St. Jude Medical SJM Confirm DM2100A User Manual
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St. Jude Medical SJM Confirm DM2100A User Manual

St. Jude Medical SJM Confirm DM2100A User Manual

External patient activator
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SJM Confirm™
Model DM2100A
External Patient Activator
User's Manual

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Summary of Contents for St. Jude Medical SJM Confirm DM2100A

  • Page 1 SJM Confirm™ Model DM2100A External Patient Activator User’s Manual...
  • Page 2 Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.
  • Page 3 Important Telephone Numbers Clinician’s office To send data...
  • Page 4 Special Instructions...

  • Page 5: Table Of Contents

    Table of Contents Introduction ..........1 What is the SJM Confirm PA? .
  • Page 6 Caring for the PA ......... . 10 Glossary .

  • Page 7: Introduction

    Your clinician has determined that it is beneficial for you to have a monitoring system to help identify the cause of symptoms you experience. Your monitoring system consists of the St. Jude Medical™ SJM Confirm™ implantable cardiac monitor and the St. Jude Medical SJM Confirm external patient acti- vator.

  • Page 8: What Is The Implant Procedure Like

    What is the implant procedure like? The implant typically involves a simple surgical procedure. The doctor numbs the area with local anaes- thesia, makes a small incision, and places the device just under the skin in the upper chest through the small incision.

  • Page 9: Why Do I Need An Identification Card

    Why do I need an identification card? You will be given an identification card with information about your device and the PA. Put the card in your wallet or carry it with you at all times. Show your card if you are ever in an emergency, are admitted to a hospital, see a new doctor, or need to prove that you have a device.
  • Page 10 • Wireless communication devices. Wireless communication devices such as computers that operate on a wireless network, handheld personal computers (PDA), cellular phones, and even cordless tele- phones may generate enough EMI to interfere with the performance of your device or the PA if you are too close to the source of EMI.

  • Page 11: Important Safeguards

    Important Safeguards Basic safety precautions should always be followed when using electrical products, especially when chil- dren are present. These include the following: • READ ALL INSTRUCTIONS BEFORE USING. • DANGER! To reduce the risk of shock: - Do not use the PA while bathing. - Do not place or store the PA where it can fall or be pulled into a tub or sink.

  • Page 12: Using The Pa

    Using The PA You will use the PA to do a variety of things. Your clinician will tell you when to do the following: • Record Data. Begin data recording in your implanted device. • Read Data. Read the data stored in your device and transfer the data to the PA. •...
  • Page 13 Figure 1. Patient Activator - front and top SJM Confirm™ Patient Activator User’s Manual...
  • Page 14 1 Record button 2 Read button 3 Send button 4 Red lights 5 Yellow lights 6 PA speaker Using The PA...
  • Page 15 Figure 2. Patient Activator - back SJM Confirm™ Patient Activator User’s Manual...

  • Page 16: Battery Status

    Battery Status The PA is designed to record data on command once a week, read data from your implanted device once a month, and send data once a month. Under these conditions you can expect the PA battery to last about 3 years.

  • Page 17: Technical Support

    If you have any trouble using the PA or have any questions regarding its use or maintenance, contact Technical Support. St. Jude Medical maintains 24-hour phone lines for technical questions and product support: • 1 818 362 6822 • 1 800 722 3774 (toll-free within North America) •...

  • Page 18: Symbols

    Symbols The following symbols may be found on the product or product label: Record Data button Read Data button Send Data button Telephone handset symbol Done action Retry action Symbols...
  • Page 19 Do not use in MRI scan room Method of sterilization using ethylene oxide STERILE EO Caution, consult accompanying documents. European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St. Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives.
  • Page 20 Manufactured by Use by Do Not Reuse Batch code Serial number Reorder number Symbols...
  • Page 21 For use within temperature limits For use within humidity limits Authorized EC Representative in the European Community Affixed to this device in accordance with European Council Directive 2002/96/EC. See Disposal on page 23. Type BF equipment Prescription only SJM Confirm™ Patient Activator User’s Manual...
  • Page 22 Interference may occur in the vicinity of this equipment Follow the instructions for use (Symbol is colored blue.) Read the instruction manual Follow instructions for use on this website TUV Listed, US and Canada. Conforms to UL 60601-1. Certified to CAN/CSA-C22.2 No. 601.1-M90. (Symbol is colored blue.) Made in USA Symbols...

  • Page 23: Technical Information

    Technical Information Note • There are no user-serviceable parts in the PA. No calibration is required. Do not modify the PA. • When used under normal operating conditions, this equipment generates no pollution. PA Model Number DM2100A Dimensions (cm) 7.1 x 5.6 x 1.8 Case material High-impact plastic Power source...

  • Page 24: Accessories

    Protection from electric shock (IEC 60601-1) Type BF Protection against ingress of liquids Ordinary equipment Mode of operation Continuous Accessories There are no accessories for the PA. Electromagnetic Compatibility The PA requires special precaution with regard to electromagnetic compatibility (EMC) and should be used in accordance with the information provided in this manual.
  • Page 25 Test Compliance Electromagnetic Environment – Guidance RF Emission CISPR 11 Group 1 The PA must emit electromagnetic energy in order to perform their intended function. Nearby electronic equipment may be affected. RF Emission CISPR 11 Class B The PA is suitable for use in all establishments, including domestic establishments.
  • Page 26 Test IEC 60601 Test Level (Actual Level) Electromagnetic Environment – Guidance Electrostatic Discharge ±6 kV contact (±6 kV contact) (ESD) IEC 61000-4-2 ±8 kV air (±8 kV air) None Power Frequency 3 A/m (3 A/m) (50/60 Hz) Magnetic None Field IEC 61000-4-8 Table 2.
  • Page 27 Test IEC 60601 Test Level Immunity Compliance Level Electromagnetic Environment – Guidance Radiated RF IEC 3 V/m 3 V/m 61000-4-3 80 MHz to 2.5 GHz Portable and mobile RF communications equipment should be used no closer to the PA, including cables, than the recommended separation distance.

  • Page 28: Rf Operating Frequencies

    2. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be con- sidered.

  • Page 29: Storage And Operating Conditions

    Table 4. Storage and operating conditions Disposal Return the PA to St. Jude Medical at the end of its operating life or dispose of the PA according to your local regulations. Contact your local St. Jude Medical representative for information on disposal.
  • Page 30 Technical Information...

  • Page 31: Index

    Index Battery Status 10 Care 10 Cleaning 10 Description, SJM Confirm PA 1 Follow-up Visits 2 Glossary 10 Identification Card 3 SJM Confirm™ Patient Activator User’s Manual...
  • Page 32 Operating Conditions 23 PA, see Patient Activator Patient Activator Description 1 Model Number 16 Precautions 3 Safeguards 5 Speaker 8 Specifications 16 Storage Conditions 23 Surgery Implant Procedure 2 Recovery From 2 Symbols 12 Technical Information 17 Technical Support 11 Index...
  • Page 36 Manufacturer: European Authorized Representative: St. Jude Medical St. Jude Medical Coordination Center BVBA Cardiac Rhythm The Corporate Village Management Division Da Vincilaan 11 Box F1 15900 Valley View Court 1935 Zaventem Sylmar, CA 91342 USA Belgium +1 818 362 6822...

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