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Zimmer CardioPort Four Instructions For Use Manual

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Instructions for Use
CardioPort Four
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Summary of Contents for Zimmer CardioPort Four

  • Page 1 Instructions for Use CardioPort Four...
  • Page 2 Schematic illustrations View and LED displays Figure 1 Device and USB connection to PC or USB power supply On/Off switch Connection LED Battery LED operating elements Inductive receiver coil according to Qi Connection for ECG patient cable or for standard (rear side) ECG suction systems LED displays Operating statuses...
  • Page 3 Description of symbols Caution, take note of On/Off switch accompanying documents / Follow instructions for use Applied part type CF with Connection LED defibrillation protection USB connection to computer Battery LED Follow instructions for use. Instructions for use In the instructions for use this CE mark according to Caution 0123...
  • Page 4 For cable-based data transmission, CardioPort Four is connected with the computer computer using the USB cable provided. If the computer to which the CardioPort Four is connected via a USB cable is not  a medical PC and does not have any equivalent isolation, a USB isolator with an isolation barrier of at least 1.5 kV must be used between the CardioPort Four...

  • Page 5: Table Of Contents

    Description of symbols Brief start-up instructions Indications / contraindications / side effects Application information Electrode placement Warnings CardioPort Four – in brief Range of services / Intended use Start-up System requirements / PC connection Operation instructions Record ECG / Charge battery...
  • Page 6 Sources of defects / troubleshooting / disposal Manufacturer's EMC declaration Index Valid for CardioPort Four USB and BT. Bluetooth functionality is only available for CardioPort Four BT. These instructions for use are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.

  • Page 7: Indications / Contraindications / Side Effects

    Indications / contraindications / side effects Indications Electrocardiography is one of the most frequently used methods to derive bioelectric Resting ECG signals in diagnostics. By analysing the shape, time and frequency of these signals, statements can be made about cardiac activity and pathological changes to the heart.
  • Page 8 Take note of the indications and contraindications listed in the medical literature as well. CardioPort Four may only be used to conduct and evaluate resting and stress ECGs and for functional diagnostic investigations of the cardiovascular system. The device is not intended for monitoring vital signs.

  • Page 9: Application Information

    CardioPort Four and the mains as well as any connected networks are in place.  If the computer to which the CardioPort Four is connected via a USB cable is not a medical PC and does not have any equivalent isolation, a USB isolator with an isolation barrier of at least 1.5 kV must be used between the CardioPort Four...

  • Page 10: Electrode Placement

    To sense the cardiac action potential from the chest wall, chest suction electrodes, according to Wilson disposable ECG electrodes or an electrode suction system (CardioAir, Zimmer MedizinSysteme) are especially suitable. To record Wilson leads, the electrode connections C1 to C6 should be placed at the...
  • Page 11 Application information Electrode placement Bipolar electrodes The Nehb leads are recorded with the following electrodes: according to Nehb Right sternal base of the second rib (NST) Yellow Site of projection of the cardiac apex on the left axillary line (Nax) Green Over the cardiac apex (Nap) Black...

  • Page 12: Warnings

    Warnings General safety  CardioPort Four may only be operated in accordance with these instructions for information use. Any other use is at the operator's responsibility.  For maintenance measures, expansions, readjustments or modifications, the provisions of the German Medical Devices Act (MPG) and the Medical Device Operator Ordinance apply.
  • Page 13 The use of components (including software) which is not included in the scope of  delivery or not approved by Zimmer MedizinSysteme for CardioPort Four may lead to measurement errors and malfunctions. Only original accessories and original spare parts from Zimmer MedizinSysteme ...

  • Page 14: Cardioport Four - In Brief

    CardioPort Four, together with its ECG signal cables, is equipped with surge protection against defibrillation voltages.  CardioPort Four can be used as a portable device and also as a stationary desktop device.  CardioPort Four enables flexible use – in the medical office, in the hospital, in emergency situations as well as during house calls, because the system can also be operated with a notebook/laptop.

  • Page 15: Start-Up

    The exact hardware and software requirements for the PC can be found in the DiagnostikSuite instructions for use. USB connection to PC CardioPort Four can be connected to the PC via a USB cable. Due to the high data rate during an ECG transmission, the ECG amplifier must be directly connected to the PC.

  • Page 16: Operation Instructions

    Alternatively, an inductive receiver coil (5) and an inductive charging pad which  meets the Qi standard can be used. To do this, place the CardioPort Four in the middle of the charging pad. During inductive charging, it is not possible to record an ECG.

  • Page 17: Technical Information

    Technical information Technical data / Storage and transport Power supply USB: +5VDC, 500 mA Lithium polymer battery, +3.7 V, 1250 mAh, 4.625 Wh Battery charging Corded via USB Inductive via a Qi loading coil Power consumption Max. 500 mA (2.5 W) Dimensions (LxWxH) 115 mm x 90 mm x 33 mm (W x L x H) Weight...

  • Page 18: Cleaning And Disinfection

    CardioPort Four has no special protection against leaking liquids or the  penetration of water or other liquids. If CardioPort Four was immersed in a liquid or a liquid was spilled on it, it should in no case be put back into operation. If liquid penetrated the device, pull out the USB cable and contact Zimmer customer service.

  • Page 19: Ce Mark

    CE mark The device has the CE mark 0123 in accordance with the EC directive 93/42/EEC. Page 13...

  • Page 20: Scope Of Delivery / Accessories / Consumables

    CardioPort Four USB device 51 300 010 ECG patient cable incl. 10 kOhm protective resistors 79 050 530 Cable, USB A/A, 3 m 10 102 594 CardioPort Four instructions for use 10 102 292 CardioPort Four guarantee 10 101 867 Long-term guarantee Accessories Item no.*...

  • Page 21: Device Combinations

    Device combinations CardioPort Four can be used in combination with many commercially available electrode suction systems. An adapter cable HDMI-DSUB is available for this purpose.  A requirement for operation is that each patient cable of the ECG suction system contains a 10 kOhm defibrillation protective resistor.

  • Page 22: Safety And Maintenance

     If liquid should penetrate the device, the device must be immediately replaced and disconnected from the mains and PC. Maintenance CardioPort Four does not contain any parts which must be repaired or maintained by the operator. Page 16...

  • Page 23: Legal Notice

    Legal notice The device is not listed in either in attachment 1 or in attachment 2 of the MPBetreibV (Medical Device Operator Ordinance). In Germany, the German Social Accident Insurance (DGUV) Regulation 3 (Electrical systems and equipment), as amended, must be observed. Note: This information applies to the operation of the unit in Germany.

  • Page 24: Functional Test

    Attach the individual components and install the drivers as well as the DiagnostikSuite PC software.  For wireless ECG recording, switch on the CardioPort Four.  Verification of the ECG signal transmission to the PC can only be tested using the DiagnostikSuite ECG analysis software.

  • Page 25: Sources Of Defects / Troubleshooting / Disposal

    Sources of defects / troubleshooting / disposal Typical sources of The following causes may be responsible for inaccurate measurements or inaccurate error evaluations of measured values and non-evaluable results:  Use of the device outside of the areas of application described in the instructions for use Use of the device despite functional problems ...
  • Page 26 Sources of defects / troubleshooting / disposal The ECG recording is Loose electrodes, insufficient Check the electrode placement distorted electrode contact Muscle tremors Superimposition of irregular "tremors" on the ECG. - Ensure that the patient is as relaxed as possible and is comfortably positioned (especially in the shoulder and neck region).
  • Page 27 +49 731 / 9761 - 115 Fax: +49 731 / 9761 - 4443 You can also receive support via email: support@zimmer.de Visit us online at: http://www.zimmer.de You will help us solve the problem if you have the following information at hand: ...

  • Page 28: Manufacturer's Emc Declaration

    Portable and mobile HF communication devices (such as mobile phones, cell phones) can affect medical electrical devices. CardioPort Four may only be operated with the original USB cable indicated in the list of the scope of delivery and accessories. Operation of the device with a different USB cable can lead to increased emissions or reduced interference immunity of the device! Guidelines and manufacturer's declaration –...
  • Page 29 Guidelines and manufacturer's declaration – Electromagnetic immunity The CardioPort Four device is intended to be operated in the electromagnetic environment as indicated below. The customer or user of the CardioPort Four device should ensure that it is used in such an environment. Immunity tests...
  • Page 30 The CardioPort Four device is intended to be operated in the electromagnetic environment as indicated below. The customer or user of the CardioPort Four device should ensure that it is used in such an environment. Immunity tests IEC 60601- test...
  • Page 31 To assess the electromagnetic environment with regard to the stationary transmitters, an electromagnetic site survey is to be recommended. If the measured field strength in the location in which the CardioPort Four device is used exceeds the above compliance level, the CardioPort Four device must be observed to verify normal operation.

  • Page 32: Index

    Index Installation .............. 6 Interface configuration ..........9 Accessories ............7, 14 Leakage currents ............ 7 Baseline wanders ..........21 Legal notice ............17 Battery capacity ............ 10 Bluetooth ..............9 Brief start-up instructions ........1 Mains supply ............3 Maintenance ............
  • Page 33 CardioPort Four Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 (0) 7 31. 97 61-291 Fax +49 (0) 7 31. 97 61-299 export@zimmer.de www.zimmer.de...

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