Idmed Algiscan Bedienungsanleitung

User Manual AlgiScan 1

USER MANUAL

AlgiScan

Version 3.2 - EN

Last update 2021/04/19

Ref: ALG-IFU_EN

USER MANUAL

User Manual AlgiScan 2

User Manual AlgiScan 3

CONTENTS

About this manual............................................................................................... 5

Indications of use................................................................................................. 5

Expected performance....................................................................................... 5

Clinical Benets..................................................................................................... 5

Important information about the use of AlgiScan ............................... 6

I Safety measures ................................................................................................ 6

I.1 Warnings..........................................................................................................................................7

I.2 Caution........................................................................................................................................... 8

I.3 Explanation of symbols.........................................................................................................10

II General description ........................................................................................12

Overview of the AlgiScan and its accessories............................................................... 12

Display screen .................................................................................................................................12

Touch screen.................................................................................................................................... 12

General use.......................................................................................................................................13

Fitting the positioning eyecup.................................................................................................13

Installation and positioning of the AlgiScan....................................................................13

Turning the device ON/OFF.......................................................................................................14

Patient Files / Measurements identication....................................................................14

Settings................................................................................................................................................14

III Using the AlgiScan.........................................................................................15

Create or select a patient’s le...............................................................................................15

Taking a measurement ..............................................................................................................16

Hold function ....................................................................................................................................16

Measurement protocols............................................................................................................. 17

Selecting the Measurement Protocol..................................................................................18

“Flash” mode .....................................................................................................................................18

“PRD” mode ........................................................................................................................................19

“Tetanus” mode...............................................................................................................................19

« PPI » Mode.......................................................................................................................................21

Connection and positioning of the stimulation electrodes ...................................22

Display of the results...................................................................................................................24

Results in the “Light ash” stimulation mode .................................................................24

User Manual AlgiScan 4

Results in the “Tetanus” mode................................................................................................26

Results in “PRD” mode .................................................................................................................27

Results in the “PPI” mode...........................................................................................................28

Review saved les / Trend charts........................................................................................29

Selecting a patient’s le.............................................................................................................29

IV Preventive maintenance, cleaning and disinfection ...................30

Preventive maintenance...........................................................................................................30

Battery and battery charging.................................................................................................30

Cleaning and Disinfection.........................................................................................................31

V Appendix 1..........................................................................................................32

Troubleshooting.............................................................................................................................32

VI Appendix 2........................................................................................................33

End of life equipment / Recycling........................................................................................33

Specication and warranty .....................................................................................................33

Environment.....................................................................................................................................33

Technical specications............................................................................................................34

VII Appendix 3 : accessories..........................................................................37

User Manual AlgiScan 5

About this manual

This operating manual contains all the information necessary to set up and use the

portable pupillometer AlgiScan manufactured by IDMED. It also describes the specic cleaning

and checking procedures that you may need to perform. This manual is intended for use by

qualied medical personnel only (state registered nurses, anaesthetists and doctors).

Keep this operating manual with the AlgiScan. It serves as a maintenance and repair manual.

Read the safety information in this manual carefully before using the AlgiScan.

Indications of use

The AlgiScan is a portable video pupillometer, intended to:

- Measure patients’ pupils quickly and easily,

- Evaluate the pupillary light reex of the patient following a photo-stimulation

- Evaluate nociceptive responses and the extent of analgesic response following an electrical

stimulation, in patients in the operating theatre, in recovery or in critical care

These patients are sedated and unable to communicate.

The usage mode for this device in non-continuous.

It provides the user with reliable, accurate and reproducible measurements. In a few

seconds the user has access not only to the measurement of the pupil diameter, but also

to the characteristics of its dynamic evolution: minimum, maximum, latency and speed of

evolution.

The size and reactivity of the pupil are considered as supplementary data which provide

more precise information on the analgesic condition and hypnotic state of the patient and his

pupillary light reex.

The use of AlgiScan allows to adjust the sedation dosage without replacing the usual practice

(clinical or pharmacological).

Two parts of the Algiscan may be in contact with the patient: the stimulation cable via the

appropriate electrodes and the eyecup.

Expected performance

The following features are the essential performance characteristics of the AlgiScan:

- Measure the average diameter of a patient’s pupil to an accuracy of +/- 0.1 mm (simulated

pupil of 3 mm diameter).

- Generate a white light stimulation with an intensity of 320 lux +/- 10%, and a duration of

1 sec +/- 0.1 sec.

- Generate electrical skin stimulation in the form of pulse train of 200μs, 100Hz, with an

amplitude between 0 and 60mA and a total duration between 0 and 8s.

Its characteristics are produced with an accuracy of +/- 10%.

Clinical Benets

The clinical benets of the AlgiScan are:

- A measurement of the patient’s analgesia level using their pupillary dilation reex.

- A precise measurement of the pupillary dilatation reex.

- A reproducible and quantitative measurement of the photomotor reex (Pupil Light Reex)

in neurological assessment.

User Manual AlgiScan 6

Important information about the use of AlgiScan

The AlgiScan compact video pupillometer is designed to be used by an authorised health

professional (anaesthetist, medical doctor or state registered nurse, anaesthetist nurse)

who has received special training in its use. The system, and all associated parameters, are

designed to be used on adult and paediatric patients in a hospital or health care facility to

monitor the responsiveness of their pupils to various stimuli.

The measurements performed by the AlgiScan on the pupillary reactivity of the patient can be

used to monitor the effects of certain anaesthetic products.

The interpretation of the results provided by the AlgiScan should always be subjected to

clinical judgement and compared with other clinical signs observed. We strongly advise

against relying solely on the results or values provided by the AlgiScan for monitoring sedated

or anaesthetised patients. The values provided by the AlgiScan should also be interpreted

with care when in the presence of certain products such as Barbiturate, Nitrous oxide, etc. It is

also necessary to interpret with care values measured on patients suffering from neurological

problems.

The AlgiScan conforms to the European directive covering medical devices and to the

regulations in force in the country of distribution.

For further information please contact IDMED, the manufacturer of the AlgiScan via their

website WWW.IDMED.FR or by post to the following address:

IDMED

Hôtel Technoptic

2 rue M. DONADILLE

13013 MARSEILLE

FRANCE

Phone : +33 (0)4.91.11.87.84

I Safety measures

INTRODUCTION

The user must read carefully the whole manual before operating the AlgiScan.

WARNING, CAUTION, NOTES

The terms Warning, Caution and Notes have precise meanings in this manual.

• WARNING warns against certain actions or situations likely to cause injury or death.

• CAUTION warns against actions or situations likely to damage the equipment, produce

inaccurate data or cancel a procedure, even if injury is unlikely.

• A NOTE provides useful information about a function or procedure.

EXPLANATION OF SYMBOLS

The symbols that may appear on the AlgiScan display are compiled and explained at the end

of this chapter.

Any serious incident occurring in connection with the device must be notied to the manu-

facturer and to the competent authority of the Member State or country in which the user and

the patient are established.

User Manual AlgiScan 7

I.1 Warnings

Explosion risk: do not use the AlgiScan in a ammable atmosphere or in places where

ammable anaesthetic products may accumulate.

The AlgiScan is not designed to operate in the environment of a SCANNER, M.R.I. or any

other appliance creating powerful magnetic elds.

The electrode wires, electrodes or connectors should not come into contact with other

conductors.

Never use the Electrical Stimulation of the AlgiScan while using high frequency surgical

appliances.

To reduce the risk of burns when using high frequency surgical appliances, do not place

the AlgiScan stimulation electrodes between the surgical site and the return electrode to

the electro surgery unit.

The connection to a patient at the same time as a high frequency surgery appliance can

cause burns at the points of contact of the AlgiScan electrodes and damage the appli-

ance.

Never use the AlgiScan simultaneously with the use of debrillation appliances.

The AlgiScan should never be connected continuously to electrodes positioned on the

patient but only for the period of measurement. Before and after the measurement, the

electric cable should be disconnected from the electrodes.

The AlgiScan must be connected to pacing electrodes or ECG electrodes supporting

voltages up to 300 Volts with a current of 60 mA. The contact area of the electrodes must

be greater than 1.8cm².

The power of the Electrical Stimulation causes nociceptive stimuli the intensity of which

should be appropriate to the patient’s analgesic level.

Never use the AlgiScan on a patient wearing a Pacemaker.

Never use the AlgiScan in the vicinity of short-wave or micro-wave therapy appliances.

Before using check that no other equipment, device or appliance is in contact with the

electrodes.

The electrodes may only be in contact with healthy, non-injured skin.

Before use, check the device, display and cable for damage. Never use the unit if any

defect or damage is found.

The AlgiScan in electrical stimulation mode (Tetanus, PPI) performs tetanus electrical

stimulus as well as increasing tetanus stimulations for a duration of 1 to 8 seconds. In

Tetanus and PPI mode, the AlgiScan provide electrical stimulation. When using a

monitoring system of neuromuscular blockade, the user should take care to wait 5

minutes after a Tetanus or PPI test before making a measurement of the patient’s level

User Manual AlgiScan 8

of neuromuscular blockade. In order not to bias the estimation of the measure of level of

neuromuscular blockade.

After taking any measurements, check the patient’s complete eyelid closure to protect

the eye from dryness and cornea alteration.

In order to prevent electromagnetic disturbance, keep minimum separation from RF

communication equipment of 30cm.

Use of this equipment adjacent to or stacked with other equipment should be avoided

because it could result in improper operation. If such use is necessary, this equipment

and the other equipment should be observed to verify that they are operating normally.

Any hardware or software modications to the device are prohibited.

Use of accessories, transducers and cables other than those specied or

provided by the manufacturer of this equipment could result in increased electromagnetic

emissionsorde-creasedelectromagneticimmunityofthisequipmentandresultinimproper

operation.

The electrodes will never be placed on the patient’s head or any other part of the body

that is judged to be potentially sensitive to electrical stimulation or may result in a risk of

injury to the patient.

Do not apply stimulation or place electrodes on the patient’s face and head (especially

the eyes, lips, entire neck). Do not position the electrodes on either side of the heart.

The use of the AlgiScan should not result in any signicant pressure of its eyecup on the

patient’s face but only putting it in contact. If too much pressure is applied, light marks

or red patches may appear on the skin in the contact area due to pressure points. They

should remain limited and not related to an injury.

I.2 Caution

Read this manual thoroughly and attentively before using the AlgiScan.

Do not autoclave the AlgiScan or any of its components or accessories other than the eyecup.

Never submerge the appliance or any of its components in liquid, or spray it or clean it with

liquid.

The AlgiScan and its components are not compatible with sterilisation processes by gas,

radiation (gamma or other), baths, steam or heat.

Follow the instructions for cleaning and disinfecting the AlgiScan given in the “Cleaning and

Disinfection” chapter.

The AlgiScan contains a lithium-ion battery. The AlgiScan battery must never in any

circumstances be removed, modied or replaced. Any intervention on the battery

presents a risk of re or explosion, only qualied technicians or IDMED company technicians

are competent to do such work.

After a long period of non-use (storage), recharge the battery of the AlgiScan for at least

4 hours before use. If the AlgiScan does not start when the device is picked up (motion

User Manual AlgiScan 9

detection), the AlgiScan must not be used and must imperatively undergo maintenance

operations.

Only qualied technicians are qualied to do repairs and maintenance, after obtaining

permission from IDMED.

The connection to a patient at the same time as a high frequency surgery appliance can

cause burns at the points of contact of the AlgiScan electrodes, and damage the appliance.

It should be noted that in all cases, in order to avoid any risk of corneal dryness, the use of

the device on the patient (open eye) should not exceed 60 seconds continuously. In order to

avoid any risk of corneal or retinal damage, the number of measurements performed on a

single patient should not exceed 10 per hour.

The AlgiScan’s users must take care not to be in contact with any other electrical appliances

when using the AlgiScan.

Before any stimulation the practitioner will evaluate the compatibility of the stimulation

intensity to the level of analgesia and sedation of the patient as well as the site of stimulation.

We strongly advise against placing the electrodes on the patient‘s thorax because of the

additional risks of cardiac brillation.

Never touch the electrodes during the stimulation phases. The electrodes are only surface

electrodes and are compatible with the application of electrical stimulation (CE marking

adapted).

Use only the accessories/components supplied by IDMED.

In order to prevent electrostatic shock, the device must be used in an electrostatic limited

environment (see Environment section).

Notice on Electromagnetic Compatibility (EMC) : This device generates, uses, and can

radiate radio frequency energy. If not set up and used in accordance with the instructions in

this manual, electromagnetic interferences may result.

The equipment has been tested and found to comply with the norm IEC60601-1-2 for medical

electrical equipment.

These limits provide reasonable protection against electromagnetic interferences when

operated in the intended environments (e.g. hospitals).

Known contraindications to use the AlgiScan: orbit structure damaged, surrounding soft tissue

oedematous, abraded skin.

User Manual AlgiScan 10

I.3 Explanation of symbols

Symbols are on the labels

Caution Serial Number

Indicates the necessity for

a separate processing from

household waste.

Marking for conformity with

the European directive cov-

ering medical appliances

Date of rst CE marking:

2010

Manufacturer IP 30

Protection class against

solid foreign bodies and

liquids.

Not protected against

liquids.

Refer to the user manual Type BF Applied Part

Catalog reference Direct Current DC

Prescription use only in the

USA Curtis-Straus Mark

(USA and Canada)

Manufacturing date Medical device

Qi Compliant Contains

FCC ID

Bluetooth module compli-

ant with the FCC regulation

part 15

Bluetooth module compliant

with Japanese regulation

YYYY Manufacturing date,

Manufacturer

Symbols on AlgiScan screen

Main button Home button

Settings menu Previous step

Delete measurements or le Conrmation of the record-

ing of the measurement

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