Instructions for use HeadApp / NEUROvitalis

Name of product

HeadApp / NEUROvitalis

Produktlogos HeadApp / NEUROvitalis

Producer

HelferApp GmbH
Zur Klus 31
39175 Gommern OT Wahlitz
Germany

Tel.: +49 392 00 491 491
Email: info@helferapp.com

EN ISO 13485 Logo The HelferApp GmbH works according to
quality management standard ISO 13485.

 

 

Medical product

Logo BfArM Bundesinstitut für Arzneimittel und MedizinprodukteHeadApp / NEUROvitalis is a Class I medical device
registered at the BfArM

Intended use of the product

HeadApp / NEUROvitalis is software for cognitive rehabilitation therapy / brain performance training. The platform provides numerous therapy programs for those affected by cognitive impairments in the areas of attention, memory, executive functions and language.

Indications

Mild cognitive impairment: A disorder characterized by impaired memory, learning difficulties, and the decreased ability to concentrate on a task for long periods of time. Often there is a feeling of mental fatigue trying to solve problems. Objectively successful learning is perceived subjectively as difficult. This disorder can occur before, during, or after a variety of cerebral or systemic infections or other physical illnesses. (ICD-10 F06.7)

Cognitive disorders can be caused by
  • Stroke, apoplexy, cerebral insult, apoplectic insult, apoplexia cerebri, ictus apoplecticus (ICD-10 I69.4, I64)
  • Damage to the brain e.g. through accidents, head trauma, concussion, operations (brain tumors), oxygen deficiency (hypoxic or anoxic brain damage), poisoning (through gases, chemicals, drugs, alcohol or drug abuse) (ICD-10 S06)
  • Cerebral haemorrhage a blood vessel or aneurysm (protuberance filled with blood) in the brain ruptures or bursts (ICD-10 I61)
  • Geriatric diseases dementia and Alzheimer’s (ICD-10 F03, G30)
  • Brain infection Meningitis (inflammation of the meninges) (ICD-10 G00) and encephalitis (ICD-10 G00) (inflammation of the brain)
  • Psychiatric disorders, depression, schizophrenia, addiction therapy, geriatric psychiatry (ICD-10 F33, F25
  • Parkinson’s (ICD-10 G20)
  • Multiple Sclerosis (ICD-10 G35)
  • ADS, ADHD (ICD-10 F90)

Patients with these diseases are the target group for the use of HeadApp / NEUROvitalis.

Contraindications

Epilepsies and other diseases with seizure-like symptoms and / or impaired consciousness (ICD-10 G40)

Patients with impaired vision and reading ability, poor hearing and impaired text comprehension and children under 12 years of age should not use HeadApp / NEUROvitalis or only use it under therapeutic supervision.

Residual risks, side effects

No residual risks and undesirable side effects are known when using HeadApp / NEUROvitalis.

Warnings, cautions, actions in the event of malfunction

According to IEC 62304, the HeadApp / NEUROvitalis software was classified in safety class A: No injury or damage to health is possible.

When using HeadApp / NEUROvitalis in clinics, practices and facilities in which several patients use the same device for therapy, the device or the input devices must be disinfected with a damp disinfectant wipe after each use.

The medical device must be used in an environment that avoids distractions and disturbances during exercise.

In the event of malfunctions, please inform HelferApp GmbH via the email address info(at)headapp.com.

Home version: use by laypeople

If you do not know which therapy modules to use, which settings to make or if the therapy is not progressing or successful, please ask your doctor, neurologist, neuropsychologist, occupational therapist, speech therapist or carer in an old people’s home for advice.

Hardware requirements

Computer technology

HeadApp / NEUROvitalis runs on all common computers and operating systems.

  • PCs / laptops with Windows from version 8, recommended screen size from 17 inches
  • PCs / laptops with Apple operating system from OS X, recommended screen size from 17 inches
  • Tablets with Android operating system from version 9 (Pie API 28), recommended screen size from 10 inches
  • Tablets with Apple operating system iPadOS 13, recommended screen size from 9.7 inches
  • Web browser: HeadApp / NEUROvitalis runs on all modern web browsers. It is recommended to always use the latest browser version. The browsers must support the following features: HTML5, ECMA script 6 and CSS Level 2.
Internet connection requirements

Therapy material is constantly being downloaded from servers on the Internet, and therapy progresses are stored on servers. A constant internet connection is necessary for this. A speed of at least 4 Mbps is necessary to ensure smooth work.

If a mobile data connection is used, an average data consumption of 200 Mbit (0.2 GB) per patient and month can be expected.

Firewall

HeadApp / NEUROvitalis communicates with various web servers via the HTTPS protocol. Which data is transferred to which servers is explained in the document “HeadApp Info Data Protection and Server”.

The HTTPS connection to the servers described in the document must be allowed in the firewall.

Version and date of issue

Version 2.1 from 02/25/2021

HeadApp program part

The HeadApp part of the program combines the modules that are used to treat brain damage caused by illness.

You can find all information about HeadApp here …

Jump to NEUROvitalis …

List of HeadApp therapy modules
Short
Name
NameTherapy goal / purposeLevels
of diff.
Link
Pick ItAttention and Focusselective attention, focus, concentration, visual scanning32Cont...
See ItDivided Attentionselective attention, divided attention, neglect, short-term memory3Cont...
Match ItFind pairs,
vis. scanning
selective, divided and spatial attention, visual scanning, neglect, arithmetic, money40Cont...
Hit ItReaction and
Impulse
Control
tonic and phasic alertness, alertness intensity and impulse control54Cont...
Learn ItLern- and Memory StrategiesTeaching of learning and memory strategies to improve the memory performance short-term memory2Cont...
Flip ItShort Term MemoryShort-term memory, memorizing and reproducing figural and verbal content32Cont...
Pair ItShort Term MemoryShort-term memory, memorizing and reproducing figural and verbal content32Cont...
Time ItTime and CalendarAnticipation (improvement of the sense of time), time (recognize, classify, evaluate, manipulate) and calendar (reading and evaluating weekly and monthly calendars18Cont...
My WorldPhoto AlbumPatient-specific, activity-oriented training, knowledge transfer and action sequences that can be personalized for each facility / patient6Cont...
Word ItLanguage: Word UsageBasic handling of words, their meaning, content and pronunciation, synonyms, antonyms, homonyms, vocabulary, word groups, abbreviations12Cont...
Struct ItLanguage: Sentence StructureBasic handling of verbs, adjectives and prepositions and sentence structure, grammar and idioms6Cont...
Sequence ItLanguage: SequencesBasic handling of letters and syllables in words and the sorting of words, parts of sentences and sentences22Cont...
Reason ItLanguage: ReasoningUsing conclusions to choose the right words, according to order, properties, similarities and contexts10Cont...

NEUROvitalis program part

In the program part NEUROvitalis, the modules are summarized which serve the therapy of brain damage caused by degenerative processes.

You can find all information about NEUROvitalis here …

Back to HeadApp …

List of NEUROvitalis therapy modules
Short
Name
NameTherapy goal / purposeLevels of. Diff.Link
Vita TestScreening6 screening tests in the areas of verbal short-term memory, visual-spatial attention, spatial cognition, working memory, language and planning
2 questionnaires: geriatr. depression scale and Bayer ADL
8
(3 parallel)
Cont...
Vita MemMemoryShort and medium-term memory for pictorial content, assignment of terms to general terms, semantic memory24Cont...
Vita PlanThinking and Problem SolvingProblem-solving skills, planning thinking, executive functions, working memory14Cont...
Vita AttAttention / FlexbilityAttention performances “selectivity” and “intensity” (focus), additionally divided attention14Cont...
Vita CitySpational CongnitionSkills for orientation, exploration and action in space, visuoconstructive performance, planning skills16Cont...
Vita LangLanguageCategorization of words, word finding, word production8Cont...
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