Blackrock Microsystems STIM Bedienungsanleitung

STIM SWITCH USER MANUAL

(REVISION 2.00)

Blackrock Microsystems, LLC

391 Chipeta Way, Suite G

Salt Lake City, UT 84108

Tel: (866) 806-3692

www.blackrockmicro.com

Stim Switch User Manual

Rev. 1.00 ® Page i

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is prohibited without prior written consent of Blackrock Microsystems, LLC

Stim Switch User Manual

Rev. 2.00 ® Page ii

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Contraindications, Warnings and Cautions

IEC60101-0102

Danger of Electrostatic Discharge (ESD)

ISO7000-0434

Warning (potentially hazardous condition);

consult accompanying documents

ISO7000-1641

Attention, consult accompanying documents

IEC60417-5019

Protective earth (ground)

IEC60417-5021

Equipotentiality Connector

IEC606417-5335

Type BF Applied Part

IEC60417-5007

ON (power)

IEC60417-5008

OFF (power)

Contraindications

•The Stim Switch should not be used with any stimulating systems that are not approved by

Blackrock Microsystems. Currently, the Stim Switch is only approved for use with Blackrock

Microsystems Stim100 neurostimulator.

•The Stim Switch should not be used with any amplifier or neural signal processing system that is not

approved by Blackrock Microsystems. Currently, the Stim Switch is only approved for use with

Blackrock Microsystems Front End Amplifier and NSP (NeuroPort™ System).

•The Stim Switch should not be used on any patient whom the physician/surgeon considers at

elevated risk of infection.

•Electrocautery should not be performed while the Stim Switch is in use.

•The Stim Switch should not be used if the device has been dropped. Dropping the device may

cause damage to internal components that affect system performance and patient safety. A

dropped device must be returned to Blackrock Microsystems for inspection and recalibration before

it can be used again (See Section 6 and 7 of the Stim100 User Manual).

•The Stim Switch should not be used with any computer that has not been tested to the IEC 60950

standards.

Warnings

•The Stim Switch must only be used by medically trained and highly qualified personnel. This

manual is to be used in support of device use by personnel who have received device training from

Blackrock Microsystems.

•Use only the supplied Stim Switch components (i.e. power cord, Stim100 Interconnection Cables,

Headstage Cables, Headstages). Substitution of components not supplied by Blackrock

Microsystems may affect system performance and patient safety.

•Do not use damaged components (i.e. power cord, Stim100 Interconnection Cables, Headstage

Cables, Headstages). Damaged components may compromise patient safety.

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LB-0357

•Use only the Front End Amplifier and Neural Signal Processor (NeuroPort™ System) supplied by

Blackrock Microsystems. Substitution of systems not supplied by Blackrock may affect system

performance and patient safety.

•The Stim Switch and Amplifier/NSP should be disconnected from the patient electrodes during

defibrillation. The Stim Switch and its subcomponents, along with the Amplifier and NSP are not

defibrillator proof.

•Do not use the Stim Switch in the presence of flammable anesthetic agents.

•Only connect Stim Switch components to properly tested, grounded and dedicated AC outlets to

reduce the risk of electrical shock. Do not use an adapter for ungrounded wall outlets.

•Do not connect the Stim Switch to an outlet controlled by a wall switch.

•Avoid strong static discharges from sources like televisions or computer monitors because it can

damage the electrical parts of the system.

•Keep the Stim Switch away from liquids. Contact with water, shower spray, or wet surfaces can lead

to the patient receiving an electrical shock.

•Each component of the system must be plugged into a separate outlet (i.e. Stim Switch, Stim100,

subcomponents of the data acquisition system and all other accessory equipment). Using a power-

strip may cause leakage currents to exceed acceptable limits.

•Do not unplug the power supply to the Stim Switch while the system is in use.

•Do not leave the Stim Switch connected to the patient electrodes when the system is not in use.

•When connecting the Stim Switch to the Stim100 or patient electrodes, use caution to minimize the

likelihood of Electrostatic Discharge (ESD). Do not connect/disconnect any cables to/from the Stim

Switch while the system is in use.

•Ensure that the Stim Switch is securely positioned on a flat surface during use.

•Use caution when placing power cords, cables, and other connectors to minimize the likelihood of

tripping or accidentally pulling on cables. Damaged cables may results in failed ground

connections.

•Connecting equipment to and from the Stim Switch may result in a summation of leakage currents

that can lead to the patient receiving an electric shock.

•Risk of Electrical Shock Hazard: Accessory equipment connected to the SIP/SOP port must be

certified according to the respective IEC standards, i.e., IEC 60950 for data processing equipment

or IEC 60601-1 for electromedical equipment in order to reduce the risk of electrical shock. All

combinations of equipment must be in compliance with IEC 60601-1-1 systems requirements.

Anyone connecting additional equipment to the SIP/SOP port configures a medical system, and

therefore is responsible that the system complies with the requirements of the system standard IEC

60601-1-1.

•IEC 60950 approved Information Technology Equipment must be placed outside the “patient

environment.” The patient environment is defined as an area 1.5m (4.92 feet) from the patient.

•The following options are recommended if there is a need to remediate system leakage current:

Stim Switch User Manual

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•Redundant protective earth connection shall be made to either the medical

device or the other equipment.

•The other equipment shall be powered from a medical grade (IEC 60601-1

compliant) separating transformer.

Cautions

•Federal law restricts this device to sale, by or on the order of a physician.

Electromagnetic Compatibility

The following tables document compliance levels and guidance from the IEC 60601-1-2 2007 Standard, for

the electromagnetic environment in which the Stim Switch should be used. Medical Electrical Equipment

requires special precautions regarding EMC and should be installed and put into service according to the

guidelines provided in the tables below.

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Stim Switch User Manual

Rev. 2.00 ® Page v

LB-0357

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Stim Switch User Manual

Rev. 2.00 ® Page vi

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Stim Switch User Manual

Rev. 2.00 ® Page vii

LB-0357

System Specifications

Model Name

128-Channel Stim Switch

Type of Protection

Class I

Degree of Protection

Type BF Applied Part

Stimulation Inputs

4 DB-37 front panel connectors

1.3 kΩimpedance between input and output when stimulation

mode is enabled.

> 10 MΩinput impedance when stimulation mode is disabled

Recording Outputs

36 Channel Samtec Connector with 32 output channels plus

reference and ground pins.

1.1 kΩimpedance between input and output when read mode is

enabled.

> 10 MΩoutput impedance when read mode is disabled.

Minimum Switching Time

< 1 µs when using the Enable In input to switch between modes

10ms when using StimComm to switch between modes

Maximum Time after

switching before action

potentials are valid

< 5 ms using Fast Settle a modified Front End Amplifier

< 4 s using an unmodified Front End Amplifier

Maximum Stimulation Input

Current

30 mA on any one channel

Maximum Stimulation Input

Voltage Range

±15 V between any input and ground on any one channel

Enable In Input Voltage Range

-0.1 V to +5.0 V

Bank to Bank Synchronization

<1 µs skew.

PC Hardware Interface

USB A-B cable

StimComm PC Software

Compatibility

Windows 2000 Pro, Windows XP Pro, Windows 7, or Windows

Vista

Power Supply

Standard 3-pin power connector accepting 120-240 VAC, 50-60

Hz, 0.5A

Emergency Off Switch

¼” Mono Phone Plug

Normally Open Switch with < 1 kΩon resistance recommended.

Water Ingress Protection

Ordinary Equipment, Not Fluid Resistant, IP20

Operating Environment

10˚C to 40˚C, 10 to 95% R.H. (non-condensing)

Storage/Transportation

Environment

-20˚C to 50˚C, 10 to 100% R.H. (non-condensing), 500 to 1060

hPA

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Rev. 2.00 ® Page viii

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Table of Contents

1$System Overview................................................................................................................1$

1.1$Packing List............................................................................................................................................1$

1.2$Stim Switch Interface Systems (sold separately)...................................................................................1$

2$Hardware............................................................................................................................2$

2.1$Stim Switch Control Module..................................................................................................................2$

2.2$Interconnection/Headstage Cables .........................................................................................................4$

2.3$Stim Switch Headstage Housing............................................................................................................4$

2.4$Computer Setup......................................................................................................................................5$

2.5$Hardware Setup......................................................................................................................................6$

2.5.1$Stim Switch Setup ..................................................................................................................................6$

2.5.2$Connection to the Stim100 Stimulation Source .....................................................................................6$

2.5.3$Connection to the Data Acquisition System...........................................................................................7$

2.4.4$Connection to the NeuroPort Electrodes................................................................................................7$

2.5$External Gating of the Stim Switch using the Enable In input ..............................................................8$

3$Software..............................................................................................................................9$

4$Device Care and Storage.................................................................................................11$

5$Troubleshooting ...............................................................................................................12$

6$Warranty ..........................................................................................................................14$

6.5$Return Merchandise Authorization ......................................................................................................14$

List of Figures

Figure 1-1: Application Overview......................................................................................................................1

Figure 2-2: Stim Switch Control Module Front Panel........................................................................................2

Figure 2-3: DB-37 Stimulator Connection Layout.............................................................................................3

Figure 2-4: Power Supply Switch......................................................................................................................4

Figure 2-5: Stim Switch Headstage Module ....................................................................................................4

Figure 2-6: Switch Schematic. Rstim = 500 MΩand Relec = 1kΩ..................................................................4

Figure 2-7: Stim Switch Computer Interface....................................................................................................5

Figure 2-8: Fast Settle modified Front End Amplifier........................................................................................5

Figure 2-9: Headstage Housing Stim Switch Connectors.................................................................................5

Figure 2-10: Headstage Housing Data Acquisition Connectors .......................................................................6

Figure 2-11: Headstage Housing Connection to Patient Pedestal...................................................................7

Figure 3-12: StimComm Main Window.............................................................................................................8

List of Tables

Table 2-1: Behavior of the Enable In Port.........................................................................................................3

Table 2-2: Headstage Module switching states ...............................................................................................5

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