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8637 Communications Regulation Reference Sheet Manufacturer Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA www.medtronic.com Tel. +1-763-505-5000 Authorized Representative EC REP in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31, Case Postale 84 CH - 1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Asia-Pacific Medtronic International Ltd. Suite 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300 Medtronic, Inc. 2017 All Rights Reserved M962271A002 Rev A
*M962271A002*
2018-04-01 Communications Regulations The following is a list of communications regulations that apply to the Model 8637. United States Compliance FCC ID: LF58637 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 operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. Canada Compliance IC: CANADA310 This device complies with Industry Canada's RSS-310. Operation is subject to the condition that this device must not cause harmful interference and must accept any interference, including interference that may cause undesired operation of the device. Cet appareil est conforme au CNR-310 dIndustrie Canada. Son exploitation est autorise condition que lappareil ne produise pas de brouillage prjudiciable et quil accepte tout brouillage, mme celui susceptible den compromettre le fonctionnement. This product operates at 175 kHz with an H-field strength of less than 30 dBA/m at 10 m. Ce produit fonctionne 175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m. Argentina Compliance CNC ID: H-17434 CNC ID: H-17433 This product conforms to Argentina Radio Requirements. Este producto cumple los requisitos de Argentina relativos a la radioelectricidad. Brazil Compliance 4876-15-5567 This equipment operates on a secondary basis and, consequently, must accept harmful interference, including from stations of the same kind, and may not cause harmful interference to systems operating on a primary basis. Este equipamento opera em carter secundrio isto , no tem direito proteo contra interferncia prejudicial, mesmo de estaes do mesmo tipo, e no pode causar interferncia a sistemas operando em carter primrio. HIDF15000146 Korea Compliance MSIP-RMI-MKL-8637 This radio device has possibility of radio interference during operation. Singapore Compliance Dealer License # DA103452 This product complies with IDA Standards.
IDA
Malaysia Compliance HIDF15000146 This product conforms to Malaysia Radio Requirement. Produk ini mematuhi Keperluan Radio Malaysia. Australia and New Zealand Compliance This product conforms to Australia and New Zealand Radio Requirements. Philippines Compliance ESD-1715923C ESD-1715922C This product conforms to Philippines Radio Requirements. Taiwan Compliance CCAF17LP0170T7 According to "Administrative Regulations on Low Power Radio Waves Radiated Devices" Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power radio-frequency devices. The low power radio-
frequency devices shall not influence aircraft security and interfere legal communications;
If found, the user shall cease operating immediately until no interference is achieved. The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. European Union Compliance Conformit Europenne
(European Conformity) Hereby, Medtronic declares that this Radio Equipment model number 8637 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
www.MedtronicCompliance.eu This product operates at 175 kHz with an H-field strength of less than 30 dBA/m at 10 m. Bulgarian Medtronic
, 8637 2014/53/.
:
www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 . Czech Spolenost Medtronic tmto prohlauje, e toto radiov zazen, slo modelu 8637, odpovd poadavkm smrnice 2014/53/EU. pln text EU Prohlen o shod je k dispozici na nsledujc internetov adrese:
www.MedtronicCompliance.eu Tento vrobek pouv frekvenci 175kHz, piem intenzita pole H je ni ne 30 dBA/m ve vzdlenosti 10m. Danish Medtronic erklrer hermed, at dette radioudstyr modelnummer 8637 er i overensstemmelse med direktiv 2014/53/EU. Den fulde tekst i EU-
overensstemmelseser-
klringen kan lses her:
www.MedtronicCompliance.eu Dette produkt fungerer ved 175 kHz med en H-feltstyrke p mindre end 30 dBA/m ved 10 m. German Hiermit erklrt Medtronic, dass dieses Funkgertmodell Nr. 8637 der Richtlinie 2014/53/EU entspricht. Der vollstndige Text der EU-
Konformittserklrung steht unter der folgenden Internetadresse zur Verfgung:
www.MedtronicCompliance.eu Dieses Produkt arbeitet mit 175 kHz und einer H-Feldstrke von weniger als 30 dBA/m in einer Entfernung von 10 m. Greek
, Medtronic M 8637 O 2014/53/E.
:
www.MedtronicCompliance.eu 175 kHz H 30 dBA/m 10 m. Spanish Por la presente, Medtronic declara que este equipo de radio, modelo nmero 8637 cumple la Directiva 2014/53/EU. El texto completo de la Declaracin de Conformidad CE est disponible en la siguiente direccin de internet:
www.MedtronicCompliance.eu Este producto opera a 175 kHz con una intensidad de campo H de menos de 30 dBA/m a 10 m. Estonian Kesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga 8637 on vastavuses direktiiviga 2014/53/EL. Kogu EL-i vastavusdeklaratsiooni tekst on saadaval jrgmisel internetiaadressil:
www.MedtronicCompliance.eu See toode ttab sagedusel 175 kHz H-vlja tugevusega vhem kui 30 dBA/m 10 m juures. Finnish Medtronic vakuuttaa tten, ett tm radiolaite, mallinumero 8637, vastaa direktiivi 2014/53/EU. EU-
vaatimustenmukaisuus-
vakuutuksen koko teksti on saatavissa seuraavasta Internet-osoitteesta:
www.MedtronicCompliance.eu Tm tuote toimii 175 kHz:n taajuudella, ja sen H-kentn voimakkuus on alle 30 dBA/m 10 m:n etisyydell. French Par la prsente, Medtronic dclare que cet quipement radio Modle 8637 est conforme la directive 2014/53/UE. Le texte intgral de la dclaration de conformit de l'UE est disponible sur le site Internet:
www.MedtronicCompliance.eu Ce produit fonctionne 175 kHz avec une intensit de champ H infrieure 30 dBA/m 10 m. Croatian Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model 8637 u skladu s Direktivom 2014/53/EU. Cjelokupan tekst europske izjave o sukladnosti dostupan je na sljedeoj internetskoj stranici:
www.MedtronicCompliance.eu Ovaj proizvod radi pri frekvenciji od 175 kHz sa snagom H polja manjom od 30 dBA/m pri 10 m. Hungarian A Medtronic ezton nyilatkozza, hogy ez az 8637 tpusszm rdiberendezs megfelel a 2014/53/EU irnyelvnek. Az EU megfelelsgi nyilatkozat teljes szvege elrhet a kvetkez internetes cmen:
www.MedtronicCompliance.eu Ez a termk 175 kHz-en gy mkdik, hogy mgneses trerssge 10 m tvolsgban kevesebb, mint 30 dBA/m. Italian Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello 8637 conforme alla direttiva 2014/53/UE. Il testo completo della dichiarazione UE di conformit disponibile su Internet al seguente indirizzo:
www.MedtronicCompliance.eu Questo prodotto funziona a 175 kHz con intensit di campo H inferiore a 30 dBA/m a 10 m. Lithuanian iuo Medtronic deklaruoja, kad is radijo rangos modelis, kurio numeris 8637, atitinka Direktyv 2014/53/EB. Vis ES atitikties deklaracijos tekst galite rasti iuo interneto adresu:
www.MedtronicCompliance.eu is gaminys veikia 175 kHz daniu, kai H lauko stiprumas yra maesnis nei 30 dBA/m 10 m atstumu. Latvian Ar o uzmums Medtronic apliecina, ka radioiekrta, modea numurs 8637, atbilst Direktvas 2014/53/EK prasbm. Pilnu ES atbilstbas deklarcijas tekstu var skatt vietn www.MedtronicCompliance.eu is izstrdjums darbojas ar 175 kHz frekvenci, un 10 metru attlum t magntisk lauka stiprums ir mazks par 30 dBA/m. Dutch Hierbij verklaart Medtronic dat deze radioapparatuur modelnummer 8637 in overeenstemming is met Richtlijn 2014/53/EU. De volledige tekst van de Europese conformiteitsverklaring is te vinden op de website:
www.MedtronicCompliance.eu Dit product werkt op 175 kHz met een H-veldsterkte van minder dan 30 dBA/m bij 10 m. Polish p mindre n 30 dBA/m p 10 m. Maltese Hawnhekk, Medtronic tiddikjara li dan it-Tagmir tar-Radju bin-
numru tal-mudell 8637 huwa konformi mad-Direttiva 2014/53/UE. It-test si tad-
dikjarazzjoni ta konformit tal-
UE hu disponibbli fdan l-
indirizz fuq l-Internet:
www.MedtronicCompliance.eu Dan il-prodott jopera f175 kHz bqawwa H-field ta inqas minn 30 dBA/m f'distanza ta' 10 m. Firma Medtronic deklaruje niniejszym, e to urzdzenie radiowe, model numer 8637, spenia wymogi okrelone w Dyrektywie 2014/53/UE. Peny tekst deklaracji zgodnoci UE jest dostpny pod nastpujcym adresem internetowym:
www.MedtronicCompliance.eu Ten produkt dziaa na czstotliwoci 175 kHz z nateniem pola H mniejszym ni 30 dBA/m w odlegoci 10 m. Portuguese Por este meio, a Medtronic declara que este modelo de equipamento de rdio, nmero 8637, est em conformidade com a Diretiva 2014/53/UE. O texto completo da declarao de conformidade da UE est disponvel no seguinte endereo da Internet:
www.MedtronicCompliance.eu Este produto opera a 175 kHz com uma fora do campo H inferior a 30 dBA/m a 10 m. Romanian Prin prezenta, Medtronic declar c acest echipament radio numr model 8637 este n conformitate cu Directiva 2014/53/UE. Textul complet al declaraiei de conformitate UE poate fi gsit la urmtoarea adres de internet:
www.MedtronicCompliance.eu Acest produs funcioneaz la 175 kHz cu o putere a cmpului H de mai puin de 30 dBA/m la 10 m. Slovak Spolonos Medtronic tmto vyhlasuje, e toto rdiov zariadenie, model 8637, je v slade so smernicou 2014/53/E. pln znenie vyhlsenia o zhode so smernicami E je k dispozcii na strnke:
www.MedtronicCompliance.eu Toto zariadenie pracuje pri frekvencii 175 kHz s intenzitou poa H niou ako 30 dBA/m na vzdialenos 10 m. Slovenian Druba Medtronic izjavlja, da je ta radijska oprema, tevilka modela 8637, v skladu z Direktivo 2014/53/EU. Celotno besedilo izjave EU o skladnosti je na voljo na naslednjem spletnem naslovu:
www.MedtronicCompliance.eu Ta izdelek deluje pri 175 kHz z jakostjo magnetnega polja H manj kot 30 dBA/m pri 10 m. Swedish Hrmed intygar Medtronic att denna radioutrustning med modellnummer 8637 verensstmmer med direktiv 2014/53/EU. Den fullstndiga texten med intyg om verensstmmelse fr EU finns p fljande internetadress:
www.MedtronicCompliance.eu Den hr produkten fungerar p 175 kHz med en H-fltstyrka
1 | User Manual | Users Manual | 1.05 MiB |
SynchroMed II Programmable pumps 8637 Implant manual Rx only 2003 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Open here Do not reuse 2 STERILIZE Do not resterilize Do not use if package is damaged STERILE EO Sterilized using ethylene oxide Consult instructions for use Use by Date of manufacture Manufacturer XX C XXX F Temperature limitation
-XX C
-XX F Keep away from magnets Serial number Conformit Europenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123). For USA audiences only 86372016-06-01English3 EC REP Authorized representative in the European community 4English86372016-06-01 Medtronic and SynchroMed are trademarks of Medtronic, Inc., registered in the U.S. and other countries. Prialt is a registered trademark of Azur Pharma International Limited. 86372016-06-01English5 6English86372016-06-01 Table of contents Description 9 Package contents 10 Patient identification card 10 Device specifications 11 Device longevity 14 Flow rate accuracy 15 Measurement error 15 Fluid volume 15 Environmental conditions 16 Declaration of Conformity 18 Instructions for use 19 Preparing for pump implant 19 Sterile procedure 20 Emptying the pump 20 Preparing to fill the pump 21 Filling the pump 21 Priming the pump before implant (if applicable) 22 Replacing an implanted pump 22 Preparing the pump pocket 23 Refer to the indications, drug stability, and emergency procedures reference manual for indications and related information. Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, and component disposal. Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.
! USA Refer to the clinical summary booklet for information on the clinical study results of the infusion system and adverse events summary. 86372016-06-01English7 Implanting the pump 23 Programming the pump 24 Updating the patient record 26 Monitoring the patient 26 Refilling the pump or accessing the catheter access port 26 Technical support 27 8English86372016-06-01 Description The implantable Medtronic Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump and a catheter. The catheter connects to the pump catheter port. The pump is anchored in the pump pocket using the suture loops on the outside of the pump (Figure 1). Reservoir fill port Suture loop Catheter access port Catheter port Figure 1. Pump exterior view. The drug is stored in the pump reservoir (Figure 2). Per a programmed prescription, the drug moves from the pump reservoir, through the internal pump tubing, catheter port, and catheter, to the infusion site. The catheter access port (CAP) allows injection of drug directly into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site. The CAP allows entry of a 24-
gauge noncoring needle to prevent accidental injection during refill procedures (which use the 22-gauge noncoring needle supplied in the refill kit). The manufacturer and model code recorded on a radiopaque identifier are visible using standard x-ray procedures. 86372016-06-01English9 Reservoir fill port Radiopaque identifier Pump reservoir Catheter access port Internal pump tubing Figure 2. Pump interior view. Package contents Pump Needle, 22-gauge (black sheath) Needle, 24-gauge (purple sheath) Product literature Registration form Patient identification card
! USA Warranty card Patient identification card A patient identification card is packaged with this device. Advise the patient to carry the identification card at all times.
! USA The patient identification card packaged with the device is temporary; a permanent card is mailed to the patient when Medtronic receives the registration form.
! USA The implant registration form registers the device warranties and creates a record of the device in the Medtronic implant data system. 10English86372016-06-01 Device specifications Table 1. Shipping and operating values for the Model 8637 SynchroMed II pump Fluid in reservoir Shipping flow rate Infusion modes Shipping Sterile water 0.006 mL/day Simple continuous Alarms Critical alarm Non-critical alarm Disabled Disabled Operating Single bolus Priming bolus Bridge bolus Simple continuous Flex Minimum rate Stopped pump Enabled with an interval programmed Enabled with an interval programmed 86372016-06-01English11 Table 2. Device specifications for the Model 8637 SynchroMed II pumpa 8637-20 19.5 mm 165/185 g 91 mL 87.5 mm 20.0 mL 1.4 mL 17.5 mL 8637-40 26.0 mm 175/215 g 121 mL 87.5 mm 40.0 mL 1.4 mL 37.5 mL 0.140 mL 0.140 mL 500 punctures 500 punctures 500 punctures 500 punctures 24 mL/day 0.048 mL/day 0.030 mL/day 24 mL/day 0.048 mL/day 0.030 mL/day 0.22 m (micron) 0.22 m (micron) Lithium hybrid cathode Rate dependent
(Figure 3) Lithium hybrid cathode Rate dependent
(Figure 3) 175 kHz
-48 dBuV/m 175 kHz
-48 dBuV/m Pump Thickness (including septum) Weight (empty/full) Displacement volume Diameter (including CAP) Pump reservoir Volume Residual volume Fill volume at shipping Internal pump tubing Volumeb Reservoir fill port Septum puncture life Catheter access port Septum puncture life Flow rate Maximum programmablec Minimum programmablec Stopped pump maximum leakage Bacterial retentive filter Pore size Power source Battery Longevity Transmitter Carrier frequency Output level (at 300 m) 12English86372016-06-01 Table 2. Device specifications for the Model 8637 SynchroMed II pumpa
(continued) 8637-20 NGP 20.68 kPa to 34.75 kPa 8637-40 NGV 20.68 kPa to 34.75 kPa Radiopaque identifier Reservoir pressure a All measurements are approximate. b When priming the pump before implant, use a priming bolus of 0.300 mL to fill the internal pump tubing with drug before connecting the catheter and implanting the pump (back table prime). The total prime volume is greater than the internal pump tubing volume to ensure that the entire fluid path in the pump is flushed and primed before implant. c Actual limits depend on pump calibration constant and selected infusion mode. Table 3. Material of components in the Model 8637 SynchroMed II sterile package Material contacts Material contacts Material Component human tissue drug Pump Exterior Reservoir Reservoir valve Tubing Reservoir fill port septum Catheter access port septum Catheter port Bacterial retentive filter Suture loops Propellant Needles Titanium Titanium Titanium Silicone rubber Silicone rubber Silicone rubber Titanium Polyvinylidene fluoride Titanium Inert gas Stainless steel Yes No No No Yes Yes Yes No Yes No Yes No Yes Yes Yes Yes Yes Yes Yes No No Yes 86372016-06-01English13 Device longevity Device longevity is a function of flow rate. Flow rates affect the battery voltage and motor revolutions (Figure 3).
) s r a e y
(
y t i v e g n o L i e c v e D l i a c p y T 10 9 8 7 6 5 4 3 2 1 0 0 0.1 0.2 0.3 0.4 0.5 0.8 0.7 0.6 Flow Rate (mL/day) 0.9 1.0 1.1 1.2 1.3 1.4 1.5 Figure 3. Typical device longevity based on flow rate. Device longevity is the calculated number of service months remaining based on actual usage rates.1 An elective replacement indicator (ERI) message displays on the programmer when the pump nears the end of its service life (EOS). At ERI, the pump continues to operate within specifications. The ERI thresholds allow the pump to operate for a minimum of 90 days, at rates up to 1.5 mL/day, between ERI activation and EOS (Figure 4). When activated, ERI is date stamped and displayed by the programmer after interrogating the pump. The EOS activation indicates the pump has reached the end of its service life. At EOS, the pump stops, but telemetry is available until the pump battery is depleted. 1 Device longevity sources include battery life (voltage), device life (years), and motor life (revolutions). 14English86372016-06-01 t
) s h n o m
(
y t i v e g n o L i e c v e D ERI EOS Time Since Implant 90 Days Figure 4. ERI and EOS. Flow rate accuracy The flow rate accuracy of the pump is within 14.5% of the programmed flow rate at 0.048-24 mL/day, 37 C, 50% reservoir volume, and 300 meters above sea level. Measurement error, fluid volume, and changes in environmental conditions (eg, body temperature and atmospheric pressure) all affect the flow rate. The effects of these changes on flow rate are cumulative if the conditions exist simultaneously. Measurement error The apparent flow rate based on clinical measurements can vary due to measurement error
(eg, syringe measurement accuracy, human error, and the volume of fluid in the extension tubing and filter). Fluid volume The flow rate of the pump varies slightly with the volume of fluid in the pump reservoir. The pump flow rate decreases as the reservoir volume approaches 1 mL. The pump flow rate decreases rapidly and then stops as the reservoir volume decreases from 1 mL to 0 mL. Therefore, the pump should be refilled prior to reaching 1 mL or less. Typically, the flow rate 86372016-06-01English15 decreases by about 4% as the volume is reduced from the half-full volume to a volume of 1 mL. The usable volume is the reservoir volume minus 1 mL (Figure 5). y c a r u c c A e t a R w o F l 130%
120%
110%
100%
90%
80%
70%
Usable Volume 1 mL Volume in Reservoir (mL) 20 or 40 mL Figure 5. Flow rate accuracy as a function of fluid volume in reservoir. Environmental conditions Body temperature The flow rate of the pump varies with body temperature. The flow rate increases as the temperature increases above 37 C and decreases as the temperature decreases below 37 C (Figure 6). 16English86372016-06-01 y c a r u c c A e a R w o F t l 120%
115%
110%
105%
100%
33 95%
90%
85%
80%
34 35 36 37 38 39 40 41 Temperature (Celsius) Figure 6. Flow rate accuracy as a function of temperature (typical effect). Atmospheric pressure Patients living or traveling (eg, airline flights, mountain climbing) at altitudes above sea level are exposed to lower atmospheric pressures. Within days of exposure to the lower pressures, the flow rate of the pump can increase and then stabilize at the higher flow rate. In circumstances where a potential increase in flow rate may pose a risk to a patient, reprogramming the infusion prescription offsets this higher flow rate (Figure 7). In rare instances, exposure to the lower atmospheric pressure can cause the pump to deliver more than 14.5% of the programmed flow rate while the patient is exposed to the lower pressure. Consider changes in drug concentrations or changes to pump programming for patients exposed to lower pressures. 86372016-06-01English17 y c a r u c c A e a R w o F t l 120%
115%
110%
105%
100%
95%
90%
85%
80%
0 500 1000 1500 2000 2500 3000 3500 4000 4500 Altitude (meters) Figure 7. Flow rate accuracy as a function of altitude (typical effect). Declaration of Conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices. For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual. 18English86372016-06-01 Instructions for use Implanting physicians should be experienced in pump and catheter implant procedures and should be thoroughly familiar with all product labeling. Cautions:
Do not implant a pump that was dropped onto a hard surface or shows signs of damage. Implanting a pump that has been dropped or damaged can result in lack of intended therapy, and require additional surgery to replace the pump. Do not implant the pump unless pump operation has been confirmed. Failure to confirm pump operation before implant can result in additional surgery to replace the pump. Do not prematurely activate the pump reservoir valve. Activation of the pump reservoir valve seals the pump reservoir valve closed. Unusual resistance or the inability to inject the entire fill volume may indicate activation of the pump reservoir valve. If the valve closes, a portion of the reservoir contents must be delivered or removed before filling can be completed. Procedural delays can occur. To prevent activation of the pump reservoir valve during emptying and filling procedures:
completely aspirate all contents of the pump reservoir before filling. do not allow air into the pump reservoir through an open needle in the do not exceed the maximum reservoir volume indicated in the pump septum or an unclamped extension. To use the nonsterile clinician programmer in a sterile field, place a sterile barrier between the patient and the programming head to prevent infection. Do not sterilize any part of the clinician programmer. Sterilization may damage the programmer. labeling. Preparing for pump implant 1. Assemble equipment and supplies. pump), and 24-gauge noncoring needle (for flushing the catheter access port) Sterile items The pump package containing the pump, 22-gauge noncoring needle (for filling the Empty 20-mL syringes (for emptying the pump) 0.22-m (micron) filter Syringe containing prescribed fluid (volume not to exceed the reservoir volume of 10-mL syringe with 12 mL of sterile, preservative-free saline (for flushing the the pump) catheter access port) 86372016-06-01English19 Nonsterile items Medtronic clinician programmer 2. Before opening the shelf package, use the clinician programmer to interrogate the pump and verify pump battery status and current settings. a. Confirm that there are no active alarm events. Note: If the pump is still in Shelf Mode, audible alarms are disabled. The pump must be interrogated to determine if an alarm has been activated. b. Confirm that the pump calibration constant displayed on the screen matches the calibration constant printed on the shelf package. Warning: The calibration constant displayed on the programmer screen after reading the pump status must match the calibration constant printed on the shelf package. If calibration constants differ, contact the appropriate Medtronic representative listed on the inside back cover of this manual. Using an incorrect calibration constant can result in a clinically significant or fatal drug underdose or overdose. 3. Attach a "FOR YOUR RECORDS" label (enclosed in the shelf package) to the patient's record. This label displays the pump model number, reservoir size, calibration constant, and serial number. Note: Updating the pump with the new parameters can be performed at this time or after the implant procedure. Refer to "Programming the pump" on page 24 for instructions. Sterile procedure 1. Open the sterile pump package and remove the pump. 2. Remove the protective cap from the catheter port (a small amount of water might be present in the protective cap). Emptying the pump 1. Assemble the 22-gauge noncoring needle and the empty syringe. 2. Insert the needle into the reservoir fill port until the needle touches the metal needle stop. 3. Withdraw the sterile water from the pump into the empty syringe (the pump is shipped nearly full). Note: If the volume of fluid in the pump reservoir exceeds the volume of the syringe used for emptying, remove the filled syringe and needle. Attach an empty syringe and needle, and repeat until the pump reservoir is empty. 4. Empty the pump reservoir until air bubbles no longer appear in the syringe, ensuring all water and air is removed from the pump reservoir. 5. Remove the syringe and needle from the reservoir fill port. 20English86372016-06-01 Preparing to fill the pump 1. If using Prialt1 (preservative-free ziconotide sterile solution), refer to the drug labeling for instructions for use of this drug with the pump. 2. For all indicated drugs refer to Table 4 to determine the fill method. Notes:
A change in concentration is not recommended at the time of replacement. The pump reservoir capacity is 20 mL or 40 mL. Because some sterile water remains in the pump reservoir, the final concentration of drug varies based on the fill method. Table 4. Expected concentration of drug in pump reservoir based on fill method Rinsing with Pump reservoir 10 mL of drug Rinsing with 3 mL of drug Filling without capacity 8637-20 8637-40 rinsing 93%
97%
98%
99%
99%
100%
3. If you are rinsing the pump reservoir before filling, rinse and discard the appropriate volume based on the fill method shown in Table 4. Filling the pump 1. Attach the filter to the syringe containing the prescribed fluid. 2. Attach the needle to the syringe containing the prescribed fluid and filter, and purge the air from the fluid pathway. 3. Read the actual fill volume in the syringe. 4. 5. Insert the needle into the reservoir fill port, and inject the prescribed fluid slowly into the pump reservoir. If the reservoir valve is activated before the pump is filled completely, discontinue injection, remove the needle from the reservoir fill port, and return to "Emptying the pump" on page 20, step 4. 6. When filling is complete, remove the needle from the reservoir fill port. 7. Flush the catheter access port using a 24-gauge noncoring needle and a syringe filled with 1 to 2 mL of saline (or a heparinized solution for vascular applications, if not contraindicated). a. Gently insert the needle into the catheter access port until the needle touches the metal needle stop. Inject fluid into the catheter access port until fluid is observed at the catheter port. b. c. Remove the needle from the catheter access port. 1 Prialt is a brand name drug for ziconotide. Prialt is listed here for USA audiences only. 86372016-06-01English21 Priming the pump before implant (if applicable) Warning: If the pump is being primed before implant, allow the prime to finish before connecting the catheter to the pump. If the prime is not finished, drug can be bolused into the catheter and can result in a clinically significant or fatal overdose. Note: Refer to the clinician programmer guide for information on how to program the priming bolus. For a full system implant or a pump replacement with aspirated catheter 1. To reduce the risk of overdose, consider using a priming bolus of 0.300 mL to fill the internal pump tubing with drug before connecting the catheter and implanting the pump (back table prime). If implanting a new pump, proceed to "Preparing the pump pocket" on page 23. If replacing an implanted pump, proceed to "Replacing an implanted pump" on page 22. 2. 3. For a pump replacement with non-aspirated catheter 1. Use a priming bolus of 0.300 mL to fill the internal pump tubing with drug before connecting the catheter and implanting the pump (back table prime). Warning: If this is a pump replacement and the catheter has not been replaced and has not been aspirated, the internal pump tubing should be primed before connecting the catheter and implanting the pump. Do not program a priming bolus after the catheter has been connected to the implanted pump. Programming a priming bolus in this situation can result in a clinically significant or fatal overdose. 2. Proceed to "Replacing an implanted pump" on page 22. Replacing an implanted pump If applicable, remove the suture at the catheter connector. 1. 2. Disconnect the implanted pump from the implanted catheter. To avoid damage to the pump connector, leave the connector attached to the catheter. Note: If you are replacing a SynchroMed EL Model 8626, 8626L, 8627, or 8627L Implantable Pump, interrogate the replaced pump for catheter volume information that may be stored in the pump. If you are replacing a SynchroMed II Model 8637 Implantable Pump, interrogate the replaced pump for catheter volume information. Enter the catheter volume information into the clinician programmer. If not replacing the catheter, slowly aspirate 1 to 2 mL of fluid from the catheter using a 1-mL tuberculin syringe. Leave the syringe in place to avoid CSF loss. Aspirating directly from the catheter clears the catheter of drug and confirms catheter patency. Note: Conditions might exist under which the catheter is not patent or is not aspirated. If the catheter is not patent it must be replaced. Refer to the appropriate catheter implant manual for catheter replacement instructions. 3. 22English86372016-06-01 Warning: During vascular applications, do not aspirate blood through the catheter access port or catheter. Blood sampling or aspiration through the catheter access port is contraindicated in vascular applications. Residual blood from aspiration or blood sampling can occlude the catheter or pump and inhibit drug delivery, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose, and require surgical revision or replacement. 4. Proceed to "Implanting the pump" on page 23. Preparing the pump pocket Prepare the subcutaneous pocket using an incision in the lower abdomen. Ensure that the subcutaneous pump pocket allows the pump to be implanted within 2.5 cm from the surface of the skin and in an area where sutures will not be directly over the reservoir fill port or catheter access port. site. Caution: Select a location in the lower abdomen that is:
away from bony structures (eg, 3 to 4 cm) to minimize discomfort at the pump away from areas of restriction or pressure to minimize the potential for skin erosion and patient discomfort. away from existing scar tissue. For programmable pumps, select a location that is also:
a minimum of 20 cm away from another programmable device to minimize in an area accessible to the patient for proper operation of a patient control device telemetry interference and incorrect or incomplete programming.
(if applicable). In the pediatric population, care must be taken to select an appropriate location by taking into consideration:
available body mass. presence of ostomies. growth and development. Implanting the pump 1. Connect the implanted catheter to the pump according to the catheter implant manual instructions. 2. Place the filled pump into the prepared pocket. 86372016-06-01English23 Cautions:
Implant the pump no more than 2.5 cm from the surface of the skin in order to maintain access to the reservoir and catheter access ports. Implantation of the pump is contraindicated if the pump cannot be implanted 2.5 cm or less from the surface of the skin. Place the pump in the prepared pocket so:
catheter access port will be easy to access after implant. the reservoir fill port is anteriorly oriented and the reservoir fill port and no sutures to the skin will be directly over the reservoir fill port or the the catheter is not kinked or twisted and is secured well away from the catheter access port. pump ports. Improper component placement can result in inaccessible pump ports, inadequate drug delivery, component damage, or procedural delays, and require surgical revision or replacement. 3. Suture the pump in the subcutaneous pocket using the following steps:
a. Suture first to the fascia in the bottom of the subcutaneous pocket. b. Use these two sutures and the lower suture loops on the pump to draw the pump into the pocket. c. Tie the sutures. d. Suture the remaining two loops at the top of the pump pocket. e. Tie the sutures, securing the pump into the pocket. Irrigate the pump pocket. 4. 5. Close the incisions per normal procedure and apply dressing. Programming the pump For a full system implant or a pump replacement with aspirated catheter 1. Enter the following into the clinician programmer: patient information, catheter model number, implanted catheter length (in centimeters), drug name and concentration, and the volume of prescribed fluid placed in the pump reservoir at implant. Note: If you are replacing a SynchroMed EL Model 8626, 8626L, 8627, or 8627L Implantable Pump, interrogate the replaced pump for catheter volume information that may be stored in the pump. If you are replacing a SynchroMed II Model 8637 Implantable Pump, interrogate the replaced pump for catheter volume information. Enter the catheter volume information into the clinician programmer. Warning: Use the catheter length recorded at implant or catheter revision when calculating catheter volume. The actual implanted catheter length and catheter model number are required to accurately calculate catheter volume. A universal value does not exist that can be used as a substitute for this knowledge. An inaccurate calculation of the catheter volume can result in a clinically significant or fatal drug underdose or overdose. 24English86372016-06-01 2. Program the implanted pump to deliver a priming bolus. Refer to the clinician programmer guide for information on how to calculate and program the priming bolus. If the pump was primed before implant, enter the catheter volume as the total a. prime volume. Warning: If the catheter is new or has been aspirated and the pump was primed before implant, prime only the catheter after connecting the catheter and implanting the pump. Do not include the internal pump tubing volume in the total prime volume calculation. An inaccurate calculation of the total prime volume can result in a clinically significant or fatal overdose. If the pump was not primed before implant, enter the sum of the internal pump tubing volume and the catheter volume as the total prime volume. Note: Priming bolus default parameters have been carefully selected based on extensive modeling and testing. To ensure optimal initiation of therapy, modifications to these values are not recommended. b. 3. Set the Low Reservoir Alarm (to at least 1 mL). 4. Program the pump with new parameters. Note: Refer to the clinician programmer guide for instructions on programming the pump. 5. Print out the patient's prescription and pump settings (pump status). For a pump replacement with non-aspirated catheter 1. Enter the following into the clinician programmer: patient information, catheter model number, implanted catheter length (in centimeters), drug name and concentration, and the volume of prescribed fluid placed in the pump reservoir at implant. Note: If you are replacing a SynchroMed EL Model 8626, 8626L, 8627, or 8627L Implantable Pump, interrogate the replaced pump for catheter volume information that may be stored in the pump. If you are replacing a SynchroMed II Model 8637 Implantable Pump, interrogate the replaced pump for catheter volume information. Enter the catheter volume information into the clinician programmer. Warning: Use the catheter length recorded at implant or catheter revision when calculating catheter volume. The actual implanted catheter length and catheter model number are required to accurately calculate catheter volume. A universal value does not exist that can be used as a substitute for this knowledge. An inaccurate calculation of the catheter volume can result in a clinically significant or fatal drug underdose or overdose. 2. Program the implanted pump to deliver the prescribed infusion. 86372016-06-01English25 Warning: If this is a pump replacement and the catheter has not been replaced and has not been aspirated, the internal pump tubing should be primed before connecting the catheter and implanting the pump. Do not program a priming bolus after the catheter has been connected to the implanted pump. Programming a priming bolus in this situation can result in a clinically significant or fatal overdose. 3. Set the Low Reservoir Alarm (to at least 1 mL). 4. Program the pump with new parameters. Note: Refer to the clinician programmer guide for instructions on programming the pump. 5. Print out the patient's prescription and pump settings (pump status). Updating the patient record 1. Place the prescription and pump settings (pump status) in the patient's records. 2. Determine the refill date from the printout. 3. Schedule a refill appointment. Monitoring the patient Medtronic recommends monitoring patients after any priming bolus procedure involving intrathecal therapy. Opioids: Patients should be monitored with pulse oximetry for a minimum of 24 hours in a facility equipped with emergency airway management, oxygen, naloxone for treatment of opioid overdose and other emergency services. Baclofen: Patients should be monitored in a facility that provides experienced nursing observation, with the ability and personnel for emergency airway management and ventilator support readily available. Patients should be monitored for a minimum of 8 hours or until they demonstrate stable neurological, respiratory and cardiac function. Ziconotide: There are no labeling guidelines for patient monitoring after starting or restarting ziconotide therapy. Published guidance recommends an overnight admission. Based on the therapeutic index of the drug and the sensitivity of the patient, some individuals may need additional monitoring until the delivered drug reaches the intended concentration. Refilling the pump or accessing the catheter access port When refilling a Medtronic pump, use the appropriate Medtronic refill kit and associated refill kit instructions for use. When accessing the catheter access port of a Medtronic pump, use the appropriate Medtronic CAP kit and associated CAP kit manuals and instructions for use. 26English86372016-06-01 Technical support To obtain a copy of the refill kit or CAP kit instructions for use, or to receive additional technical support:
US only: Contact Medtronic Technical Services at 1-800-707-0933. Technical support service is available 24 hours a day for clinicians managing patients with Medtronic implantable infusion pumps. Outside of the US: Contact your local representative by using the phone numbers listed on the last pages of this manual. 86372016-06-01English27 Contacts:
Asia:
Medtronic International Ltd. Tel. 02919-1300 Fax 02891-6830 Medtronic Asia Ltd. Tel. (02)-548-1148 Fax (02)-518-4786 Australia:
Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde, NSW 2113 Australia Tel. +61-2-9857-9000 Fax +61-2-9878-5100 Toll-free 1-800-668-670 Austria:
Medtronic sterreich GmbH Tel. 01-240440 Fax 01-24044-100 Belgium:
Medtronic Belgium S.A. Tel. 02-456-0900 Fax 02-460-2667 Canada:
Medtronic of Canada Ltd. Tel. (1-905)-460-3800 Fax (1905)-826-6620 Czech Republic:
Medtronic Czechia s.r.o. Tel. 2-965-795-80 Fax 2-965-795-89 Denmark:
Medtronic Danmark A/S Tel. 45-32-48-18-00 Fax 45-32-48-18-01 Finland:
Medtronic Finland Oy/LTD Tel. (09)-755-2500 Fax (09)-755-25018 France:
Medtronic France S.A.S. Tel. 01-5538-1700 Fax 01-5538-1800 Germany:
Medtronic GmbH Tel. (02159)-81490 Fax (02159)-8149100 Greece:
Medtronic Hellas S.A. Tel. 210-67-79-099 Fax 210-67-79-399 Hungary:
Medtronic Hungria Kft. Tel. 1-889-06-00 Fax 1-889-06-99 Ireland:
Medtronic Ireland Ltd. Tel. (01)-890-6522 Fax (01)-890-7220 Italy:
Medtronic Italia SpA Tel. 02-241371 Fax 02-241381 Tel. 06-328141 Fax 06-3215812 Japan:
Medtronic Japan Tel. 03-6776-0017 Fax 03-6774-4645 Latin America:
Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244 Norway:
Medtronic Norge AS Tel. 67-10-32-00 Fax 67-10-32-10 Poland:
Medtronic Poland Sp. z.o.o. Tel. (022)-465-69-00 Fax (022)-465-69-17 Portugal:
Medtronic Portugal, Lda. Tel. 21-724-5100 Fax 21-724-5199 Russia:
Medtronic Russia Tel. (8495) 580-7377 Fax (8495) 580-7378 Slovakia:
Medtronic Slovakia, o.z. Tel. 0268 206 911 Fax 0268 206 999 Spain:
Medtronic Ibrica, S.A. Tel. 91-625-0400 Fax 91-650-7410 Sweden:
Medtronic AB Tel. 08-568-585-00 Fax 08-568-585-01 Switzerland:
Medtronic (Schweiz) AG Tel. 031-868-0100 Fax 031-868-0199 The Netherlands:
Medtronic B.V. Tel. (045)-566-8000 Fax (045)-566-8668 Turkey:
Medtronic Turkey Tel. +90 216 636 1000 Fax +90 216 636 1008 U.K.:
Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004 USA:
Medtronic, Inc. Tel. (1-763)-505-5000 Fax (1-763)-505-1000 Toll-free: (1-800)-328-0810 Manufacturer Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA www.medtronic.com Tel. +1-763-505-5000 Fax +1-763-505-1000 Authorized Representative EC REP in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31, Case Postale 84 CH - 1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300 Fax +852-2891-6830 Contacts for specific countries are listed inside this cover.
*M221311A060*
Medtronic, Inc. 2016 All Rights Reserved M221311A060 Rev A
1 | Manual Labeling Attestation Letter | ID Label/Location Info | 113.91 KiB |
Marchs 29, 2018 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Regarding: Application for certification for FCC id:
LF53058, LF53023, LF58637, LF597713, LF597714, LF537601, LF537602, LF537612 Gentlemen:
We are seeking a Non-Routine Request for permanent confidentiality for our internal photos exhibit, block diagram and electrical schematic. The reasons are for the immediate protection of patients and to protect intellectual property related to the implant internal hardware. In addition, we seek approval under Section 15 submission for labeling deviation. The FCC ID number associated with the transmitter and the information required by Section 2 of the FCC Rules will be placed in the instruction manual for the transmitter, in lieu of being placed directly on the transmitter. The device being implanted in the human body makes marking the device with supplemental information a manufacturing hardship and additional safety risks. If you have any questions regarding this application, please feel call me at 763-526-0652 or contact via email at guillaume.girard@medtornic.com Sincerely, Guillaume Girard Medtronic, Inc. Tel 763-526-0652 guillaume.girard@medtronic.coms
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-05-25 | 0.175 ~ 0.175 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-05-25
|
||||
1 | Applicant's complete, legal business name |
Medtronic, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0008250839
|
||||
1 | Physical Address |
8200 Coral Sea Street NE
|
||||
1 |
Mounds View, Minnesota 55112
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@siemic.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
LF5
|
||||
1 | Equipment Product Code |
8637
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G****** G******
|
||||
1 | Title |
Sr. RF Regulatory Program Manager
|
||||
1 | Telephone Number |
763-5********
|
||||
1 | Fax Number |
651-3********
|
||||
1 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 11/21/2018 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Programmable Pump | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Bureau Veritas Consumer Products Services, Inc.
|
||||
1 | Name |
L**** B******
|
||||
1 | Telephone Number |
408-5********
|
||||
1 | Fax Number |
408 5********
|
||||
1 |
l******@siemic.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | IT | 0.17500000 | 0.17500000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC