MAGSTIM

Neurosign 100 Operating Manual Rev 03 March 2013

Operating Manual

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Neurosign 100 Operating Manual NOP01-EN Revision 03

May 2013

Neurosign 100 Operating Manual

TABLE OF CONTENTS Table of Contents ... i Guarantee ... ii Section 1 Introduction ... 1 1.1 Indications for Use ... 1 1.2 Contraindications ... 1 1.3 Devices Covered ... 1 Section 2 Warnings and Precautions ... 2 Section 3 Product Descriptions... 4 3.1 Device Description ... 4 3.2 Front Panel ... 4 3.3 Rear Panel ... 6 3.4 Pre-amplifier Pod ... 7 3.5 Stimulator Pod ... 7 3.6 Mute Sensor... 8 3.7 Accessories ... 8 Section 4 Operating Instructions ... 9 4.1 Preparation ... 9 4.2 Connection... 9 4.3 Operation ... 10 4.4 Interpreting Neurosign 100 Sounds ... 11 4.5 Troubleshooting... 12 Section 5 Maintenance ... 13 5.1 User Maintenance and Calibration ... 13 5.2 Voltage Selection and Fuse Rating ... 13 5.3 Cleaning and Disinfecting ... 13 5.4 Servicing ... 14 5.5 Device Lifetime ... 14 5.6 Disposal ... 14 Section 6 Specifications ... 15 6.1 Safety Specifications... 15 6.2 Technical Specifications ... 16 6.3 Environmental Conditions ... 17 6.4 Packing Instructions... 17 Section 7 Contact Details ... 18 7.1 Product Enquiries ... 18 7.2 Servicing Enquiries ... 18 7.3 Sales Enquiries ... 18 APPENDIX A – STIMULATION CURRENTS ... 19 APPENDIX B – ELECTRODE PLACEMENT DIAGRAM ... 20 APPENDIX C – MANUFACTURER’S EMC DECLARATIONS ... 22

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Neurosign 100 Operating Manual

GUARANTEE Equipment manufactured by The Magstim Company Limited is fully guaranteed, covering both materials and workmanship, for a period of one year from the date of shipment. The Magstim Company Limited reserves the right to perform guarantee services in its factory, at an authorised repair station, or at the customer’s installation. Single use needle electrodes and stimulating probes are guaranteed to be free of defect upon use. Sterilisation is guaranteed subject to the packaging being undamaged and the product being within the serviceable life as stated by the sterilisation date shown on the label. Any obligations which The Magstim Company Limited has under this guarantee are limited to repairs or, should the company so choose, replacement of any defective parts of the equipment, except batteries, without charge provided that the said defects occur during normal service. Claims for damages during shipment must be filed promptly with the transportation company. All correspondence concerning the equipment must specify the model name and/or number as well as the serial number exactly as they appear on the invoice for the equipment. Improper use, mishandling, tampering with, or operation of the equipment without following specific operating instructions will void this guarantee and release The Magstim Company Limited from any further guarantee obligations. The Magstim Company Limited will only accept responsibility for effects on safety, reliability and performance of the equipment if: •

modifications or repairs are carried out by persons authorised by The Magstim Company Limited;

•

the electrical installation of the relevant room complies with local regulations; and

•

the equipment is used in accordance with the instructions for use.

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Neurosign 100 Operating Manual

SECTION 1 INTRODUCTION 1.1

Indications for Use The Neurosign 100 Nerve Monitor has been designed to meet the needs of operating theatre staff by stimulating and continuously monitoring cranial and peripheral motor neural pathways which are at risk during surgically invasive procedures. The Neurosign 100 detects EMG within muscle and amplifies this to make an audible signal which is heard by the surgeon. Disturbance of the nerve being monitored is heard instantly. In addition, a stimulator provides an electrical impulse which directly stimulates neural tissue and elicits an audible response. A number of outputs are available on the rear of the Neurosign 100 Unit enabling connection to other equipment for analysis either during or post surgery. The Neurosign 100 and its accessories (pre-amplifier, stimulating pod and mute sensor) are intended to be used in a operating theatre by medically qualified personnel during surgical procedures. The Neurosign 100 and its accessories are transportable, non-sterile reusable devices intended for multi-patient use. They are not intended to come in contact with body tissue. To achieve its intended use the Neurosign 100 is to be used with a range of electrodes and probes which are supplied sterile.

1.2

Contraindications The Neurosign 100 is contraindicated for use with paralyzing anaesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

1.3

Devices Covered This document is applicable to the following devices. •

Neurosign 100 Nerve Monitor (P/N: 9883-01)

•

Neurosign 100 Pre-amplifier Pod (P/N: 1719-00)

•

Neurosign Stimulator Probe Pod (P/N: 9967-00)

•

Mute Sensor (P/N: 1020-00)

Note: Please also consult any labelling and information accompanying stimulating probes and electrodes for safety and use information regarding these devices. Always consult labelling and any instructions for use accompanying stimulating probes and electrodes for use with the Neurosign 100.

1.4

Frequently Used Functions •

Frequently used functions as defined during Magstim’s usability process are identified with (*). Frequently used functions are functions of the Neurosign 100 that frequently involve user interaction.

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Neurosign 100 Operating Manual

SECTION 2 WARNINGS AND PRECAUTIONS

Attention Consult Operating Manual: Consult the operating manual prior to using this device.

Operating Manual: Further information can be located in the operating manual

Type BF Applied Part: Refer to Section 6.1 for further information.

High Voltages: High voltages are present in the Neurosign 100 during operation. Do not remove covers. Refer servicing to qualified personnel. If there is any sign of external damage or if any parts are damp or wet, they must not be used.

Explosive and Flammable Anaesthetics: The Neurosign 100 and accessories must not be used in an explosive atmosphere or in the presence of flammable anaesthetics.

Electrical Safety: At no point should users or third parties be allowed to come into contact with the patient and the output connectors on the rear of the Neurosign 100 unit simultaneously.

Protective Earth: To avoid the risk of electric shock, the Neurosign 100 must only be connected to a supply mains with protective earth.

Modification: No modification of this equipment is allowed. Neurosign Users: The Neurosign 100 is designed for use during surgical procedures and must only be used by medically qualified personnel. This instrument is designed as an aid to surgeons in the identification and monitoring of motor nerves at risk during surgery. It is not a replacement for experience in surgical decision-making. USA: RX Only Neuromuscular Block: Muscle contractions are only possible if limited or no neuromuscular block is used. The Neurosign 100 may not respond to spontaneous stimulation in instances where the patient is paralysed. The train of four test should not be used as proof that any blockade has dissipated; the Neurosign 100 can detect EMG well below the threshold of visible muscle movement. It is recommended that a suitable anaesthetic protocol is implemented so as not to impede muscle movement. Rear Panel Outputs: Only equipment that meets the relevant IEC standards and is configured in compliance with Clause 16 of IEC 60601-1: 2005, should be connected to the Neurosign 100. Mute Sensor: When not in use, disconnect the Mute Sensor from the Neurosign 100 unit. Spurious muting may occur if the Mute Sensor is left connected while not being used. Current Control: Currents in excess of 1mA should not be used to directly stimulate nerves during surgery involving cranial nerves.

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Neurosign 100 Operating Manual

Stimulating Probes: Stimulating probes should not be left standing in saline or allowed to come into contact with other electrical devices when being used. Disconnection: Parts of the Neurosign 100 system should not be disconnected by pulling on the connection cable as damage may occur. Ventilation: Care should be taken so that ventilation holes on the Neurosign 100 unit are not obstructed. Damage: If any cracks or damage are found on the Neurosign 100 system, it must not be used and should be returned to The Magstim Company Limited for servicing. Electrosurgical Equipment: The Neurosign 100 should only be used with surgical equipment which has an automatic cut-out feature and measures return pad impedance. It is suggested that bipolar diathermy should be used instead of monopolar diathermy as bipolar diathermy uses its own active return electrode. Stray RF: In order to reduce any possible induced current in the needle electrode leads from stray RF emitted by the electrosurgical unit, the electrode leads should be kept as far as possible from the unit. Cables from the electrosurgical unit, both active and return, should also be kept as far as possible from the electrode leads, especially whilst monopolar diathermy is being used. Magnetic Fields: The Neurosign 100 must not be used in the vicinity of objects that are sensitive to magnetic fields.

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Neurosign 100 Operating Manual

SECTION 3 PRODUCT DESCRIPTIONS 3.1

Device Description The Neurosign 100 provides an audio and visual representation of small voltages detected within a group of muscles. The voltages are detected by the sensing electrodes which are placed adjacent to or into the muscle group. Pulses or clicks can be heard when stimulating tissue using a stimulation probe indicating nervous tissue is being stimulated.

3.2

Front Panel The front panel, shown below, allows control of the N100 unit and provides the connection for the stimulator pod.

Figure 3.1: Neurosign 100 front view

3.2.1

Frequency* (1)

The frequency switch has 2 positions labelled 30Hz and 3Hz and controls the frequency at which the stimulator current is applied through the stimulating probe. Typically this should be set to 30Hz. In situations where muscular block has to be used, this should be set to 3Hz.

3.2.2

Probe* (2)

The Stimulator Probe Pod should be connected to the probe socket if required during the procedure.

3.2.3

Current* (3)

The current control varies the amount of current delivered to the Stimulator Probe Pod. Turning the control clockwise increases the current. Turning anticlockwise decreases the current. Most of the travel of the control is on the lower current levels. Current is delivered as a 200µs pulse at the set frequency. Please see Appendix A for suggested stimulation current settings.

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Neurosign 100 Operating Manual

3.2.4

Current Confirm (4)

Current confirm will illuminate as an indication that the correct current has passed through the stimulating probe. If the Frequency is set to 3Hz, it may take 2 or 3 seconds for the Current Confirm to illuminate. If the current confirm is permanently lit or does not light as expected, this could be an indication that a probe is faulty. Please refer to Section 4 Operating Instructions.

3.2.5

Channel 1* and Channel 2* (5)

Each channel has a switch to turn it on or off. When the channel is off the on/off indicator will be orange. When the channel is on the on/off indicator will be green.

3.2.6

Electrode Warning (6)

Each channel has an Electrode Warning indicator and this will illuminate if a level of artefact or unwanted voltages are detected by the Neurosign 100 unit continuously for a period of 20 seconds. A short beep will repeat every 8 seconds until the problem is cleared.

3.2.7

Bar Graph (7)

Each channel has a bar graph indicator which will illuminate showing the level of EMG activity detected by the Neurosign 100 unit. When EMG is detected, the bar graph rises to the detected level. When EMG ceases, the bar graph falls, however, the top segment of the bar graph will remain illuminated for several seconds to allow the EMG level to be determined by the user. The Bar Graph is independent to the volume and is not altered by changes to the volume level.

3.2.8

Volume* (8)

The volume control allows the volume of the internal speaker to be altered. Turning the control clockwise increases the volume. Turning anticlockwise decreases the volume. Please note: The volume cannot be set to zero. This is an intentional safety feature.

3.2.9

Channel Ident* (9)

When switched on, channel ident introduces a different texture to the sound of each channel heard through the speaker and can be used to differentiate between the two channels when they are on simultaneously.

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Neurosign 100 Operating Manual

3.3

Rear Panel The rear panel, shown below, provides connections for power, headphones, pre-amplifier pod, mute sensor and outputs for connection to external equipment.

Figure 3.2: Neurosign 100 rear view

3.3.1

Power* (1)

The Power switch allows the power supplying the unit to be switched on (also labelled I) or off (also labelled O).

3.3.2

Mains Connector* (2)

The standard IEC mains lead should be connected to the unit prior to the unit being switched on.

3.3.3

EMG Output* (3)

The EMG Outputs provide the ability to connect to, and view or record, EMG waveforms or signals externally to the Neurosign 100. These outputs are taken following the 10kHz filters within the Neurosign 100 unit, but before any signal processing occurs. The signal amplifiers have a gain of 500 and an output in the range of 15mV to 10V peak-to-peak.

3.3.4

Trigger Output* (4)

The Trigger Output provides the ability to connect to external devices to trigger or synchronise with the Neurosign 100 Unit. The trigger signal output is at the same frequency as that set on the front panel: either 3Hz or 30Hz.

3.3.5

Mute Sensor* (5)

The Mute Sensor socket allows connection of a mute sensor to the Neurosign 100 unit.

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Neurosign 100 Operating Manual

3.3.6

Stimulation Current Record* (6)

The Stimulation Current Record output allows external connection to view or record the stimulation current applied to the patient. It provides a voltage output proportional to the stimulation current being delivered and is only present when Current Confirm is illuminated.

3.3.7

Headphones Volume* (7)

The Headphone Volume is controlled by a thumbwheel knob. Rotating the thumbwheel upwards increases the volume. Downwards decreases the volume.

3.3.8

Headphones Socket* (8)

The headphone socket allows connection of headphones with a 3.5mm jack plug.

3.3.9

Pre-amp Pod Input* (9)

The Neurosign 100 pre-amplifier pod should be connected to this socket.

3.4

Pre-amplifier Pod The Pre-amplifier Pod provides connections for electrodes. The Pre-amplifier Pod connects to the Pre-amp Pod connection on the rear panel.

Figure 3.3: Neurosign 100 pre-amplifier

3.5

Stimulator Pod The Stimulator Pod provides connections for stimulating probes. The Stimulator Pod connects to the Probe connection on the front panel.

Figure 3.4: Neurosign stimulator pod

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Neurosign 100 Operating Manual

3.6

Mute Sensor The Mute Sensor enables the sound artefact from monopolar and/or bipolar electrocautery to be muted and connects to the Mute Sensor socket on the rear panel. Bar graphs on the front of the Neurosign 100 and EMG outputs on the rear of the Neurosign 100 will show a high level of artefact during electrocautery.

Figure 3.5: Neurosign mute sensor

3.7

Accessories A range of stimulating probes and electrodes are available for use with the Neurosign range of products. For more details, please contact the Sales department. Contact details are shown in section 7. Please note: The use of the correct accessories is essential to the functioning of the Neurosign 100. The Magstim Company Limited cannot guarantee the instrument’s performance unless accessories used are obtained from The Magstim Company Limited. Only Neurosign accessories purchased from The Magstim Company Limited should be used with the Neurosign 100 system.

...…….

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Neurosign 100 Operating Manual

SECTION 4 OPERATING INSTRUCTIONS Note: Please ensure you are familiar with all sections of this operating manual prior to following these operating instructions.

4.1

Preparation 1. At the start of each session the operator must check the Neurosign 100, Pre-amplifier Pod and Stimulator Pod for any signs of external damage and to identify any cleaning required*. If any cracks are visible in the housing, or there is damage to any of the cables, the items must not be used and should be returned to The Magstim Company Limited for servicing and repair. If cleaning is required, please follow the instructions in Section 5 of this Operating Manual. 2. Ensure that any electrodes or stimulating probes to be used are sterile. Magstim single use electrodes and probes are supplied sterile.

4.2

Set-up Note: ensure not to position the N100 unit so that it is not difficult to disconnect the power lead. 1. Ensure that the Neurosign 100 unit is switched off on the rear panel and that Channel 1, Channel 2 and Channel Ident are switched off on the front panel. 2. Raise the front of the Neurosign 100 by altering the handle position to allow low level sounds to be heard.

4.3

Connection 1. Insert the electrode(s) into the patient and connect them to the pre-amplifier pod as directed by the electrode(s) accompanying documentation. Information on electrode placement can be found in Appendix B. Additional information may be available from The Magstim Company Ltd. if necessary. Please refer to Contact Details in Section 7. Note: The electrode leads and the connection points on the pre-amplifier pod are colour coded. 2. Attach the Pre-amplifier Pod to the patient or bed and plug the cable into the pre-amp pod input on the rear panel of the Neurosign 100*. 3. Once the patient is sterile, if a stimulating probe is to be used, connect the stimulating probe to the Stimulator Pod as directed by the probe(s) accompanying documentation. Note: The stimulator probe leads and the connection points on the stimulator pod are colour coded. 4. Attach the Stimulator Pod to the Probe socket on the front of the Neurosign 100 unit. If probes are connected to both sockets, it is important to realise that both probes will be “live” when stimulation is active. 5. Attach the Stimulator Pod to the patient or bed*. Please note: The Pre-amplifier Pod and Stimulator Pod are not sterile and should be positioned in the non-sterile area. It is advised that the Pre-amplifier Pod is positioned at the top of the

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Neurosign 100 Operating Manual operating table near the patient’s head, with the Stimulator Pod at the bottom of the table near the patient’s feet. 6. The Neurosign 100 can reject high level input signals such as those caused by using electrocautery equipment, however, if muting of the Neurosign 100 sound output is required during electrocautery, connect the Mute Sensor to the Mute Sensor socket on the rear of the Neurosign 100 and clip the sensor to the electrocautery cable near to the diathermy machine*. Please note: If muting is not required, the Mute Sensor should not be connected. Spurious muting may occur is the Mute Sensor is connected when not required. 7. Headphones, connections to external equipment and other required items should be connected as necessary. 8. Connect the power lead to the rear of the Neurosign 100 unit.

4.4

Operation 1. Set the power switch on the rear of the Neurosign 100 unit to the on (I) position *. The current confirm should not be illuminated. Channel 1 and Channel 2 indicators should be orange. 2. Turn on Channel 1 and Channel 2 as required*. The orange indicator should change to green when the channel is switched on. It is normal for segments of the bar graph to flicker for the first few minutes following needle insertion but no segments should remain lit. Permanently lit segments may indicate incorrect electrode placement and electrodes should be removed and reconnected to the patient to rectify this. Electrode placement should be checked before the patient is draped. Once the patient is draped, the probe can also be checked at this point by shorting the tips together using a damp cloth. When shorted the Current Confirm LED should illuminate. 3. Set the volume to the desired level and, if required, switch on Channel Ident to allow differentiation between the audio of Channel 1 and Channel 2. 4. Set the Frequency switch to the desired setting*. This is usually set to 30Hz except in cases where the patient has to be paralyzed for the whole procedure when this should be set to 3Hz. Responses to stimulation will be reduced at 3Hz. 5. Set the Stimulator Current to the lowest level appropriate for the procedure*. At this point, there should be no sound output or bar graph activity other than that associated with spontaneous firing of the nerve. 6. Check the area for nerve fibres. When the Stimulating Probe comes into contact with a neural pathway, the instrument will register a response dependant upon the level of stimulation. If there is either a weak or no reaction from the unit, the Stimulator Current may be increased. 7. Set an appropriate Stimulator Current according to the guidance in Appendix A*. 8. On completion of the procedure, set the power switch on the rear of the Neurosign 100 unit to the (O) position to switch the unit off* 9. Section 4.2 should be repeated in reverse to disconnect the Neurosign 100*. The Neurosign 100 and accessories should be stored within the environmental conditions specified in section 6.3*.

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Neurosign 100 Operating Manual Note: Care should be taken when removing the Pre-Amplifier pod, Stimulator pod and Mute Sensor from the Neurosign 100 unit. Please follow the following instructions to remove each connector. 1. To remove the Pre-amplifier pod from the Neurosign 100 unit, hold the body of the connector press the leaver and pull the connector out at a horizontal angle*. 2. To remove the Stimulator pod from the Neurosign 100 unit, hold the body of the connector and pull the connector out at a horizontal angle*. 3. To remove the Mute Sensor from the Neurosign 100 unit, hold the body of the connector turn anti-clockwise and pull the connector out at a horizontal angle*. Under no circumstance should any of the above connectors removed by pulling the cable. Failure to remove the connectors as instructed above could result in damage to the Neurosign 100 unit and accessories.

4.5

Interpreting Neurosign 100 Sounds There are four basic sounds from the instrument when used correctly: 1. A long series of pulses lasting as long as the nerve is stimulated is due to direct electrical stimulation. The volume of the signal will vary according to the current being passed, the amount of neuromuscular block (if any) used, and the integrity of the nerve. 2. A burst of clicks is caused by direct manipulation of the nerve. This is caused by a brief mechanical contact caused by the surgeon working close to the nerve and ends as the contact is removed. 3. A regular, repetitive ‘train’ of clicks lasting several seconds or even minutes. This ‘train’ of pulses may be caused by mechanical manipulation of the nerve, by compressing or stretching it, or by a change in temperature, as when irrigating the area with saline or heating the area by diathermy or with a laser. Unless the train of pulses is caused by irrigation, it may be advisable to allow the nerve to recover before continuing with the procedure. 4. An absence of sound could be caused because the instrument has not detected any voltage in the muscle and the muscle must contract in order for a sound to be heard. The muscle may not contract for a variety of reasons; the nerve may not be stimulated, the nerve may be damaged or transected, or any neuromuscular block may be too deep. Silence may also be a sign that the surgery is not irritating the nerve.

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Neurosign 100 Operating Manual

4.6

Troubleshooting Below are some potential cures to problems you may experience.

Problem No indicators light when power is switched applied Background theatre noise obscures Neurosign 100 information Loud noise when using electrocautery

No response at start of operation

Little or no mechanically evoked responses Constant clicking noise and bar graph display with no stimulation; Electrode Warning indicator on and beep sounding

No response when using Stimulator

Current Confirm indicator stays lit after Stimulation is finished Bipolar probe is too big under the microscope and penetrates too far through tissue Difficulty in differentiating between the two channels Data-logging is required

Potential Cure Check Power Switch is set to 1: check power socket; check voltage selector; check unit fuses Increase volume or use headphones Attach the mute sensor and clip it to the electrocautery cable – bipolar diathermy should not affect the Neurosign 100, but this can also be muted if necessary This is normal! It may take a long time to reach the nerve or tissue to which the nerve is attached; if in doubt, use the stimulator set at a high current (2-3mA) to check the area – a faint clicking may be heard indicating the nerve lies deep to the probe If any neuromuscular block has been used, only direct electrical stimulation is likely to be heard – the train of four test is not a guarantee that the neuromuscular junction is free of blockade Part of the bar graph has been lit for more than 20 seconds. The electrodes may be poorly placed or faulty, giving rise to artefact. Check if possible before the patient is draped a) If a neuromuscular block has been used, set Frequency to 3Hz b) If neuromuscular block is deep, a response is unlikely c) Is the Current Confirm indicator lighting? d) Increase current setting up to a maximum of 1mA e) Did the patient have a normal nerve pre-operatively? (!!) Check for liquid material between probe tips and clean as necessary. Concentric probes may cause the indicator to stay lit for several seconds because of the proximity of the electrodes The concentric probes have a diameter of 1mm and also have very much reduced current spread, making these probes suitable for use under the microscope and, for example, differentiating between VIIth and VIIIth cranial nerves . Alternatively, try the precision bipolar probe Set INDENT feature to ON, and ensure that the muscle group for each channel is noted Use EMG Channels, Trigger Output and Stimulation Current Record to log activity as required using as oscilloscope or chart recorder

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Neurosign 100 Operating Manual

SECTION 5 MAINTENANCE 5.1

User Maintenance and Calibration There are no user maintenance or calibration requirements for the Neurosign 100 and accessories. However, it is important that they are checked for any sign of damage at the start of each session*. If any cracks are visible in the plastics, or if there is damage to any of the cables, the items must not be used and should be returned to The Magstim Company Limited for servicing and repair (see Section 7.2 for contact details).

5.2

Voltage Selection and Fuse Rating The Neurosign 100 is preset at the factory to operate at 100V, 120V, 220V or 240V A.C., as appropriate. If 230V operating voltage is required please select the 240V A.C. voltage selector. The following are the fuse ratings:

Supply Voltage 100V-120V~

Qty 2

Fuse Size 20 x 5mm

Rating T630mAL, 250V

220V-240V~

20 x 5mm

T5AH, 250V

T denotes timed or antisurge fuses. Fast acting fuses are not recommended. L denotes low breaking capacity (glass fuse). Fuse Replacement: The Neurosign 100 must be disconnected from the mains by disconnecting the power cord from the rear of the unit. Insert the tip of a small blade screwdriver or similar tool into the slot at the top of the fuse access cover and lever to open. Pull out the fuse tray (marked with an arrow) and replace the blown fuse(s) with one of the correct rating (See above to ensure the correct fuse is replaced). Replace the fuse tray and close the fuse access cover, ensuring the retaining lip clicks into place. Changing The Voltage Selector Setting: The Neurosign 100 must be disconnected from the mains by disconnecting the power cord from the rear of the unit. Open the fuse access cover as instructed above, rotate the voltage selector to the desired setting and replace the cover. A legend will indicate the voltage selected when the fuse cover is replaced. Only replace fuses with those of the correct rating, and only operate the instrument with the voltage selector set at the appropriate voltage. Failure to do so may cause serious damage to the device(s).

5.3

Cleaning and Disinfecting The Neurosign 100 and accessories cannot be sterilised; therefore, do not allow them to become contaminated with bodily fluids. They may be cleaned using a cloth moistened with isopropyl alcohol, however ensure that the Neurosign 100 and accessories have dried thoroughly before use. It is the responsibility of the user to ensure the Neurosign 100 is cleaned when necessary. Note: The Magstim Company Ltd recommends that a solution of 70% isopropyl alcohol should be used.

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Neurosign 100 Operating Manual

5.4

Servicing Servicing of Neurosign 100 and accessories must only be carried out by The Magstim Company Limited or one of its authorised service centres. To arrange a return or for further information, contact the service department at The Magstim Company Limited (see Section 7.2 for contact details).

5.5

Device Lifetime The lifetime of the Neurosign 100, Stimulator Probe Pod and Pre Amplifier Pod are defined as being five years from the date of shipment. The Magstim Company Limited will support the products for the duration of their lifetime.

5.6

Disposal When the Neurosign 100 or its accessories reach the end of its serviceable life it should not be disposed of in general waste. The Magstim Company Limited should be contacted (see Section 7.2 for contact details) for advise on its disposal in compliance with the appropriate environmental regulations. Failure to do so could cause an environmental hazard as a result of decomposition of materials used in its construction. Single use disposable accessories should be disposed of immediately following use, using a “sharps” disposal box.

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Neurosign 100 Operating Manual

SECTION 6 SPECIFICATIONS 6.1

Safety Specifications During use, the type of protection against electric shock provided by the Neurosign 100 System is classified as Class 1. The degree of protection against electric shock for applied part accessories is classified as Type BF Applied Parts. This means that the Stimulating Probes, Stimulator Pod circuits, Electrodes and Preamplifier Pod circuits are electrically isolated from the other parts of the equipment and meet Type BF leakage current limits as required by IEC 60601-1. The Neurosign 100 and accessories comply with the requirements of Safety Standard IEC 60601-1 and with EMC Standard EN 60601-1-2. To avoid problems with EMC interference, the Neurosign 100 and accessories should not be used in the vicinity of any equipment that does not comply with EMC Safety Standard EN 60601-1-2, including mobile phones. Any interface cable which connects the Neurosign 100 unit to an external piece of equipment must be no more than 1.5m in length. Only equipment that meets the relevant IEC standards and is configured in compliance with Clause 16 of IEC 60601-1:2005, should be connected to the Neurosign 100. The Neurosign 100 and accessories are classified as IPX0 (Not Protected), as there is no specialised protection provided against the ingress of liquids. The Neurosign 100 and accessories are not protected against flammable anaesthetic mixtures. They are not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. The mode of operation of the Neurosign 100 and accessories is classified as continuous.

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Neurosign 100 Operating Manual

6.2

Technical Specifications Stimulator Output Current Output: Stimulator Frequency: Waveform: Isolation: Amplifier Channels: Frequency range: Isolation: Audio compression ratio: Channel ident: Speaker: Amplifier output: Display Bargraph: Range: Indicators:

Output Ports Dual EMG output: Headphone socket: Stimulation Current Record: Trigger output: Power Supply Power: Fuse(s):

Constant, 50µA – 5mA ±20% or ±25µA, whichever is greater 30Hz or 3Hz 200µs pulse width, negative going pulse 1.5kV r.m.s. to ground

2, Input noise of 8µV peak to peak, CMRR greater than 95dB 10Hz to 10kHz ± 3dB 1.5kV r.m.s. to ground 10:1 Tuned filter system 165mm 14W

Twin 20 segment logarithmic, trailing segment 30µV to 20mV ±20% peak to peak Channel 1 and 2 on-off indicators Channel 1 and 2 artefact warning indicators Stimulation Current flow current confirm indicator

Gain of 500 >16 ohm impedance, mono 1V/mA for data logging purposes TTL level

220-240/100-120V~ 50-60Hz; 50VA 2 x T630mA 20x5mm for 100-120V~ 2 x T315mA 20x5mm for 220-240V~

General Specifications Dimensions: Weight:

290mm x 260mm x 100mm 6kg

Software:

Neurosign 100 Bar graph - Revision 00 (Software ref: 1682)

Please note: All specifications are subject to alteration.

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Neurosign 100 Operating Manual

6.3

6.4

Environmental Conditions* Operating temperature:

5°C to 30°C

Transport and storage temperature:

-19°C to 60°C

Operating, transport and storage relative humidity:

10% to 80% (non-condensing)

Operating atmospheric pressure:

80kPa to 106kPa

Transport and storage atmospheric pressure:

50kPa to 106kPa

Packing Instructions If, for any reason, it is necessary to return your Neurosign 100 unit care should be taken to ensure that the equipment is adequately packed to prevent transit damage. Ideally the equipment should be returned in its original packing. If this or an adequate replacement is not available, replacement shipping cartons can be obtained from the Magstim Company Limited. The Neurosign 100 System must be completely disconnected before shipping. Failure to do so is likely to result in transit damage to the casing.

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