Renamic Users Guide Nov 2013

1

Table of Contents Indications for Use... 4 Intended Use... 4 Contraindications... 5 Warnings... 6 Precautions... 9 General Safety Instructions... 12 System Overview... 16 Device Overview... 18 Start Up... 21 Connecting to Renamic... 21 Switching Renamic On and Off... 25 Using Renamic... 27 Keys, Displays, and Signals... 27 Emergency Programs... 28 Telemetry... 30 Device Programs... 33 Using the Internal Printer... 34 ECG and IEGM Functions... 37 Taking Screenshots... 37 Renamic PSA... 38 Overview... 38 Parameter Overview... 43 PSA Module... 43 Saving Measurements... 45 Preferred Settings... 45 Max. pacing... 46 Burst Pacing... 47 Report... 49 Implant Testing... 51 Sensing... 51 Impedance... 52 Threshold... 53

2

Table of Contents

Report... 54 Additional Functions... 55 Adjust... 55 Freeze Screen... 57 Patient Data... 60 ID... 60 First Name/Last Name... 61 Date of Birth... 62 Gender... 63 Symptom... 64 ECG Indication... 64 Etiology... 64 Implantation... 65 Hospital and City... 66 Physician... 66 Remark... 67 Lead Information... 67 Lead type... 67 Serial Number... 68 Manufacturer... 68 Type... 68 Implantation... 69 Channels... 69 Printing the information... 70 Maintenance... 73 Safety... 74 Operating Conditions... 75 Electromagnetic Interference and Grounding... 76 Technical Data... 77

3

Table of Contents

Supplementary Information... 81 Scope of Delivery and Accessories... 81 Accessories... 82 Country-Related Information... 82 Symbols on the Right Side of the Device... 85 Symbols on the Left Side of the Device... 85 Symbols on the Monitor ... 85 Symbols on the Components... 85 Symbols on the Renamic PSA... 86 Symbols in the PGH Compartment... 87 Symbols on the Programming Head... 87 Legend for the Label... 88

4

Indications and Contraindications for Use

Note: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications for Use The Renamic programmer is indicated for use with BIOTRONIK pacemakers and defibrillators. Therefore, the indications for use for the specific implantable devices are applicable.

Intended Use Renamic provides communication with the implantable pulse generator or ICD during the implantation procedure or followups. Renamic is intended to be used for the following tasks: • Conduct sensing, pacing threshold, and impedance tests • Interrogate data of the implanted device, such as program parameters, recorded statistical data, episodes, as well as real-time IEGMs • Display, printout, save and export data of the implanted device for analysis and reporting purposes • Transfer parameters to the implanted device The Renamic programmer with PSA module is intended to be used for the following tasks: • Evaluation of the position and integrity of leads • Determination of appropriate pacing parameters for the implanted device For this intended purpose, the device provides the following measurement/diagnostic functions: • For the sensing of intrinsic cardiac events: оо P/R wave amplitudes and slew rate оо Rates (PP, PR interval) оо Intrinsic AV delay (PR interval) оо Conduction times (antegrade, retrograde)

5

Indications and Contraindications for Use

оо Wenckebach point оо VV delay • For the pacing of the heart: оо Pacing threshold in up to 3 chambers оо Lead impedances оо Burst pacing

Contraindications Please refer to the contraindications in the Technical Manual of the specific implantable devices.

6

Warnings and Precautions

Warnings Exposure to fluids may result in fatal injury Before cleaning and disinfecting device surfaces, pull the power plug. Danger to the user Danger of tripping over connected cables during device transport. • Prior to transporting the device, remove the attached cables and store them in the compartments intended for this purpose. Danger to the patient The device is not sterile and cannot be sterilized. • Do not set up the device in a sterile area, and do not position the device so that the fan blows air into a sterile area. Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to patients. • Do not use damaged cables. Danger to the patient Electrostatic potential differences can cause currents that are dangerous to the patient. • Balance possible differences in electrostatic potential with the patient by touching the patient with your hand at a point a safe distance from the leads. Danger to the patient or user from electrical currents in surface ECG leads Electrical energy that flows into surface ECG leads can cause injuries to the skin or cause an arrhythmia. • The plugs of the ECG cables must not touch any

7

Warnings and Precautions

conductive or grounded components, nor should they be inserted in electrical outlets or other connectors. • Attach all PK-222 plugs on the patient end securely to the patient. • Attach all unused plugs (e.g., if not all of the surface ECG connections are used) securely to the patient. Danger to patient from allergic reactions and inflammations If the cable comes into contact with open wounds, it can cause allergic reactions. • Prevent the cable from coming into contact with open wounds and the patient's skin. Danger from loss of function Damp cables have limited functionality and pose a danger to patients. • Do not use damp cables. Danger from electrical currents Unused cable contacts can conduct electrical currents to patients. • Adhere unused cable contacts close to the patient. Danger to the patient Connecting and disconnecting USB devices may result in malfunctioning. • Do not connect any USB devices other than the SafeSync Module to the programmer during follow-up. • Do not disconnect any USB devices from the programmer during follow-up. Danger to the user when connecting non-conforming USB accessories. Leakage currents can cause injuries to the skin or cause an arrhythmia.

8

Warnings and Precautions

• When using in combination with other devices, do not use portable multiple socket outlets, but connect all devices to fixed outlets in the same electrical circuit used for medical purposes. Danger to the patient from high electrical energies High levels of electrical energy are conducted to the patient through the emergency programs. • Only activate the safe program or emergency shock under the supervision of a physician. Danger due to defibrillation The device is defibrillation protected. During defibrillation, do not touch the patient or there is a danger that you may suffer an electrical shock. • During defibrillation, do not touch the patient, the programmer which the patient is connected to, or the attached accessories. • Following a defibrillation, check all functions of the programmer. Danger due to electrosurgery Electrosurgery can induce electrical currents in patient cables which can enter the patient's heart. • Disconnect patient cables from the leads to the extent possible when conducting electrosurgical examinations. • If the device is connected to the patient during an electrosurgical examination, check the operation of the Renamic and the PSA module afterwards for proper functioning. Danger due to electrostatic charges Electrical currents can be dangerous for patients. • Discharge any electrostatic charges in your body before

9

Warnings and Precautions

touching the patient, the patient cables or the device.

Precautions Functional impairment due to external damage Mechanical impact, for example dropping the unit - even from a height of over 5 cm if unpackaged - can permanently impair the function of the system. • Do not use the device if it shows visible damage. • Contact BIOTRONIK for testing and, if necessary, repair of the equipment. Loss of functioning due to electrostatic discharges Electrostatic discharge can result in sparks and damage to the PSA module and Renamic. • Never install the PSA module if Renamic is switched on. • Disconnect the power plug from Renamic before inserting the PSA module. • Never touch the electrical contacts of the PSA module. Danger of explosion if exposed to cleaning and disinfecting agents Let cleaning and disinfection agents evaporate before operating the device. Damage caused by cleaning agents Strong and abrasive cleaning agents and other organic solvents, such as ether or benzene, corrode the surface of the device and must not be used. Mains voltage - risk of death from electric shock Before changing the fuses, switch off the device and disconnect the power cord. Risk of death from electric shock Defective fuses may indicate a technical defect in the device. Conduct an inspection after changing fuses and before

10

Warnings and Precautions

resuming operation of the device. Risk of exceeding the leakage currents when connecting external devices with their own power supply or an electrically conductive connection to other devices. • Only connect devices that comply with IEC standard 60601-1:2005 or IEC 60950. • Line-powered devices must comply with the standard IEC 60601-1:2005 or must be connected to the USB port via an isolating separator (IEC 60601-1: 2005 paragraph 16.5) with a dielectric strength of at least 1.5 kV (e.g. an isolating USB hub model UISOHUB4 by B&B Electronics). Should the separator require an independent power supply, it must also comply with IEC 60950. • Place devices that do not adhere to the IEC 60601-1:2005 standard at least 1.5 m away from the patient. • Before initial startup, check and document all device combinations according to IEC 60601-1:2005 paragraph 16. • Perform this inspection at least once per year according to the legal requirements.

11

Warnings and Precautions

Danger to data integrity Sudden disconnection from the power source can lead to the corruption of data. • Only use the ON/OFF button of the software user interface menu to switch the device OFF. Risk to magnetically sensitive objects The programming head contains a strong magnet. • Do not place the programming head close to magnetically sensitive objects such as magnetic data media, credit cards, or wristwatches. Higher energy consumption SafeSync RF telemetry requires somewhat more power. Consumption during implantation corresponds to approximately 10 days of service time and consumption during a 20-minute follow-up corresponds to approximately three days of service time. After five minutes without input, the SafeSync RF telemetry switches to the economy mode. • Only establish SafeSync RF telemetry if necessary. • Check the device's battery capacity regularly. Low printout quality or potential damage to the printer The use of paper not intended for this device can lower the quality of the printout or cause damage to the device. • Use paper specified by BIOTRONIK at all times.

12

General Safety Instructions

General Safety Instructions Technical Manual The device may be used only in accordance with this technical manual. Risks of improper handling Disregarding the safety warnings can endanger the patient, the user, or others, as well as the equipment. Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability. The following dangers may arise in the event of improper use: • Failure of important device functions. • Personal endangerment due to electrical effects. Physician supervision The device may only be operated under the constant supervision of a physician. During a procedure, the patient must be continuously monitored by medical personnel with the aid of a surface ECG monitor. Emergency equipment During the procedure, always have emergency resuscitation equipment (e.g., external pacemaker, defibrillator) readily available and ready for use at all times during an examination to be able to perform immediately life-supporting measures. External pacing The device may not be used as a life-support system. During the duration of the implantation, the device is suitable for temporary external pacing while the patient is being continuously monitored by medical personnel.

13

General Safety Instructions

Changes not permitted Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device. Touching clips of cables and leads Do not touch the metal clips on the patient cable or the pacing lead. The device is in electrical contact with the patient's heart and blood via the implanted leads. Touching the metal clips on the patient cable or the pacing lead may expose the patient's heart to dangerous electrical currents. Connecting cables to leads Check to make sure that the patient cables are connected to the proper lead and the proper connection before starting the device. Connecting the patient cable to the wrong lead may result in ineffective sensing and pacing behavior and loss of pacing support. Patient cables Check to make sure all patient cables are secure. Cables and wounds Do not allow the cable to come into contact with an open wound. Unused cable connections Attach unused cable connections close to the patient. Protective sleeves of cables Before connecting cables, make sure the protective sleeves are correctly attached. Liquids Never use a damp or wet device or cable. Protect the device from accidental ingression of fluids (e.g. infusion fluids).

14

General Safety Instructions

Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are balanced. Before handling the device, the electrostatic potential between the doctor or medical staff and the patient must be balanced by touching the patient at a point as far away from the leads as possible. Leakage currents Avoid leakage currents between all connected devices, the patient cable, and the patient if line-powered devices are used in the vicinity of the patient. Such leakage currents may trigger lethal arrhythmias. Potential equalization cables, if present, must be attached to all connected components. National and international regulations concerning the use of electromedical devices also apply to patient cables. Threshold test Examine the patient's health before performing a threshold test. A loss of capture, asystole and pacing during the vulnerable periods can occur. Termination of pacing Do not abruptly terminate pacing. The sudden termination of pacing can lead to extended periods of asystole in some patients. Gradually decrease the pacing rate until the patient's intrinsic rate is detected. Mode selection Select a mode that is consistent with the patient cable connections to the leads. Loss of pacing could cause danger to the patient.

15

General Safety Instructions

Wenckebach test Since atrial single-chamber pacing is contraindicated for use in patients with no AV conduction, the Wenckebach test must not be performed on these patients. Burst pacing Burst pacing can induce or accelerate dangerous arrhythmias. Always have emergency resuscitation equipment immediately available when using this feature. Using in combination with radio frequency devices While the device is designed and tested for limited protection from the effects of high-frequency surgery, disconnect the patient cables from the pacing leads when performing an electrosurgical procedure whenever possible. Use of RF surgery equipment may damage the device and/or induce dangerous currents in the patient cable which can be conducted into the patient’s heart. Perform an inspection of Renamic and the PSA module after use with RF surgery equipment. Defibrillation When connected with the authorized cables, the device is defibrillation protected. During defibrillation, do not touch the patient, the programmer the patient is connected to or the attached accessories. Otherwise, there is a danger that you may suffer an electrical shock. Following a defibrillation, check all functions of the device. Electrocautery Disconnect the patient cables from the leads during electrocautery even though the device has been designed to provide protection against such effects. If the device is connected to the patient during electrocautery, check the operation of the Renamic and the PSA module afterwards for proper functioning.

16

General Safety Instructions

Sensitivity The higher the level of sensitivity is set by selecting a low sensitivity value, the higher the occurrence of interferences from electromagnetic fields. Low sensitivity values should only be set if absolutely necessary for medical reasons.

17

System Overview

System Overview Renamic is a portable programmer and monitoring device. It is used during the implantation and follow-up of implantable pulse generators and implantable cardioverterdefibrillators. The programmer is intended to be used for the following tasks: • Conduct sensing, pacing threshold, and impedance tests. • Interrogate data stored on the implanted device, including program parameters, recorded statistical data, and episodes. • Record ECG "freeze" screens and real time IEGMs. • Display, print, save and export data stored on the implanted device for analysis and reporting purposes. • Transfer parameters to and program the implanted device.

18

Device Overview

Device Overview Anti-slip Pads

Ergonomic Handle

Release Buttons

ON/OFF LED

Figure 1: Renamic in transport position

Renamic has an ergonomic handle in the front and a gripping tab in the back, which can be used to safely transport the device in any position. The specially designed anti-slip pads allow for horizontal or vertical positioning of the device.

19

Device Overview Touchscreen Multiple touch options

Back compartment Power cord storage

Front compartment Programming head and ECG cable storage PGH Feed-through

Figure 2: Renamic in the operating position

While Renamic is in the transport position (screen closed, shown in Figure 1), unlock the screen by pressing both release buttons, located on the right and left sides of the device, at the same time. The unlocking mechanism can be heard and felt when released. Hold the sides of the screen with both hands and tilt the screen up to the operating position, as shown in Figure 2. The screen can pivot around the upper end of the screen arm. The operating position can be smoothly adjusted as needed and will hold a wide range of working positions.