Digitimer D360R-4 Manual de usuario

Digitimer

D360R-4

Isolated 4-Channel Research Amplifier/Filter

OPERATOR’S MANUAL

For Research Use Only

“Digitimer” is a registered trademark of Digitimer Limited

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

WARNING

For Subject and Operator Safety, this manual

should be FULLY read and understood

before use of this product

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0 
 
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Digitimer Ltd. Copyright ©2021 
Table of Contents 
Section 1 - General Information .............................................................................................................7 
D360R-4 Intended Usage & Description .............................................................................................7 
Precautions and Warnings ..................................................................................................................8 
Operator’s Manual..........................................................................................................................8 
Risks to Subject Safety.....................................................................................................................8 
Defibrillator Warning.......................................................................................................................8 
Subject Exclusion Criteria................................................................................................................8 
Explosion and Fire ...........................................................................................................................8 
High Voltages...................................................................................................................................8 
Damage............................................................................................................................................8 
Moisture..........................................................................................................................................8 
Temperature....................................................................................................................................9 
Input/Output Connectors................................................................................................................9 
Disconnection & Siting ....................................................................................................................9 
Electrical Interference.....................................................................................................................9 
Cleaning Maintenance & Servicing .....................................................................................................9 
Environmental Considerations..........................................................................................................10 
Modification Status...........................................................................................................................10 
Unpacking..........................................................................................................................................10 
Supplied Components & Accessories............................................................................................10 
Optional Accessories .....................................................................................................................11 
Mains Connections............................................................................................................................11 
Mains Plug Connections................................................................................................................11 
Mains Plug Fuse.............................................................................................................................11 
Mains Voltage Selector..................................................................................................................11 
Mains Inlet Fuses...........................................................................................................................12 
Product Registration .........................................................................................................................12 
Why Register Your Purchase? .......................................................................................................12 
How to Register Your Purchase.....................................................................................................12 
Product Announcement Mailing List.............................................................................................12 
Contact Addresses.............................................................................................................................13 
Manufacturer ................................................................................................................................13 
Main Representatives....................................................................................................................13 
Specifications ....................................................................................................................................14 

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0 
 
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Digitimer Ltd. Copyright ©2021 
Safety.............................................................................................................................................14 
Power requirements......................................................................................................................14 
Headstage......................................................................................................................................14 
Deblock..........................................................................................................................................14 
Analogue Channels........................................................................................................................14 
Outputs..........................................................................................................................................15 
Software ........................................................................................................................................15 
Physical Size...................................................................................................................................15 
EU Declaration of Conformity...........................................................................................................16 
Warranty Information.......................................................................................................................17 
Limited Warranty ..........................................................................................................................17 
Obtaining Warranty Service ..........................................................................................................17 
Product change or discontinuation...............................................................................................17 
Section 2 - Hardware Overview............................................................................................................19 
Tour of the Hardware........................................................................................................................19 
Front Panel Components...............................................................................................................19 
Headstage Components ................................................................................................................20 
Main Amplifier Front Panel & Headstage Printed Symbols ..........................................................21 
Rear Panel Components................................................................................................................21 
Rear Panel Symbols.......................................................................................................................22 
Section 3 –Software & Hardware Installation .....................................................................................23 
Software Installation.........................................................................................................................23 
Hardware Installation........................................................................................................................25 
Section 4 –Navigating the D360R-4 Control Software.........................................................................29 
Overview ...........................................................................................................................................29 
D360R-4 Control Panel......................................................................................................................30 
Channel Enable/Disable Switches .................................................................................................30 
Channel Linking .............................................................................................................................30 
Gain Settings..................................................................................................................................30 
Low Cut Filter Settings...................................................................................................................31 
High Cut Filter Settings..................................................................................................................32 
Notch Filter Settings......................................................................................................................32 
Deblock Control.............................................................................................................................33 
Loading and Saving Protocol Settings ...........................................................................................33 
D360R-4 API Programmer’s References............................................................................................34 

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0 
 
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Digitimer Ltd. Copyright ©2021 
Section 5 –Using the D360R-4 Amplifier..............................................................................................35 
Introduction ......................................................................................................................................35 
Considerations for Use......................................................................................................................35 
Preparing the D360R-4 for Use .....................................................................................................35 
Electrode Selection........................................................................................................................36 
Skin Preparation............................................................................................................................36 
Electrode Lead Routing .................................................................................................................36 
D360R-4 Shutdown Procedure......................................................................................................36 
Troubleshooting ............................................................................................................................37 
Bibliography...................................................................................................................................37 
User Notes.....................................................................................................................................37

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

Product Registration

Please take time out to register your new product.

Details are included in the Section 1 - General Information

You can even do it online at:-

www.digitimer.com/register

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

Section 1 - General

Information

D360R-4 Intended Usage & Description

The D360R-4 is a computer controlled 4-channel isolated research amplifier and analogue filter

system. Featuring four AC-coupled, differential channels, it has been designed for use in human

research where it may be employed for applications including electromyography (EMG),

electroencephalography (EEG) or evoked potential (EP) studies.

The Digitimer D360R-4 Amplifier is intended to be used by persons appropriately trained in such

techniques, who are familiar with the principles and safety issues of human physiological recordings.

Users should be able to operate the D360R-4, the controlling software, and any associated

instruments correctly before carrying out any human studies.

The D360R-4 is NOT approved or intended for use in clinical diagnostic, treatment or life support

situations and is NOT a medical device.

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

The system comprises a main amplifier unit with a remote active headstage and D360R-4 Client

Software. Any number of D360R-4 amplifiers may be connected to a single PC allowing multiples of

4-channels to be controlled by one PC system. Full and instant control is provided by the Windows

PC Client Software, supplied with the system, which gives independent control of each channel.

It is expected that the preamplifier headstage would be placed near to the subject, while the main

amplifier unit would be sited near the operator who would be using the host computer and data

acquisition equipment.

Precautions and Warnings

Operator’s Manual

Carefully study this Operator’s Manual before using the D360R-4 4-Channel Amplifier.

Risks to Subject Safety

Operation of the D360R-4 in close proximity (e.g. 1m) to a shortwave or microwave therapy

equipment may produce instability.

The D360R-4 is not suitable for use in close proximity to extreme magnetic fields, such as those

generated by MRI scanners.

Under no circumstances should the D360R-4 Operator simultaneously touch the D360R-4 main unit

and the subject.

WARNING - The D360R-4 should not be modified as this may present a safety hazard to the subject.

Defibrillator Warning

The D360R-4 is NOT classified as defibrillator proof and should not be connected to a subject

undergoing defibrillation. Use under such circumstances may cause damage to the D360R-4 and/or

impair the function of the defibrillator being used.

Subject Exclusion Criteria

At this time we are not aware of any justification for subject exclusion, but this is continuously under

review.

Explosion and Fire

The D360R-4 must not be used in an explosive atmosphere or in the presence of flammable

anaesthetic gasses.

High Voltages

Dangerous voltages are present within this unit. Do not remove covers or make any modifications to

the D360R-4. Refer all servicing to a Digitimer representative.

Damage

The D360R-4 and/or any accessories must not be used if there are any signs of external damage.

Please report any such damage to the local Digitimer representative.

Moisture

The D360R-4 and/or any accessories must not be used if any parts are wet or damp.

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

Temperature

The D360R-4 and/or accessories should be stored or transported at temperatures between -40°C

and +70°C. The recommended usage temperature range is between +10°C and 40°C.

Input/Output Connectors

Only equipment that complies with EN(IEC) 60601 (Medical Equipment), EN(IEC) 60950 (IT

Equipment) or EN(IEC) 61010 (Laboratory Equipment) should be connected to the D360R-4

input/output connectors.

Disconnection & Siting

The D360R-4 may be isolated from mains supply by uncoupling the appliance coupler or by

disconnecting the mains plug. The operator should ensure that access to the appliance coupler and

mains plug is maintained in all normal use.

Electrical Interference

The D360R-4 has been tested to all of the immunity requirements of EN60601-1-2:2015. Whilst the

control systems of the D360R-4 were unaffected and safety not compromised, features of the

D360R-4 make it inherently sensitive to RF fields. Certain precautions should be taken when

installing medical electrical equipment:-

This unit should NOT be used near radio transmitters as RF equipment can affect medical

electrical equipment. If any ‘strange’ behaviour of the unit is noted, discontinue use

immediately and refer to a qualified EMC engineer.

The D360R-4 should not be used adjacent to or stacked with other equipment. If such use is

required, then the behaviour of the amplifier should be monitored to confirm normal

operation in this configuration.

All cables (except electrode leads) connected to the D360R-4 should be no longer than 3

metres in length.

Cleaning Maintenance & Servicing

If the amplifier requires cleaning, it should be unplugged from the mains power supply and wiped

with a damp cloth.

This equipment does not require any regular maintenance but in the absence of in-house biomedical

engineering tests, Digitimer recommends that all our products designed for human use are returned

to the factory for inspection and re-testing every 2 years. Please contact us for a reference number

and instructions before despatching the unit.

As no parts of the D360R-4 are expected to wear out the only limitation to the service life is likely to

be the ongoing ability to replace electronic components that may randomly fail and damage

sustained during normal use. The components chosen are used conservatively and are all well-

established parts, so availability can be expected for many years. However, a life expectancy of 10

to 15 years may be useful for lifespan planning purposes.

Before each use, the case and all leads should be inspected for any damage. The equipment (or the

leads) should be sent for repair or replaced if any damage is found.

For all servicing requirements please contact Digitimer, who can advise on best course of action.

Digitimer Ltd –D360R-4 Operator’s Manual Version 1.0

Environmental Considerations

This unit does not produce any waste. As with all electronic devices, at the end of its life it should be

disposed of by a registered waste contractor who is made aware of its nature. As part of our legal

obligation, Digitimer Limited is a registered EEE producer. Our WEEE registration number is

WEE/BJ0052TQ. For further information relating to the correct method of disposal of any of our

equipment, which carries this symbol , please contact us.

Modification Status

The green and white serial number label affixed to the rear of each D360R-4 contains the unique

serial number of that unit. This serial number should be quoted whenever technical support is

requested from Digitimer or one of our representatives.

The D360R-4 amplifier system has serial numbers of the following format: D360R-4-xx (main unit)

D360R-4-H/S-xx (preamplifier headstage).

The lower section of the label contains the “MOD. RECORD STATUS” (Modification Record Status)

which indicates the build status of the unit and any modifications that have been subsequently

performed to the unit.

Unpacking

After unpacking the D360R-4 from the shipping carton, please inspect each piece for any sign of

shipping damage. Please contact the carrier and your distributor, or Digitimer Limited, immediately

if there is any damage. Do NOT dispose of the shipping carton, as the carrier will want to examine it

in order to process a damage claim. Digitimer Limited and their distributors insure all shipments to

cover shipping damage.

It is also advisable to keep the shipping carton in the event that the instrument needs to be returned

for service.

Supplied Components & Accessories

D360R-4 Main amplifier unit.

D360R-4 H/S headstage.

Amplifier to headstage inter-connection cable (2m long).

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