Mammendorfer Institut für Physik und Medizin

MRI Patient Monitoring Systems

Tesla M3 User Manual Ver 3.1

User Manual

138 Pages

Instructions for Use Version 3.1 Tesla M3 MRI Patient Monitoring System 0120 Instructions for Use TeslaM3 MRI Patient Monitoring System All rights reserved – MIPM GmbH 2016 (English-Master-Version 3.1) 1

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Page 1

Instructions for Use Version 3.1

Tesla

MRI Patient Monitoring System

0120

MIPM Mammendorfer Institut für Physik und Medizin GmbH, herein after called MIPM. Printed in Germany Subject to change without prior notice. For further information contact MIPM. It is possible that some features or functions described in this user manual are not available on your device. Please contact MIPM or your local partner for further information. All rights reserved to MIPM. MIPM assume no responsibility for damages, which can result from using the monitor. The monitor is intended for use by qualified medical personnel only. Before using the monitor, read all the manuals that are provided with your device carefully. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

NOTE: A note presents information that helps you operate the equipment or connected devices.

CAUTION: A caution provides information or instructions that must be followed to ensure proper operation and performance of the equipment.

WARNING: A warning contains important information regarding possible danger to you or the patient that is present during normal operation of the equipment.

The indicator refers to a possible action that can be performed by the user.

Tesla operating system software from version: 2.00

Chapter Overview 1.

Overview... 9

Preparations for use ... 41

Monitor configuration ... 44

Patient Admission/Release ... 60

Routine Use ... 66

Trend and patient data transfer ... 115

The Service Menu ... 119

Accessories and applied parts ... 120

Cleaning and disinfection ... 122

10.

Trouble shooting ... 124

11.

Technical specification ... 125

12.

Disposal ... 138

13.

Glossary ... 138

List of Contents Overview... 9

1. 1.1.

Intended use... 9

1.2.

General Safety Information ... 10

1.3.

Preliminary remarks for use ... 11

1.4.

Placement in the MRI Room ... 14

1.5.

Magnet Indicator TeslaSpy ... 16

1.6.

Reducing EMI ... 18

1.7.

Electrical Safety ... 19

1.7.1.

Electrostatic discharge (ESD) information ... 19

1.7.2.

ESD precautions to be taken ... 19

1.7.3.

Electromagnetic compatibility and interference GUIDANCE ... 20

1.7.4.

Guidance and manufacturer's declaration - Electromagnetic Emissions Table 1 ... 21

1.7.5.

Guidance and manufacturer's declaration - Electromagnetic Immunity Table 2 ... 22

1.7.6.

Guidance and manufacturer's declaration - Electromagnetic Immunity Table 3 ... 23

1.7.7. Recommended separation distances between portable and mobile RF communication equipment and TeslaM3 Table 4 ... 24 Electrical Safety ... 25

1.7.8. 1.8.

Connecting external devices ... 25

1.9.

Safety, Inspections, Maintenance ... 27

1.10.

Safety during HF surgery and defibrillation ... 28

1.11.

General Description ... 29

1.12.

Front and Back of the device ... 30

1.12.1.

Back of the device ... 30

1.12.2.

Front of the device ... 32

1.13.

Symbol Description ... 33

1.13.1.

Symbols in Graphical User Interface (GUI) ... 33

1.13.2.

Symbols on the Device ... 36

1.14.

The display ... 38

1.14.1.

The menu bar ... 38

1.14.2.

Main screen ... 38

1.14.3.

Status bar... 38

1.15.

Alarms ... 39

1.15.1.

Technical Alarm... 39

1.15.2.

Parameter Alarm ... 39

1.16.

Touch screen and rotary knob ... 39

1.17.

Documentation TeslaM3 ... 40

Preparations for use ... 41

2. 2.1.

General remarks ... 41

2.2.

Initial Inspection ... 41

2.3.

Default settings ... 42

2.4.

Assembly and positioning of the TeslaM3 ... 43

Monitor configuration ... 44

3. 3.1.

Initial setup ... 44

3.2.

Battery power and Main power ... 44

3.2.1.

Main unit ... 44

3.2.2.

Wireless sensors ... 45

3.2.3.

Remote Screen ... 45

3.3.

Switching on the monitor ... 45

3.4.

Choosing the patient mode ... 46

3.4.1.

Free patient mode ... 46 Main screen configuration ... 46

3.5. 3.5.1.

Available parameters ... 47

3.5.2.

System configuration – The Options Menu ... 47

3.5.3.

Language ... 48

3.5.4.

Date and Time ... 49

3.5.5.

Alarm function ... 50

3.5.6.

Perfusion Index (PI) ... 51

3.5.7.

Parameter settings ... 52

3.5.8.

Service Menu ... 55

3.6.

Monitor volume and Standby mode ... 56

3.7.

Connecting Patient Sensors to the TeslaM3 ... 56

3.7.1.

The ECG sensor ... 57

3.7.2.

The SpO2 sensor ... 57

3.7.3.

NIBP tubes and cuffs ... 58

3.7.4.

IBP interface cable ... 58

3.7.5.

Gas sample lines and water traps ... 59

3.7.6.

The temperature sensor ... 59

Patient Admission/Release ... 60

4. 4.1.

Patient Mode ... 60

4.1.1.

Adult mode ... 61

4.1.2.

Pediatric mode ... 61

4.1.3.

Neonatal mode ... 61

4.1.4.

Free patient mode ... 61

Patient admission ... 62

4.2. 4.2.1.

Enter patient data ... 63

4.2.2.

Utilization of patient data ... 64

4.3.

Patient release ... 64

4.4.

Connecting TeslaM3 to a hospital network (PDMS) ... 65

Routine Use ... 66

5. 5.1.

Switching on/off the monitor ... 66

5.2.

Switching on/off the Remote Monitor ... 67

5.3.

Handling the wireless sensors ... 68

5.3.1.

The ECG sensor ... 69

5.3.2.

The SpO2 sensor ... 70

5.4.

The main screen ... 71

5.5.

Alarms ... 73

5.5.1.

Battery alarms ... 73

5.5.2.

System Alarms ... 74

5.5.3.

Parameter Alarms ... 75

5.5.4.

Alarm priorities ... 79

5.5.5.

Activate and deactivate the alarm function ... 79

5.5.6.

Activate and deactivate single parameter alarms ... 80

5.5.7.

Alarm silence and the adjust alarm function ... 81

5.6.

ECG and heart rate ... 83

5.6.1.

Remarks ECG during MRI examination ... 84

5.6.2.

ECG electrodes and skin preparation ... 85

5.6.3.

The ECG menu ... 86

5.6.4.

Setting the alarm limits ... 87

5.6.5.

Choosing the ECG lead ... 87

5.6.6.

Changing the ECG amplitude ... 88

5.6.7.

ECG Cascade mode ... 88

5.6.8.

Choosing the pulse tone source ... 89

5.6.9.

Cardiac Gating function ... 89

5.7.

SpO2 Monitoring ... 90

5.7.1.

Remarks SpO2 monitoring during MRI examination ... 91

5.7.2.

Soft touch finger adapter – Placing the SpO2 sensor ... 92

5.7.3.

The SpO2 menu ... 94

5.7.4.

Setting the alarm limits ... 94

5.7.5.

Changing the SpO2 scaling ... 94

5.7.6.

Choosing the pulse tone source ... 95

5.7.7.

The SpO2 gating function ... 95

Perfusion index and signal inadequacy indicator ... 96

5.7.8.

Noninvasive blood pressure (NIBP) ... 97

5.8. 5.8.1.

Remarks NIBP during MRI examination ... 99

5.8.2.

The NIBP menu ... 99

5.8.3.

Setting the alarm limits ... 99

5.8.4.

Setting the NIBP measurement interval ... 100

5.8.5.

Automatic / Manual measurements ... 100

5.8.6.

Operating steps ... 101 Invasive blood pressure (IBP)... 101

5.9. 5.9.1.

Remarks IBP during MRI examination ... 101

5.9.2.

Use of IBP transducers ... 102

5.9.3.

Connecting the IBP with the TeslaM3 ... 103

5.9.4.

The IBP menu ... 103

5.9.5.

Zeroing and calibration check ... 103

5.9.6.

Setting the alarm limits ... 104

5.9.7.

Changing the IBP scaling ... 104

5.10.

Capnography ... 105

5.10.1.

Adapting the sample rate ... 106

5.10.2.

Installing / removing the water trap ... 106

5.10.3.

Connecting the sample gas line ... 106

5.10.4.

The capnography menu ... 106

5.10.5.

Setting the alarm limits ... 107

5.10.6.

Changing the CO2 scaling ... 107

5.10.7.

Setting the O2 Concentration ... 107

5.10.8.

Setting the N2O Concentration ... 108

5.11.

Multigas Module ... 109

5.11.1.

Warm Up ... 110

5.11.2.

Installing/removing the water trap... 110

5.11.3.

Connecting the sample gas lines ... 111

5.11.4.

The Multigas menu... 111

5.11.5.

Setting the alarm limits ... 112

5.11.6.

Manual or automatic choice of the anesthetic agent ... 113

5.12.

Temperature measurement ... 113

5.12.1.

Remarks Temperature Measurement during MRI examination: ... 114

5.12.2.

The Temperature menu ... 114

5.12.3.

Setting the alarm limits ... 114

Trend and patient data transfer ... 115

6. 6.1.

The Trend menu ... 115

6.2.

Graphical trends ... 116

6.3.

Trend table ... 116

6.4.

Event memory ... 117

6.5.

Printing trend data ... 117

6.6.

Data transfer to a USB storage device ... 118

6.7.

Deleting the trend memory ... 118

The Service Menu ... 119

Accessories and applied parts ... 120 8.1.

ECG Accessories ... 120

8.2.

SpO2 Accessories ... 120

8.3.

NIBP Accessories ... 120

8.4.

IBP Accessories ... 120

8.5.

Capnography Accessories ... 121

8.6.

Multigas Module Accessories ... 121

8.7.

Temperature Accessories ... 121

8.8.

TeslaM3 Accessories ... 121

Cleaning and disinfection ... 122

9. 9.1.

Main unit and remote screen ... 122

9.2.

Patient connection cables and wireless sensors ... 122

9.3.

NIBP cuffs... 122

9.4.

Reusable pressure measurement accessories ... 123

9.5.

Multigas Module / Capnography module ... 123

10.

Trouble shooting ... 124

11.

Technical specification ... 125

12.

Disposal ... 138

13.

Glossary ... 138

1. Overview 1.1. Intended use M3

The MRI Patient Monitoring System Tesla is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. M3

The Tesla is capable for continuous monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO2), Oxygen and Anesthetic Agents.

The Tesla

is intended for use by health care professionals.

Prescription: In the USA, federal law restricts this device to sale by or on the order of a physician.

Contraindication: The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive or flammable environment.

1.2. General Safety Information Read all operating instructions carefully before using the monitor. Specific warnings and Cautions are found throughout the User Manual where they apply. The Tesla M3 must only be used by qualified and trained medical staff. In order to be trained, please contact MIPM or an authorized representative.

The Tesla

is intended for use in the same room as magnetic resonance equipment (MRI).

Use only batteries that are approved by MIPM (contact your local representative). The use of non-approved batteries may damage the device.

NOTE: Lithium batteries have to be disposed according to the local regulations. In order to prevent the danger of explosion or fire batteries should never be burned! MIPM is only responsible for the safety of this device if: a) maintenance, repairs, and modifications are carried out by authorized personnel, b) if components are replaced with MIPM approved spare parts only and c) the devices are used in accordance with MIPM Operating Instructions. A full technical description is available upon request from your local MIPM representative. M3

The transport position for the Tesla

should be with the monitor ahead.

1.3. Preliminary remarks for use

DANGER OF ELECTRIC SHOCK  Do not immerse the patient monitor in liquid. This may lead to electrocution.  Do not open the patient monitor.  Maintenance and repair of this unit must be performed by qualified and authorized personnel only. Repairs should not be made by persons not having knowledge and experience in the repair and security of this patient monitor.  The product only fulfils the requirement written in the Documentation only if the installation, handling as well as all maintenance, repair and service works are in accordance with the instructions in this manual.  MIPM recommends to perform a function test and electrical safety test every 12 month. A technical control including calibration should be performed at least every 24 month. Please refer to your national regulatory requirements.  A functional check should always be performed before using the monitor.  A damaged device may not be used! Missing parts or parts that are: broken, worn out or contaminated have to be replaced. If a repair of the monitor is necessary please contact your technical service, your local dealer or MIPM directly.  This device, its components or accessories may only be repaired or changed after MIPMs written approval.  The user is solely responsible for malfunctions that arise due to faulty handling or maintenance as well as inadequate repair works or changes to the device performed by unauthorized personnel.  The user shall not touch the monitor (accessible contacts of connectors, contacts of fuse holders) and the patient simultaneously. Caution: 

  

 

To ensure patient safety, interference free performance of the Tesla as well as interference free MR images do only use original MIPM accessories that have been especially developed for the use in the MRI environment. Other cables and accessories may negatively affect also EMC performance. Do not place the devices in direct vicinity to the magnetic centre of the scanner. M3 The Tesla has to be positioned outside the magnetic field strength of 20 mT (200G) The fiber optic part of the SpO2 Sensor consists of synthetic material and glass fibres. There is no danger of heating or attraction to the MRI scanner. Metal pigments in the colours used in the sensors may change the magnetic field homogeneity in the examination area. Place the sensor outside of the examination area Do not open the sensors! Opening the sensors without proper training and qualification destroys the RF shielding. Reusable accessories with patient contact may be cleaned with regular disinfection lotion or spray and dried with a soft tissue.

Safety information, Warnings and general remarks 



           

WARNING! DANGER OF EXPLOSION! Do not operate the monitor in presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide. Do not use the monitor near devices with microwave or other high frequency emissions that may interfere with the monitors operation. Excluded is the use in MRI-environment. Check parameter alarm limits before using the monitor M3 The Tesla is intended only as an adjunct in patient assessment. It must be used in conjunction with assessment of clinical signs and symptoms. M3 The use of the Tesla is restricted to one patient at a time. If an alarm condition (other than the exceptions listed herein) occurs while the audible alarm mute function is engaged, only the visual alarm indications are displayed. Do not silence an audible alarm, engage the audible alarm mute function, or decrease the audible alarm volume if patient safety could be compromised. Blocking the speaker may result in an inaudible alarm tone. M3 Do not place the Tesla in any position that might cause it, or any device connected to it, to fall on the patient or operator. Do not lift or carry the M3 Tesla by the power supply cable. Do only use MIPM accessories. Connect only items that have been specified in this manual as part of the Tesla M3 system or specified as being compatible with the Tesla M3 system. All parts of the Equipment are not serviced or maintained while in use with the patient. Do not touch simultaneously the monitor, monitor parts and a patient. Do not position the equipment to make it difficult to operate the disconnection device from supply mains via unplugging the appliance coupler or mains plug. In general for all parameters: The drop below the minimum amplitude or minimum value of patient physiological signal leads to inaccurate measurements. The measurement ranges derived from that are shown in Section 11, Technical Specification.

U.S. Federal and Canadian laws restrict this device to sale by or on the order of a licensed medical practitioner (Rx only)!

   

Do not place the Tesla on electrical equipment that may disturb the Tesla from working properly. M3 Do not expose the Tesla to extreme moisture, such as direct exposure to M3 rain. Extreme moisture can cause the Tesla to fail or perform inaccurately. M3 Do not place containers holding liquids on or near the Tesla . Liquids spilled M3 on the Tesla may cause it to perform inaccurately. M3 In the event the Tesla is damaged and cannot be repaired, dispose of the M3 Tesla through an approved hazardous materials disposal facility in accordance with local regulations, or return it to MIPM or an authorized distributor. The internal battery contains Lithium, which is hazardous waste. M3

The Tesla may be operated during defibrillation but the parameter values may be biased for a short period. Instructions for Use TeslaM3 MRI Patient Monitoring System All rights reserved – MIPM GmbH 2016 (English-Master-Version 3.1)

Tesla

Power sources

The monitor can be operated with battery power or connected to line power inside the MRI room. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 

 



Connect the Tesla monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly installed three-wire receptacle. If a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. Do not under any circumstances remove the grounding conductor from the power plug. Do not use extension cords, adapters or multiple socket-outlets of any type. Otherwise the safety and function of the device can be disrupted. The power cord and plug must be intact and undamaged. If there is any doubt about the integrity of the protective earth conductor arrangement, M3 operate the Tesla on internal battery power until the AC power supply protective conductor is fully functional.

For questions please contact your local distributor or the manufacturer:

MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH Oskar-von-Miller Straße 6 82291 Mammendorf GERMANY Phone: +49 (8145) 9209-0 Fax: +49 (8145) 9209-33 www.mipm.com [email protected]

1.4. Placement in the MRI Room

MR Conditional

The device may be operated at a maximum magnetic field strength of 20mT / 200G. Depending on the different scanners this means a distance of approximately 1.5m / 5ft to the opening of the bore (based on actively shielded 3T scanner). Spy For exact positioning of the monitor please use the integrated Magnet Indicator Tesla .

Do not place the Tesla

any closer than 1m / 4ft to the MRI scanner.

Observe the Signals of the Tesla

Spy

(see next chapter).

Fix the position of the Monitor due to locking the brakes of castors.

Symbol

Description MR conditional (The device do not cause any hazard in a specified MR Environment) Magnetic Field: maximum 20 mT / 200 Gauss Distance to MR Scanner: minimum 1.5m Caution! Observe the Magnet Indicator. Obligation for the user to consult the Instructions for use for important warnings and precautions

Lock the brakes of the four castors

1.5. Magnet Indicator TeslaSpy Spy

The Magnet Indicator Tesla must be switched on during each application of the Spy monitor. The activation status can be detected due to indicator of Tesla (see Spy Spy Spy Indicator of Tesla below). If you have to switch on the Tesla , use the Tesla switch at the bottom of the display enclosure (picture below).

Spy

The Tesla is an integrated self-sustaining system for continuously measuring the magnetic field M3 density. The magnetic field detection also works if the Tesla is turned off. Any violation of preset alarm limits will be recorded and can be sorted out by qualified personnel. Spy M3 The Tesla is a tool to position the Tesla inside the MRI room as close to the scanner as possible while ensuring safety for patients, personnel and the monitor itself. Spy The Tesla is battery powered and backed up by a separate power supply. Tesla

Spy

is equipped with an alarm system for:  Violation of the magnetic field strength limit  System malfunction  Critical battery level Spy

The indicator of the Tesla can be found in the upper right corner of the display. The status is indicated with 3 colors.

Spy

How to use Tesla : M3 Slowly move the Tesla towards the MRI scanner. As long as you are in the secure magnetic field M3 area the LED flashes green. When reaching the limit for the operation of the Tesla the LED flashes Yellow and an alarm sound appears. Spy Do not go any closer to the magnet from this point! Pull back the monitor until the LED of the Tesla flashes green again.

If the critical limit for the operation of the Tesla is exceeded a red LED is flashing and a continuous M3 alarm sound appears. Remove the Tesla from that position immediately and make sure to place the monitor in a safe position (LED flashes green). Once you have placed the monitor use the breaks to fix the unit. M3 MIPM recommends marking the position for the Tesla with a line, or a square on the floor.

Signal Nr. 1

Color TeslaSpy

Positioning

Priority

Display

Instruction

Green

Normal operation; Magnetic field < 20 mT

Low

LED flashes each 2 seconds.

The monitor is located outside the critical magnetic field area. (20 mT / 200G) Safe operation is ensured.

Medium

Yellow LED flashes each 1.5 second and speaker sounds an audible signal.

You have reached the limit of the critical magnetic field strength. Remove the TeslaM3 from the MRI scanner until the green LED flashes again.

High

LED flashes each 500 ms and speaker sounds an audible signal. (Event is stored in the internal memory)

The TeslaM3 is located inside the critical magnetic field strength. Safe and reliable operation of the monitor cannot be guaranteed. Remove the monitor from the MRI scanner. The red alarm has been saved in the memory of the TeslaSpy. Please contact technical service or MIPM. Before using the monitor again a functional test should be conducted.

High

LED flashes each 500 ms and speaker sound an audible signal.

Function has to be checked by technical service.

Yellow

Red

Caution! Magnetic field 20 – 40 mT

Warning! Magnetic field > 40 mT

System Error (e.g. Watchdog failure / Measurement failure / Power supply error)

1.6. Reducing EMI

To reduce possible problems caused by electromagnetic interference, we recommend the following:  Use only MIPM-approved accessories (See Section 8). Use of other accessories may result in increased emissions or decreased immunity of M3 the Tesla . 

 

  

Ensure that other products used in areas where patient monitoring and/or life-support are used comply with legal emissions standards. If the products are used inside the MRI room, make sure that the products are labeled MRI conditional or MRI Safe. M3 Try to maximize the distance between Tesla and other Wifi electro medical devices. Strictly limit exposure and access to portable radio-frequency sources (e.g., cellular phones and radio transmitters). Be aware that portable phones may periodically transmit even when in standby mode. Maintain good cable management. Do not route cables over electrical equipment. Do not intertwine cables. Ensure all electrical maintenance is performed by qualified personnel. The medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information. M3 RF communications equipment can affect the Tesla . The data is transmitted via WLAN between master and remote monitor. The channel 2 (2417 MHz; 100 mW) is set. The data is transmitted via MiWi between master monitor and both sensors (wireless ECG Sensor and wireless Pulse Oximetry Sensor). There are sixteen channel frequencies in the 2.4 GHz band:

The transmitter is a direct conversion architecture with a 0 dBm maximum output (typical) and 36 dB power control range.

1.7. Electrical Safety 1.7.1. Electrostatic discharge (ESD) information Warning:  Electronic components and semiconductors can be destroyed by electrostatic discharge (ESD). In particular, MOS components can be damaged from direct or indirect discharges. Damage caused by ESD is sometimes not immediately identifiable and malfunctions can even occur after a longer period of operation.  Exceeding and / or repeating the test level attained in guidance & manufacturer's declaration on EMC may permanently damage the device and / or cause serious malfunctions as loss of communication and system reboot. Caution:  

  

Connector panel symbol All panel connector and communication ports are sensitive to electrostatic discharges; it is necessary to take precautions before touching connectors (pins or shield), connecting or disconnecting the associated cables. Touching communication ports without taking ESD precautions may result in potential fatal error and ESD protection failure. Points (e.g. screws) and surfaces that are only accessible for maintenance also require precautions. Points (e.g. battery contacts for battery replacement) and surfaces that are accessible only by intervention service users also require precautions.

1.7.2. ESD precautions to be taken The following instructions related to electrostatic sensitive components (ESD standards) must be observed: floor coatings made from wood, tiles and concrete, with relative humidity at least 40%. If it is not possible to guarantee this environment, additional precautions must be taken, such as: use of anti-static equipment, preliminary user discharge and wearing of anti-static clothes. The best precaution is the preliminary user discharge on a metal ground such as a metal rail, metal M3 pole or metal part located at the rear of Tesla . M3 For maintenance operation performed on Tesla , the device must be placed on a conductive working surface and the operator must wear a special ESD conductive wristband.

1.7.3. Electromagnetic compatibility and interference GUIDANCE

Electromagnetic Compatibility M3

The MRI (MRI conditional) Patient Monitor Tesla fulfills the following standards referring to creation and inhibition of electromagnetic interferences: EN55011 and IEC60601-1-2. M3

Tesla has been tested in accordance with the electromagnetic compatibility standards applicable to medical devices. Its immunity is designed to ensure correct operation. Limitation of the emitted radiation avoids undesirable interference with other equipment. M3 Tesla is classified as a Class B device according to CISPR 11 emitted radiation and should not be used outside the hospital environment. If used outside the hospital environment, this equipment might not offer adequate protection to radio-frequency communication services. The user might be required to take mitigation measures, such as relocating or re-orienting the equipment. Use of accessories and cables other than those recommended by MIPM, could result in increased M3 emissions and / or decreased immunity of the Tesla system. M3

If Tesla is placed near devices such as HF surgical equipment, X-ray equipment, cell phones, DECT phones or wireless access points, portable RFID reader, large scale RFID reader and RFID Tags, it is M3 essential to observe a minimum distance between the Tesla and this equipment (refer to 'Table 4 Recommended separation distances between portable and mobile RF communication equipment and M3 Tesla ). M3 If Tesla causes harmful interference or if it is itself disrupted, the user is encouraged to try to correct the interference by one of the following actions:          



Reorient or relocate the Tesla or patient or disruptive equipment. Change the routing of cables. Separate power cables from the communication cables / signals. M3 Connect Tesla mains plug on protected / backed-up / filtered supply or directly on UPS circuit (uninterruptible power supply). Be careful with ground / earth loops formed by communication cables and / or power circuits: use class II powered systems or insulated bridges to break loops. M3 Maintain earth potential at the same level between Tesla circuit and the circuit of the remote equipment. M3 Increase the separation between the Tesla and patient or disruptive equipment. M3 Connect the Tesla into an outlet on a circuit different from that to which the patient or disruptive equipment is connected. In any case, whatever the context, the user should conduct interoperability testing in a real situation to find the right setup and good location. M3 The Tesla shall not be used adjacent to or stacked directly with other devices. If an M3 operation of the Tesla stacked directly with or used adjacent to other devices is M3 required, the Tesla should be observed to verify its proper operation used in this arrangement. M3 The Tesla may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

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