Renamic Neo Medical Programmer and Monitoring Device Technical Manual Rev G

© BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner.

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] www.biotronik.com

1

Table of Contents

Table of Contents 1 2

3

4

5

Introduction ...

2

About the Device ...

2

Safety during Use ...

5

General Safety Instructions ...

5

General Safety Instructions on the Pacing System Analyzer (PSA)...

8

Operating Conditions ...

9

Electromagnetic Interferences ...

12

Maintenance, Care, and Disposal ...

15

Startup ...

19

First Steps ...

19

Device Overview ...

20

Symbols on the Device...

25

Transportation and Setup...

27

Power Supply (Power Supply Brick and Battery) ...

29

Connections and Cables ...

32

Setting up Wireless and Network Connections...

38

Switching On and Off...

39

Using Renamic Neo ...

41

Screen ...

41

Indicators and LEDs on the Device ...

42

Programming Head (PGH)...

46

Communication with the Implanted Devices and Cardiac Monitors ...

48

Pacing System Analyzer (PSA) ...

50

Emergency Programs...

52

Appendix ...

54

Technical Data ...

54

Accessories and Spare Parts ...

60

Country-Related Information ...

62

Legend for the Label...

63

Index ...

65

2

1

Introduction About the Device

Introduction

About the Device General description Renamic Neo is a portable programmer and monitoring device with an integrated pacing system analyzer (PSA), which is used in the implantation and follow-up of implantable pacemakers, ICDs (implantable cardioverter-defibrillators), or implantable cardiac monitors of BIOTRONIK. In daily operation, it can be operated with a power supply brick or, alternatively, with a battery. It can be custom-equipped with a mobile internet stick authorized by BIOTRONIK.

Intended purpose The programmer provides communication with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs) during the implantation procedure or patient follow-up. The programmer is intended to enable the intended use of the implantable products by supplying the user interface to the device functions. Therefore, the programmer is used: •

to verify and optimize the therapy delivered by the devices.

•

to support diagnosis of the patient status through data delivered by the devices.

The PSA (pacing system analyzer) of the programmer supports lead implantations during the implantation procedure. Therefore, the PSA is used: •

to support lead implantations with intraoperative measurements of electrophysiological parameters.

The Intended purpose is achieved by providing product characteristics that allow performing the following tasks: •

Identify the supported implantable devices and retrieve, display, and print the current parameter settings

•

Retrieve, display, and print the recorded statistical data and episodes from the devices’ memory

•

Retrieve real-time IEGM data from the devices

•

Retrieve real-time ECG data from ECG electrodes applied to the patient for assessment of the function of the implanted devices

•

Select appropriate settings for the supported implantable devices by the user

•

Program the supported devices with the selected parameter values

•

Perform test functions (such as sensing, pacing threshold, and impedance tests) to determine the internal status of the devices, the connected leads, and the patients

•

Initiate special pacing programs and shocks for therapeutic purposes

•

Support lead implantations with intraoperative measurements of electrophysiological parameters such as sensing of intrinsic cardiac signals, pacing threshold, lead impedance, timing characteristics, and provision of temporary external pacemaker functions

•

Export data (including snapshots of real-time data) of the implanted devices for analysis and reporting purposes to a storage unit or a data processing system such as the Home Monitoring Service Center (HMSC) as an automatic and user-initiated operation

Intended clinical benefit The programmer has a clinical benefit when used in combination with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs), as part of a medical device system. The clinical benefit is to enable the intended use of the implantable products.

3

Introduction About the Device

Medical indication This device is indicated for use with all supported BIOTRONIK pacemakers, ICDs, and ICMs during implantation or follow-up of an implantable device. The PSA is indicated to support intraoperative measurement of implantable cardiac leads. Temporary pacing by the PSA is indicated for patients who require pacing during implantations.

Contraindications The device is intended for use with all supported BIOTRONIK pacemakers, ICDs, and implantable cardiac monitors (ICMs) during an implantation or follow-up of an implantable device. There are no contraindications for the device itself. Please refer to the contraindications in the technical manual of the specific implantable device. The following applications are contraindicated for use of the integrated pacing system analyzer (PSA): •

With AV conduction disorders: –

•

With competing intrinsic rhythms: –

•

•

•

Modes that have no sensing and inhibition function in the corresponding chamber

With chronic atrial tachycardia as well as chronic atrial fibrillation or flutter: –

•

Atrial single-chamber pacing

Atrial-controlled modes (DDD, VDD)

With poor tolerance of high ventricular rates (e.g., angina pectoris): –

High upper rate

–

Under certain conditions: atrial-controlled modes

With retrograde conduction after ventricular pacing: –

Programming a shorter AV delay

–

Under certain conditions: DDI, DVI, or VVI mode

Use as an external pacemaker outside of the implantation procedure

Possible complications Depending on the patient's condition and depending on the scope and type of pacing program, the following possible complications associated with the use of pacing system analyzers are reported in medical references: life-threatening atrial and ventricular arrhythmia, bradycardia, tachycardia, and asystole.

Intended user The use of the device and the technical manual are intended for trained and experienced physicians, hospital technicians and nursing staff, general practitioners, as well as sales representatives of BIOTRONIK, who are familiar with the following topics: •

use of implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs),

•

risks and possible contraindications accompanying the use of these systems,

•

experience with programmers for implantable devices.

The user of the programmer performs: •

follow-up and emergency follow-up,

•

implantation support with post-implantation follow-up.

BIOTRONIK offers user trainings for specific target groups. Current information on training and education opportunities can be requested from: [email protected]

4

Introduction About the Device

Patient group The device is intended for use with patients who have a BIOTRONIK implanted device, regardless of their age or state of health. Patients may be anesthetized, partially sedated, or conscious.

Residual risk The risk analysis carried out by the manufacturer's Risk Management team has determined that the residual risk is at the lowest possible level. Prerequisites for this are the intended use of a device that has been serviced and inspected according to the manufacturer's specifications by qualified medical staff and the compliance with the safety-relevant instructions in this technical manual. Please note the following residual risks when using the device: •

During diagnostic tests as part of the follow-up, ICD therapy is temporarily inactive.

•

During sensing tests and intrinsic rhythm tests, bradycardia therapy is limited or inactive.

5

2

Safety during Use General Safety Instructions

Safety during Use

General Safety Instructions Technical manuals Only use the programmer in accordance with this technical manual. This technical manual provides the user with the safety information required to use the programmer. The following topics are covered in this manual: •

Device startup

•

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

Explanation of the essential features and basic functions of the programmer's software is provided in a separate technical manual on the internet. Technical manuals are either included in hard copy form in the storage package or available in digital form on the internet: https://manuals.biotronik.com. 1. 2.

Follow all relevant technical manuals. Keep the technical manuals for later use.

To ensure safe operation, in addition to this technical manual, please also consult the following technical manuals: •

Technical manual for the implanted device

•

Technical manuals for the leads

•

Technical manuals for the programmer's software

•

Technical manuals for cables, adapters, accessories

•

Technical manuals for other devices, such as external monitors

Risks of improper handling Disregarding the safety instructions can endanger the patient, the staff, and the technical equipment. Failure to observe the safety instructions 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

Changes not permitted Only the manufacturer BIOTRONIK or a party expressly authorized by the manufacturer may perform corrective maintenance, enhancements, or modifications to the device, the battery, and other accessories and spare parts.

Spare parts and accessories For your own safety, only use accessories and spare parts authorized by BIOTRONIK. The use of any other parts voids the warranty and eliminates the manufacturer's liability for any consequences. In addition, the accessories and spare parts authorized by BIOTRONIK must only be used for their intended purpose and as described in this technical manual.

Defects Do not use defective or damaged devices.

6

Safety during Use General Safety Instructions

Physician supervision The device should only be used on the patient under supervision of a physician. During operation of the device, monitor the patient’s heart rate using external surface ECG with rate control and make sure that for each pacing, the appropriate events and responses are exhibited (using an external ECG monitor).

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 Ensure that basic emergency equipment is available in order to be able to take immediate life-support action. For example, this may include: •

External defibrillator

•

Intubation set

•

Oxygen

•

Emergency drugs

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

Life support system The device must not be used as a life support system. During implantation, the device is suitable for temporary external pacing, but the patient must be monitored constantly by medical personnel.

Liquids Never use a damp or wet device. Protect the device from accidental ingression of fluids (e.g., infusion fluids). Protect the device from condensation.

Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are balanced. Before handling the device, the electrostatic potential between the physician or medical staff and the patient must be balanced by touching the patient at a point as far away from the electrodes as possible.

Defibrillation The device is defibrillation protected only in connection with the authorized ECG cable. During defibrillation, do not touch the patient, the programmer that the patient is connected to, or the attached accessories. Otherwise, there is a danger that you may suffer an electrical shock. The device’s recovery time after defibrillation is 5 seconds. Following a defibrillation, check the device for proper functioning.

Using in combination with high-frequency devices The device is protected against damage when using it in conjunction with high-frequency surgical instruments. Even though this protection was tested, its effectiveness depends on the strength, wave shape, and transmission path of the induced current. When used in conjunction with RF surgery equipment, this device does not protect the patient from burns. Dangerous currents can be induced in the patient, which could enter the patient's heart. •

Disconnect the patient cables from the device when using with high-frequency surgical instruments.

•

Perform an inspection after use with high-frequency surgical instruments.

7

Safety during Use General Safety Instructions

Battery charging status A battery may be included in the package contents of the device upon customer request. Due to aviation regulations, the charging status at the time of delivery is a max. 30%. Only ship devices with a battery, or the battery itself, with a max. charging status of 30%. Before using the device on the patient for the first time, the battery should be fully charged; this is reached after approximately 3 hours. The battery is charged by inserting it into the device and connecting the device to the electrical power supply using the power supply brick. Only use the device to charge the battery, as this is the only way to ensure its proper functionality. Charge the battery for a few hours before using it on the patient in order to ensure an adequate charging status. Ensure that the storage conditions are met and pay attention to their effect on the charging status of the battery (see Transport and storage [Page 9]).

IT network When the device is integrated into an IT network, the following hazardous situations may occur: • The follow-up may be disturbed by an active data connection. • The device may be put to an undefined state due to an impaired connection. In addition, integrating the device into an IT network that includes other devices may present previously unknown risks to patients, users, or third parties. You, as the organization responsible for integrating the device into an IT network, must identify, analyze, assess, and control the risks. The following changes to the IT network can lead to new risks and therefore require additional analyses and actions, where required: • Changes to the configuration of the IT network • Connecting additional elements to the IT network • Removing elements from the IT network • Updates to devices that are connected to the IT network • Upgrade of devices that are connected to the IT network

Storage of follow-up data The device is not designed for long-term archiving of follow-up data. Ensure archiving of the follow-up data via an external management system, for example, by printing or exporting the data.

Data protection As a user of the device and the ReportShare® service, the responsibility rests with the user to comply with the applicable confidentiality and data protection laws in the country in which the programmer and ReportShare® service are used. BIOTRONIK is an external service provider that does not evaluate or interpret medical data. BIOTRONIK also does not make recommendations on treatment of patients nor does it intervene in them. BIOTRONIK is only liable to pay damages, regardless of the legal basis, in cases of intent or gross negligence. In cases of simple negligence, BIOTRONIK is only liable for damage resulting from injury to life, limb, or health. In the case of damage arising from a failure to fulfill a material contractual obligation (breach of contract), liability is limited to foreseeable, typically occurring damage. Obtain the prior, written consent from the patient for the collection, processing, and recording of patient data as part of using the device and ReportShare®. The sole responsibility for the diagnosis and treatment of the patient rests with the user of the device and ReportShare®. Handling patient data in the event of a change of ownership For reasons of confidentiality and data protection, patient data stored on the device must be deleted before the programmer changes ownership. Handling patient data for BIOTRONIK servicing of device Back up and delete the patient data stored on the device before sending it to BIOTRONIK for service. BIOTRONIK does not guarantee that data and passwords will still be available after the service.

8

Safety during Use General Safety Instructions on the Pacing System Analyzer (PSA)

General Safety Instructions on the Pacing System Analyzer (PSA) Patient cable If the patient cable is connected to the leads and the device connector of the patient cable is not yet connected to the programmer, this can result in unintended introduction of electrical energy. First connect the patient cable to the programmer and then the leads to the patient cable.

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.

Stopping the pacing Do not stop the pacing abruptly as this can result in sustained asystoles in some patients. Gradually decrease the pacing rate until the patient's intrinsic rhythm is detected.

Mode selection While selecting the mode, make sure that the leads required for it are used with the appropriate patient cables. Loss of pacing could pose a risk to the patient.

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.

Sensitivity Selecting a lower sensitivity value could lead to greater interference from electromagnetic fields due to increased sensitivity of the device. Low sensitivity values should only be set if absolutely necessary for medical reasons.

9

Safety during Use Operating Conditions

Operating Conditions Transport and storage If the package is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.

Caution 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.

•

Carry out an inspection or contact BIOTRONIK for the testing and, if necessary, for repair of the device.

Attention Functional impairment due to condensation Due to significant changes in temperature, for example, when transporting the device from a cold environment to a warm environment, condensation can occur on or in the device and permanently damage the electronics. •

Allow the device and its accessories to acclimate to the new ambient conditions for a sufficiently long period of time. Before connecting the power supply brick and switching on the device, wait at least 1 hour to allow condensation to evaporate.

Store and transport the battery in a way that protects it from damage and dirt at all times. Pay attention to the following while storing the battery: •

Minimize the risk of short-circuit by using the original packaging, a plastic bag, or covering the contacts with masking tape.

•

Store the battery in a way that protects it from exposure to heat. Do not leave the battery in the car at high temperatures. Do not put it in the microwave.

•

Store the battery in a way that protects it from water, chemicals, and foodstuffs.

•

Do not store the battery in pressurized containers.

•

Store the battery out of the reach of children, and never leave children unsupervised with the device if the battery is inserted.

Only use undamaged batteries. If you notice any change (color, smell, etc.) in the battery while storing, inserting, handling, charging, or during normal use of the battery, remove it immediately or do not use it. Comply with the following ambient conditions for storing the battery: Temperature range for storage

0°C ... +50°C / 32°F ... 122°F

Recommended storage temperature

23°C/73°F

If the battery has been damaged due to high temperatures, rinse the leaking liquid with sufficiently clean water. If the leaking liquid comes into contact with the eyes, rinse them with sufficiently clean water and consult a suitable physician.

10

Safety during Use Operating Conditions

Depending on the storage temperature, the charging status and the actual battery capacity may be reduced to the extent that the battery becomes completely discharged and can no longer be used. Therefore, depending on the storage temperature, the battery must be charged at regular intervals: Storage temperature of the battery

Moment to charge the battery

≤ 35°C/95°F

After 6 month

≤ 45°C/113°F

After 3 month

≤ 50°C/122°F

After 1 month

Setup location

Caution Risk of electromagnetic interference The use of this device close to or in direct contact with other devices should be avoided, as this may lead to the device operating incorrectly. •

Where usage in such a manner is unavoidable, you should monitor this device and the other device(s) being used with it in order to ensure that they are all working correctly.

WARNING Risk of electromagnetic interference through the use of portable RF communication equipment If portable RF communication devices (including peripheral devices such as antenna cables and external antennae) are operated closer than 30 cm (12 inches) from this device, this can result in a reduction in its performance. This applies even when using associated cables. •

When operating portable RF communication devices (including peripheral devices such as antenna cables and external antennae), keep such devices at a distance of at least 30 cm (12 inches) from this 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 in a manner that does not allow it to slip, even while the cables are connected, and protects it from liquids and moisture. Also, ensure that the patient only comes into contact with the applied parts, namely the programming head, ECG cable, and patient cable for the PSA. In addition to this, ensure that the power plug of the power supply brick is easily accessible and can be pulled out of the outlet at all times. The physician must not touch any visible plug connections such as USB ports, nor any device contacts for the battery in the battery compartment, simultaneously with the patient. To prevent overheating of the device and the programming head, take the following measures: •

Place the programming head outside of the PGH/ECG cable compartment.

•

Ensure that the ventilation slots are free so that the exhaust air can circulate freely.

•

Do not place the device on hot surfaces.

•

Open the screen into working position.

•

Comply with the operating temperatures and regulate the ambient temperature accordingly.

If these measures are not sufficient and the device exceeds a certain temperature limit, the device will automatically switch off in order to prevent overheating.

11

Safety during Use Operating Conditions

Power supply The device can be operated while line powered and in battery operation. When line powered, the device is operated through the power supply brick and power cord provided with the device. The electrical port must fulfill the following conditions: •

The electrical installation at least fulfills the requirements of IEC 60364‑7‑710:2002 Group 1.

•

The power plug of the power supply brick goes directly into a permanently installed electrical outlet of a power supply with PE conductor. No portable multiple socket outlets or extension cables should be used.

•

The power plug of the power supply brick must be easily accessible at all times in order to be able to disconnect the device at any time from the power supply.

•

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

•

Only power connection cables (power cords) and power supply bricks authorized by BIOTRONIK must be used (see Accessories and Spare Parts [Page 60]).

To disconnect the device from the electrical power supply, pull its power plug out of the outlet. Please note that the device does not switch off when the battery is inserted, but instead switches over to battery operation. If the device has been disconnected from the power supply, and no battery is inserted, the device switches off completely. In the process, the follow-up data generated may be lost and the pacing of the PSA will be terminated. Use the device with the battery inserted when using the PSA.

Cable and plug connections •

Replace cables of any type immediately whenever damage is detected, even if it is only minor.

•

Lay all cables between the patient and the programmer, 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.

•

Do not establish any connection with an external device or a network during implantation or followup to avoid disruptions in the communication between the programmer and the implanted device.

•

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 do not pull on the cable to release the lock when disconnecting the plugs.

•

All plug connections are non-interchangeable and encoded at the connecting points.

Patient environment The device can be operated in the patient environment. Place the device on a flat, dry surface in such a way that the patient only comes into contact with the applied parts, namely the programming head, ECG cable, and patient cable for the PSA. The physician must not touch any visible plug connections such as USB ports, nor any device contacts for the battery in the battery compartment, simultaneously with the patient.

Use with other devices The device may be used in the vicinity of high-frequency surgical instruments. Remove all patientcables if used in conjunction with high-frequency surgical instruments. If this is not possible, perform an inspection (see Inspection [Page 16]) following use in conjunction with high‑frequency surgical instruments.

Current software version The range of functions of the device depends on the correct software version. •

Make sure that the current software version is installed.

Software is available for download on the internet at: software.biotronik.com or by contacting BIOTRONIK.

12

Safety during Use Electromagnetic Interferences

Electromagnetic Interferences Possible electromagnetic interference This device is protected against electromagnetic interference and electrostatic discharges in the specialized environment in the vicinity of high-frequency surgical instruments. When used in a residential area, this device does not provide adequate protection for radio services. At the same time, the emitted interference is reduced to a minimum. The device thus meets all requirements of IEC 60601-1-2. The following tests were conducted according to IEC 60601‑1‑2: 2014: Section

Test

Test level

7.1

EN 55011 (CISPR 11)

•

Group 1

Conducted interference emissions

•

Class B

•

Class A

•

Class A

IEC 61000‑4‑2

•

±8 kV contact discharge

Electrostatic discharge (ESD)

•

±15 kV air discharge

IEC 61000‑4‑3

•

Modulation: 2 Hz

Electromagnetic fields

•

Modulation: 10 Hz

•

Modulation: 1 kHz

•

3 V/m, 80 MHz – 2.7 GHz

•

Limits for RF communication equipment per Table 9 in IEC 60601-1-2 (9–28 V/m)

EN 55011 (CISPR 11) Radiated emission 7.2.1

IEC 61000‑3‑2 Harmonic distortion (harmonic currents in the power supply)

7.2.2

IEC 61000‑3‑3 Voltage fluctuations and flicker in the power supply

8.9

8.9/8.10

13

Safety during Use Electromagnetic Interferences

Section

Test

Test level

8.9

IEC 61000‑4‑4

•

± 2 kV power supply line

Transient conducted surge voltages (EFT, bursts)

•

± 1 kV signal line

IEC 61000‑4‑5

•

±0.5 kV, ±1 kV, ±2 kV common mode

Surge voltage waves on supply lines

•

±0.5 kV, ±1 kV push-pull mode

IEC 61000‑4‑6

•

Modulation: 2 Hz

Conducted radiofrequency interference

•

Modulation: 10 Hz

•

3V

•

6 V in ISM bands

IEC 61000‑4‑8

•

30 A/m

AC frequency magnetic fields

•

50/60 Hz

IEC 61000‑4‑11

•

0% UT; 0.5 cycles

Voltage fluctuations and interruptions in supply voltage

At 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° •

0% UT; 1 cycle At 0°

•

70% UT; 25 cycles, 30 cycles At 0°

•

0 % UT; 250 cycles, 300 cycles

However, strong electromagnetic interference (EMI) that occurs in the close vicinity of electrical motors, high-voltage power lines, PCs, monitors, or other, possibly defective, electrical devices may in certain cases interfere with the ECG/IEGM, interfere with transmission via wireless RF telemetry, and compromise the function of the device when using the PSA. This kind of device malfunction should be considered as a possible cause if the following is observed: •

The device switches on unintentionally.

•

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

•

The device displays other abnormal behaviors.

If this kind of interference is present, only use telemetry via the programming head for communication between the device and the implanted device, rather than wireless RF telemetry. Correct operation of the device can be restored by the following methods: •

Switch off the interfering electrical device.

•

Remove the source of interference from this device.

•

Switch this device on and off or break the electrical connection between this device and the source of interference, if this can be done safely.

If the interference continues, contact BIOTRONIK immediately.

14

Safety during Use Electromagnetic Interferences

Caution Risk of electromagnetic interference The use of this device close to or in direct contact with other devices should be avoided, as this may lead to the device operating incorrectly. •

Where usage in such a manner is unavoidable, you should monitor this device and the other device(s) being used with it in order to ensure that they are all working correctly.

WARNING Risk of electromagnetic interference through the use of unauthorized accessories The use of accessory parts, transducers, or cables not listed by BIOTRONIK, or other than those specified by BIOTRONIK, can produce elevated electromagnetic emissions or cause degradation in the device's resistance to electromagnetic interference. Such effects can lead to the faulty operation of the device. •

Only use accessories authorized by BIOTRONIK.

WARNING Risk of electromagnetic interference through the use of portable RF communication equipment If portable RF communication devices (including peripheral devices such as antenna cables and external antennae) are operated closer than 30 cm (12 inches) from this device, this can result in a reduction in its performance. This applies even when using associated cables. •

When operating portable RF communication devices (including peripheral devices such as antenna cables and external antennae), keep such devices at a distance of at least 30 cm (12 inches) from this device.

In the case that the presence of external noise resulting from electromagnetic interference (EMI) exceeds limit values, the PSA will switch to asynchronous pacing. The sensing amplifier is turned off for the duration of the presence of the noise in the channel in which the noise is detected. Pacing still continues if it is switched on in this channel. This noise will be visible on the IEGM channel, but no markers will be displayed.

Detecting electromagnetic interferences (EMI) Wireless RF telemetry and telemetry between the programming head and the implanted device may be impaired by electromagnetic interference (EMI). This can be observed when transmission using wireless RF telemetry is disturbed or it becomes difficult, or even impossible, to interrogate or program the implanted device. When using telemetry between the programming head and the implanted device, sources of electromagnetic interference may be detected using the EMI test (refer to device software help). If this kind of interference is present, the source of interference must be located and turned off. When using wireless RF telemetry, sources of electromagnetic interference may be detected using the RF monitor (refer to device software help). If this kind of interference is present, only use telemetry via the programming head for communication between this device and the implanted device, rather than wireless RF telemetry.

15

Safety during Use Maintenance, Care, and Disposal

Maintenance, Care, and Disposal Cleaning and disinfecting You may use the following cleaning agents to manually clean the device and the programming head: •

Mild cleaning agents with a pH value of 4 ... 10

You may use the following active ingredient classes to manually disinfect the device and the programming head: •

Alcohol-based disinfectant

•

Hydrogen peroxide-based disinfectant

•

Quaternary compound-based disinfectant

The disinfection of the device and the programming head was tested using the following agents: •

•

Alcohol-based disinfectant –

Mixture of 70% isopropyl and 30% water

–

Mixture of 85% ethanol and 15% water

–

Aerodesin 2000 (manufactured by Lysoform Dr. Hans Rosemann GmbH)

Hydrogen peroxide-based disinfectant –

•

2-percent solution for use with terralin® PAA (manufactured by Schülke & Mayr GmbH)

Quaternary compound-based disinfectant –

2-percent solution for use with terralin® protect (manufactured by Schülke & Mayr GmbH)

Cleaning the device and the programming head 1. 2. 3.

Clean the device and the programming head thoroughly using a lint-free, soft cloth. Clean areas that are difficult to reach or view (such as grooves and gaps) with a soft plastic brush until they are visibly clean. Vacuum the ventilation slots regularly.

Cleaning the battery 1.

Clean the contacts of the battery using a dry, lint-free, soft, and clean cloth.

Disinfecting the device and the programming head 1. 2.

Please follow the instructions for use given by the manufacturer of the disinfectant. Disinfect the device and the programming head thoroughly using a lint-free, soft cloth.

After cleaning and disinfection 1.

2. 3.

After cleaning, visually inspect to check whether all impurities have been removed. Make sure that the contacts for all connections and cables to be connected are clean and free from any kind of contamination. If necessary, repeat the cleaning procedure. After cleaning and disinfecting, check all components for dryness. If necessary, dry them using a soft and lint-free cloth. Never use a damp device, a damp programming head, or a damp battery. After cleaning and disinfecting, check all components for damage. Never use a damaged device, a damaged programming head, or a damaged battery.

16

Safety during Use Maintenance, Care, and Disposal

Sterilizability The device and the programming head (PGH) cannot be sterilized. Only use the PGH in the sterile area with the sterile cover for the PGH (see Accessories and Spare Parts [Page 60]).

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 function test: 1. 2. 3. 4. 5.

Inspect the housing for mechanical damage, dents, loose parts, cracks, etc. Inspect the cables (for insulation, fractures, etc.) and cable connection areas. Inspect the labeling for legibility. Check the indicators and the screen (e.g., time and date). Perform a simple electrical function test: Switch on the device. „ An internal function test is performed automatically.

If no error message appears, no errors were found and the device can be used. If you find any damage or failures, please contact BIOTRONIK.

Inspection The inspection consists of the regular technical safety check according to medical device standards. This ensures the safety of the device. Inspections must be performed in the following situations: •

After use in conjunction with high-frequency surgical instruments or cardiac defibrillators.

•

If malfunctions are suspected.

•

At the regular intervals prescribed by the national regulations and at least every two years.

This inspection can be performed by BIOTRONIK. The inspection must conform with the manufacturer’s specifications, which are available upon request. The specifications list all necessary test steps and the necessary equipment.

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Safety during Use Maintenance, Care, and Disposal

Replacement of various components The exchangeable spare parts can be found in the following section: Accessories and Spare Parts [Page 60]. Programming head (PGH) and ECG cable compartment cover

The cover for the PGH and ECG cable compartment can be replaced by you or by BIOTRONIK. To replace the cover, proceed as follows: 1. 2. 3. 4. 5. 6. 7.

Press the release key and open the PGH and ECG cable compartment. Take out the programming head and place it aside. Press one of the two bearing caps from the bottom out of the housing until the pins on the cover are visible. Simultaneously pull out the pins of the cover from the bearing position of the bearing cap. To do this, pull the cover on an angle toward the front. Do the same with the second bearing cap and remove the cover. Dispose of the cover to be replaced properly in accordance with applicable directives. Attach the new cover in the reverse sequence. The pins snap audibly into place.

USB port cover

To replace the cover, proceed as follows: 1. 2. 3.

The cover can be pushed down sideways. To do this, press your finger on the cover and slide it sideways away from the device. Dispose of the cover to be replaced properly in accordance with applicable directives. Slide the replacement cover for the USB port sideways completely up to the snap-in point on the device.

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Safety during Use Maintenance, Care, and Disposal

Battery compartment cover and battery

To replace the cover, proceed as follows: 1. 2. 3. 4.

Place the device on its back with the bottom facing up. Press the lock of the battery compartment cover downwards and slide the cover off in the direction of the printed arrow. Dispose of the cover to be replaced properly in accordance with applicable directives. Slide the replacement cover for the battery compartment completely up to the snap-in point on the device.

To replace the battery, proceed as follows: Prerequisite • The device is switched off and the on/off light indicator is not lit. 1. 2. 3. 4.

5.

Place the device on its back with the bottom facing up. Press the lock of the battery compartment cover downwards and slide the cover off in the direction of the printed arrow. Remove the battery using the tag. Insert a new battery. Ensure the correct position of the contacts and also that the battery is completely inserted in the battery compartment. While doing this, ensure a suitable position of the tag for easy removal of the battery. Slide the battery compartment cover completely up to the snap-in point on the device.

Do not insert or remove any battery in the device while using the device on a patient in order to ensure provision of error-free and continuous care to the patient. Pay attention to the charging status of the battery before using the device on the patient. Never use the device without the battery compartment cover in order to prevent conduction of leakage currents when the contacts are touched.

Disposal

The symbol on the type plate, a crossed out garbage can, indicates that the device must be disposed of in accordance with the Directive 2012/19/EU on waste electrical and electronic equipment (WEEE 2). Disposal of this device in an environmentally unfriendly manner will result in environmental pollution, as this device contains materials that must be disposed of in accordance with environmental protection regulations (e.g., WEEE, RoHS, REACH). Return devices that are no longer in use to BIOTRONIK. The battery must not enter the environment uncontrolled. It must be disposed of in an environmentally friendly manner according to the applicable country-specific directives; a suitable recycling method is recommended. Do not throw the battery into any sewage/water system, and do not burn it. Do not break or damage the battery before disposal. The battery should be completely discharged before it is recycled.