Instructions for use HeadApp / NEUROvitalis
Name of product
HeadApp / NEUROvitalis
Producer
HelferApp GmbH
Zur Klus 31
39175 Gommern OT Wahlitz
Germany
Tel.: +49 392 00 491 491
Email: info@helferapp.com
The HelferApp GmbH works according to
quality management standard ISO 13485.
Medical product
HeadApp / 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 | Name | Therapy goal / purpose | Levels of diff. | Link |
|---|---|---|---|---|
| Pick It | Attention and Focus | selective attention, focus, concentration, visual scanning | 32 | Cont... |
| See It | Divided Attention | selective attention, divided attention, neglect, short-term memory | 3 | Cont... |
| Match It | Find pairs, vis. scanning | selective, divided and spatial attention, visual scanning, neglect, arithmetic, money | 40 | Cont... |
| Hit It | Reaction and Impulse Control | tonic and phasic alertness, alertness intensity and impulse control | 54 | Cont... |
| Learn It | Lern- and Memory Strategies | Teaching of learning and memory strategies to improve the memory performance short-term memory | 2 | Cont... |
| Flip It | Short Term Memory | Short-term memory, memorizing and reproducing figural and verbal content | 32 | Cont... |
| Pair It | Short Term Memory | Short-term memory, memorizing and reproducing figural and verbal content | 32 | Cont... |
| Time It | Time and Calendar | Anticipation (improvement of the sense of time), time (recognize, classify, evaluate, manipulate) and calendar (reading and evaluating weekly and monthly calendars | 18 | Cont... |
| My World | Photo Album | Patient-specific, activity-oriented training, knowledge transfer and action sequences that can be personalized for each facility / patient | 6 | Cont... |
| Word It | Language: Word Usage | Basic handling of words, their meaning, content and pronunciation, synonyms, antonyms, homonyms, vocabulary, word groups, abbreviations | 12 | Cont... |
| Struct It | Language: Sentence Structure | Basic handling of verbs, adjectives and prepositions and sentence structure, grammar and idioms | 6 | Cont... |
| Sequence It | Language: Sequences | Basic handling of letters and syllables in words and the sorting of words, parts of sentences and sentences | 22 | Cont... |
| Reason It | Language: Reasoning | Using conclusions to choose the right words, according to order, properties, similarities and contexts | 10 | Cont... |
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 …
List of NEUROvitalis therapy modules
| Short Name | Name | Therapy goal / purpose | Levels of. Diff. | Link |
|---|---|---|---|---|
| Vita Test | Screening | 6 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 geriatr. everyday skills | 8 (3 parallel) | Cont... |
| Vita Mem | Memory | Short and medium-term memory for pictorial content, assignment of terms to general terms, semantic memory | 24 | Cont... |
| Vita Work | Working Memory | Improves the processing capacity of the brain, supports concentration, reasoning and learning. | 53 | Cont... |
| Vita Plan | Thinking and Problem Solving | Problem-solving skills, planning thinking, executive functions, working memory | 14 | Cont... |
| Vita Att | Attention / Flexbility | Attention performances “selectivity” and “intensity” (focus), additionally divided attention | 14 | Cont... |
| Vita City | Spational Congnition | Skills for orientation, exploration and action in space, visuoconstructive performance, planning skills | 16 | Cont... |
| Vita Lang | Language | Categorization of words, word finding, word production | 8 | Cont... |