PHYSICIAN'S LEAD MANUAL RELIANCE 4 FRONT Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable

Size: px

Start display at page:

Download "PHYSICIAN'S LEAD MANUAL RELIANCE 4 FRONT Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable"

婞灌茅
4 years ago
Views:

0692, 0693 Dual Shock Coils with GORE Coating REF 0658, 0695, 0696 Single Shock Coil with Silicone Back

1 PHYSICIAN'S LEAD MANUAL RELIANCE 4 FRONT Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation Single Shock Coil with GORE Coating REF 0657, 0692, 0693 Dual Shock Coils with GORE Coating REF 0658, 0695, 0696 Single Shock Coil with Silicone Back Fill REF 0652, 0672, 0673 Dual Shock Coils with Silicone Back Fill REF 0653, 0675, A

3 (INFORMATION FOR USE)... 1 (Device Description)... 1 (Related Information)... 3 MR Conditional (MR Conditional System Information)... 3 (Indications and Usage)... 4 (Contraindications)... 4 (Warnings)... 4 (Precautions)... 6 (Potential Adverse Events) (PRE-IMPLANT INFORMATION) (Surgical Preparation) (Items Included) (Accessories) (Vein Pick) (Radiopaque Suture Sleeve) (Stylets) DF-4 (DF-4 Lead Cap) (Connector Tool) (IMPLANTATION) (Attaching the Connector Tool to the Lead) (Inserting the Stylet) (Handling the Fixation Helix) (Inserting the Lead) (Positioning Lead in Right Ventricle) (Lead Fixation) (Checking for Lead Stability) (Repositioning the Lead) (Evaluating Lead Performance) (Connection to a Pulse Generator) (Electrical Performance) (Conversion Testing) (Securing the Lead) (Tunneling the Lead) (POSTIMPLANT) (Postimplant Evaluation) (Explantation)... 34

4 (SPECIFICATIONS) ( ) (Specifications (Nominal)) (Lead Introducer) (Symbols on Packaging)... 37

5 DF4 LLHH 5 DF4-LLHH DF4 LLHO 5 DF4-LLHO 4 1. ( ) 2. ( ) 3. ( ) Boston Scientific Corporation EZ-4 IMAGEREADY IROX RELIANCE 4 FRONT

7 (INFORMATION FOR USE) (Device Description) RELIANCE 4-FRONT (ICD) (CRT-D) 7.3 (8F ) DF-4 RELIANCE 4-FRONT GORE TM : 4-FRONT : DF4-LLHH DF4-LLHH DF4-LLHO DF4-LLHH DF4-LLHO DF4: 1 L: ; 1 L ( ) ; 2 L ( ) H: ; 1 H ( ) ; 2 H ( ) ( ) O: ( ) : DF4-LLHH/LLHO RELIANCE 4-FRONT GDT-LLHH DF4-LLHH MR Conditional: MR Conditional MRI (3 "MR Conditional (MR Conditional System Information)") : IROX : ( ) Anode (+) Cathode (-) Anode (+) 1. DF4 ISO 27186:2010 1

8 GORE (eptfe) 2 : eptfe IROX : (IROX) : (35 6 " ( )") : : Cathode (-) : : : : (14 " (Stylets)") 2. GORE W.L. Gore and Associates 2

9 (Related Information) MRI ImageReady MR Conditional Defibrillation System MRI Technical Guide (MRI Technical Guide) (Intended Audience) MR Conditional (MR Conditional System Information) MR Conditional MRI MR Conditional MRI Technical Guide MRI MR Conditional Programmer/Recorder/Monitor ( PRM) PRM MR Conditional MRI MRI Technical Guide MRI (Implant-related MRI Conditions of Use) MRI MRI MRI Technical Guide MR Conditional 3

10 (Indications and Usage) (Contraindications) 1.1mg (Warnings) (General) 1 CPR 4

11 (Handling) PSA ( ) ECG (Implant Related) MRI Zone III American College of Radiology Guidance Document for Safe MR Practices 3 Zone III MRI ( ) MR Conditional MRI MRI Zone III IV (PSA) DF4-LLHH DF4-LLHO 3. Kanal E, et al., American Journal of Roentgenology 188: ,

12 (Post-Implant) (MRI) MRI ( MRI Technical Guide ) MRI MR Conditional MRI MRI Technical Guide (Precautions) (Clinical Considerations) Physicians' Desk Reference 4 (Sterilization and Storage) ( ) 25 C(77 F) C(59 86 F) 50 C(122 F) Physicians' Desk Reference Thomson Healthcare, Inc. 6

13 (Handling) eptfe (Implantation) 10 A 7

14 (35 6" ( )") ( ) Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE.1993;16:

15 ( ) R 9

16 (Hospital and Medical Environments) (RF) (MTR) PIC 10

17 (Follow-up Testing) VF EP 1 (Potential Adverse Events) ( ) (Air embolism) (Allergic reaction) (Arterial damage with subsequent stenosis) (Bleeding) (Bradycardia) (Breakage/failure of the implant instruments) (Cardiac perforation) (Cardiac tamponade) (Chronic nerve damage) (Component failure) (Conductor coil fracture) (Death) (Electrolyte imbalance/dehydration) (Elevated thresholds) (Erosion) (Excessive fibrotic tissue growth) ( ) (Extracardiac stimulation (muscle/nerve stimulation)) (Fluid accumulation) (Foreign body rejection phenomena) (Formation of hematomas or seromas) (Heart block) (Hemorrhage) (Hemothorax) (Inability to defibrillate or pace) 11

18 ( : ATP ) (Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing)) (Incisional pain) (Incomplete lead connection with pulse generator) (Infection including endocarditis) (Lead dislodgment) (Lead fracture) (Lead insulation breakage or abrasion) (Lead tip deformation and/or breakage) (Local tissue reaction) (Low amplitude VF signals) (Malignancy or skin burn due to fluoroscopic radiation) ( : ) (Myocardial trauma (e.g., irritability, injury, tissue damage)) (Myopotential sensing) (Oversensing/undersensing) (Pericardial rub effusion) (Pneumothorax) (Post-shock rhythm disturbances) (Pulse generator and/or lead migration) (Shunting current during defibrillation with internal or external paddles) (Syncope) (Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation) (Thrombosis/thromboemboli) (Valve damage) (Vasovagal response) (Venous occlusion) ( : ) (Venous trauma (e.g., perforation, dissection, erosion)) MRI ImageReady MR Conditional Defibrillation System MRI Technical Guide (PRE-IMPLANT INFORMATION) 12

19 (EP) ( ) (Surgical Preparation) (Items Included) : (Accessories) (Vein Pick) 13

20 (Radiopaque Suture Sleeve) : ( 6403) : (Stylets) 1. a (Soft) (Firm) a. 2. (cm) ( ) DF-4 (DF-4 Lead Cap) DF-4 DF-4 DF-4 DF-4 : DF-4 ( 7007) 14

21 (Connector Tool) PSA (+) (-) 1. (IMPLANTATION) : 5 10cm 29 " (Securing the Lead)" : MR Conditional MRI Technical Guide MR Conditional MR Conditional MR Conditional MRI Technical Guide : MRI MRI 15

22 (Attaching the Connector Tool to the Lead) 1. (16 2 " ") (Inserting the Stylet) ( 10cc 12cc ) (17 3 " ") : 16

23 cm : 4. : (Handling the Fixation Helix) 1. (17 4 " ") 4. : (35 6 " ( )") 17

24 : : : 2. : 3. (18 5 " ") 5. (Inserting the Lead) 1 18

25 : 6. : : ( ) 7 6. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE.1993;16: Magney JE, et al. A new approach to percutaneous subclavian venipuncture to avoid lead fracture or central venous catheter occlusion. PACE. 1993;16:

1. St ( ) Cp ( ) (20 7 " ") V Cp Ax St 7. 2.

26 1. St ( ) Cp ( ) (20 7 " ") V Cp Ax St St Cp 3 (Ax ) 3. 3 (V ) cm ( 2cm ) (21 8 " ") 20

27 Cp V St (Positioning Lead in Right Ventricle) 1. : 2. : 3. : : 21

28 9. 4. ( ) : ( ) 5. : : (Lead Fixation) ( ) 22

29 : 1. (PSA) : : (35 6" ( )") ( ) 5. (23 3 " ") : 23

30 (Checking for Lead Stability) cm : : (Repositioning the Lead) : (35 6" ( )") ( ) : 3. : (Evaluating Lead Performance) (PSA) 1. PSA 24

(PSA) (-) (+) (-) (+) (25 10 " PSA ") : (PSA) DF4-LLHH DF4-LLHO 10. PSA 2.

31 (PSA) (-) (+) (-) (+) (25 10 " PSA ") : (PSA) DF4-LLHH DF4-LLHO 10. PSA a 5 mv < 100 ms 1.5 V mv < 150 ms a. 0.5ms PSA TRIAD 25

32 : R 3. PSA 10 26

33 4. PSA 5. (PSA) PSA (Connection to a Pulse Generator) : 3. : : : DF-4 DF-4 27

34 4. (Electrical Performance) (27 " (Connection to a Pulse Generator)") 3. EGM 4. (Conversion Testing) (VF) (VT) (25 4 " ") : VF : VF (DFT) VF 28

35 1 : DFT (CER) DFT CER DFT 9 10J 9 10J : VF (Securing the Lead) : : : : 29

36 : (Percutaneous Implant Technique) 1. (30 11 " ")

37 (Venous Cutdown Technique) (31 12 " ")

38 (Tunneling the Lead) : PSA ( ) ECG 2. : 3. : 32

39 4. : : : : 5. (POSTIMPLANT) (Postimplant Evaluation) : EP 1 : CPR : 33

40 (Explantation) : : 1 ( ) : 34

41 (SPECIFICATIONS) ( ) (Specifications (Nominal)) 5. eptfe cm cm cm cm cm cm cm cm cm cm cm cm 6. ( ) a a Electrode ( ): DF4-LLHH( ) DF4-LLHO( ) DF4-LLHH DF4-LLHO DF4-LLHH GDT-LLHH mm 450 mm 2 ( ) 660 mm mm 2 ( ) 18 cm 35

42 6. ( ) ( ) Diameter ( ): Material ( ): (eptfe ) (eptfe ) Maximum Lead Conductor Resistance ( ): ( ) ( ) ( ) ( ) ( ) 12 mm 2.7 mm (8F) 2.4 mm (7.3F) 1.3 mm (75D) MP35N b MP35N b PTFE DFT ETFE (IROX) Pt-Ir eptfe 0.96 mg a. b. MP35N SPS Technologies, Inc. 36

43 (Lead Introducer) 7. a 8F (2.7 mm) a. 10.5F (Symbols on Packaging) (37 8 " ") 8. ID CE 37

44 8. ( ) MR Conditional 38

45 Memo

46 Memo

47 Memo

4- G AFx 0658/0695/0696/0653/0675/0676 4- SG AFx 0657/0692/0693/0652/0672/0673 www.

PHYSICIAN'S LEAD MANUAL FINELINE II STEROX Implantable Lead 4456/4457/4458/4459/4479/ A

PHYSICIAN'S LEAD MANUAL FINELINE II STEROX Implantable Lead 4456/4457/4458/4459/4479/4480 2016-03 91095046-01A (DESCRIPTION)... 1 MR Conditional (MR Conditional System Information)...1 MRI (Implant-related