Biotronik
Reocor S Technical Manual Rev G April 2012
Technical Manual
284 Pages
Preview
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Deutsch
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Bedienungshinweise
Deutsch
Bedienelemente und LEDs
Bild 1:
Bedienfeld Reocor S
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General Description ...53 Product Description ... 53 Indications ... 54 Contraindications ... 54 Potential Side Effects ... 54 Handling Instructions ... 55 Visual and Acoustic Signals ... 60 Operating Notes ...61 General Remarks ... 61 Operating Devices and LEDs ... 63 Protective Cover ... 64 Lead Connection ... 65 Start Up ... 72 Attachment ... 73 Battery Exchange ... 74 Pacing Modes and Parameters ...76 Pacing Modes ... 76 Rate ... 77 Pulse Amplitude and Pulse Width ... 77 Sensitivity ... 77 Interference interval ... 77 Burst ... 78 Handling, Care and Maintenance ...79 Reocor S ... 79 Reusable Patient Cables ... 80 Maintenance, Service, Inspections ... 81 Disposal ... 82 Technical Safety ...83 Technical Data ...84 Conformity According to IEC 60601-1-2 ...87 Scope of Delivery and Accessories ...92 Legend for the Label ...95
Deutsch English
Contents
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General Description
General Description Product Description Reocor S is a battery-powered, external single-chamber pacemaker for in-clinic use. The pacemaker is connected to temporary pacemaker leads (including myocardial heart wires and transvenous implantable catheters). The connection is made directly or via a separate patient cable and adapter, if necessary. There are three pacing modes available: SSI, S00, SST as well as a burst function. Pacing mode, rate, sensitivity, pulse amplitude and burst rate are adjustable. LEDs display the sense (Sense), pace (Pace) and battery status (Low battery). An acoustic signal sounds when a very high frequency or very low sensitivity value is set and when the lead impedance is not optimal. A defect of the device (failed self-test after the device was switched on) is indicated by continuously lit LEDs and an intermittent acoustic signal. If the self-test does not find any errors, the acoustic and visual signals will turn off after a few seconds. The safety features of Reocor S include: •
Visual display of sensed and paced events
•
Microprocessor-controlled pacing parameters
•
Lead impedance monitoring
•
Visual warning when the battery is almost depleted
•
A movable, transparent cover of the controls to prevent accidental changes of the programmed parameters
Temporary catheters, heart wires, leads with 2-mm plugs can be connected directly to Reocor S. Additional patient cables and adapters are available, too.
English English
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General Description
This system offers a secure connection of transvenous catheters and myocardial leads, which are applied either as unipolar or bipolar.
English
Indications Temporary pacing with Reocor S 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
Contraindications •
Reocor S cannot be sterilized and is therefore not suitable for use within the sterile field.
•
Atrial single-chamber pacing is contraindicated for patients with existing AV conduction disturbances.
•
The use of an external pacemaker is contraindicated in the presence of an active, implanted pacemaker.
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.
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General Description
Complications when inserting transvenous leads include: Wound infection, arterial puncture, pericardial friction, cardiac perforation and dysrhythmia after lead insertion.
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 S 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 S interacts with the human heart. There is also an interaction with the patient's skin and blood vessels.
Intended use
•
Reocor S and the cables and accessories approved along with the device may only be used in accordance with this technical manual.
•
Reocor S must not be connected to other electromedical devices.
•
Reocor S 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.
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.
English English
Handling Instructions
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English
Behavior before use
Lead connection
General Description
•
Keep an external defibrillator, oxygen, intubation equipment and emergency drugs on hand.
•
Before use, Reocor S 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 S, 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 S.
•
Even though Reocor S is protected from dripping water, the device and all plugs should be kept clean and dry.
•
Reocor S cannot be sterilized.
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The connections of Reocor S and the temporary pacing leads must be secured and checked regularly.
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The patient cable must first be connected to Reocor S and then to the leads.
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The temporary leads, to which the Reocor S 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.
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If the cable is disconnected from the Reocor S, 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.
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General Description
•
During use of Reocor S, the protective cover must be completely closed to prevent accidental resetting of the programmed parameters.
•
Secure Reocor S 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.
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Reocor S must not be worn directly on the skin.
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During use of Reocor S, the heart rate of the patient must be monitored with an ECG monitor with alarm function.
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In case of disturbances caused by electromagnetic interference (EMI), Reocor S will switch to operating mode S00 when certain limits are exceeded.
Pacing with high rates
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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 according to page 79.
•
Do not use rechargeable batteries. The service time of these batteries is difficult to estimate, making it possible to inadvertently exceed the ERI1) time, resulting in sudden cessation of pacing.
Behavior during use
Battery operation
1)
Reocor S reminds you to replace the battery with the ERI signal (Low Battery LED flashes).
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General Description
Only 9-volt batteries with the international code IEC 6LR61 must be used. When using the battery type MN 1604 Duracell® Procell®, external pacing is possible for at least 600 hours before the battery must be replaced. English
It is possible to exchange a battery while Reocor S 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 S 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 S should be at least 10 cm. - After a defibrillation, Reocor S must be switched off and then on again so that the device can perform a complete self-test. Additionally, after defibrillation the pacemaker function and pacing threshold must be checked and monitored for a sufficient period of time.
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Interference resistance
General Description
•
Reocor S is protected against interference due to electromagnetic radiation, electrostatic discharge and transferred interference. The radiation emitted by Reocor S has also been minimized. Thus, the device meets the requirements of IEC 606011-2. However, it is still possible that strong electromagnetic 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 S. 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 S exhibits unexpected behavior. Measures to restore proper function of Reocor S: - Check the connection between device and temporary pacing leads and adjust, if necessary. - Correctly adjust the sensitivity of the Reocor S: Often, the sensitivity safety margin is half the average intrinsic signal amplitude. - Turn off all electric devices in the vicinity of Reocor S 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 S. - If safe to do: Switch Reocor S off and on again to reset the pacemaker to interference-free operation. - If the technical failure persists, please contact BIOTRONIK.
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General Description
English
Visual and Acoustic Signals
Warning
•
During the self-test after switching on Reocor S, all LEDs light up and brief acoustic signals can be heard. The self-test is finished after a few seconds.
•
If the self-test does not find any errors, the LEDs and warning signals turn off.
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When the self-test finds a defect, all LEDs flash continuously and warning signals sound.
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A required battery replacement is indicated by the flashing red Low battery LED.
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The Sense (green) LED signals sensing of a P wave or R wave.
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The Pace (yellow) LED signals pulse delivery.
•
The LEDs and acoustic signals also provide the following warnings during operation:
Meaning
Error correction
A pulse amplitude of 1 V or Check whether the set a rate of 180 ppm is pro- values are suitable for grammed. the patient. Impedance outside of the Check whether all conFast sequence of permissible range nectors are securely sounds plugged in. Check whether the leads have the desired position. Turn the device off and Acoustic signal and High rate protection has return it to BIOTRONIK. flashing of the Pace been triggered; and Sense LEDs self-test failed. Low battery LED ERI has been reached. Replace the battery; flashes. and about 36 hoursa) of service time remain. Acoustic signal for two seconds
a) When using the battery type MN 1604 Duracell®, Procell®
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Operating Notes
Operating Notes
Caution!
The connections of Reocor S and the temporary pacing leads must be secured and checked regularly.
Self-test
After the device is switched on, Reocor S performs a self-test for a few seconds. This includes: •
Check of the program code and the microprocessor
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Memory test
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Function test of the LEDs and the acoustic signals
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Test of the pacing and sensing capability
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Test of the efficacy of high rate protection
When the self-test finds a defect, all LEDs flash continuously and acoustic 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 S 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. Warning messages
The following warnings can appear during use: •
A required battery replacement is indicated by the flashing Low battery LED.
•
If the lead impedance is not within a permissible range (e.g. due to a fractured lead or a loose contact), a rapid sequence of sounds can be heard no earlier than 5 seconds after activation.
English English
General Remarks
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Operating Notes
•
If the pulse amplitude is set to values 1 V or the rate to values 180 ppm, an acoustic signal sounds for about two seconds.
•
If the rate is too high (see page 85 “High rate protection”) or if the self-test has not passed, a continuous acoustic signal sounds and the Pace and Sense LEDs flash.
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Operating Notes
English English
Operating Devices and LEDs
Figure 1: Reocor S operating panel
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Operating Notes
Designation
Function
1 Patient connection INDIFF.+; DIFF.-
For cables with 2-mm plug or for Redel adapters (red = plus; blue = minus)
2 Battery compartment
For 9-V block battery
3 Low battery LED
Provides a warning when the battery voltage is too low
4 LED Pace
Yellow display for stimulated event
5 LED Sense
Green display for sensed event
6 Ampl. control dial
Setting the pulse amplitude
7 Sens. control dial
Setting the sensitivity
8 Start burst
Starting the burst function
9 Velcro harness
Secures Reocor S to patient, bed or infusion stand
10 Burst rate control dial Setting the burst rate 11 Select burst
Selection of the burst function
12 Rate control dial
Setting the pacing rate
13 Mode dial
Selection of the pacing mode and off switch
Table 1:
Description of elements in Figure 1
Bold labels of the operating devices indicate safe values for the intended use of the device.
Protective Cover 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 2). Correct:
Figure 2: Correct positioning of the protective cover
False:
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Operating Notes
To release the protective cover (see Figure 3): Push the release lever up with one hand.
English English
At the same time, use your other hand to slide down the protective cover.
Figure 3: Unlocking the protective cover
To lock the protective cover: Slide the protective cover upwards along the rail until it locks into place (see Figure 2). The protective cover can be removed completely for cleaning. Push the cover all the way down to the stop and then remove it. Caution!
During use of Reocor S, the protective cover must be locked to prevent inadvertent resetting of the rotary switch and control dial, and thus of the programmed parameters.
Lead Connection Reocor S has two connector ports for direct connection of leads with touch-proof 2-mm plugs. To connect cables with Redel plugs, the Redel adapter must be fitted on the correct side and screwed in (Figure 4). The Redel adapter is attached to the correct side if it can be screwed on to the Reocor S. Note:
The function of the Redel adapter is only guaranteed if it is attached to the correct side!
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Operating Notes
English
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Figure 4: Redel adapter for Reocor S
Reocor S can be used with the following patient cables and adapters: •
Patient cable PK-83-B with two screw terminals for temporary leads on the patient side and Redel plug on the Reocor S side (use the Redel adapter).
Figure 5: Patient cable PK-83-B
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Operating Notes
Patient cable PK-83 with two insulated screw terminals for temporary leads on the patient side and two touch-proof 2-mm plugs on the Reocor S side.
English English
•
Figure 6: Patient cable PK-83
•
Patient cable PK-82 with two insulated alligator clips for temporary leads on the patient side and two touch-proof 2-mm plugs on the Reocor S side.
Figure 7: Patient cable PK-82
• Patient cable PK-67-L and PK-67-S Patient cable PK-67-L (2.6 m) and PK-67-S (0.8 m) differ only in length. On the Reocor S side you have a Redel plug (use the Redel adapter) and on the patient side a connection for the adapter according to Figure 13 and for the single-use cable according to Figure 9.
Figure 8: Patient cable PK-67-L and PK-67-S
• Cable for single use The single-use cables Remington 301-CG (USA only) and PK-155 with alligator clips are connected to the patient via the cable PK-67-S.
Figure 9: Single-use cables PK-155 and 301-CG (USA only)
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Operating Notes
English
Only for USA: The single-use cables S-101-97 and FL-601-97 by Remington Medical Inc. are connected via the reusable adapter cable ADAP-2R to the Reocor S (Figure 10).
Figure 10: USA only: Remington single-use cable and adapter
Reocor S can also be used with patient cables with 4 connections for dual-chamber pacemakers. Reocor S only uses the ventricular channel of these cables. The following cables are possible: •
Patient cable PK-141 with 4 alligator clips on the patient side and Redel plug on the Reocor S side (use the Redel adapter). The ventricular channel is indicated by the label Vent Diff/Indiff on the protective sleeves.
Figure 11: Patient cable PK-141