Mediracer Ncs User manual

 
Mediracer NCS User’s Manual v6 
Copyright © 2019 Mediracer Ltd 
All rights reserved 
 
Page: 1 (33) 
 
Valid from: 30.8.2018 
 
 
Mediracer NCS User’s Manual 
 
 
Table of Contents 
GLOSSARY................................................................................................................................................................... 3 
1PRODUCT INFORMATION .................................................................................................................................. 4 
1.1 SAFETY INSTRUCTIONS.............................................................................................................................................4 
1.1.1 General ..................................................................................................................................................... 4 
1.1.2 Test Device................................................................................................................................................ 4 
1.2 SYMBOL DEFINITIONS..............................................................................................................................................5 
1.3 INTENDED USE AND OPERATING PRINCIPLE .................................................................................................................6 
1.4 CONTENTS OF THE PRODUCT ....................................................................................................................................7 
1.4.1 Basic examination set............................................................................................................................... 7 
1.4.2 Test Device................................................................................................................................................ 7 
1.4.3 Stimulation and Recording Cables ............................................................................................................ 9 
1.4.4 Charger ................................................................................................................................................... 10 
1.4.5 Docking Station....................................................................................................................................... 10 
1.4.6 Electrodes ............................................................................................................................................... 10 
1.4.7 Bluetooth Connection ............................................................................................................................. 12 
1.4.8 PC............................................................................................................................................................ 12 
1.4.9 Symptoms Questionnaire ....................................................................................................................... 12 
2GETTING STARTED ............................................................................................................................................12 
2.1 SETTING UP THE TEST DEVICE.................................................................................................................................12 
2.2 SETTING UP THE PC..............................................................................................................................................13 
2.3 PREPARING THE ENVIRONMENT ..............................................................................................................................13 
3OPERATING INSTRUCTIONS..............................................................................................................................14 
3.1 PREPARING FOR AN EXAMINATION...........................................................................................................................14 
3.1.1 Preparing the Patient ............................................................................................................................. 14 
3.1.2 Preparing a Patient File .......................................................................................................................... 14 
3.1.3 Preparing an Examination File................................................................................................................ 14 
3.2 PERFORMING THE EXAMINATION.............................................................................................................................15 
3.2.1 Preparing a Test File ............................................................................................................................... 15 
3.2.2 Attaching the Electrodes......................................................................................................................... 15 

 
Mediracer NCS User’s Manual v6 
Copyright © 2019 Mediracer Ltd 
All rights reserved 
 
Page: 2 (33) 
 
Valid from: 30.8.2018 
 
3.2.3 Performing the Test ................................................................................................................................ 15 
3.2.4 Device display explanation ..................................................................................................................... 16 
3.2.5 Checking the Test Result ......................................................................................................................... 16 
3.3 AFTER THE EXAMINATION ......................................................................................................................................17 
4SERVICE AND MAINTENANCE ...........................................................................................................................17 
4.1 CLEANING THE PRODUCT .......................................................................................................................................17 
4.2 TESTING THE SYSTEM ............................................................................................................................................18 
4.3 CHARGING THE TEST DEVICE...................................................................................................................................19 
4.4 REPLACING THE BATTERY .......................................................................................................................................21 
4.5 REPLACING THE STIMULATION AND RECORDING CABLES ..............................................................................................23 
4.6 DISCARDING THE PRODUCT AND THE COMPONENTS....................................................................................................24 
4.7 OTHER SERVICES ..................................................................................................................................................24 
5SPECIFICATIONS................................................................................................................................................24 
5.1 TECHNICAL DATA .................................................................................................................................................24 
5.2 EMC INFORMATION .............................................................................................................................................26 
5.2.1 Guidance and manufacturer’s declaration – electromagnetic emissions............................................... 27 
5.2.2 Guidance and manufacturer’s declaration – electromagnetic immunity............................................... 27 
5.2.3 Guidance and manufacturer's declaration - electromagnetic immunity in RF-field ............................... 28 
5.2.4 Recommended separation distances between portable and mobile RF communications equipment and 
the Test Device ........................................................................................................................................................ 29 
6MANUFACTURER IN RESPONSE ........................................................................................................................30 
7STORAGE AND TRANSPORTATION CONDITIONS...............................................................................................30 
8USER INTERFACE STRUCTURE ...........................................................................................................................30 
9CHANGE HISTORY.............................................................................................................................................33 
 
 

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GLOSSARY

Averaging

A method where the measured signals are converted to digital format and data from several signals are

added together and averaged to improve signal/noise ratio.

Bluetooth

A standardized radio frequency wireless link for data transfer using radio waves.

The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.

Electrode

Here: A non-invasive disposable surface electrode, type SE-02 or UNE-01 to be used to measure sensory

nerve action potentials. The low impedance skin contact is made with conductive adhesive developed for

medical use.

EAC (Electrode Activation Code)

Electrode Activation Code ensures that proper Electrode is used during test.

EMC (Electromagnetic Compatibility)

Electromagnetic Compatibility studies the unintentional generation, propagation and reception of

electromagnetic energy with reference to the unwanted effects.

EU (European Union)

European Union.

IEC (International Electrotechnical Commission)

International Standards and conformity assessment for government, business and society for all electrical,

electronic and related technologies.

Lifetime of Mediracer NCS

The time which Mediracer NCS is designed to operate in normal use. The lifetime for Mediracer NCS is defined

to 5 years by the Manufacturer.

Mediracer®

Internationally registered trade mark owned by Mediracer Ltd. Used to identify products belonging to the

Mediracer® product family.

MAC (Mediracer Analysis Center)

A software application, which is a part of the products belonging to the Mediracer® product family. Provides

support for patient management and real-time graphical visualization of signals etc.

Mediracer Ltd

The manufacturer of the Mediracer® product family.

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Mediracer® NCS

A product designed for NCS, belonging to the Mediracer® product family.

Test Device

Hand held test unit (product code ENG-CC-02), part of the Mediracer® NCS product.

NCS (Nerve Conduction Study)

A nerve conduction study (NCS) is a test commonly used to evaluate the function, especially the ability of

electrical conduction of the motor and sensory nerves of the human body.

Nerve response

The electric response peak measured with surface Electrodes from the nerve through the skin.

Here: Portable Computer. The acronym “PC” is commonly known as “Personal Computer”.

Recording amplifier

An amplifier to amplify the measured signal recorded at the wrist or arm and passed to the Test Device

through the interconnecting cable.

Stimulation

Electric stimulation of the nerve with adjustable voltage to activate a Nerve response.

User's Manual

This document.

1 PRODUCT INFORMATION

1.1 SAFETY INSTRUCTIONS

1.1.1 General

The Mediracer® NCS has been designed and tested according to the IEC-standard 60601-1 (EN 60601/BS

5724). This User’s Manual consists of instructions and precautions, which the user must follow to ensure the

safe use of the product and to maintain the product in good operating condition.

The Mediracer® NCS can be used by physician, licensed practitioner or personnel trained in basic health care

practice according to the order of a physician or a licensed practitioner (See Chapter 1, Product Information

and Chapter 3, Operating Instructions).

1.1.2 Test Device

The Test Device has been designed to be used at normal room temperature (+10 C° - +32 C°) and in normal

room humidity and atmospheric pressure at the range of normal conditions. The Test Device is not

waterproof. Therefore, care should be taken not to let any liquid enter the Test Device. Cleaning according

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to cleaning instructions is allowed (See Chapter 4, Service and Maintenance). The charger included in the

product case is medically approved and can be connected to the mains voltage with or without protective

grounding. This can be either medically or non-medically classified.

When the Test Device is not being used it should be stored in the product case or on the Docking Station.

The Test Device fulfils the demands of EMC-standard IEC 60601-1-2 (See EMC Information). Nevertheless, it

is recommended to keep all sources producing strong electromagnetic disturbances far away from the Test

Device and the cables when operating the device.

Device or its parts temperature may rise above the temperature limit described in IEC

60601-1 if the ambient temperature is exceeding the normal use temperature.

Measuring such high temperatures should be avoided.

During the measurement if patient feels hot or burning sensation on the skin area of

electrodes measuring must stopped immediately.

1.2 SYMBOL DEFINITIONS

Symbol

Definition

B-type connection. An accurate explanation can be found from the standard IEC 60601-1,

paragraph 6.8.1-2.

BF-type connection. An accurate explanation can be found from the standard IEC 60601-

1, paragraph 6.8.1-2.

Item containing this symbol meets all the essential requirements of all applicable EU

directives and the applicable conformity assessment procedures have been applied to it.

The Mediracer NCS product is CE marked and has been designed according to the

directive for medical devices 93/42/EEC.

Attention, consult accompanying documents.

Electromagnetic interference may occur in the vicinity of equipment marked with this

symbol.

JQA-symbol. Japan Radio Law Certificate for Radio Frequency devices

Prescription only - device restricted to use by or on the order of a physician

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1.3 INTENDED USE AND OPERATING PRINCIPLE

The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves. The

measured data can be utilized in diagnosing and evaluating patients suspected of having focal or systemic

neuropathies. The measured data must be used in the context of other patient information and must be

reviewed and interpreted by a physician.

Testing is conducted using disposable, non-invasive single patient use Electrodes designed for the product.

The nerve is stimulated with electric pulses and the Nerve responses are recorded. The measured data is

automatically transferred to a PC via Bluetooth. The Nerve response data is displayed on the PC screen with

Mediracer Analysis Center (MAC) software and from that data can be found information on the condition of

the nerve between the stimulus and recording points.

Do not modify or alter the device or its parts. Modifying or altering voids warranty and

Mediracer Ltd. will not take any responsibility damages incur.

Use only for nerve conduction studies (e.g. CTS) from the limbs. The Electrodes must

not be placed on any other part of the body!

Patient with an implanted electronic device should not be subjected to electrical

stimulation unless specialist medical opinion has first been obtained!

Patient with an acute lesion in the hand, e.g. skin laceration, abscessed skin infection

or swelling should have the examination done only after the lesions have healed.

Connection of a patient to an h.f. surgical equipment and an electromyograph or

evoked response equipment may result in burns at the site of the electrical stimulator

of biopotential input part electrodes and possible damage to the electrical stimulator

or biological amplifiers!

Operation in proximity of short wave or microwave therapy equipment may produce

instability in the electrical stimulator output!

Avoid accidental contact between connected but unused applied parts and other

conductive parts including those connected to protective earth!

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1.4 CONTENTS OF THE PRODUCT

1.4.1 Basic examination set

Mediracer NCS device and its parts are delivered in intended box.

1.4.2 Test Device

The Test Device (ENG-CC-02) is a hand-held unit, which is used for acquiring nerve response data from

patients.

The front side of the Test Device contains the operation buttons, which are arrow up, arrow down and OK

button. The OK button is used for switching the Test Device on and for proceeding when a dialogue is

presented on the display. The arrow buttons are used for adjusting the Stimulation level and for navigation

in the system menu.

Above the operation buttons is an LCD display, where the user is able to follow the dialogue and proceed

with using the Test Device.

The white light above the display starts blinking, when the Test Device is connected to a charger. When the

battery is fully charged, the light is constantly on. When the device is not connected to a charger, the light is

off.

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Figure 1 The CTS Test Device from the front side

The top side of the Test Device contains the terminals for the Stimulation and recording cables, and a terminal

for the Charger.

Figure 2 The CTS Test Device from the top side

The bottom side of the Test Device contains connection pads for the Docking Station. The voltage is

connected from the Docking Station to the Test Device via these connection pins. Connection pads at the

bottom of the device and the pins in the docking station. The back side of the Test Device contains the battery

cover.

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Figure 3 Charger pins at the bottom

1.4.3 Stimulation and Recording Cables

The Stimulation cable (SC-01) is used for connecting the Stimulation Electrode to the Test Device through the

Stimulation cable terminal. The recording cable (CC-01, CC-02, CC-03) is used for connecting the recording

Electrode to the Test Device through the recording cable terminal, respectively. The stimulation cable (SC-

02) has a reusable metal stimulation head attached to it. The cables are already connected to the cable

terminals on the Test Device when the product is delivered (See Replacing the Stimulation and Recording

Cables).

Never wrap the cables around the Test Device or twist them with a small radius.

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1.4.4 Charger

The Charger (FW8002M/12) is used for charging the Test Device. The Charger can be connected directly to

the Test Device through the Charger terminal, or to the Docking Station (See Charging the Test Device).

1.4.5 Docking Station

The Docking Station (CR-01) can be used for charging the Test Device by simply placing the Test Device on it

(See Charging the Test Device). The Docking Station requires the Charger, which needs to be connected to

the backside of the Docking Station.

1.4.6 Electrodes

The Electrodes are used for stimulating the nerves and for recording Nerve response signals through the skin.

Figure 4 CTS Electrode

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Figure 5 UNE electrode

The disposable Electrodes are sold separately as sets. There are two types of disposable electrodes available,

CTS and UNE for different purposes. Universal EMG/EEG electrodes can be used only with unique adapter

AD-01. Each set contains two electrodes; one for the Stimulation and one for the recording. Each set is packed

in a sealed pouch to prevent the drying of the conductive adhesive on the Electrodes. When the Electrodes

are stored in sealed pouches at room temperature, protected from direct sunlight, they are usable up to the

expiration date stated on the pouch label (See Storage and Transportation Conditions).

The Electrode pouch has a label with an Electrode Activation Code (EAC) on it. The EAC is used to ensure the

quality of the Electrode and to check that the Electrodes being used are specifically designed for the Test

Device. When a new examination file is prepared for tests (See Preparing for an Examination), the MAC

software asks for the EAC, which must be read into the file with a bar code reader, or by typing in the 20-

character code. The software allows up to 20 tests to be performed on the same patient within 24 hours

period, inside the same examination file, with one EAC.

Reusable, a fixed stimulation bar electrode can alternatively be used together with a recording part of the

disposable electrode for ulnar nerve entrapment ad CTS motor tests. With the fixed electrode, the metal

studs need to be moistened with water or gel for better conduction to locate and stimulate the nerve.

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Figure 6 SC-02 Bar electrode

1.4.7 Bluetooth Connection

When operating with a PC with an internal Bluetooth device the dongle is not needed. Otherwise a Bluetooth

Dongle is supplied with the product for connecting the Test Device to the PC. The wireless connection is

automatically created for the devices by the software.

1.4.8 PC

The PC connects with the other parts of the product, i.e. Test Device, Bar Code Reader, and Bluetooth Dongle

(in case of non-built-in BT in PC).

1.4.9 Symptoms Questionnaire

Special questionnaire templates are provided, which are used to map examination specific symptoms. The

mapped symptoms are used together with the results of the NCS for accurate diagnosis.

2 GETTING STARTED

Before the Mediracer® NCS can be used properly, the following steps must be taken.

2.1 SETTING UP THE TEST DEVICE

Charge the battery of the Test Device, as instructed in Charging the Test Device.

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2.2 SETTING UP THE PC

Refer to the instructions supplied with the PC on how to set up the PC the first time. For the Mediracer® NCS,

perform the following steps:

Make sure the PC is switched OFF.

Connect the Bar Code Reader in one of the USB terminals of the PC.

Connect the Bluetooth Dongle in one of the USB terminals of the PC if the PC does not have a built-in

Bluetooth device.

Switch ON the PC.

The PC is not a medical approved device; therefore, it must not be used inside the

patient treatment area. The patient treatment area is approximately 1.5 m of free

space around the patient (See the standard IEC 60601-1-1 for a more detailed

explanation).

2.3 PREPARING THE ENVIRONMENT

Eliminate the electrical interference coming from surroundings. Keep away from all devices which can cause

electromagnetic disturbances during examination. For example, a refrigerator, a heater panel, or a mains

cables. Note

For accurate results, the mains voltage cable of the examination table (if within

treatment area) should be disconnected before the examination.

The software of the Test Device eliminates the effects of random external disturbances

by discarding the samples with excess noise from the averaged Nerve response. High

electrical disturbance in the environment can cause too few samples to be averaged

and the low sample count can be seen on the data display.

Every test situation is different and every examination room has different electrical disturbances. Therefore,

attention should be paid on eliminating any sources of electrical interference to achieve the best quality of

signals with the Test Device. Due to unpredictable nature of electromagnetic interference, sometimes you

may need to change the location in the room to get the noise level down. When the potential sources of

electromagnetic interference are eliminated, you can move to the next step, and start preparing the patient

for the examination.

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3 OPERATING INSTRUCTIONS

3.1 PREPARING FOR AN EXAMINATION

3.1.1 Preparing the Patient

Prepare the patient's hands for nerve conduction study in order to get the best possible contact for the

Electrodes. The electrode placement area must be washed properly with soap and warm water and dried. If

hand lotion has been used, the hand washing must be done more thoroughly. Normally, hand washing is

sufficient for preparation. If the noise level is too high due to poor skin contact,clean the electrode placement

area by wiping the skin with alcohol or other medical grade cleaning agent, and dry out to get a better contact

for the Electrodes.

If the patient has damaged or blistered skin where the Electrodes should be placed, consult the doctor before

starting the preparations.

3.1.2 Preparing a Patient File

If this is the patient's first NCS examination at the current location, you need to prepare a new patient file

into MAC. Otherwise, you may open the existing patient file.

3.1.3 Preparing an Examination File

Before any tests can be done, a new examination file needs to be created.

At this point, you will need the bar code reader (See Bar Code Reader) and the EAC found on the Electrode

pouch label.

Figure 7 Activation code

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Check that the expiration date has not passed and that the pouch is undamaged before

opening it and using the Electrodes. A damaged pouch will most likely contain a dried

Electrode.

You may use the same Electrode for the same patient during 24 hours for the same

examination for 20 tests, which should be enough. After that, the EAC will expire and

you need to use a new Electrode. The used EAC works only for the patient for whom it

was initially activated.

3.2 PERFORMING THE EXAMINATION

Perform the following steps for each nerve conduction study.

3.2.1 Preparing a Test File

See the instructions for creating a new test file.

3.2.2 Attaching the Electrodes

Depending on the type of examination being done, see the electrode positioning instructions for CTS or UNE.

The disposable Electrodes are for single patient use. Do not reuse the disposable

Electrodes. To prevent cross infection or contamination do not move the Electrode

from one patient to another. Once used dispose of the Electrode according to your

local procedure for waste disposal.

Take care of the Test Device before connecting the Electrodes to the cable terminals to

prevent the Test Device dropping on the floor. The connecting operation occupies both

hands of the operator.

A good Electrode adhesive is moist and has a good adherence on the skin. A fresh

Electrode and proper preparation of the skin are the key elements for a high-quality

test. If the Electrode dries too much during many tests for the same person, you can

moisten it with a drop of water to finish the test. If the wrist is hairy, remove the hairs

with a razor from the Electrode contact area.

3.2.3 Performing the Test

Please refer to the step by step instructions

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3.2.4 Device display explanation

Establishing the Bluetooth connection takes some time and the test signal should be

visible on the PC screen in 10 to 30 seconds. The baseline should locate within the

green area, between values 15 and 25. If the baseline of the signal is not within the

green area, and the background is red, there is too much noise during the test and one

should not continue the test.

To minimize the noise, the patient must be away from sources of electrical interference

such as lifts and mains voltage cables. The Electrode contacts must also be checked,

since poor contact increases noise.

It is essential to get the patient fully relaxed during the nerve conduction study to

minimize muscle tension related disturbances, which are the most common source of

noise.

Continuous muscle tension effects the test results more than small random

movements, because the Test Device eliminates the Nerve responses with excessive

noise level from the Averaging.

If nothing helps to get the noise level down, test the whole system with the test

module as described in Testing the System. A broken cable or broken Electrode contact

can cause similar type problems.

3.2.5 Checking the Test Result

Take a look at the results to confirm the quality of the test. First observe the overall form of the curve, if it

matches a typical result from the corresponding target. Furthermore, check the “Samples” value (20 out of

64 is adequate in most cases, but the cursor placing is proposed by the software only when 32 or more

samples are averaged). If the quality of the test is not good enough, perform a new test on the same target

(return to Preparing a Test File). Otherwise, continue with the examination. Typical result from ring finger

Text on

display

Explanation

Start test?

Displayed when the device is ready for a test

Low battery

The battery level is too low for a test. For continuing, recharge the battery.

Check cable

The recording cable is of wrong type or not connected properly. Check the cable

connection to continue.

Set level

The device is sending stimulation pulses with the displayed level (0-100). Level can

be adjusted with the arrow keys.

Completed!

The device has completed a test.

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Figure 8 Test View

3.3 AFTER THE EXAMINATION

When needed tests have been done to the patient:

Disconnect the Electrodes from the Electrode terminals.

Remove the Electrodes from patient. Adhesive, which may sometimes remain on the skin, is water soluble

and therefore easy to remove.

Dispose of the used Electrodes according to local regulations and instructions.

Place the Test Device into the Docking Station to charge the battery for next tests.

4 SERVICE AND MAINTENANCE

4.1 CLEANING THE PRODUCT

When needed, clean the Test Device and the cables as described below:

Turn off the power from the Test Device and disconnect the charger if connected.

Use clean tissue or cotton, slightly moistened with isopropanol or alcohol. You can also use the cleaning

tissues used to clean your PC display and keyboard. The adhesive from Electrodes may attach to the Test

Device but is easily removed with water moistened tissue.

Take care no water or other liquids enter inside the Test Device or connectors. Do not use a wet tissue.

Clean the cables with water or mild dish washing detergent. Do not use solvents because those may damage

the cables.

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Dry the surfaces with dry tissue when needed.

Never use any solvent, silicone based nor abrasive cleaning agent. Be sure no liquid

enters inside the Test Device through the openings nor connectors during the cleaning

process. If you are going to use any other cleaning agent except those recommended

in this User's Manual, contact your reseller for advice.

4.2 TESTING THE SYSTEM

To check the functionality of the whole test system, connect the test module (PS-01) found in product case

to the Test Device, between the Electrode terminals. Perform a test normally, as with patient. To avoid using

new EAC code you can perform the test adding a new test to a valid examination file of a patient and delete

the test afterwards. This test should be repeated half-yearly to ensure proper operation of the system.

Figure 9 PS-01

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Figure 10 PS-01 Attached to cables

Use Stimulation level 50. The Test Device should give two peaks at 2.4 ms and 3.8 ms. The peak values should

be 2.4 ms +/- 0.2 ms and 3.8 ms +/- 0.2 ms and the difference between the peaks should be 1.4 ms +/- 0.2

ms.

Figure 11 Test result of calibration testing

4.3 CHARGING THE TEST DEVICE

Charge the Test Device on regular basis, once a month when not used. In daily use, store the Test Device in

the Docking Station (if possible) to ensure the maximum capacity of the batteries for carrying out

examinations.

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