Renamic Users Guide Sept 2012

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Table of Contents Indications and Contraindications for Use... 2 System Overview... 8 Device Overview... 9 Start Up... 12 Connecting to Renamic... 12 Switching On and Off... 16 Using Renamic... 18 Keys, Displays, and Signals... 18 Emergency Programs... 19 Telemetry... 21 Device Programs... 24 Using the Internal Printer... 25 ECG and IEGM Functions... 28 Taking Screenshots... 28 Maintenance... 29 Safety... 30 Operating Conditions... 31 Electromagnetic Interference and Grounding... 32 Technical Data... 33 Supplementary Information... 35 Scope of Delivery and Accessories... 35 Accessories... 35 Country-Related Information... 36 Symbols on the Components... 38 Legend for the Label... 40

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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 and 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

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

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.

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Indications and Contraindications for Use

• 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 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.

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Indications and Contraindications for Use

Danger to patient from allergic reactions If the cable comes into contact with open wounds, it can cause allergic reactions. • Prevent the cable from coming into contact with open wounds. 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. • 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.

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Indications and Contraindications for Use

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.

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. Danger of explosion if exposed to cleaning and disinfecting agents Let cleaning and disinfection agents evaporate before operating the device. May be damaged by cleaning agents Strong and abrasive cleaning agents and other organic solvents, such as ether or benzine, 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 resuming operation of the device.

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Indications and Contraindications for Use

Allergic reactions and inflammations Prevent the cable and programming head from coming into contact with the patient's wounds or skin. 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. 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.

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Indications and Contraindications for Use

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 3 days. After 5 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. Printouts that cannot be used or cause 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.

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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.

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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.

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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

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Device Overview

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.

Figure 3: Power cord storage compartment

The power cord storage compartment, shown open in Figure 3, is located at the rear of Renamic. To open this compartment, simply push the compartment door in the direction of the arrow displayed on top of the drawer. The locking mechanism will disengage, allowing for the door to be swiveled up and open.

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Start Up

Start Up

USB Port (Recommended for Bluetooth® Applications)

ON/OFF LED

PGH Feed-through

Figure 4: Programming head compartment with lid open, viewed from above Connecting to Renamic

Programming Head The Programming Head (PGH) port is inside the top right portion of the PGH compartment. To attach the PGH, pull the short end of the cable out of the PGH compartment and connect the PGH cable to the device PGH port. Feed the cable attached to the PGH through the PGH compartment feedthrough, as shown in Figure 4.

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Start Up

Cables Renamic can be used with the PK-222 ECG cable, shown in Figure 5. This cable cannot be sterilized. RL LL

PK 222 BIOTRONIK

LA RA

Figure 5: PK-222 ECG cable

Cables should only be connected or disconnected when the device is switched off, unless expressly permitted in the corresponding section of this user's guide. Do not force plugs into the connector ports and do not pull on the cable when trying to release the lock. Lay all cables between the patient and the device in such a way that tripping hazards are minimized. Ensure that the contacts of all connections and plugs are clean. Soiled contacts can lead to signal distortions, and thus to false diagnoses. Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations.

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Start Up

ECG Port and USB Device Ports The PK-222 cable can be attached via an ECG port located on the back right of the device, as shown in Figure 6.

Figure 6: ECG Port and USB Ports

There are three USB ports located on the back right of the device, as shown in Figure 6, and one USB port located in the PGH compartment for the Bluetooth® adapter, shown in Figure 4. A USB drive can be disconnected and reconnected while Renamic is still active. Note: 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.

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Start Up

Bluetooth® biotronik supplies a compatible Bluetooth® adapter with the programmer. When the Bluetooth® adapter is connected to the Renamic, various Bluetooth®-compatible devices can communicate wirelessly with the programmer. The recommended port for the Bluetooth® adapter is located in the PGH compartment on the right hand side of the compartment underneath the protective cap, as shown in Figure 4. Renamic arrives preconfigured with a Bluetooth® adapter. If needed, to connect the Bluetooth® adapter, follow the instructions below: • Turn Renamic OFF. Proper installation of a Bluetooth® adapter requires that Renamic be powered OFF. • Open the PGH compartment and remove the protective cap from the port for the Bluetooth® adapter. • Connect the Bluetooth® adapter to the USB port. • Replace the protective cap over the Bluetooth® adapter.

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Start Up

Power Supply

ON/OFF LED

Figure 7: Power supply port

The connection for the power supply is located on the back of Renamic on the left, as shown in Figure 7. Connect the provided power cord to Renamic’s power cord port and then to a properly grounded power outlet. Switching Renamic On and Off

The ON/OFF button is located on the back left of Renamic, near the power cord plug in, as shown in Figure 7. To switch ON the device, press and depress the ON/OFF button once. The ON/OFF LED on the front left of the device lights up. The device can be switched ON in both the working position (screen open, Figure 1) and in the transport position (screen closed, Figure 2). Connect the PGH to Renamic before turning on the device. After turning the device ON, the operating system will boot. During this time (roughly one minute) Renamic is not yet ready for use. After successfully booting up the operating system, the device will display the Start Screen. The device is now ready for use.

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Start Up

When possible, use the ON/OFF button on the software user interface to turn the device OFF. Alternatively, to switch the device OFF, press and depress the ON/OFF button once. Note: Sudden disconnection from the power source can lead to the corruption of data. Note: The device does not automatically switch OFF when the screen is closed. Therefore, the device can be left in an operational mode and put aside temporarily to save space. By reopening the screen, the programmer is immediately functional again.

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Using Renamic

Using Renamic Keys, Displays, and Signals

The device has several keys to which fixed functions are assigned. See Table 1 for a description of these keys. Renamic Key

Function On/Off Button Emergency Shock Button

VVI

Safe Program Button

10

Key for setting printer speed to 10 mm/s

25

Key for setting printer speed to 25 mm/s

50

Key for setting printer speed to 50 mm/s Key used to stop printing Feed button to feed the paper to the beginning of the next page

Table 1: Summary of Renamic keys

The ON/OFF light indicator shows whether the device is switched ON (LED is lit) or OFF (LED is not lit). It is located on the front left edge of the device, as shown in Figure 1. The device screen is a touch screen that is operated using a stylus or the user’s finger. The screen displays items including parameters and measured values, a surface ECG, IEGMs with marker channels, and various buttons. Buttons on the screen respond to light pressure from the stylus or finger.

19 Emergency Programs

Using Renamic

Renamic features two emergency buttons that implement a safe program or deliver an emergency shock by pressing a single button. Both buttons are located on the bottom left corner of the screen, as shown in Figure 8.

Figure 8: Emergency Pacing/Shock Buttons

Emergency Pacing Emergency pacing uses the following parameters: • Mode: • Basic rate: • Pulse amplitude: • Pulse width:

VVI 70 ppm 7.5 V 1.5 ms

These parameters are non-programmable. To deliver emergency pacing, establish telemetry contact by positioning the PGH above the implanted device or by enabling the SafeSync RF telemetry. Press the button. Emergency pacing will immediately commence. This may be done with both pacemakers and ICDs. VVI

To stop emergency pacing, load the Parameters screen. Program the desired permanent parameters and transfer them to the implanted device.