Sex-ductus praesensor pre-wired frontalis pro continuo EEG acquisitione in ICU, operatio sala, somni laboratorio et ambulatoria neurologia. Screen-printed Ag/AgCl super composito flexibili trilayer - unum pelliculam, unum positionem, sex canales.
WHY THIS BUILD
One carrier. Six channels. No montage guesswork.
A pre-wired forehead array removes the variable that makes cup-electrode EEG slow and operator dependent: where each contact lands.
01Fixed inter-electrode geometry
All six leads are die-cut on one carrier, so montage spacing is set at the factory. Placement no longer depends on operator technique.
02Three-layer flexible composite
PET / PEN substrate, screen-printed Ag/AgCl conductive layer and a skin-contact hydrogel or non-woven layer, laminated in register.
03Single-piece application
One peel, one placement, one connector insertion. Typical set-up drops from a multi-cup montage to well under a minute.
04Built for OEM integration
Lead count, tail length, connector pitch, gel chemistry and print artwork are all open to specification.
Six identified channels, fixed at the tooling
Lead identification is printed on every branch, so the montage reads the same in every ward and every lot.
Left: hydrogel sensor build / Right: printed silver-trace FPC build — one shared outline
CHANNEL MAP
CT
Centre top
Communis referentia / terra ad frontalem medium lineam
CB
Centrum inferius
Secundus contactus medius, regio glabellae
R1
Dexter interior
Dexter canalis frontalis, positio interior
R2
Dexter exterior
Dexter canalis frontotemporalis, positio exterior
L1
Sinister interior
Sinister canalis frontalis, positio interior
L2
Sinister exterior
Canalis frontotemporalis sinister, positio externa
CT est punctum referentiae commune. Numerus canalium et spatium inter ramos reciduntur ad montagium clientis.
Mensuratum secundum methodum ANSI/AAMI EC12
Figurae infra sunt quae vere acquisitio frontalis videt: offset, drift, impedantia contactus, fundus rumoris, et recuperatio post descensum defibrillationis.
| Parametrum | VMANX VA-EEG-900 |
| Tensio directa compensata | <= 100 mV (typ. <= 20 mV) |
| Instabilitas offset combinata et drift | <= 150 µV/s (typ. <= 50 µV/s) |
| Impedantia AC ad 10 Hz, 100 µA | <= 2 kΩ (typ. <= 800 Ω) |
| Recuperatio supercarricis defibrillationis | <= 100 mV, 5 s post descensu |
| Velocitas derivae post defibrillationem | <= 1 mV/s |
| Rumor internus, 0.15–100 Hz | <= 150 µV p-p (typ. <= 30 µV p-p) |
| Tolerantia currentis bias directi | 200 nA, sine functionis amissione |
| Concordantia impedantiarum inter canales | <= 15 % deviatio per totam seriem |
| Resistentia conductoris, ducens ad pad | <= 200 ohm per canal, typ. |
SAMPLING PER-LOT
• Introientis
Lotus filmi, inki et gelis verificati ante liberationem ad lineam.
• In Processu
Registratio impressionis et latitudo trace verificatae ad frequentiam praefinitam.
• Electricum
Impedantia et offset DC examinatae secundum methodum EC12.
• Finalis
Examinatio visualis, dimensional is et integritatis sigilli ante immissionem in pouch.
Compositum flexibile trilaminare
Impressum, exscissum et laminatum in registro — stratum determinat tam comportamentum electricum quam comfortum usus.
01Substratum dielectricum flexibile
PET vel PEN pellicula, 75–125 µm. Conturum exscissum per laser definit geometriam sex ductuum et collium pro relaxatione tensionis in cauda.
02Stratum conductivum per serigraphiam impressum
Inkum Ag/AgCl impressum et curatum in linea controllata, deinde isolatum per superimpressionem dielectricam, ut tantum fenestra sensoria pateat.
03Stratum interfaciale cutaneum
Gel hydrophile conductivum solidum vel cuneus non-texilis humectus cum adhaesivo sensibili ad pressionem medico, dimensionatus pro singulo canali.
04Terminatio
Contactus caudales aurei vel carbonacei patefacti in passu 1,0 / 1,25 mm, vel habitaculum super-mouldatum pro connexionem clavulatam et caecam.
Limites dimensionales, mechanici et tractationis
MECHANICUS / DIMENSIONALIS
| Configuratio array | sex ductus, unicum corpus, praevinctum |
| Spissitudo totalis laminatae | 0.30 - 0.45 mm (0.35 mm typ.) |
| Area patellae sensoriae, per canalum | 150 - 320 mm2, per specificatio |
| Cauda Longitudo | 150 - 1200 mm, secundum ordinem |
| Interstitium contactus caudae | 1.00 / 1.25 mm, aurum vel carbo |
| Durabilitas flectionis, collum caudae | > 5000 cycli ad R5 mm, nullus circuitus apertus |
| Adhaesio detractionis, 180 gradus ad ferrum | 4 – 8 N/25 mm, secundum selectionem gelis |
| Tempus usus validatum | usque ad 24 h continuo |
AMBIENS / CONDITIO
| Temperatura operativa | 10 °C ad 40 °C |
| Humiditas Operandi | 30 % ad 75 % RH, non condensans |
| Temperatura servandae | 5 °C ad 30 °C, in sacculo foliaceo clauso |
| Vita Shelf | 18 mensium ab die fabricati, typ. |
| Optio sterilisationis | EO vel gamma, validatum ad petitionem |
| Status praebitionis praedefinitus | Non sterilis, ad usum singularem, in sacculo hermetice clauso |
| Emballagium primum | Sacculus laminatus ex folio, desiccans ad petitionem |
| Optio portans | Vagina thermoformata ex PETG pro alimentatione lineae automatizatae |
Systema materiae
Substratum
PET / PEN, sine halogenis
SYSTEMA CONDUCTIVUM
Ag/AgCl impressum per serigraphiam
Interfacies cutanea
Conductive hydrogel or wet non-woven
Tenaces
Medical grade acrylic PSA
TAIL CONTACTS
Immersion gold or carbon
Optiō Cāsūs
Over-moulded TPE / PP
LATEX CONTENT
Sine Latice
Substance Compliance
RoHS / REACH declared
Real parts, shipped configurations
Every image below is an actual VMANX build of this platform - not a render. The same die-cut geometry is released in several interface and termination options.
The released baseline build. Six leads on one carrier with the midline CT / CB pair and the paired R1 / R2 and L1 / L2 frontotemporal channels, terminated in an exposed gold tail contact block for a direct ZIF insertion.
• Fixed montage geometry, no operator spacing error
• Printed lead identification on every branch
• Strain-relief neck between array and tail
The same die-cut outline is released in two interface builds: a hydrogel sensor build for wet-contact acquisition, and a fully printed silver-trace build on a flexible circuit tail for direct board-level termination.
• Hydrogel build for standard clinical acquisition
• Printed silver-trace build for FPC-terminated systems
• Common footprint keeps one application procedure
Pro lineas OEM quae alimentationem automatizant, arayum in portatore thermoformato cum custodia connexorum super-mouldata suppeditatur. Custodia clavata facit coniunctionem caecam et repetibilem ad lectum.
• Custodia super-mouldata clavata, coniunctio caeca
• Vagina thermoformata PETG pro alimentatione per captum-et-ponendum
• Cavitas vaginae ad formam liberatam adaptata
Impressio per cribrum, recisio per formulam et laminatio in instrumentis registratis fiunt, ita ut positio fenestrae sensoriae et latitudo tracium impressorum per totum lotum repetantur. Impedantia et offset directus per singulum lotum ante liberationem examinantur.
• Instrumenta registrata, fenestra sensoria repetibilis
• Examina impedantiae et offset directi per singulum lotum
• Plena tractabilitas per totum lotum ab aggregato lineari usque ad saccellum
Ubi arayum frontale praeviratum suum locum meretur
ICU —— Electroencephalographia continua ad lectum
Monitoratio diuturna patientium sedatorum et in cura critica, absque plena capsula montagii.
LABORATORIUM SOMNI —— Polysomnographia
Acquisitio frontalis humilis quae manet applicata per totam noctem.
SALA OPERATORIA —— Profunditas anaesthesiae
Positio cito unius partis ad inductionem, cum coniunctione claviformi ad modulum anaesthesiae.
NEUROLOGIA —— Ambulatoria examinatio
Operatio recorderis cincturae, ubi patiens clinica excedit sensorio induto.
Quod ad specificandum aperimus
Haec est platforma componentium, non elementum catalogi. Elementa infra ad descriptum delineationem clientis resecantur.
Numerus ductuum et dispositio
Numerus canalium, distantia, et geometria ramorum ad dispositum clientis resecantur.
Cauda et terminatio
Longitudo, interstitium, metallizatio contactuum, rigidificator FPC, aut custodia super-moldata.
Interfacies cutanea
Chemia gelis, adhaesivitas, et area disci ad tempus indumenti et ad typum cutis adaptata.
Print & identification
Customer artwork, lead marking, lot and UDI field printed in line.
Emballatio
Pouch, tray, kitting and labelling to the customer released drawing.
Documenta
Drawing pack, per-lot test record and biocompatibility evidence under ISO 10993.
Certified where it counts, honest about the rest
ISO 13485:2016
Medical QMS
ISO 10993
Compatibilitas biologica
RoHS / REACH
Substance Compliance
VMANX supplies this product as an OEM component. ISO 13485:2016 covers the VMANX quality management system and ISO 10993 covers biocompatibility evaluation of the patient-contacting materials. Registration, clinical validation and market approval of the finished medical device remain the responsibility of the legal manufacturer placing that device on the market. Typical values are production means, not guaranteed limits; the released specification governs. Specifications are subject to change without notice.
Dongguan Zhongman Industrial Co., Ltd.
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