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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  first  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

MM

YYYY

Manufacturing date, 

Manufacturer

Symbols on AlgiScan screen

Main button

Home button

Settings menu

Previous step

Delete measurements or file

Confirmation of the record

-

ing of the measurement

Содержание Algiscan

Страница 1: ...User Manual AlgiScan 1 USER MANUAL AlgiScan Version 3 2 EN Last update 2021 04 19 Ref ALG IFU_EN USER MANUAL...

Страница 2: ...User Manual AlgiScan 2...

Страница 3: ...reen 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 identification 14 Settings 14 III Using...

Страница 4: ...patient s file 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 A...

Страница 5: ...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 precis...

Страница 6: ...cessary 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...

Страница 7: ...easurement 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 t...

Страница 8: ...nt 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 significant pressure of its eyecup o...

Страница 9: ...gesia 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 fibrillation N...

Страница 10: ...ds 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...

Страница 11: ...electrode symbol Correct electrode conduc tion level skin Yellow electrode symbol Moderate electrode conduc tion level skin Red electrode symbol Non functional electrical stimulation conduction probl...

Страница 12: ...y screen in the Flash mode measurement mode used for measuring the pupillary light reflex Touch screen The AlgiScan is designed in such a way that all controls are accessible with a simple touch of a...

Страница 13: ...by the user by selecting one of the available modes of the AlgiScan This type of measurement will then give a series of results with figures and a curve representing the variation in the size of the p...

Страница 14: ...es numbered 1 to 20 If there is no barcode scanning the user will either choose one of those files or create additional files numbered 21 and above to save the measurement results Settings Setting the...

Страница 15: ...enu follow the steps below Select settings menu by pressing on Then select data transfer by pressing on Using the arrows select the transfer mode PC HL7 Connect your receiver module on PC ref NL WDT o...

Страница 16: ...upil detection When the pupillometer is ready for a measure the following icon will appear at the bottom right of the video image Note when the pupil detection is not correct the red icon will appear...

Страница 17: ...is used to measure the pupil reactivity to a standardized electrical stimulation Before starting the user selects the intensity of the electrical stimulation which will be applied and makes sure it i...

Страница 18: ...s strength is fixed at 320 Lux The overall duration of the test is 4 seconds Selection of light stimulation To select light stimulation and adjust its power Press the symbol on the screen representing...

Страница 19: ...red in green on the screen Start recording by pressing the main button Press and hold the main button for the duration of the recording Recording stops automatically at 60s or when the user releases t...

Страница 20: ...by pressing the navigation arrows until the desired value is displayed Confirm your selection by pressing the following symbol Note To exit the pop up window or cancel the intensity selection press th...

Страница 21: ...tion is more than 13 during the 30 mA stimulation stage 40 6 The pupil s variation is more than 13 during the 40 mA stimulation stage 50 5 The pupil s variation is more than 13 during the 50 mA stimul...

Страница 22: ...the end of the electrical stimu lation Note that the AlgiScan emits a first beep when the electrical stimulation starts Dur ing the stimulation the device emits a beep at each new level the tone of wh...

Страница 23: ...ring Patient Electrodes conduction level and skin resistance The level of conduction of the electrodes is checked by the AlgiScan as soon as an electrical stimulation with a non zero current is select...

Страница 24: ...displayed depend on the protocol used It is important to control the quality of the displayed curve and to verify that measurement values are not artefacts Thus the blue and black horizontal lines ind...

Страница 25: ...ualitative scale of the photomotor reflex 5 levels 3 colours to determine commentary on pupil reactivity level The quantitative and qualitative scale of the photomotor reflex and resulting commentary...

Страница 26: ...time It also displays the evolution of the variations in pupil size for the same file over time Normal zone strong reactivity Diameter 10 01 12h00 12h00 2 mm 4 6 8 Variation 10 20 30 40 History scale...

Страница 27: ...olours The value taken into account for the qualitative quantitative scale of the Pupillary Reflex Dilation and for the display of the comment is the amplitude of the reflex value as a percentage They...

Страница 28: ...itude of the reflex value as a percentage They are only indicative and must be corroborated with other physiological indicators commonly used Amplitude of the PRD reflex in PRD 5 5 PRD 12 12 PRD 20 PR...

Страница 29: ...ds Barcode reading Create new patient s file Home page Note If a data transfer mode is active the following icon is displayed on the screen It allows send all the patient s data to the configured rece...

Страница 30: ...ed to carry out repairs or maintenance operations Battery and battery charging Battery The AlgiScan contains a rechargeable Lithium Ion battery It is fitted with thermal protection and protection agai...

Страница 31: ...Note Only qualified technicians or IDMED personnel are authorised to carry out repairs or maintenance operations on the battery Cleaning and Disinfection Attention Do not autoclave the AlgiScan or any...

Страница 32: ...be cleaned with a lint free cloth and wiped carefully to avoid any stains or reflections The electrode wire used with the AlgiScan should not come into direct contact be submerged sprayed or filled wi...

Страница 33: ...isposed of or recycled according to the regulations in force Specification and warranty Environment Storage and expedition The AlgiScan and its accessories should be stored or transported within the l...

Страница 34: ...icker IEC 61000 3 3 Compliant The AlgiScan can be connected to the public mains network EMC Immunity Phenomenon Basic EMC standard Professional healthcare facility environment Immunity Test Levels Com...

Страница 35: ...ce keep minimum separa tion from RF communication equip ment of 30cm RATED power frequency magnetic fields IEC 61000 4 8 30 A m 50 Hz or 60 Hz 30 A m 50 Hz or 60 Hz Mains power quality should be that...

Страница 36: ...IAB Please check with your authorized distributor or with the manufacturer which products are available and approved in your country Light Stimulation Duration 1 second Intensity fixed at 320 Lux prec...

Страница 37: ...MED references Medical accessories of the AlgiScan Reference Description STA W2 Wireless charging station for AlgiScan CAB STIM3 Electric stimulation cable for AlgiScan Other accessories Reference Des...

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