response about certification

FCC ID: YSGKA961

Cover Letter(s)

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FCCID_1583578

To: SISSOKO PHILIPPE, LCIE Bureau Veritas philippe.sissoko@lcie.fr From: Tim Harrington Tim.Harrington@fcc.gov Re: FCC ID: YSGKA961 Applicant: SORIN CRM Correspondence Reference Number: 39724 Form 731 Confirmation Number: EA466506 Date of Original E-mail: 04/22/2011 THIS IS RE-SEND, RENEW, AND REPLACE OF CORRESP. SENT 4/22/11 TO: Agent CC: Applicant --- Please address the following items to facilitate continued FCC application processing. 1) a) as we understand this application is for a programmer / controller / monitor transmitting device intended to communicate with a 95 subpart I implant transmitter - we note that attachments mention "IMD" i.e. implant transmitter - fyi note that complete separate form-731 and 2.1033(c) and maybe 2.1033(b) contents AND a separate different FCC ID are required for an implant transmitter device; i.e. this application does not pertain to equipment auth. requirements for any implant transmitter devices This application is not an implant transmitter device, but communicates with. This monitor communicates with an IMD. This equipment object of this application is a monitor transmitting device intended to communicate with a 95 subpart I implant transmitter. This is not an implant transmitter device. MedRadio is use in all documentation in place of “IMD” 1) b) although this application was submitted as forn-731 eqpt. class TNT "transmitter worn on body", based on info at hand it does not appear this device has intended nor reasonably expected worn-on-body and/or body-adjacent or held-on-body transmitting configurations - or if it does, please provide details about such use configurations if such body use is not applicable, fyi we will change eqpt. class to be TNB (or PCB, depending on response to item 2 herein) OK I think that the class is TNB and form-731 has been modified. 1) c) fyi note that eqpt. auth. for 95 subpart I devices such as this that are not implant transmitters can be processed by TCBs [(http://www.fcc.gov/oet/ea/procedures.html#sec3),

(http://www.fcc.gov/oet/ea/ea_app_info.html)]; in contrast implant transmitters (with associated numerical electromagnetics modelling data to demonstrate compliance with RF exposure SAR limits) must submit application at FCC not TCB I propose to continue this certification with FCC 1) d) if you want to continue with processing of this application as filed at FCC rather than a TCB, the other items in this corresp. need to be addressed accordingly; alternatively in reply you could request that FCC dismiss this application, after which the fee paid to FCC would be refunded and you could contact a TCB to arrange processing and under their independent fee structure We want to continue with processing of this application as filed at FCC rather than a TCB, 2) as submitted this form-731 has only one rule-part/freq. line entry, i.e. for 95 subpart I; however other contents indicate device contains also 15.247 and GPRS functions, each of which have their own specific equipment auth. and filing requirements especially, and related to 47 CFR 2.1033(e), for devices operating under both licensed-service [2.1033(c)] and part 15 [2.1033(b)] rules, two or more form-731 applications are required, in accordance with the following considerations Yes, device contains also 15.247 and GPRS functions, Ok I note that it has its own specific equipment auth. and filing requirements especially, other form-731 applications has been submitted for 15.247. Note that GPRS is already certified as a modular approval. 3) as we understand the 15.247 function/component is an integral part of this device, and device will always be marketed and operated with the 15.247 component installed for the 15.247 portion, an f-731 under eqpt. class DTS or DSS must be submitted, depending on which sections of 15.247 are applicable in that case this FCC ID YSGKA961 represents the combination of at minimum the 95-I and 15.247 components / functions; the GPRS component / function is discussed in the next item Yes, 15.247 is applicable, I suggest that FCC ID YSGKA961 represents the combination of at minimum the 95-I and 15.247 components / functions. 2 applications form-731 have been completed. 4) a) as we understand this product contains a GPRS component / function that has a pre-existing FCC ID associated with modular or limited-modular approval unless complete parts 22 & 24 filing contents and test data will be filed for the GPRS module as installed in this product, then the module FCC ID must be labelled on this device, and other provisions related to "module re-use" described in KDB pub. 996369 must addressed - please revise labelling and other exhibits accordingly OK, test data will be filled for the GPRS module as installed in this product; note that the module FCC ID is labelled on this device as “Contains transmitters ….) 4) b) in case pre-exisitng modular FCC ID will NOT be labelled product, then other changes and amendments will be needed for this FCC ID YSGKA961 application, i.e. test reports and 2.1033(c) content requirements for GPRS part 22 & 24 Pre-exisitng modular FCC ID will be labelled product 4) c) regardless whether the GPRS component will utilize "module re-use" or not, in general radiated power and emissions test data for parts 22 & 24 requirements remains needed in this filing for the specific configuration as installed in this product OK for radiated power and emissions test data for parts 22 & 24 requirements remains needed in this filing for the specific configuration as installed in this product. The GPRS module is used in this product without any modification with an antenna with a gain in accordance with tests done.

5) please explain what are MedRadio and 15.247 transmit paths and components in the block diag. exhibit (i.e. f-731 exhibit type 4, presently has 1-page .pdf), and/or revise where appropriate to show those There are included in the same equipment and PCB. The block Diagram has been modified. (https://apps.fcc.gov/oetcf/eas/misc/EasFaq.cfm) Question: What are the exhibit types required for an electronic filing? Answer: There are 13 different exhibit types; they are listed below: (The number of exhibits required for a submittal is dependent upon the type of equipment for which authorization is sought.) 1. ID Label/Location Info 2. Attestation Statements 3. External Photos 4. Block Diagrams 5. Schematics 6. Test Report 7. Test Setup Photos 8. User's Manual 9. Internal Photos 10. Parts List/Tune-up Info 11. RF Exposure Info 12. Operational Description 13. Cover Letters th These 13 items have been sent (see last mail on November 4 2011) 6) we did not see a confidentiality request cover letter in this filing Ok, done fyi note also in general internal photos exhibits do not qualify for permanent confidentiality, as described in e.g. KDB pub. 726290 Ok, done 7) Some attachments mention "MICS" - fyi since approx. May 2009 MICS is renamed to be MedRadio; therefore "MICS" is generally not applicable OK, done MedRadio replace MICS

8) per 15.101(b), the receiver function in a MedRadio transceiver is subject to Verification eqpt. auth., which then requires also inclusion of the 15.19(a)(1) statement labelled on the device or in the documentation [15.19(a)(5)] - please explain compliance and/or revise exhibit(s) where appropriate OK, done in the documentation. fyi note this requirement is separate from the 15.105(b) statements required for Class B digitial devices 9) emc/radio report pg 4 mentions "OKK for 2400-2483.5" - please explain what is OKK, or revise where appropriate OKK was a mistake, modification done in test report. 10) for pg 14 of emc/radio report, because limit uses unit of microwatt, please revise to include listing of results as converted to microwatt Done 11) one label/location photo shows fccid YSGKA961 = not applicable, please revise Done The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information within 60 days of the original e-mail date may result in application dismissal and forfeiture of the filing fee pursuant to Section 1.1108 DO NOT Reply to this email by using the Reply button. In order for your response to be processed expeditiously, you must upload your response via the Internet at www.fcc.gov, E-Filing, OET Equipment Authorization Electronic Filing, Submit Correspondence, Select Correspondence pertaining to EAS (Equipment Authorization System). Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the email address listed below the name of the sender.


Document Created: 2011-11-18 18:27:49
Document Modified: 2011-11-18 18:27:49
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