-T / 338 171 Serial No.: 12345678 MftN/NBIOTRONIK/004 Device / No.: Belos DR-T / 338 171 Serial No.: 12345678 MftN/NBIOTRONIK/004 Belos VR-T Implantable Cardioverter Defibrillator Order No.: 342 874 VVIRD, IS-1/BI, 2 x DF-1 Serial No.: 12345678 Use Before: 99/99/9999 DEVICE DESCRIPTION: One single chamber, rate adaptive implantable cardioverter defibrillator with active housing and with one IS-1 connector receptacle and two DF-1 connector receptacles. Belos VR-T contains Biotronik's Home Monitoring capabilities. Programmable Parameters* Factory Settings Bradycardia Mode OFF Tachycardia Detection OFF Home Monitoring OFF CAUTION: When shipped, all tachycardia and bradycardia functions are inactive! *See technical manual for detailed specifications. STERILE: Cardioverter Defibrillator as identified and accessories NON-STERILE: Package inserts (documentation), refer to technical manual for additional information. STERILIZATION: This unit has been gas sterilized with ethylene oxide. Sterility cannot be guaranteed if the package has been damaged during transportation. Please examine the package carefully before opening. If it shows any evidence of damage or mishandling, it should be returned immediately to BIOTRONIK. Once the box seal has been broken, title passes to the hospital and a purchase order is required. CAUTION: Recommended Storage Temperature: 5° C - 55° C (41° F - 131° F). CAUTION: ICD and lead systems which do not expressly claim to agree with the IS-1 or DF-1 dimensions generally have to be regarded as incompatible with IS-1 or DF-1 connectors. Consult your BIOTRON…
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Page 1 of 10 1-Substrate (Dycostrate) 1994085 11 2-Panel Label (3) 1330172-00 A/RA/R 3-Product Label 1330172-03A/RA/R 4-Solder (3) 197050-012 A/RA/R High Temperature Tape 1600412-04 Alternate 1600412-00 6- Adhesive, Non-conductive (Loctite 3615) 2060060 A/RA/R Underfill Material 2060061-02 Alternate 2060061-01 8-Solder Wire 197053-004 A/RA/R 9-Hand Solder Paste 197050-011 A/RA/R 10- No Clean Flux 1970061 A/RA/R 11C803, C804 2.7 pF, 10%, 50V, 0402 Cer Cap4162R70CFANTBC 20 12C810 1.8 pF, 10%, 50V, 0402 Cer Cap4161R80BFANTBC 10 A/RA/R 5A/RA/R- 7- Letter P R DCN NO.02-185712/16/2002MAP DCN NO.03-10591/23/2003AMC Proprietary InformationTach 20 DR-T (VDDR Version) Rev. R RevisionsDateApproval Micro Systems Engineering, Inc. BILL OF MATERIALS BOM 7084085-02 SMT ASSEMBLY ITEM REFERENCE NUMBER DESCRIPTION Micro Sys tems Engineering PART NUMBER VDDR-T (-02) VD DR (-05) NOTES: 1. The assembly is electro-static discharge sensitive and requires special handling per SOP 8010001. 2. Moisture sensitive device, issue to nitrogen storage. 3. Issue to secondary processing station. 4. Th e TA CH20_ DR-T Vers io n VR " -00" an d " -03" is d efin ed in BOM 7084085-00. 5. The TACH20_DR-T Version DR "-01" and "-04" is defined in BOM 7084085-01. 6. The test coupon shall only be populated for TACH20_DR-T Version DRT"-01" where specific components are identified by "TC*". 7. The Telemedicine circuitry is identified by reference des ignator 8xx s eries . Thes e are required for the T-option (-00,-01,-02) vers ions and are not required for the non-T options (-03, -04, -05). LOT NO.HYBRID VERSION PULL DATETOP ASSEMBLY REVISION AUDIT DATESUB ASSEMBLY REVISION RELEA SE DA TEBOM REVISION 3001179-1/APROPRIETARY INFORMATION Page 2 of 10 ITEM REFERENCE NUMBER DESCRIPTION Micro Sys tems Engineering PART NUMBER VDDR-T (-02) VD DR (-05) 13C813 4.7 pF, 5%, 50V, 0402 Cer Cap4164R70CFANTBC 10 14C812 10 pF, 5%, 50V, 0402 Cer Cap41610R0DFANTBC 10 33 pF, 5%, 50V, 0402 Cer Cap20233R0JHANTBA Alternate20233R0JHANTBC 47 pF, 5%, 50V, 0402 Cer Cap20247R0JHANTBA Alternate 20247R0JHANTBC 68 pF, 5%, 16V, 0402 Cer Cap20268R0JEANTBA Alternate 20268R0JEANTBC 100 pF, 5%, 50V, 0402 Cer Cap 2021000JHARTBA Alternate2021000JHANTBA Alternate 2021000JHARTBC 220 pF, 5%, 50V, 0402 Ceramic Cap 202200JHARTBA Alternate 2022200JHARTBC 330 pF, 5%, 50V, 0402 Cer Cap2023300JHARTBA Alternate 2023300JHARTBC 560 pF, 5%, 50V, 0402 Cer Cap2025600JHARTBA Alternate2025600JHARTBC 750 pF, 5%, 50V, 0402 Cer Cap2027500JHARTBA Alternate 2027500JHARTBC 1 nF, 5%, 50V, 0402 CerCap2021001JHARTBA Alternate 2021001JHARTBC 1.5 nF, 5%, 50V, 0402 Cer Cap2021501JHARTBA Alternate 2021501JHARTBC 2.2nF, 5%, 50V, 0402 Cer Cap2022201JHARTBA Alternate 2022201JHARTBC 10 nF, 5%, 16V, 0402 Cer Cap2021002JEARTBA Alternate 2021002JEARTBC 22 nF, 5%, 25V, 0603 Cer Cap2022202JFCRTBA Alternate 2022202JFCRTBC 33 nF, 5%, 16V, 0603 Cer Cap2023302JECRTBA Alternate 2023302JECRTBC 47 nF, 5%, 16V, 0603 Cer Cap2024702JECRTBA Alternate 2024702JECRTBC C118, C145, C146, C147, C151, C452, C353 7729 C249 1128 C125 1127 ,, C603, C604, C236, C237,C238, 121126 C134, C135 2225 2223 C233, C233A2224 121 C231, C232, C231A, C232A 4422 0 19 C806, C808, C811, C807 40 C216, C21722 20 18 1 16C215 11 15C466 1 17C802 1 C124 1 C128, C556 C229, C230, C56133 3001179-1/APROPRIETARY INFORMATION Page 3 of 10 ITEM REFERENCE NUMBER DESCRIPTION Micro Sys tems Engineering PART NUMBER VDDR-T (-02) VD DR (-05) 68 nF, 5%, 16V, 0603 Cer Cap 2026802JECRTBA Alternate 2026802JECRTBC 100 nF, 5%, 16V, 0603 Cer Cap(3) 2021003JECRTBA Alternate 2021003JECRTBC 330 nF, 5%, 16V, 0805 Cer Cap2023303JEFRTBA Alternate2023303JEFRTBC 470 nF, 10%, 16V, 0805, Cer Cap2024703KEFRTBA Alternate 2024703KEFRTBC 34C141, C143 1 μF, 10%, 16V, Tantalum Cap2091004KDVTRBA22 35C142 3.3 μF, 10%, 10V Tantalum Cap2093304KCVTRBA 11 10 μF, 10%, 10V Tantalum Cap 2091005…
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6024 Jean Road · Lake Oswego, Oregon · United States
| # | Rule Parts | Frequency Range | Power Output | Emission | Tolerance |
|---|---|---|---|---|---|
| 1 | 95I | 403.6 MHz - 403.6 MHz | 0.00 µW | 20K0F1D | 9.9100000000 ppm |

Cylos DR-T
Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body
Lexos DR-T & Lexos VR-T
Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body
Philos DR-T (aka Actros C-T)
Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body
Patient Device
Equipment Class
PCT - PCS Licensed Transmitter worn on body