Renamic Technical Manual Nov 2015

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1

Introduction

Introduction

Introduction1377213Technical ManualRenamic

About the Device General description

Renamic is a portable programmer and monitoring device that can be customequipped with a UMTS module. It is used during the implantation procedure and follow-up of BIOTRONIK implantable pacemakers, ICDs (implantable cardioverter-defibrillators), or implantable cardiac monitors.

Primary functions

The device has the following primary functions: Function

Purpose

Programming and testing functions

Program BIOTRONIK pacemakers, ICDs, and implantable cardiac monitors during the implantation procedure or follow-ups

ECG recorder and  ECG monitor

Display and printout of up to three leads of surface ECGs, as well as up to three intracardiac derivations (IEGMs) and the corresponding event markers, in real-time

Data management

Store parameter values and ECG/IEGM recordings for computer-aided archiving and evaluation

Documentation

Print out follow-up reports using the internal and/or external printer

About this Technical Manual Objective

This technical manual provides the user with all the safety information required to use the Renamic programmer. The following topics are covered in this manual: •

Device startup

•

Interrogation, testing, and programming of BIOTRONIK implantable pacemakers, cardioverter-defibrillators (ICDs), or implantable cardiac monitors

You will find all explanations of the essential features and basic functions of the programmer's software in a separate technical manual on the programmer or on the Internet at the following address: manuals.biotronik.com.

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Target group

Introduction

This technical manual is intended for physicians and trained medical personnel who are familiar with the following: •

The use of implantable pacemakers, ICDs, and implantable cardiac monitors

•

The risks and possible complications associated of using these systems

Additional requirements include: •

Medical knowledge:

•

Technical knowledge: - Ability to work with a PC - Ability to use software-controlled medical devices

Other technical manuals

•

Technical manual for the basic functions of the programmer's software

•

Technical software manual for programming the intended implantable pacemaker / ICD / implantable cardiac monitor

•

Technical manual for the intended implantable pacemaker / ICD / implantable cardiac monitor

English

- Basic medical knowledge of the therapy applied - Training in the handling and programming of implantable pacemakers, ICDs, and implantable cardiac monitors

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Safety during Use

Safety during Use 

2

Safety during Use2377213Technical ManualRenamic

Intended Medical Use Intended medical use

The Renamic programmer provides communication with the implantable pacemaker, ICD, or implantable cardiac monitor during the implantation procedure or follow-ups. The Renamic programmer 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

Required Expertise Required expertise

The programmer is intended for use by physicians and trained medical staff. Along with their basic medical knowledge, a detailed knowledge of cardiac electrotherapy is also required. Only qualified medical specialists with knowledge of cardiac electrotherapy can properly operate the device.

German medical device ordinance

This ordinance only applies in the Federal Republic of Germany. However, we recommend that customers in other countries comply with this ordinance as well. According to section 2, § 5, operation and use: "The user may operate a (...) listed medical product only after the manufacturer or the authorized agent who acts on behalf of the manufacturer has performed the following requirements: •

1. Functionality of this medical product has been checked at the location where the device will be used.

•

2. The staff appointed by the user has been trained to correctly handle, use and operate the medical product. This training must include handling, using and operating the product in conjunction with other medical products, implements and accessories in accordance with the technical manual, as well as any applicable safety-related information and maintenance instructions.

(...) (3) Proof of a functional test have been performed as stated in Paragraph 1 Item 1, and the training record of the staff appointed by the user, discussed in Paragraph 1 Item 2, are to be documented."

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Safety during Use

Residual Risk Risk analysis

The risk analysis carried out by the manufacturer's Risk Management Team has determined that the residual risk is as low as reasonably possible.

General Safety Warnings Technical manual Risks of improper handling

Only use the device in accordance with this technical manual. Disregarding the safety warnings can endanger the patient, the staff and the equipment. Note: Failure to observe the safety warning 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 impact

Installing modules

Modules for Renamic should be installed exclusively by trained professionals, who have extensive experience handling medical electrical devices. In addition, the BIOTRONK directives must be adhered to.

Changes not permitted

Only the manufacturer or a party expressly authorized by BIOTRONIK is allowed to perform corrective maintenance, enhancements or modifications to the device, except for the enhancement of modules.

Replacement parts and accessories

To ensure safety compliance, use only original replacement parts and accessories authorized by BIOTRONIK. Using any other parts voids the manufacturer's liability for any consequences, guarantee and warranty.

Defects

Do not use defective or damaged devices.

Physician supervision

The device should only be used under constant supervision by a physician. During operation of the device, it is necessary to monitor the patient’s heart rate and ensure that for each stimulation, the display of events and their results (using an external ECG monitor) is plausible.

Patient observation

Ensure that patients are individually observed over a suitable period of time in order to monitor the compatibility and effectiveness of parameter combinations.

Emergency equipment

Always ensure that in the event of an emergency, the following basic equipment is available: •

Defibrillator

•

Intubation set

•

Oxygen

•

Emergency drugs

For pacemaker-dependent patients, an additional external pacemaker must also be available.

English

It is a prerequisite that the programmer has been serviced and inspected according to the manufacturer's specifications by qualified medical staff and in compliance with the safety-relevant instructions in this technical manual.

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Life support system Liquids

Safety during Use

Do not use this device as a life support system. •

Never use a damp or wet device.

•

Protect the device from accidental ingression of fluids (e.g. infusion fluids).

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.

External ECG device

During the implantation procedure, the patient's heart rate should be additionally monitored using an ECG monitor or ECG recorder.

Defibrillation

Storage of follow-up data

•

The device is defibrillation protected only if connected with the authorized ECG cable. Check all device functions after a defibrillation.

•

During defibrillation, do not touch the patient, the programmer which the patient is connected to, or the attached accessories. Otherwise, there is a danger that you may suffer an electrical shock.

Renamic is not designed for long-term archiving of follow-up data. Ensure archival of the follow-up data in an external management system by, for example, printing or exporting the data.

Operating Conditions Transport and storage

•

If the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.

CAUTION

! Set-up location

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 device.

Only operate the device in rooms that fulfill the following conditions: •

No danger of explosion

•

Suitable for medical purposes

•

Class I power outlet with protective conductor connection

Place the device on a flat, dry surface. It should be placed so that it can not slip even with the cable connected and so that the patient can only come into contact with the applied parts, namely the programming head and ECG cable.

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Power supply

Safety during Use

The device is operated via the 230 V / 50 Hz or 115 V / 60 Hz AC current of a room used for medical purposes. The electrical port must fulfill the following conditions: •

The network installation fulfills at least the requirements of IEC 60364-7-710: 2002 group 1.

•

The device cable feeds directly into a permanently installed socket. No portable multiple socket outlets are switched in.

•

When used in combination with other devices, no portable multiple socket outlets should be used.

•

Only those power connection cables which are suitable for medical devices may be used, e.g. BIOTRONIK power cords (see Accessories, p. 85) or power cords of equal value labeled H05VV 3 x 0.75 mm, H05VV 3 x 1 mm or SJT AWG18.

To disconnect the programmer from the mains supply, pull its power plug. Cable and plug connections

Patient environment

•

Replace any cable that shows even slight damage.

•

Lay all cables between the patient and the device, as well as within the measuring apparatus, in such a way that they pose no danger of tripping over them and that any tensile forces that may occur can be safely buffered.

•

As a general rule, cables should only be connected or disconnected when the device is switched off, unless expressly permitted in the corresponding section of this technical manual.

•

Ensure that the contacts of all connections and plugs are clean. Soiled contacts can lead to signal distortions, and thus to false diagnoses.

•

Ensure that there is no condensation on the plugs or in the connector ports.  If condensation is present, dry it before use.

•

Do not force plugs into the connector ports and when disconnecting the plugs, do not pull on the cable to release the lock.

•

All lead connections are swap-safe and encoded at the lead connectors.

This device may be used in the patient environment. Place the device on a flat, dry surface so that the patient can only come into contact with the applied parts, namely the programming head and ECG cable. The physician must not simultaneously touch the patient and plug connections such as USB ports or interfaces for modules or the programming head.

Use with other devices

The device may not be used on the patient in conjunction with high frequency surgical equipment.

Start parameters and default settings

Once switched on, the device functions according to BIOTRONIK's default settings or the user-defined start parameters. Note: In addition to BIOTRONIK's default start parameters, the user-defined start parameters can also be saved and recalled.

English

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Safety during Use

Electromagnetic Interference Possible electromagnetic interference

The programmer is protected from disturbances resulting from electromagnetic interference, electrostatic discharges and other sources, including interference from cables. Simultaneously, the emitted interference has been reduced to a minimum. Thus the programmer conforms to the requirements of EN 60601-1-2  (in the revision valid at the time of delivery) . However, strong electromagnetic interferences that occur in the close vicinity of electrical motors, power cables, PCs, monitors, or other – possibly defective – electrical devices may compromise the function of the programmer in certain cases. This kind of device malfunction should be considered if the following is observed: •

The device switches on by itself.

•

The device senses false intrinsic events in the ECG, IEGM or marker channel (artifacts).

•

The device displays other inexplicable functions.

Correct operation of the device can be restored with the following: •

Switch off the malfunctioning electronic device.

•

Remove the source of interference from the device.

•

Switch the programmer on and off or break the electrical connection between the device and the source of the interference as much as possible without causing any danger.

If the interference continues, contact BIOTRONIK immediately. Note: If accessories other than those specified by BIOTRONIK are used, increased interference or lower resistance to interference can be expected. Note: If accessories specified by BIOTRONIK are used on other devices, increased interference or lower resistance to interference can be expected. Note: Portable radio communication devices can interfere with the programmer functioning.

EMI test

The telemetry between the programming head and the implanted device can be impaired by electromagnetic interference (EMI). This can be observed when it becomes difficult or even impossible to interrogate or program the implanted device. Using the EMI test (refer to device software help), the source of the electromagnetic interference can be located and then turned off.

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Safety during Use

Maintenance, Care and Disposal The following regulations are valid for the device. WARNING

!

Exposure to fluids may result in fatal injury Before cleaning and disinfecting device surfaces: Pull the power plug!

!

Danger of explosion if exposed to cleaning and disinfecting agents Let cleaning and disinfection agents evaporate before operating the device.

CAUTION

!

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.

Cleaning and disinfecting

•

Use lint-free, soft cloths.

•

Clean the housing with a damp cloth and mild soap solution or 70% isopropanol. Disinfect with alcohol or aldehyde-based agents such as Aerodesin 2000, Fugaten spray, Lysoformin 2000 or Aldasan 2000.

•

Vacuum the ventilation slots regularly.

•

Visually inspect the connections: make sure that the contacts for all connections and cables are clean and free of any type of dirt.

•

To disinfect the patient cable and patient adapter, use a mixture of 70% isopropanol and 30% water or Lysoformin 3000: Allow it to take effect for 15 minutes at 2% concentration.

Sterilization

•

The device cannot be sterilized.

Test before each use

•

A short test of the device and the approved accessories should be performed prior to each use. This test consists of the following visual inspections and a simple functional test: - Inspect the housing for mechanical damage, dents, loose parts, cracks, etc. - Inspect cables and connection areas to ensure proper insulation, no breaks, etc. - Inspect that the stylus is in place - Inspect the labeling for legibility - Inspect the displays (e.g. time and date) - Simple electrical function test: switch the device on; an internal function test will be conducted automatically. - If no error message appears, then no errors were found and the device can be used.

English

CAUTION

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Inspection

Safety during Use

The inspection consists of the regular safety inspection according to medical device standards. This ensures the safety of the device. •

The inspection must be performed - After use in conjunction with high-frequency surgical instruments or defibrillators - If malfunctions are suspected - Once a year

Changing a fuse

•

This inspection can be performed by BIOTRONIK.

•

The inspection should conform with the manufacturer specifications. These are available upon request. The specifications list all necessary test steps and the necessary equipment.

The fuses are located above the power cord port in a fuse holder. CAUTION

!

Mains voltage - risk of death from electric shock Before changing the fuses, switch off the device and disconnect the power cord.

CAUTION

!

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 (see Inspection, p. 58). Step

Disposal

Disposal of cables

Action 1

Unscrew the fuse holders with a screwdriver.

2

Extract the fuses from the fuse holders.

3

Replace the old fuses with new ones of the same type (see Power cord port , p. 84).

4

Reintroduce the fuse holders with the replaced fuses and screw them tight using a screwdriver. To prevent damage to the fuses and the fuse holders, do not apply more force than necessary to insert the fuse holders until they stop without protruding.

•

This device contains materials that must be correctly disposed of in accordance with environmental protection regulations. The European Directive 2012/19/EC regarding waste electrical and electronic equipment (WEEE) applies.

•

The symbol on the label – a crossed out garbage can – indicates that the device must be disposed of in accordance with the WEEE directive. The black bar indicates that the device was sold after the national implementation of the WEEE directive had been enforced locally.

•

Return devices that are no longer in use to BIOTRONIK.

Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations. Non-contaminated cables must be disposed of in accordance with the European Directive 2012/19/EU regarding waste electrical and electronic equipment (WEEE).

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3

Startup

Startup

Startup3377213Technical ManualRenamic

Device Overview English

Device in operating position

13

1

12

2 11

3 10

4

5

9

8

6

7

Fig. 1:

Explanation of items

Device operating element in working position, viewed from the front right

Explanation of the individual items: Item 1 2 3 4 5 6 7 8 9 10 11 12 13

Designation / description Screen (touchscreen) Device body USB ports ECG port Slot for expansion module Screen release key (right) Fixation for carrying strap (right) Pen holder PGH compartment lid release key Printer keys Stylus in pen holder Safe program key Emergency shock key

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Startup

Device in transport position

20 19

18

16

15 14

Fig. 2:

Explanation of items

Device operating element in transport position, viewed from the front left

Explanation of the individual items: Item

Designation / description

14

Carrying handle

15

Fixation for carrying strap (left)

16

Screen release key (left)

18

Paper tray for internal printer

19

On/off key

20

Power cord port and device fuse

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61

Startup

27

21

26 22

23

25

24

Fig. 3:

Explanation of items

Device operating elements, PGH compartment with lid open, viewed from above/in front

Explanation of the individual items: Item

Designation / description

21

PGH port

22

USB slot for Bluetooth USB adapter

23

PGH cable and ECG cable

24

Cable feedthrough for PGH cable

25

On/off light indicator

26

Programming head (PGH)

27

PGH compartment lid

English

PGH compartment

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Startup

Power cord storage compartment

31 30

29 28

Fig. 4:

Explanation of items

Device operating elements, power cord storage compartment with lid open, viewed from above/behind

Explanation of the individual items: Item

Designation / description

28

Anti-slip stand

29

Gripping tab

30

Power cord in power cord storage compartment

31

Power cord compartment lid

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Startup

Transporting the device

•

Renamic has an integrated ergonomic handle in the front and a gripping tab in the back, which can be used to safely transport the device in any position.

•

A carrying strap can also be attached to the device.

•

The specially designed anti-slip pads allow for horizontal or vertical positioning of the device.

•

When the device is slightly lifted in the front (using the handle), the slick corners of the base allow for easy positioning on smooth surfaces (tables, shelves).

•

After setting the device down, the anti-slip pads keep the device securely in place.

WARNING

!

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.

Setting up the device WARNING

!

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.

Note: The device can be operated in the patient's environment. •

Place the device on a flat dry surface. Make sure that it cannot shift even with the cable connected and that the patient can only come into contact with the applied parts, namely the programming head and ECG cable. The physician must not simultaneously touch the patient and plug connections such as USB ports or interfaces for modules or the programming head.

English

Transportation and Setup

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Tilting the screen up

Startup

•

In transport position (screen closed), unlock the screen by pressing both release keys at the same time. You can hear and feel the device unlock.

•

Hold the sides of the screen with both hands and tilt it up to the position you would like to use it in (1).

•

Pivot the screen around the upper end of the screen arm (2.). The operating position can be smoothly adjusted as needed. The screen will remain in any position due to its self-retaining bearings.

The two hinges of the screen arm allow for a wide range of working positions.

2.

1.

Fig. 5:

Tilt radius of the screen and screen arm

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Startup

Connections and Cables Basic notes for cables and connections

Note: Do not force the plugs into the ports. When disconnecting plugs, do not pull on the cable.

CAUTION

! Connect programming head

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

The PGH port is located at the top right of the device inside the PGH compartment. Refer to figure PGH compartment, p. 61, item 21. •

Pull the short end of the cable out of the PGH compartment and connect the PGH cable to the device PGH port.

•

Feed the PGH cable through the PGH compartment cable feedthrough. Refer to figure PGH compartment, p. 61, item 24.

Note: Since the device remains ready for operation in the transport position (screen flipped down and locked), the programming head can remain connected while the device is in this position.

Connect ECG cables WARNING

!

Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to patients. •

Do not use damaged cables.

WARNING

!

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 away from the leads.

WARNING

!

Danger to the patient or user from electrical current induction in surface ECG leads Electrical energy induced 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.

English

Note: Only connect external devices that conform to DIN EN 60601 or  DIN EN 60950 standards. Only then is the faultless functioning of the device  guaranteed.

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Startup

WARNING

!

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.

WARNING

!

Danger from loss of function Damp cables have limited functionality and pose a danger to patients. •

Do not use damp cables.

WARNING

!

Danger from electrical currents Unused cable contacts can conduct electrical currents to patients. •

Adhere unused cable contacts close to the patient.

Note: The ECG port can be disconnected and reconnected while the device is still active. Renamic can be used with the PK-222 ECG cable:

Fig. 6:

ECG cable PK-222 with banana plugs for extremity leads (Einthoven)

The ECG cable PK-222 has the following connections: •

Device: Redel plug, P series, 14-pole, 40°coded

•

Patient: 4 color-coded banana plugs

Note: The PK-222 ECG cable is provided unsterile and cannot be sterilized. Follow the instructions on cleaning and disinfecting in section Maintenance, Care and Disposal, p. 57.

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Startup

English

The ECG port is located on the back right of the device.

Fig. 7:

•

Position of the ECG port

Connect the ECG cable to the ECG port.

Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations. Note: Information regarding approved adhesive and clamp leads for surface ECG electrodes can be found in section Optional accessories (compatibility with third party suppliers), p. 86.

Connection of USB devices

The device's USB ports are intended for connection to various compatible devices, e.g. a USB flash memory stick, an adapter for an external monitor or an adapter for a serial interface. Note: The USB port can be disconnected and reconnected while the device is still active. WARNING

!

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.

WARNING

!

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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Startup

CAUTION

!

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 the IEC standard 60601-1 or IEC 60950.

•

Line-powered devices must comply with the standard IEC 60601-1 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 standard at least 1.5 m away from the patient.

•

Before initial commissioning, check and document all device combinations according to IEC standard 60601-1.

•

Perform this inspection at least once per year according to the legal requirements.

There are three USB ports located on the back right of the device and one in the PGH compartment (recommended USB port for the Bluetooth adapter).

Fig. 8:

•

Equipping the device with a Bluetooth adapter

Position of the USB ports

Connect the USB device or USB cable to the USB port.

If you equip the device with a Bluetooth adapter, various Bluetooth compatible devices can communicate wirelessly with the programmer. Note: The Bluetooth adapter used for data transfer must support the Microsoft Bluetooth standard. BIOTRONIK supplies a compatible Bluetooth adapter with the programmer. •

Before using the Bluetooth adapter, ensure that it is authorized for Bluetooth radio communication in your respective country / region.

The recommended port for this Bluetooth adapter is located in the PGH compartment on the right hand side of the device underneath the protective cap. Refer to figure PGH compartment, p. 61, item 22. We recommend connecting the Bluetooth adapter while the device is turned 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.