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St. Jude Medical SJM Confirm DM2100A, User Manual

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20

Technical Information

Test

IEC 60601 Test Level (Actual Level)

1

1. Figures in parentheses are the immunity compliance levels for each test.

Electromagnetic Environment – Guidance

Electrostatic Discharge 
(ESD)
IEC 61000-4-2

±6 kV contact (±6 kV contact)

±8 kV air (±8 kV air)

None

Power Frequency
(50/60 Hz) Magnetic 
Field
IEC 61000-4-8

3 A/m (3 A/m)

None

Table 2.  Guidance and manufacturer’s declaration – electromagnetic immunity 

Summary of Contents for SJM Confirm DM2100A

Page 1: ...SJM Confirm Model DM2100A External Patient Activator User s Manual ...

Page 2: ...ark 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 Pat http patents sjm com 2017 St Jude Medical LLC All Rights Reserved ...

Page 3: ...Important Telephone Numbers Clinician s office To send data ...

Page 4: ...Special Instructions ...

Page 5: ... 1 What is the implant procedure like 2 What is recovery like 2 What is a follow up visit like 2 What do I do after I record my heart s electrical activity with the PA 2 Why do I need an identification card 3 When can I begin using the PA 3 What special precautions do I need to follow 3 Important Safeguards 5 Using The PA 6 Battery Status 10 ...

Page 6: ...r the PA 10 Glossary 10 Technical Support 11 Symbols 12 Technical Information 17 Accessories 18 Electromagnetic Compatibility 18 RF Operating Frequencies 22 Storage and Operating Conditions 23 Disposal 23 FCC Information 23 Index 25 ...

Page 7: ...l handheld device similar to a handheld computer The PA uses radio waves to com municate with your implanted device The PA initiates recording of the heart s electrical activity by your implanted device reads stored data from your implanted device and sends stored data to a clinician How does my monitoring system work Your monitoring systems works in two ways Automatically Your clinician will set ...

Page 8: ...hing What is a follow up visit like You will go to your clinician s office or clinic for follow up visits During a follow up visit your clinician uses a programmer a specialized computer to review information stored in your device Your clinician can also use the programmer without surgery to change how your device is set up Your clinician uses the information from your device to help identify the ...

Page 9: ... and have no moving parts However you should avoid devices which generate a strong electric or magnetic interference EMI EMI could cause inappropriate data stor age or prevent data storage Moving away from the source of EMI or turning it off will usually allow the device or the PA to return to its normal mode of operation You should always use caution with the following Medical procedures Although...

Page 10: ...ines with poorly shielded ignition systems Metal detectors and security systems Metal detectors found in airports and government build ings and electronic article surveillance anti theft EAS systems such as those at the point of sale and entrances exits of stores libraries banks etc emit signals that may interfere with the performance of your device or the PA To minimize the possibility of interfe...

Page 11: ... risk of burns shock fire or injury to persons Supervision is necessary when the PA is used by on or near children Use the PA only for its intended use as described in this manual Never operate the PA if it is not working properly if it has been dropped or damaged or if it has been dropped into water or other liquid Contact Technical Support page 11 for service or replacement instructions Never dr...

Page 12: ... Begin data recording in your implanted device Read Data Read the data stored in your device and transfer the data to the PA Send Data Send the data stored in the PA using your telephone line Clear Data Remove all stored data from the PA Note You can record important telephone numbers and special instructions at the beginning of this book ...

Page 13: ...SJM Confirm Patient Activator User s Manual 7 Figure 1 Patient Activator front and top 1 4 5 3 2 4 5 ...

Page 14: ...8 Using The PA 1 Record button 2 Read button 3 Send button 4 Red lights 5 Yellow lights 6 PA speaker ...

Page 15: ...SJM Confirm Patient Activator User s Manual 9 Figure 2 Patient Activator back ...

Page 16: ... clean the outside of the PA with a cloth dampened with water The PA is classified as IPX0 because it is not waterproof Do not immerse the PA in any liquid There is no shut down procedure for the PA The battery is not intended to be removed while in use The PA does not contain any user serviceable parts Do not open the case Preventive maintenance including periodic safety checks is not required fo...

Page 17: ...eld equipment that you use to record read and send data from your device 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 46 8 474 4147 Sweden ...

Page 18: ...12 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 ...

Page 19: ...irective 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 The full text of the European Union RE directive 2014 53 EU declaration of conformity is available at the following internet address www sjmglobal com euconformity This product operates between 9 and 200 kHz with an H field strengt...

Page 20: ...14 Symbols Manufactured by Use by Do Not Reuse Batch code Serial number Reorder number ...

Page 21: ...se 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 ...

Page 22: ...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 ...

Page 23: ...n 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 1 cell 3 6 V nominal Chemistry Lithium Thionyl Chloride Battery longevity 3 years Audible output level 60 dB minimum at 10 0 cm Classification with respect to electric shock Internally powered ...

Page 24: ...in Tables 1 2 and 3 The user should ensure that it is used in such an environment Protection from electric shock IEC 60601 1 Type BF Protection against ingress of liquids Ordinary equipment Mode of operation Continuous WARNING The PA is intended for in home use It complies with the limits for medical devices contained in IEC EN 60601 1 2 However the PA may cause radio interference or may disrupt t...

Page 25: ... 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 Table 1 Guidance and manufacturer s declaration electromagnetic emissions ...

Page 26: ...ty compliance levels for each test Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 6 kV contact 8 kV air 8 kV air None Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 3 A m 3 A m None Table 2 Guidance and manufacturer s declaration electromagnetic immunity ...

Page 27: ...n distance Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the PA in watts W according to the PA manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey2 should be less than the compliance level in each frequency range Interfere...

Page 28: ...ths 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 If the measured field strength of the location in which the...

Page 29: ...osal FCC Information This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a residential installation Property Storage Operating Minimum Temperature C F 20 4 0 32 Maximum Temperature C F 55 131 50 122 Minimum Humidity non condensi...

Page 30: ...24 Technical Information ...

Page 31: ...SJM Confirm Patient Activator User s Manual 25 Index B Battery Status 10 C Care 10 Cleaning 10 D Description SJM Confirm PA 1 F Follow up Visits 2 G Glossary 10 I Identification Card 3 ...

Page 32: ...atient Activator Patient Activator Description 1 Model Number 16 Precautions 3 S Safeguards 5 Speaker 8 Specifications 16 Storage Conditions 23 Surgery Implant Procedure 2 Recovery From 2 Symbols 12 T Technical Information 17 Technical Support 11 ...

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Page 36: ...Manufacturer St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 sjm com Manufacturing Site St Jude Medical Puerto Rico LLC Lot A Interior 2 Rd Km 67 5 Santana Industrial Park Arecibo PR 00612 USA Manufacturing Site St Jude Medical Operations M Sdn Bhd Plot 102 Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone 11900 Penang Malaysia ...

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