Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
INFORMATIONS SUR LA CONFORMITÉ RÉGLEMENTAIRE EN MATIÈRE DE RADIO Industrie Canada Ce dispositif est conforme aux normes RSS d'exemption de licence d'Industrie Canada. Le fonctionnement est soumis aux deux conditions suivantes : (1) ce dispositif ne doit pas produire d'interférences et (2) ce dispositif doit accepter toutes les interférences, y compris les interférences susceptibles d'entraîner un fonctionnement indésirable du dispositif. IC : 3408D-BLEIMPLANT4 Modèles Cobalt™ XT VR MRI SureScan™ Cobalt™ VR MRI SureScan™ Crome™ VR MRI SureScan™ Cobalt™ XT DR MRI SureScan™ Cobalt™ DR MRI SureScan™ Crome™ DR MRI SureScan™ Cobalt™ XT HF Quad CRT-D MRI SureScan™ Cobalt™ XT HF CRT-D MRI SureScan™ Cobalt™ HF Quad CRT-D MRI SureScan™ Cobalt™ HF CRT-D MRI SureScan™ Crome™ HF Quad CRT-D MRI SureScan™ Crome™ HF CRT-D MRI SureScan™ Émission par induction de l'émetteur radio Ce dispositif fonctionne à 175 kHz avec une intensité de champ H inférieure à -28,8 dBμA/m à 300 m. Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 États-Unis www.medtronic.com +1 763 514 4000 Représentant agréé dans la Communauté européenne Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen Pays-Bas +31 45 566 8000 Europe/Moyen-Orient/Afrique Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Suisse +41 21 802 7000 Australie Medtronic Australasia Pty Ltd 5 Alma Road Macquarie Park, NSW 2113 Australie 1800 668 670 Canada Medtronic of Canada Ltd 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada +1 905 460 3800 Manuels techniques www.medtronic.com/manuals *M977855A002* © 2016 Medtronic M977855A002 A 2019-06-06
RADIO REGULATORY COMPLIANCE INFORMATION Industry Canada This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. IC: 3408D-BLEIMPLANT4 Models Cobalt™ XT VR MRI SureScan™ Cobalt™ VR MRI SureScan™ Crome™ VR MRI SureScan™ Cobalt™ XT DR MRI SureScan™ Cobalt™ DR MRI SureScan™ Crome™ DR MRI SureScan™ Cobalt™ XT HF Quad CRT-D MRI SureScan™ Cobalt™ XT HF CRT-D MRI SureScan™ Cobalt™ HF Quad CRT-D MRI SureScan™ Cobalt™ HF CRT-D MRI SureScan™ Crome™ HF Quad CRT-D MRI SureScan™ Crome™ HF CRT-D MRI SureScan™ Inductive Radio Transmitter Output 7KLVGHYLFHRSHUDWHVDWN+]ZLWKDQ+¿HOGVWUHQJWKRIOHVVWKDQG%ȝ$PDWP Medtronic, Inc. 0HGWURQLF3DUNZD\ 0LQQHDSROLV01 USA www.medtronic.com Authorized Representative in the European Community 0HGWURQLF%9 (DUO%DNNHQVWUDDW 6422 PJ Heerlen The Netherlands Europe/Middle East/Africa Medtronic International Trading Sàrl 5RXWHGX0ROOLDX &DVH3RVWDOH &+7RORFKHQD] Switzerland Australia Medtronic Australasia Pty Ltd 5 Alma Road 0DFTXDULH3DUN16: Australia Canada Medtronic of Canada Ltd 99 Hereford Street %UDPSWRQ2QWDULR/<5 Canada Technical manuals ZZZPHGWURQLFFRPPDQXDOV *M977855A001* 0HGWURQLF 0$$
RADIO REGULATORY COMPLIANCE INFORMATION FCC Compliance Information: The following provision applies to the low frequency communications system in the device: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired RSHUDWLRQ7KHXVHULVFDXWLRQHGWKDWFKDQJHVRUPRGL¿FDWLRQV not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Cobalt™ and Crome™ Models FCC ID: LF5BLEIMPLANT4 The device uses Bluetooth 1 wireless technology utilizing a 2 Mhz bandwidth and capable of transmitting up to 6.5 feet (2 m) in an environment that is conducive for wireless transmission and reception. 1 The Bluetooth® word mark is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. *M995428A001* © 2010 Medtronic, Inc. M995428A001 Rev.A 2019-04-30 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636 Technical manuals: www.medtronic.com/manuals
Å ̧·ÂÊʡ ËÈ»¹·Äʡʹʻ Åĺ¿Ê¿ÅÄ·Â¿ÃÆÂ·ÄÊ· ̧»ɿĽ»¹¾·Ã ̧»È¹·Èº¿ÅÌ»ÈʻȺ»¼¿ ̧ȿ·ÊÅÈͿʾËÈ»¹·Äʡ Ê»¹¾ÄÅÂŽϷĺÂË»ÊÅÅʾ ʞ ͿȻ»ÉÉʻ»ûÊÈÏƺƖ ƻ »Ì¿¹»·ÄË·Â ¾»¼ÅÂÂÅͿĽ¿ÉʿĹÂ˺»ÉÊÈ·º»Ã·ÈÁÉÅÈÈ»½¿ÉʻȻºÊÈ·º»Ã·ÈÁÉż»ºÊÈÅÄ¿¹¿Äʾ»Ä¿Ê»ºÊ·Ê»É·Äº ÆÅÉÉ¿ ̧ÂÏ¿ÄÅʾ»È¹ÅËÄÊÈ¿»ÉƔÂÂÅʾ»ÈÊÈ·º»Ã·ÈÁɷȻʾ»ÆÈÅÆ»ÈÊÏżʾ»¿ÈÈ»ÉÆ»¹Ê¿Ì»ÅÍÄ»ÈÉƔ ¹Ê¿Ì»·ÄƑËȿĽ¾·È½¿Ä½ƑÂË»ÏĹƑ·ÆÊËÈ»·Ä·½»Ã»ÄÊƑ·Èº¿·¹ÅÃÆ·ÉÉƑ·È»Â»ÈÊƑ ·È»¿ÄÁƑ¾·È½»·Ì»ÈƑÅ ̧·ÂÊƑ ÄÊÈ¿ÄÉ¿¹Ƒ»ºÊÈÅÄ¿¹Ƒ»ºÊÈÅÄ¿¹·È»Â»ÈÊƑ»ºÊÈÅÄ¿¹·È»¿ÄÁƑ ÆÊ¿ÅÂƑ¾ÏÉ¿ÅËÈÌ»ƑË¿¹ÁÅÅÁƑ÷ÈʾŹÁƑËÈ»¹·ÄƑƖ¾Å¹ÁƑÈË ÅÄÊ»ÄÊÉ ʸ ÏÉÊ»ÃÅÌ»ÈÌ¿»Íʻ ʸƔʸ ÷ÈÁż¹ÅļÅÈÿÊÏʻ ʸƔʹ ÄÊÈź˹ʿÅÄʻ ʸƔʺ ÏÉʻú»É¹È¿ÆÊ¿ÅÄʻ ʸƔʻ ĺ¿¹·Ê¿ÅÄɷĺËÉ·½»ʽ ʸƔʼ ÅÄÊÈ·¿Äº¿¹·Ê¿ÅÄÉʽ ʸƔʽ ¹Åĺ¿Ê¿ÅÄɼÅÈËÉ»ʽ ʸƔʾ È»Ɩ¿ÃÆÂ·ÄʹÅÄÉ¿º»È·Ê¿ÅÄʾ ʸƔʿ »·ÊËÈ»ÉËÃ÷ÈÏʾ ʸƔˀ ·Ê·É»¹ËÈ¿ÊÏʸʷ ʸƔʸʷ ·¹¿Ä½Ãź»¿Ä¼ÅÈ÷ʿÅÄʸʷ ʹ ·ÈĿĽÉƑÆÈ»¹·ËÊ¿ÅÄÉƑ·ÄºÆÅÊ»ÄÊ¿·Â·ºÌ»ÈÉ»»Ì»ÄÊÉʸʸ ʹƔʸ »Ä»È·ÂÍ·ÈĿĽɷĺÆÈ»¹·ËÊ¿ÅÄÉʸʸ ʹƔʹ ÎÆÂ·Äʷĺº¿ÉÆÅÉ·Âʸʹ ʹƔʺ ·ÄºÂ¿Ä½·ÄºÉÊÅÈ·½»¿ÄÉÊÈ˹ʿÅÄÉʸʹ ʹƔʻ »·º»Ì·ÂË·Ê¿Åķĺ»·º¹ÅÄÄ»¹Ê¿ÅÄʸʺ ʹƔʼ »Ì¿¹»ÅƻȷʿÅÄʸʺ ʹƔʽ ÅÊ»ÄÊ¿·Â·ºÌ»ÈÉ»»Ì»ÄÊÉʸʼ ʺ ÃÆÂ·ÄÊÆÈŹ»ºËÈ»ʸʼ ʺƔʸ ȻƷȿĽ¼ÅÈ·Ä¿ÃÆÂ·ÄÊʸʼ ʺƔʹ »Â»¹Ê¿Ä½·Äº¿ÃÆÂ·ÄʿĽʾ»Â»·ºÉʸʾ ʺƔʺ »ÉʿĽʾ»Â»·ºÉÏÉÊ»Ãʸʿ ʺƔʻ ÅÄÄ»¹Ê¿Ä½Ê¾»Â»·ºÉÊÅʾ»º»Ì¿¹»ʸˀ ʺƔʼ »È¼ÅÈÿĽ̻ÄÊÈ¿¹Ë·Ⱥ»¼¿ ̧ȿ·ʿÅÄʾȻɾźʻÉÊÉʹʷ ʺƔʽ ÅɿʿÅĿĽ·ÄºÉ»¹ËȿĽʾ»º»Ì¿¹»ʹʸ ʺƔʾ ÅÃÆÂ»Ê¿Ä½Ê¾»¿ÃÆÂ·ÄÊÆÈŹ»ºËÈ»ʹʹ ʺƔʿ »ÆÂ·¹¿Ä½·º»Ì¿¹»ʹʺ ʻ Èź˹ÊÉÆ»¹¿¼¿¹·Ê¿ÅÄÉʹʻ ʻƔʸ ¾ÏÉ¿¹·Â¹¾·È·¹Ê»È¿ÉÊ¿¹Éʹʻ ʻƔʹ »¹ÊÈ¿¹·ÂÉÆ»¹¿¼¿¹·Ê¿ÅÄÉʹʼ ʻƔʺ »ÆÂ·¹»Ã»Äʿĺ¿¹·ÊÅÈÉʹʿ ʻƔʻ ÈÅÀ»¹Ê»ºÉ»ÈÌ¿¹»Â¿¼»ʹˀ ʻƔʼ ĻȽÏ»̻ÂɷĺÊÏÆ¿¹·Â¹¾·È½»Ê¿Ã»Éʺʷ ʻƔʽ ·½Ä»Ê·ÆÆÂ¿¹·Ê¿ÅÄʺʷ ʼ »Ì¿¹»Æ·È·Ã»Ê»ÈÉʺʷ ʼƔʸ ûȽ»Ä¹ÏÉ»ÊʿĽÉʺʷ ʼƔʹ º»Ê»¹Ê¿ÅÄÆ·È·Ã»Ê»ÈÉʺʸ ʼƔʺ ·¹¾Ï·ÈȾÏʾÿ·º»Ê»¹Ê¿ÅÄÆ·È·Ã»Ê»ÈÉʺʹ ʼƔʻ »ÄÊÈ¿¹Ë·ÈÊ·¹¾Ï·ÈȾÏʾÿ·Ê¾»È·ÆÏƷȷûʻÈÉʺʺ ʼƔʼ ·¹¿Ä½Æ·È·Ã»Ê»ÈÉʺʽ ʼƔʽ »ºÊÈÅÄ¿¹·È»Â»ÈÊÆ·È·Ã»Ê»ÈÉʺʿ ʼƔʾ ·Ê·¹Å»¹Ê¿ÅÄÆ·È·Ã»Ê»ÈÉʻʷ ʼƔʿ ÏÉÊ»ÃÊ»ÉÊÆ·È·Ã»Ê»ÈÉʻʸ ʼƔˀ ÊËºÏÆ·È·Ã»Ê»ÈÉʻʹ ʺ ʸÏÉÊ»ÃÅÌ»ÈÌ¿»Í ʸƔʸ÷ÈÁż¹ÅļÅÈÿÊÏ ʹʷʸˀ ʸƔʹ ÄÊÈź˹ʿÅÄ ¾¿É÷Ä˷º»É¹È¿ ̧»Éʾ»»ºÊÈÅÄ¿¹Åº»ÂʹʻÅ ̧·ÂÊ ËÈ»¹·ÄɿĽ»¹¾·Ã ̧»ÈƑ¿ÃÆÂ·ÄÊ· ̧» ¹·Èº¿ÅÌ»ÈʻȺ»¼¿ ̧ȿ·ÊÅÈƺ ƻƔ ʹÅÄÊ·¿ÄÉÃź»ÂƖÉÆ»¹¿¼¿¹¼»·ÊËÈ»¿Ä¼ÅÈ÷ʿÅÄƑ¿Äº¿¹·Ê¿ÅÄɷĺ¹ÅÄÊÈ·¿Äº¿¹·Ê¿ÅÄÉƑ Í·ÈĿĽɷĺÆÈ»¹·ËÊ¿ÅÄÉƑ¿ÄÉÊÈ˹ʿÅÄɼÅÈ¿ÃÆÂ·ÄʿĽʾ»º»Ì¿¹»ƑÇË¿¹ÁÈ»¼»È»Ä¹»ÉÆ»¹¿¼¿¹·Ê¿ÅÄÉƑ·ÄºÆ·È·Ã»Ê»È Ê· ̧»ÉƔ ¾»¼ÅÂÂÅͿĽ÷ÄË·ÂɷĺºÅ¹ËûÄÊÉ·ÂÉŹÅÄÊ·¿Ä¿Ä¼ÅÈ÷ʿÅÄ· ̧ÅËÊʾ»º»Ì¿¹»Ɠ Ê»¹¾Ä¿¹·Â÷ÄË·ÂƯ¾¿É÷ÄË·ÂÆÈÅÌ¿º»É ƖÉÆ»¹¿¼¿¹ÆÈŹ»ºËȻɷĺͷÈĿĽɷĺÆÈ»¹·ËÊ¿ÅÄÉƔ »¼»È»Ä¹»Ã·ÄË·ÂƯ¾¿É÷Ä˷¿ĹÂ˺»É¿Ä¼ÅÈ÷ʿÅÄ· ̧ÅËʺ»Ì¿¹»¼»·ÊËÈ»ÉƔ¾»È»¼»È»Ä¹»Ã·ÄË·Â·ÆÆÂ¿»ÉÊÅ ÃËÂÊ¿ÆÂ»Ãź»ÂÉż º»Ì¿¹»ÉƔ ÃÆÂ·ÄÊ· ̧»º»Ì¿¹»·ÆÆ¾»ÂÆƯ¾»¾»ÂÆ»ÎÆÂ·¿ÄɾÅÍÊÅËɻʾ»¿ÃÆÂ·ÄÊ· ̧»º»Ì¿¹»·ÆÆÊÅÆÈŽȷÃʾ»º»Ì¿¹» É»ÊʿĽɷĺ̿»Íʾ»ÉÊÅÈ»ºº»Ì¿¹»º·Ê·Ɣ ÎÆÂ·Ä·Ê¿ÅÄżÉÏà ̧ÅÂÉƯ¾¿ÉºÅ¹ËûÄʺ»¼¿Ä»Éʾ»ÉÏà ̧ÅÂÉʾ·ÊÃ·Ï·ÆÆ»·ÈÅÄʾ»º»Ì¿¹»Æ·¹Á·½»Ɣ»¼»ÈÊŠʾ»Æ·¹Á·½»Â· ̧»ÂÊÅÉ»»Í¾¿¹¾ÉÏà ̧ÅÂÉ·ÆÆÂÏÉÆ»¹¿¼¿¹·ÂÂÏÊÅʾ¿Éº»Ì¿¹»Ɣ »º¿¹·ÂÈŹ»ºËÈ»·Äº ·ÈĿĽÉƑÈ»¹·ËÊ¿ÅÄÉƑ·Äº Ë¿º·Ä¹»·Ä˷¼ÅÈ »·Âʾ·È» Èż»ÉÉ¿ÅÄ·ÂÉƯ¾¿É÷ÄË·ÂÆÈÅÌ¿º»ÉÍ·ÈĿĽÉƑÆÈ»¹·ËÊ¿ÅÄÉƑ·Äº½Ë¿º·Ä¹»¼ÅȾ»·Âʾ¹·È»ÆÈż»ÉÉ¿ÅÄ·ÂÉ;ŠƻȼÅÈÃûº¿¹·Âʾ»È·Æ¿»É·Äºº¿·½ÄÅÉÊ¿¹ÆÈŹ»ºËÈ»ÉÅĹ·Èº¿·¹º»Ì¿¹»Æ·Ê¿»ÄÊÉƔ¾¿É÷Ä˷·ÂÉſĹÂ˺»É ¿Ä¼ÅÈ÷ʿÅÄ· ̧ÅËʾ·Ð·ÈºÉ¼ÈÅÃÉÅËȹ»Éż»Â»¹ÊÈÅ÷½Ä»Ê¿¹¿Äʻȼ»È»Ä¹»ƺ ƻ¿Äʾ»Æ·Ê¿»ÄÊƠɾÅûƑÈ»¹È»·Ê¿ÅÄ·Â »ÄÌ¿ÈÅÄûÄÊÉƑ·ÄºÅ¹¹ËÆ·Ê¿Åķ»ÄÌ¿ÈÅÄûÄÊÉƔ ·º¿ÅÈ»½Ë·ÊÅÈϹÅÃÆÂ¿·Ä¹»¿Ä¼ÅÈ÷ʿÅÄƯ¾¿ÉºÅ¹ËûÄÊÆÈÅÌ¿º»É¹ÅÃÆÂ¿·Ä¹»¿Ä¼ÅÈ÷ʿÅÄȻ·ʻºÊÅʾ» È·º¿Å¹ÅÃÆÅÄ»ÄÊÉżʾ»º»Ì¿¹»Ɣ ʸƔʺÏÉʻú»É¹È¿ÆÊ¿ÅÄ ¾»Åº»ÂʹʻɿĽ»¹¾·Ã ̧»ÈƑ¿ÃÆÂ·ÄÊ· ̧»¹·Èº¿ÅÌ»ÈʻȺ»¼¿ ̧ȿ·ÊÅÈƺ ƻ¿É·ÃËÂÊ¿ÆÈŽȷÃ÷ ̧»¹·Èº¿·¹ º»Ì¿¹»Ê¾·ÊÃÅÄ¿ÊÅÈɷĺȻ½Ë·ʻÉʾ»Æ·Ê¿»ÄÊƠɾ»·ÈÊÈ·Ê» ̧ÏÆÈÅÌ¿º¿Ä½É¿Ä½Â»¹¾·Ã ̧»ÈƑÈ·Ê»ƖÈ»ÉÆÅÄɿ̻ ̧È·ºÏ¹·Èº¿·Æ·¹¿Ä½·ÄºÌ»ÄÊÈ¿¹Ë·ÈÊ·¹¾Ï·ÈȾÏʾÿ·Ê¾»È·Æ¿»ÉƔ¾¿Éº»Ì¿¹»¼»·ÊËÈ»ÉÂË»ÊÅÅʾͿȻ»ÉÉ Ê»¹¾ÄÅÂŽÏƔ ʸ ¾»º»Ì¿¹»¹·Äº»Ê»¹ÊÌ»ÄÊÈ¿¹Ë·ÈÊ·¹¾Ï·ÈȾÏʾÿ·Éƺƭ ƻ·ËÊÅ÷ʿ¹·ÂÂϷĺÆÈÅÌ¿º»ÊÈ»·ÊûÄÊͿʾ º»¼¿ ̧ȿ·ʿÅÄƑ¹·Èº¿ÅÌ»ÈÉ¿ÅÄƑ·Äº·Äʿʷ¹¾Ï¹·Èº¿·Æ·¹¿Ä½Ê¾»È·Æ¿»ÉƔ¾»º»Ì¿¹»È»ÉÆÅĺÉÊÅ ̧È·ºÏ·ÈȾÏʾÿ·É ̧Ï ÆÈÅÌ¿º¿Ä½ ̧È·ºÏ¹·Èº¿·Æ·¹¿Ä½Ê¾»È·ÆÏƔ¾»º»Ì¿¹»·ËÊÅ÷ʿ¹·ÂÂϺ»Ê»¹ÊɷĺȻ¹ÅȺÉʾ»Å¹¹ËÈȻĹ»Å¼·ÊÈ¿·Â ¼¿ ̧ȿ·ʿÅÄƺ ƻ¼ÅȺ¿·½ÄÅÉÊ¿¹ÆËÈÆÅÉ»ÉƔ ʸ ¾»ÂË»ÊÅÅʾ ʞ ÍÅȺ÷ÈÁ¿É·È»½¿ÉʻȻºÊÈ·º»Ã·ÈÁżÂË»ÊÅÅʾ Ƒ ĹƔ·Äº·ÄÏËɻżʾ¿É÷ÈÁ ̧Ï »ºÊÈÅÄ¿¹¿ÉËĺ»È¿¹»ÄÉ»Ɣ ʻ ¾» ËÈ»¹·Ä¼»·ÊËȻƻÈÿÊÉ·Ãź»Å¼ÅƻȷʿÅÄʾ·Ê·ÂÂÅÍÉ·Æ·Ê¿»ÄÊͿʾ·ËÈ»¹·ÄÉÏÉÊ»ÃÊÅ ̧»É·¼»ÂÏ É¹·ÄÄ»º ̧Ï·Ä Ã·¹¾¿Ä»Í¾¿Â»Ê¾»º»Ì¿¹»¹ÅÄÊ¿ÄË»ÉÊÅÆÈÅÌ¿º»·ÆÆÈÅÆÈ¿·Ê» ̧È·ºÏ¹·Èº¿·Æ·¹¿Ä½Ɣ¾»Ä ÆÈŽȷÃûºÊÅÄƑ ËÈ»¹·ÄÅÆ»È·Ê¿Åĺ¿É· ̧»ɷÈȾÏʾÿ·º»Ê»¹Ê¿Åķĺ·ÂÂËÉ»ÈƖº»¼¿Ä»ºº¿·½ÄÅÉÊ¿¹ÉƔ »¼ÅȻƻȼÅÈÿĽ·Ä ɹ·ÄƑÈ»¼»ÈÊÅʾ» Ê»¹¾Ä¿¹·Â÷ÄË·ÂƔ ¾»º»Ì¿¹»·ÂÉÅÆÈÅÌ¿º»Éº¿·½ÄÅÉÊ¿¹·ÄºÃÅÄ¿ÊÅȿĽ¿Ä¼ÅÈ÷ʿÅÄʾ·Ê·ÉÉ¿ÉÊÉͿʾÉÏÉʻû̷ÂË·Ê¿ÅķĺƷʿ»ÄÊ ¹·È»Ɣ ʸƔʺƔʸÉ·½»»ÄÌ¿ÈÅÄûÄÊÉ ¾»º»Ì¿¹»¿É¿Äʻĺ»ºÊÅ ̧»ËÉ»º¿Äʾ»¼ÅÂÂÅͿĽ»ÄÌ¿ÈÅÄûÄÊɷĺ¹Åĺ¿Ê¿ÅÄÉƓ Ѐ ¾»º»Ì¿¹»Í¿Â ̧»¿ÃÆÂ·ÄÊ»º¿Ä·ÆÈÅÆ»ÈÂÏ»ÇË¿ÆÆ»ºƑÉÊ·¼¼»ºƑ·ÄºÉʻȿ»ÉËȽ¿¹·Â»ÄÌ¿ÈÅÄûÄÊƔ ÃÆÂ·ÄÊÍ¿ÂÂÊ·Á» ÆÂ·¹»Ëĺ»ÈÉʷĺ·ÈºÉËȽ¿¹·ÂÆÈÅÊŹÅÂɷĺ¿Äʾ»Æ·Ê¿»ÄÊÆÅÆË·ʿÅļÅÈ;¿¹¾Ê¾»º»Ì¿¹»¿É¿Äº¿¹·Ê»ºƔ Ѐ ÅÉÊƖÉËȽ¿¹·ÂÆ·Ê¿»Äʷĺº»Ì¿¹»¼ÅÂÂÅÍƖËÆ¹·È»Í¿ÂÂÊ·Á»ÆÂ·¹»¿Ä·ÆÈÅÆ»ÈÂÏ»ÇË¿ÆÆ»º·ÄºÉÊ·¼¼»º¹·Èº¿ÅÂÅ½Ï ¹Â¿Ä¿¹ÅÈż¼¿¹»Ɣ Ѐ ÆÈŹ»ºËȻɼÅÈÆ·Ê¿»ÄÊÉͿʾʾ¿Éº»Ì¿¹»Í¿ÂÂÊ·Á»ÆÂ·¹»¿Ä·ÆÈÅÆ»ÈÂÏ»ÇË¿ÆÆ»º·ÄºÉÊ·¼¼»º¼·¹¿Â¿ÊÏƑ·Äº ¿Ä¹ÅÄÉ¿º»È·Ê¿ÅÄżʾ»¹Åĺ¿Ê¿ÅÄɷĺȻÇ˿ȻûÄÊɺ»É¹È¿ ̧»º¿Ä»¹Ê¿ÅÄʸƔʽƔ Ѐ ¼Ê»È¾·Ì¿Ä½·Ä¿ÃÆÂ·ÄÊƑÆ·Ê¿»ÄÊÉ÷ÏÈ»ÉËûʾ»¿È¿̻ɷʾÅûƑ·ÊÍÅÈÁƑ·Äº¿ÄÅʾ»È»ÄÌ¿ÈÅÄûÄÊÉͿʾ ¹ÅÄÉ¿º»È·Ê¿ÅÄżʾ»·ºÌ¿¹»·ÄºÈ»ÉÊÈ¿¹Ê¿ÅÄɺŹËûÄÊ»º¿Äʾ»…
Text truncated - open the document above for the full version.
Medtronic Inc. 710 Medtronic Parkway Minneapolis MN 55432 December 18, 2019 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To whom it may concern. Reference: Application for Medtronic Cobalt and Crome single and dual chamber implantable cardioverter defibrillators FCC ID: LF5BLEIMPLANT4 I, the undersigned, as the authorized signatory for the Medtronic, Inc. hereby apply to seek original grant for: CobaltTM XT VR MRI SureScanTM, CobaltTM VR MRI SureScanTM, CromeTM VR MRI SureScanTM, CobaltTM XT DR MRI SureScanTM, CobaltTM DR MRI SureScanTM, CromeTM DR MRI SureScanTM, CobaltTM XT HF Quad CRT-D MRI SureScanTM, CobaltTM XT HF CRT-D MRI SureScanTM, CobaltTM HF Quad CRT-D MRI SureScanTM, CobaltTM HF CRT-D MRI SureScanTM, CromeTM HF Quad CRT-D MRI SureScanTM, CromeTM HF CRT-D MRI SureScanTM Authorization is sought under FCC rule parts 15.247 All emissions from the 175 kHz inductive radio are at least 40 dB below the limits in 15.209 The Medtronic Cobalt and Crome single and dual chamber implantable cardioverter defibrillators with cardiac resynchronization therapy (CRT-D) are multiprogrammable cardiac devices that monitor and regulate the patient’s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. The Device pairs with Medtronic Programmers to allow interrogation and/or programming. It contains Radio telemetry at 175 KHz and BLE wireless technology to communicate with the Medtronic apps running on mobile devices. The following reports are being submitted to support this filing. The radios are electrically and mechanically identical to those in the reports. Thank you in advance, should you have any questions please feel free to contact me. Sincerely, ___________________________ Daniel Johnson Radio Regulatory Affairs Specialist Cardiac Rhythm Heart Failure Tel 763-526-0820 EMAIL: [email protected]
Medtronic Medtronic, Inc. Cardiac Rhythm a nd Heart Failure 7000 Old Central Ave NE Minneapolis, MN 55432 USA www.medtronic.com office 763.526.0652 mobile 612.99 1.3108 Guillaume Girard Medtronic Inc. October 11, 2019 F ederal Communications Commission Lab oratory Division 7 435 Oak land Mills Rd Col umbia, MD 21045 Attn: Equipment Authorization and Compliance Branch Chief I , the undersigned, as the authorized signatory for Medtronic, Inc., grantee code LF5, hereby authorize Daniel L Johnson, Radio Regulatory Affairs Spcialist of Medtronic, Inc., to ac t on my behalf in all manners relating to app lication for equipment authorization, including signing of all documents relating to such a pplication. Any an d all acts carried out by Daniel L Johnson of Medtronic, Inc. on o ur behalf shall have the same effects as acts of my own. This authoriz ation shall be sent along with each application when filing with the F CC or TCB for certification of products covered by the above specified FCC ID. This authorization is valid until August 1, 2022. l f t here are any q uestions related to this letter, please c ontact me at Guillaume.girard®medtronic.com (mobile 612.991.3108). Respectfully, Guillaume Girard, Medtronic Inc.
April 1, 2019 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Subject: Confidentiality Request Letter pertaining to the certification of FCC ID No: LF5BLEIMPLANT4 Ladies and gentlemen, Medtronic, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Commission’s Rules, 47 C.F.R. § 0.457(d) and 0.459, following grant of the application. The confidential information is embodied in circuit diagrams, detailed explanations, parts lists, block diagram, and internal photographs of a device designed for patients under the care of a medical professional. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. The information for which confidentiality is sought is employed in the design and manufacture of medical device systems that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought. Long-Term Confidentiality The materials set forth in the following exhibits, which are segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Long-Term Confidentiality: - Internal Photos - Schematics - Block Diagram - Theory of Operation / Operational description - Parts list / Tune Up Info Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN-55432, USA www.medtronic.com Following the Equipment Authorization Confidentiality Request Procedures as described in KDB Guidance 726920 D01 of April 8 th 2016, Internal Photos may be held Long-Term Confidential under the condition that the circuit board or internal components are not accessible to users. Medtronic’s Implantable Pulse Generators, which are the subject of this future filing, are not available to the public. The devices are Class 3 devices regulated by the FDA and are available by prescription only by health care professionals and implanted directly in the patient. As the devices are sealed hermetically by a titanium can, opening the device is not possible without destroying it. Therefore, the equipment to which this Long-Term Confidentiality request pertains satisfies this criterion. Short-Term Confidentiality The materials set forth in the following exhibits, which are also segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Short-Term Confidentiality for a period of 180 days from the date of the grant: - External Photos - Test Setup Photos - User Manuals Respectfully, ____________________________ Daniel Johnson RF Regulatory Affairs Specialist Medtronic, Inc. Email:[email protected] Phone: +1-763-526-0820
0('7521,&,1&0,11($32/,60,11(627$86$ (1*,1((5,1* 6L]H 3$57180%(5 5(9 6+((7 '$7( 6&$/(1$ 02'(/7,7/( TIM WIEGAND 12-Sep-2019LABEL IMAGE SPEC-COBALT XT HF QUADCRTD MRI DTPA2QQ OUS MKT 0('7521,&&21),'(17,$/ 7+,6'2&80(17,67+( 3523(57<2)0('7521,&,1&$1'0867%($&&2817(')25 ,1)250$7,21+(5(21,6 &21),'(17,$/'2127 5(352'8&(,75(9($/,772 81$87+25,=('3(5621625 6(1',72876,'(0('7521,& :,7+2873523(5 $87+25,=$7,21 DeviceImageSpecEnd3_05 DTPA2QQ A94231 A B 1 of 2 LABEL IMAGE SPEC TEMPLATE: A83320 REV E 1. The label images shown are a representation of printed labels using the EBOM label stock and label software files XX with the label system database and manufacturing-provided data. 2. Manufacturing printed content: XX a. Printers shall be configured to enable printability of all content. XX b. Printed content shall be positioned on each individual label stock approximately as shown. XX c. Size and position of printed content may vary. XX d. Printed content shall be indelible. XX e. No parts of a letter, whole letter, symbol or graphic shall be blurred, missing or broken which impairs legibility XXXX when viewed without magnification. 3. Data provided by manufacturing:XX a. Serial Number shall be ten alpha-numeric characters. XX b. Use by Date to populate the indicated format of YYYY-MM-DD. XX c. Date of Manufacture to populate the indicated format of YYYY-MM-DD and be determined from the date of initial battery XXXX connection. XX d. PIN number shall be ten alpha-numeric characters. XX e. REF number XX f. "Manufactured in:" text per the Specification Tabulation table. 4. The GS1-128 bar code on End Label 1 shall contain:XX a. Encoded bar code data in the following order: XXXXX i. Application Identifier 01 followed by the GTIN (also known as UPN) XXXXX ii. Application Identifier 17 followed by the Use by Date in format YYMMDD XXXXX iii. Application Identifier 21 followed by the Serial Number XX b. Human readable text below the bar code in the following order: XXXXX i. (01) followed by GTIN XXXXX ii. (17) followed by Use by Date in format YYMMDD XXXXX iii. (21) followed by Serial Number 5. Data matrix codes shown on the indicated labels (Shelf Box, Sterile Pack, End Label 1, End Label 3, FYR [upper left corner])XX are provided to facilitate manufacturing. Encoded information is at the discretion of the manufacturing site. 6. The FYR Labels shall contain:XX a. Encoded data: XXXXX i. REF Number for the REF Code 39 bar code XXXXX ii. Serial Number for the SN Code 39 bar code XXXXX iii. Serial Number for the SN data matrix code XX b. Human readable text: XXXXX i. REF Number above the REF Code 39 bar code XXXXX ii. Serial Number above the SN Code 39 bar code XXXXX iii. Serial Number below the SN data matrix code 7. The label printed in manufacturing may be at an equal or later model data and template revision as shown on each label. Specification Tabulation "Manufactured in:" Text A94231-001 Tolochenaz, Switzerland PART NUMBER SHEET REV A94231 A NOTE: IMAGES NOT TO SCALE DeviceImageSpecEnd3_05 0('7521,&&21),'(17,$/7+,6,1)250$7,21,6&21),'(17,$/'21 275(352'8&(,75(9($/,7721210('7521,&3(56216256(1',7 2876,'(0('7521,&:,7+2873523(5$87+25,=$7,21 LABEL IMAGE SPEC TEMPLATE: A83320 REV E 7,7/(LABEL IMAGE SPEC-COBALT XT HF QUADCRTD MRI DTPA2QQ OUS MKT Shelf Box Label Sterile Pack Label SPEC TAB A94231-001 FYR Labels End Label 1 End Label 2 2 of 2 End Label 3
Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 1 of 10 The purpose of this document is to record the antenna information for the following family of products 1. General antenna information Table 1: General antenna information Telemetry: Inductive Antenna Type: Integral loop Manufacturer: Medtronic Model number: M957902A001A Connection with transmitter: Proprietary connector Antenna Gain: N/A Implant depth: 4 cm Polarization: N/A Telemetry: BTLE Antenna Type: Monopole Manufacturer: Medtronic Model number: M966458A001 Connection with transmitter: Proprietary connector Antenna Gain: -31.86 dBi Implant depth: 4 cm Polarization: Linear Product Model Names – Cobalt, Crome family of ICD and CRT models Single Chamber Cobalt TM XT VR MRI SureScan TM Cobalt TM VR MRI SureScan TM Crome TM VR MRI SureScan TM Dual Chamber Cobalt TM XT DR MRI SureScan TM Cobalt TM DR MRI SureScan TM Crome TM DR MRI SureScan TM Triple Chamber Cobalt TM XT HF Quad CRT-D MRI SureScan TM Cobalt TM XT HF CRT-D MRI SureScan TM Cobalt TM HF Quad CRT-D MRI SureScan TM Cobalt TM HF CRT-D MRI SureScan TM Crome TM HF Quad CRT-D MRI SureScan TM Crome TM HF CRT-D MRI SureScan TM Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 2 of 10 2. Antenna Photos Antenna identified by pointer Model Cobalt XT VR MRI SureScan - M966588A001 Antenna (VR DF-1 connector) Model Cobalt XT VR MRI SureScan – right angle Model Cobalt XT VR MRI SureScan – thickness Models that use M966588A001 Antenna (VR DF-1 connector) Cobalt TM XT VR MRI SureScan TM DVPA2D1 Cobalt TM VR MRI SureScan TM DVPB3D1 Crome TM VR MRI SureScan TM DVPC3D1 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 3 of 10 Model Cobalt XT VR MRI SureScan - M966636A001 Antenna (VR_DF4 connector) Model Cobalt XT VR MRI SureScan – right angle Model Cobalt XT VR MRI SureScan – thickness Models that use M966636A001 Antenna (VR_DF4 connector) Cobalt TM XT VR MRI SureScan TM DVPA2D4 Cobalt TM VR MRI SureScan TM DVPB3D4 Crome TM VR MRI SureScan TM DVPC3D4 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 4 of 10 Model Cobalt XT DR MRI SureScan – right angle Model Cobalt XT DR MRI SureScan - thickness Model Cobalt XT DR MRI SureScan M966588A001 Antenna (DR DF-1 connector) Models that use M966588A001 Antenna (DR DF-1 connector) Cobalt TM XT DR MRI SureScan TM DDPA2D1 Cobalt TM DR MRI SureScan TM DDPB3D1 Crome TM DR MRI SureScan TM DDPC3D1 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 5 of 10 Model Cobalt XT DR MRI SureScan – right angle Model Cobalt XT DR MRI SureScan - thickness Model Cobalt XT DR MRI SureScan M966636A001 Antenna (DR_DF4 connector) Models that use M966636A001 Antenna (DR_DF4 connector) Cobalt TM XT DR MRI SureScan TM DDPA2D4 Cobalt TM DR MRI SureScan TM DDPB3D4 Crome TM DR MRI SureScan TM DDPC3D4 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 6 of 10 Model Cobalt XT HF CRT-D MRI SureScan – right angle Model Cobalt XT HF CRT-D MRI SureScan - thickness Model Cobalt XT HF CRT-D MRI SureScan M966458A001 Antenna (CRT DF-1 connector) Models that use M966458A001 Antenna (CRT DF-1 connector) Cobalt TM XT HF CRT-D MRI SureScan TM DTPA2D1 Cobalt TM HF CRT-D MRI SureScan TM DTPB2D1 Crome TM HF CRT-D MRI SureScan TM DTPC2D1 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 7 of 10 Model Cobalt XT HF CRT-D MRI SureScan – right angle Model Cobalt XT HF CRT-D MRI SureScan - thickness Model Cobalt XT HF CRT-D MRI SureScan M964248A001 Antenna (CRT_DF4 connector) Models that use M964248A001 Antenna (CRT_DF4 connector) Cobalt TM XT HF CRT-D MRI SureScan TM DTPA2D4 Cobalt TM HF CRT-D MRI SureScan TM DTPB2D4 Crome TM HF CRT-D MRI SureScan TM DTPC2D4 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 8 of 10 Model Cobalt XT HF Quad CRT-D MRI SureScan – right angle Model Cobalt XT HF Quad CRT-D MRI SureScan - thickness Model Cobalt XT HF Quad CRT-D MRI SureScan M966462A001 (QP_DF-1 connector) Models that use M966462A001 Antenna (QP_DF-1 connector) Cobalt TM XT HF Quad CRT-D MRI SureScan TM DTPA2Q1 Cobalt TM HF Quad CRT-D MRI SureScan TM DTPB2Q1 Crome TM HF Quad CRT-D MRI SureScan TM DTPC2Q1 Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 9 of 10 Model Cobalt XT HF Quad CRT-D MRI SureScan – right angle Model Cobalt XT HF Quad CRT-D MRI SureScan - thickness Model Cobalt XT HF Quad CRT-D MRI SureScan M964248A001 (QP_DF4 connector) Models that use M964248A001 Antenna (QP_DF4 connector) Cobalt TM XT HF Quad CRT-D MRI SureScan TM DTPA2QQ Cobalt TM HF Quad CRT-D MRI SureScan TM DTPB2QQ Crome TM HF Quad CRT-D MRI SureScan TM DTPC2QQ Antenna Information - Basic Cobalt, Crome Medtronic Confidential Page 10 of 10 M957902A001 – Inductive Antenna Inductive radio antenna & bobbin
This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. More: https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/14-commerce-country-chart/fileT Medtronic, Inc. Cobalt XT HF Quad CRD-D MRI SureScan FCC 2.1093:2019 Bluetooth Low Energy Report # MDTR0748.10 NVLAP Lab Code: 200630 CERTIFICATE OF EVALUATION 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: Thursday, December 5, 2019 Medtronic, Inc. EUT: Cobalt XT HF Quad CRD-D MRI SureScan RF Exposure Evaluation Standards Specification Method FCC 2.1093:2019 FCC 447498 D01 General RF Exposure Guidance v06 Results Method Clause Description Applied Results Comments 4.3.1 SAR Test Exclusion Yes Pass None Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. MDTR0748.10EAR-Controlled Data2/9 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. MDTR0748.10EAR-Controlled Data3/9 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test…
Text truncated - open the document above for the full version.
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 1.00 mW |
Confirma DR/SR MRI SureScan, Effectra DR/SR MRI SureScan, Refina CSP DR/SR MRI SureScan, Restoria CSP DR/SR MRI SureScan, ReSyncra CSP DR MRI SureScan, HarmoniaBP DR MRI SureScan
Equipment Class
DTS - Digital Transmission System
MyCareLink Home Communicator Model 26950
Equipment Class
DTS - Digital Transmission System
MyCareLink Home Communicator Model 26900
Equipment Class
DTS - Digital Transmission System
Implantable Neurostimulator
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
MCS3101CO
Equipment Class
DTS - Digital Transmission System