Reocor D-S Users Guide Sept 2012

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Table of Contents Indications and Contraindications for Use... 3 Product Description... 14 Protective Cover for Reocor D/S... 14 Safety... 16 Connecting to Reocor D/S... 17 Reusable Patient Cables... 19 Start-Up... 20 Programming Reocor D/S... 21 Burst Pacing... 23 Visual and Audible Signals... 24 Common Interference Sources and Recommendations... 27 Battery Information... 28 Care and Maintenance... 30 Supplementary Information... 31 Symbols on the Components... 33

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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 (or properly licensed practitioner).

Indications for Use:

Temporary pacing with Reocor is suitable for the following applications for patients of any age: • Treatment of arrhythmias and heart block • Symptomatic sinus bradycardia • Sick sinus syndrome • Pre-, intra- and postoperative pacing of patients with heart surgery • Termination of supraventricular tachyarrhythmias • Prophylactic pacing for prevention of arrhythmias • Emergency pacing • Checking the pacing thresholds

Intended Use

Reocor is a battery powered external pacemaker, that is used in combination with a lead system for temporal atrial, ventricular and AV - sequential stimulation in a clinical environment. The Reocor is a product family of external pacemakers. These pacemakers are used for temporary pacing.

Contraindications:

Use of the Reocor Family of External Pacemakers is contraindicated for: • The Reocor external pacemaker family can not be sterilized and is therefore not dedicated for the use in a sterile patient environment. • Atrial single chamber stimulation is contraindicated for patient with AV conduction problems. • The use of an external pacemaker is contraindicated in the presence of an active, implanted pacemaker.

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Indications and Contraindications for Use

Use of the Reocor D External Pacemakers is contraindicated for: • The atrially triggered pacing modes (DDD and VDD) are contraindicated for atrial fibrillation, atrial flutter and other fast atrial rhythms. • When high ventricular rates are not well tolerated by the patient (e.g., in the presence of angina pectoris), atriumcontrolled modes can be contraindicated. • If retrograde conduction is encountered after ventricular pacing, extending the atrial refractory period and/or shortening the AV delay may be necessary programming options to prevent pacemaker- mediated tachycardia. It may be necessary in such cases to program a VVI mode. Potential Side Effects Potential complications associated with the application of temporary external pacing include asystole after abrupt cessation of pacing (e.g., if the patient cable is inadvertently disconnected, the leads are loosened or the settings are incorrect) or pacemaker dependency. Complications when inserting transvenous leads include: Wound infection, arterial puncture, pericardial friction, cardiac perforation and dysrhythmia after lead insertion.

Warnings: • Danger to patient by damaged cables. Damaged cables are limited in functionality and pose a danger to patients. Do not use damaged cables. • 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

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Indications and Contraindications for Use

unused cable contacts close to the patient. • After a burst stimulation in the atrium, the ventricular blanking interval can prevent sensing of intrinsic signals and lead to asynchronous pacing in the ventricle. • After a burst stimulation in the atrium, the ventricular blanking interval can prevent sensing of intrinsic signals and lead to asynchronous pacing in the ventricle. Pacing the heart with rates higher than 180 ppm over a long time period can cause severe hemodynamic complications. Pacing with high rates should only be performed when continuous monitoring is ensured.

оо The mode for high-frequency pacing is used to terminate certain supraventricular tachycardias (SVT) and should only be considered for atrial applications. The application of asynchronous high-frequency stimuli can interrupt an SVT by depolarizing portions of a reentry path. When an ectopic atrial focus is responsible for an SVT, the application of high-frequency stimuli in the atrium can also lead to increased suppression of the ectopic center. оо Various risks have to be considered in association with high-frequency atrial pacing. The risks include possible ventricular pacing and ventricular tachycardia or fibrillation. This can be caused by poor placement of the leads or the presence of anomalous stimulus conduction paths that circumvent the normal atrioventricular stimulus conduction (e.g. Wolff-Parkinson-White Syndrome). Patient discomfort and asystole after highfrequency pacing are other possible problems.

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Indications and Contraindications for Use

• Never use a damaged device or a device that exhibits abnormal behavior; especially if it has been dropped or could have been damaged by high-frequency or defibrillation voltage. • The temporary leads that are connected to Reocor represent a low-impedance conductor to the myocardium for electric current. Therefore, line-powered devices that are operated in the patient's vicinity must be grounded in accordance with established guidelines. • The pacemaker must not be used in areas at risk for explosion. • All additional maintenance work and repairs should only be performed by BIOTRONIK.

Precautions: • The connections of Reocor and the temporary pacing leads must be secured and checked regularly. • During use of Reocor, the protective cover must be locked to prevent inadvertent resetting of the rotary switch and control dial, and thus of the programmed parameters. • Allergic reactions and inflammations. Prevent the cable from coming into contact with the patient's wounds or skin. • During use of Reocor, the heart rate of the patient must be monitored with an ECG monitor with alarm function. • The preferred pole orientation is marked in the battery compartment. When inserting the new battery you only need to ensure that the battery poles point to the middle of the housing. The position of the plus and minus pole can be selected freely. • If an armband is used, Reocor must not be worn directly on the skin. • Even though Reocor is protected from dripping water, the device should be kept clean and dry.

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Indications and Contraindications for Use

General Safety Instructions: Depending on the pacing settings and the patient's underlying illness, pacing can induce arrhythmias. To ensure the patient's safety, certain procedures should be observed and the precautionary measures listed below taken. Please read about additional procedures and precautionary measures in appropriate medical publications. Users Reocor may only be used by persons with knowledge of cardiology who were trained in the handling of the device. Potential users are technical and medical hospital staff and physicians. Mode of action Reocor interacts with the human heart. There is also an interaction with the patient's skin and blood vessels. Intended use Reocor and the cables and accessories approved along with the device may only be used in accordance with this technical manual. • Reocor must not be connected to other electromedical devices. • Reocor must not be used in areas with a danger of explosion. Changes not permitted • Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device.

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Indications and Contraindications for Use

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. Devices on hand • In case of pacemaker dependency of the patient, an emergency pacemaker should be kept on hand. • Keep an external defibrillator, oxygen, intubation equipment and emergency drugs on hand. Behavior before use • Before use, Reocor should be visually inspected for damages and dirt. • Never use a device that is damaged or shows abnormal behavior. Replace any cable that shows even slight damage. • Before using Reocor, the patient cable or leads, the user should touch the patient to equalize electrical potentials. • It is strongly recommended to examine all set parameters before the leads are connected to Reocor. • Even though Reocor is protected from dripping water, the device and all plugs should be kept clean and dry. • Reocor cannot be sterilized. If the device needs to be used in a sterile environment, it can be packed into a sterile cover. Lead connection • The connections of Reocor and the temporary pacing leads must be secured and checked regularly. • The patient cable must first be connected to Reocor and then to the leads.

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Indications and Contraindications for Use

• The temporary leads, to which the Reocor is connected, represent a low-impedance conductor to the myocardium for electric current. Therefore line-powered devices that are operated in the patient's vicinity must be grounded in accordance with established guidelines. • When handling already implanted leads, their connector pins and metal contact surfaces must not touch or come into contact with electrically conductive or wet surfaces. • If the cable is disconnected from the Reocor, it must be reconnected immediately and the security of the connection has to be examined. • When using unipolar leads, two unipolar leads must be used for effective pacing. Behavior during use • During use of Reocor, the protective cover must be completely closed to prevent accidental resetting of the programmed parameters. • Secure Reocor either horizontally on a non-slip surface or on the patient with an armband, or operate it from a hanging position on the infusion stand using the hanger on the back of the device. • Reocor must not be worn directly on the skin. • During use of Reocor, the heart rate of the patient must be monitored with an ECG monitor with alarm function. Reocor S: • In case of disturbances caused by electromagnetic interference (EMI), Reocor will switch to operating mode S00 when certain limits are exceeded. Reocor D: • For disturbances caused by electromagnetic interference (EMI), Reocor D will trigger asynchronous pacing when certain limits are exceeded. Depending on whether the

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Indications and Contraindications for Use

interference was sensed in the atrium or in the ventricle, the following operating modes will result for the duration of the interference: Undisturbed operating mode

Interference by EMI

SSI, SST

S00

VDD

VAT, VVI, V00

DDD

DAD, DVI, D00

Pacing with high rates • Pacing the heart with rates higher than 180 ppm over a long period of time can cause severe hemodynamic complications. Pacing with high rates should only be performed when continuous monitoring is ensured. Behavior after use • After a defibrillation or cauterization, the device should be subjected to a function test. • If the device will be stored for a long period of time, the battery should be removed to prevent damage due to leakage. • A damp cloth and mild soap can be used for cleaning. Strong cleaning agents or organic solvents should be avoided, as these can corrode the plastic housing. • Inspection and maintenance work should be performed. Battery operation • Do not use rechargeable batteries. The service time of these batteries is difficult to estimate, making it possible to inadvertently exceed the ERI time1, resulting in sudden cessation of pacing. • Only 9-volt batteries with the international code IEC 6LR61 must be used. When using the battery type MN 1) Reocor reminds you to replace the battery with the ERI signal (low battery LED flashes).

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Indications and Contraindications for Use

1604 Duracell® Procell®, external pacing is possible for at least 600 hours (Reocor S) and 500 hours (Reocor D) before the battery must be replaced. • It is possible to exchange a battery while Reocor is in use. The device remains ready for use for at least 30 s at the ambient temperature (20 ± 2°C) when the battery is removed. • For safety reasons, the patient should be paced by another source during the battery replacement. Electrocautery • Electrocautery should definitely not be performed at a distance less than 15 cm from the leads, as it is possible that ventricular fibrillation will be induced or the pacemaker could be damaged. • The pacemaker should be set to asynchronous pacing to avoid pacemaker inhibition due to interference signals. During treatment, the peripheral pulse of the patient should be continuously monitored. After treatment, the pacemaker function must be inspected. Defibrillation • The circuitry of Reocor is protected from the shock energy that can be induced by a defibrillation. Nonetheless, the following precautionary measures should be taken, if possible:

-- The set energy should not be higher than necessary for defibrillation. -- The distance between the leads of the cardiac defibrillator and the leads of Reocor should be at least 10 cm. -- After a defibrillation, Reocor must be switched off and then on again so that the device can perform a complete self-test.

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Indications and Contraindications for Use

Additionally, after defibrillation the pacemaker function and pacing threshold must be checked and monitored for a sufficient period of time. Interference resistance • Reocor is protected against interference due to electromagnetic radiation, electrostatic discharge and transferred interference. The radiation emitted by Reocor has also been minimized. However, it is still possible that strong electro-magnetic fields, which can occur (e.g., in the direct vicinity of electric motors, transformers, power lines and other electric devices), may impair the function of Reocor. Electromagnetic interference can lead to the following errors:

-- Unexpected reset (self-test is executed). -- Cardiac events are sensed but do not appear on the ECG monitor. -- Reocor exhibits unexpected behavior. Measures to restore proper function of Reocor:

-- Check the connection between device and temporary pacing leads and adjust, if necessary. -- Correctly adjust the sensitivity of the Reocor: Often, the sensitivity safety margin is half the average intrinsic signal amplitude. -- Turn off all electric devices in the vicinity of Reocor if they can cause electromagnetic interference and their operation is not absolutely necessary. -- Move the interference source to a location where the interference cannot have an affect on the Reocor. -- If safe to do: Switch Reocor off and on again to reset the pacemaker to interference-free operation.

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Indications and Contraindications for Use

-- If the technical failure persists, please contact BIOTRONIK. • For Reocor D: If atrial sensitivity is set to a value <1 mV, interference from electromagnetic fields could result. Thus, if possible sensitivity values higher than 1 mV should be programmed. Programming sensitivity values to <1 mV requires explicit medical necessity. Values like this can only be set and retained with physician supervision. Self-test After the device is switched on, Reocor performs a self-test for a few seconds. This includes: • Check of the program code and the microprocessor • Memory test • Function test of the LEDs and the audible signals • Test of the pacing and sensing capability • Test of the efficacy of high rate protection When the self-test finds a defect, all LEDs flash continuously and audible warning signals sound. In this case, the pacemaker must be turned off and sent to BIOTRONIK. If the self-test did not find any errors, the LEDs and warning signals turn off and Reocor starts to deliver pacing pulses in accordance with the programmed parameters. The negative electrode (cathode) should therefore only be connected when it has been ensured that the pacing mode, pacing rate, pulse amplitude and sensitivity have been programmed correctly. Setting the rotary switch for the operating mode to OFF prevents pacing pulses from being delivered to the patient immediately after connecting the leads.

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Product Description / Protective Cover for Reocor D/S

Product Description

Figure 1: Reocor D

Figure 2: Reocor S

Reocor D/S is a battery-powered external pacemaker used to provide temporary pacing support in a clinical setting. Reocor D, as shown in Figure 1, is a dual-chamber device, providing temporary atrial, ventricular, or A-V sequential pacing. Reocor S, as shown in Figure 2, is a single-chamber device, providing temporary atrial or ventricular pacing.

Protective Cover for Reocor D and Reocor S To release the protective cover (see Figure 3): • Push the release lever up with one hand. • At the same time, use your other hand to slide down the protective cover. To lock the protective cover: • Slide the protective cover upwards along the rail until it locks into place (see Figure 4). The protective cover is locked when the cover has been pushed to the stop, passing two snap-in points and when the lever is resting on the rail (see Figure 3). Make sure that the

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Protective Cover for Reocor D/S

protective cover is locked in place while the device is in use to avoid accidental resetting of the rotary switches and the control dial, as this would affect the program parameters.

Figure 3: Protective cover for Reocor D and Reocor S

Correct Figure 4: Correct positioning of the protective cover

Incorrect

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Safety

Safety

Figure 5: Reocor D safely secured to IV stand.

The following precautions can be taken to ensure device and patient safety: • Have an alternative emergency external pacemaker available if the patient is pacemaker dependent. • Before use, inspect the device visually for dirt or damage. • Never use a device that is damaged or shows abnormal behavior.

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Connecting to Reocor D/S

• Keep the transparent cover closed during use to prevent accidental reprogramming. • Place the device on a horizontal, non-slip surface, on an IV stand using the hanger on the back of the device, as shown in Figure 5, or affixed to the patient with an armband. If an armband is used, Reocor D/S must not be attached directly to the skin. • During use of Reocor, the heart rate of the patient is to be monitored with an ECG monitor with alarm function.

Connecting to Reocor D/S

Figure 6: ADAPT D adaptor for Reocor D

Reocor D/S comes with an ADAPT D or ADAPT S adapter that has a Redel connector, which must be fitted on and screwed in, as seen in Figure 6. When connecting lead adapters to the Reocor, the patient cables should be connected to Reocor D/S first, then the patient leads.

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Connecting to Reocor D/S

Reocor D/S can be used with the following adapters: Redel plug

• ADAP-2R: This adapter has a Redel plug and connects to single-use cables, ADAP 2000 and FL-601-97. Redel plug

• PK-67-L/S: These patient cable adapters differ only in length and have a Redel plug. These cables are used with the PA-1-B adapter.

Redel plug

• PK-175: This patient cable has a Redel plug and four screw terminals for open heart wires.

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Reusable Patient Cables

Reusable Patient Cables Prior to opening, the package of a sterile cable must be inspected for damage to determine whether sterility has been compromised.

Cleaning The reusable patient cables can be cleaned and disinfected with hospital cleaning agents following many different methods. However, aggressive chemicals (such as acetone) may never be used. The use of a wiping cloth with regular, alcohol-free hand soap or the cleaning agent Stabimed by Braun is the recommended cleaning method for the cables. Subsequently, the cables must be cleaned from cleaning agent residue with electrolyte-free water and then wiped with a clean, dry cloth.

Disinfection For disinfection in a disinfectant bath, an aldehyde-based (e.g. Lysoformin 3000) or alcohol-based (e.g. Aerodesin 2000) disinfectant agent must be used in accordance with the manufacturer information and in accordance to the respective hospital guidelines. After disinfection, the cable must be cleaned from residues of the disinfectant by rinsing it in electrolyte-free water.

Sterilization A steam sterilization can be carried out at 121°C and 1.1 bar for 20 min.

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Start-Up

Start-Up Before connecting Reocor D/S to the patient cables, program the device. Refer to “Programming Reocor D/S” on page 21 for further instructions. Selecting the mode will initiate a self test. The self test is an automatic test that lasts a few seconds. During the test, the device checks the program code, memory, LEDs and audible signals, pacing and sensing capability, and efficacy of high rate protection. If the self test detects an error, LEDs will light up and audible signals will sound. Also, if an error is detected, pacing will be disabled. If this occurs, the device must be turned off and returned to BIOTRONIK. If the self test does not detect any errors, Reocor D/S will begin pacing and sensing as programmed. Once the self test is finished, connect the device to adapter cables, and then patient leads. Monitor for proper operation per ECG.