Safety and legal recommendations
Product description
Technical specifications
Instructions for use
Maintenance
5.1 CHARGING THE BATTERY
The device can only be used on battery power. Therefore, the battery must be charged regularly. One battery charge is sufficient for approximately 2500 measurements or 19 hours of continuous use.
To charge the battery, place the MESI THERMO UNIT on the MESI LARGE CHARGING PLATE (CS4SYS) or MESI SMALL CHARGING PLATE (CS2SYS). During the charging process, the light on the module will flash orange. Only when the device is completely charged will it start flashing green. For more information, see chapter 4.7 – Multifunctional buttons.
If the capacity of the battery is significantly decreased after a period of intensive use, the battery is most likely spent and should be replaced. As the device does not contain any parts that can be replaced by a user, contact your local distributor or the manufacturer for battery replacement.
5.2 CLEANING AND DISINFECTION
⚠️Before cleaning, disconnect from the mains. Due to constant standby mode of the device, do not clean the terminals as this may cause electrical shock.
⚠️Only perform routine cleaning and maintenance procedures specifically described in these Instructions for Use.
MESI THERMOMETER UNIT
If correctly used and maintained the device will have a minimum service life of 5 years. The device can be stored under suitable conditions for a maximum of 5 years. When using the device after storage, we recommend that you carry out a thorough maintenance check on the device.
10.4 NETWORK CONNECTIVITY AND INTEGRATION REQUIREMENTS
The mTABLET may be connected to an IT-NETWORK (e.g., hospital network or cloud infrastructure) to support integration with healthcare information systems, secure data transmission, and remote service access. This section outlines the technical and procedural requirements for safe and effective network integration.
a) Purpose of the mTABLET connection to an IT-NETWORK
The mTABLET connects to an IT-NETWORK to:
Synchronize data with cloud services (optional)
Exchange patient and measurement data with hospital information systems (HIS/EHR)
Enable secure remote maintenance and software updates (where applicable)
b) Required characteristics of the IT-NETWORK
The IT-NETWORK must fulfill the following characteristics:
Support for standard TCP/IP communication
2.4GHz or 5GHz Wi-Fi or Ethernet (mTABLET dock)
WPA2 or WPA3 encryption (Enterprise or PSK)
Sufficient bandwidth for low-latency medical data transmission
c) Required configuration of the IT-NETWORK
The IT-NETWORK should be configured with:
DHCP or Static IP assignment
Open ports for HTTPS (443), and DNS (53)
Allowed outbound access to MESI cloud services (if cloud is used)
Correct certificate and identity management (if WPA2-Enterprise or EAP is used)
d) Technical specifications of the network connection, including security specifications
Transport protocols: HTTPS over TLS 1.2 or higher
Application protocols: REST API, GDT, HL7, DICOM, XML, JSON or proprietary integration formats
Data encryption: all transmitted patient and system data is encrypted in transit
e) Intended information flow
| Source | Destination | Data Type |
|---|---|---|
| mTABLET | EHR/HIS systems | Patient data, test results |
| mTABLET | Cloud (MESI) | Patient data, test results |
| Cloud (MESI) | mTABLET | Device sync, software updates |
| HIS/EHR | mTABLET | Patient demographics, worklist |
Information is routed via secure channels and does not traverse public networks unless explicitly configured for cloud operation.
f) Hazardous Situations from IT-NETWORK Failures
The following hazardous situations may arise if the IT-NETWORK does not meet required characteristics:
Loss or delay of critical medical data
Incomplete synchronization leading to outdated records
Unauthorized data access due to misconfigured firewalls or certificates
Network downtime causing delayed diagnostics or workflow disruptions
NOTE: In the event of IT-NETWORK failure, the mTABLET continues to operate in standalone mode. All locally stored measurement results and patient data remain accessible to the user directly on the device, ensuring continuity of care even when network connectivity is lost.
Information for the Responsible Organization
The responsible organization (e.g., hospital IT department) is accountable for ensuring that the network environment where the mTABLET operates complies with the following:
Proper segmentation and access control for medical devices
Secure and reliable wireless or wired infrastructure
Routine patching and monitoring of the network and access points
Risk assessment when modifying the network or adding new devices
Changes to the network that may impact device performance include:
Reconfiguration of switches, firewalls, or Wi-Fi access points
Network topology changes or bandwidth limitations
Introduction of new connected devices that may overload the infrastructure
NOTE: The mTABLET is validated by the MANUFACTURER for operation over standard networks but is not validated for all possible IT-NETWORK configurations. The f inal network design and integration remain under the responsibility of the healthcare organization or integrator.
Summary of Network Risks
The MESI mTABLET system depends on secure network communication for functions such as cloud synchronization, analytics, remote configuration, and integration with third-party systems. The following network-related risks have been identified during the cybersecurity threat modeling process:
| Risk | Threat Category | Potential Impact | Mitigation Type |
|---|---|---|---|
| Loss or delay of data transmission | Denial of Service | Delayed synchronization or data upload systems | Local caching of data, retry mechanisms, |
| Incomplete data transfer or interrupted workflows | Denial of Service | Temporary loss of remote features (e.g., cloud backup, PDF export) | Device retains full functionality and data access offline |
| Unauthorized access to network endpoints | Spoofing / Elevation of Privilege | Potential for data leakage or control hijacking | TLS 1.2+ encryption, JWT token expiration, API key authentication |
| Data interception or tampering | Tampering / Information Disclosure | Compromised data integrity during transmission | HTTPS for all traffic, hashing, replay protection, CSRF mitigation |
| Audit trail or log integrity compromise | Repudiation | Difficulty tracking incidents or user actions | Logging with timestamped source validation, Sentry monitoring |
| Weak authentication or impersonation | Spoofing / Information Disclosure | Bypass of security controls or unauthorized access | Strong credential handling, 2FA, certificate pinning, no USB debug |
| Analytics or error reporting unavailability | Denial of Service | Temporary loss of insights or usage data | Does not affect patient care; app continues operating normally |
NOTE: Even in the case of full IT-NETWORK failure, the MESI mTABLET remains operational in standalone mode. All locally stored patient data and test results remain accessible directly on the device, ensuring uninterrupted use at the point of care.
General warnings
10.1 CHARGING THE BATTERY AND STORING
If you wish to use the device on battery power, you must ensure that the battery is charged regularly. Between use the MESI mTABLET UNIT should be placed on the MESI mTABLET WI-FI DOCKING UNIT to charge its battery.
If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely worn out and you should contact your dealer or the manufacturer about replacing the battery.
When the device is charging the display on MESI mTABLET UNIT will be displaying charging status.
10.2 CLEANING INSTRUCTIONS
Cleaning the device regularly with a soft, dry or slightly damp cloth – is recommended. Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device.
10.3 PRODUCT LIFE AND STORAGE
If correctly used and maintained the device will have a minimum service life of 5 years. The device can be stored under suitable conditions for a maximum of 5 years. When using the device after storage, we recommend that you carry out a thorough maintenance check on the device.
10.4 NETWORK CONNECTIVITY AND INTEGRATION REQUIREMENTS
The mTABLET may be connected to an IT-NETWORK (e.g., hospital network or cloud infrastructure) to support integration with healthcare information systems, secure data transmission, and remote service access. This section outlines the technical and procedural requirements for safe and effective network integration.
a) Purpose of the mTABLET connection to an IT-NETWORK
The mTABLET connects to an IT-NETWORK to:
Synchronize data with cloud services (optional)
Exchange patient and measurement data with hospital information systems (HIS/EHR)
Enable secure remote maintenance and software updates (where applicable)
b) Required characteristics of the IT-NETWORK
The IT-NETWORK must fulfill the following characteristics:
Support for standard TCP/IP communication
2.4GHz or 5GHz Wi-Fi or Ethernet (mTABLET dock)
WPA2 or WPA3 encryption (Enterprise or PSK)
Sufficient bandwidth for low-latency medical data transmission
c) Required configuration of the IT-NETWORK
The IT-NETWORK should be configured with:
DHCP or Static IP assignment
Open ports for HTTPS (443), and DNS (53)
Allowed outbound access to MESI cloud services (if cloud is used)
Correct certificate and identity management (if WPA2-Enterprise or EAP is used)
d) Technical specifications of the network connection, including security specifications
Transport protocols: HTTPS over TLS 1.2 or higher
Application protocols: REST API, GDT, HL7, DICOM, XML, JSON or proprietary integration formats
Data encryption: all transmitted patient and system data is encrypted in transit
e) Intended information flow
| Source | Destination | Data Type |
|---|---|---|
| mTABLET | EHR/HIS systems | Patient data, test results |
| mTABLET | Cloud (MESI) | Patient data, test results |
| Cloud (MESI) | mTABLET | Device sync, software updates |
| HIS/EHR | mTABLET | Patient demographics, worklist |
Information is routed via secure channels and does not traverse public networks unless explicitly configured for cloud operation.
f) Hazardous Situations from IT-NETWORK Failures
The following hazardous situations may arise if the IT-NETWORK does not meet required characteristics:
Loss or delay of critical medical data
Incomplete synchronization leading to outdated records
Unauthorized data access due to misconfigured firewalls or certificates
Network downtime causing delayed diagnostics or workflow disruptions
NOTE: In the event of IT-NETWORK failure, the mTABLET continues to operate in standalone mode. All locally stored measurement results and patient data remain accessible to the user directly on the device, ensuring continuity of care even when network connectivity is lost.
Information for the Responsible Organization
The responsible organization (e.g., hospital IT department) is accountable for ensuring that the network environment where the mTABLET operates complies with the following:
Proper segmentation and access control for medical devices
Secure and reliable wireless or wired infrastructure
Routine patching and monitoring of the network and access points
Risk assessment when modifying the network or adding new devices
Changes to the network that may impact device performance include:
Reconfiguration of switches, firewalls, or Wi-Fi access points
Network topology changes or bandwidth limitations
Introduction of new connected devices that may overload the infrastructure
NOTE: The mTABLET is validated by the MANUFACTURER for operation over standard networks but is not validated for all possible IT-NETWORK configurations. The f inal network design and integration remain under the responsibility of the healthcare organization or integrator.
Summary of Network Risks
The MESI mTABLET system depends on secure network communication for functions such as cloud synchronization, analytics, remote configuration, and integration with third-party systems. The following network-related risks have been identified during the cybersecurity threat modeling process:
| Risk | Threat Category | Potential Impact | Mitigation Type |
|---|---|---|---|
| Loss or delay of data transmission | Denial of Service | Delayed synchronization or data upload systems | Local caching of data, retry mechanisms, |
| Incomplete data transfer or interrupted workflows | Denial of Service | Temporary loss of remote features (e.g., cloud backup, PDF export) | Device retains full functionality and data access offline |
| Unauthorized access to network endpoints | Spoofing / Elevation of Privilege | Potential for data leakage or control hijacking | TLS 1.2+ encryption, JWT token expiration, API key authentication |
| Data interception or tampering | Tampering / Information Disclosure | Compromised data integrity during transmission | HTTPS for all traffic, hashing, replay protection, CSRF mitigation |
| Audit trail or log integrity compromise | Repudiation | Difficulty tracking incidents or user actions | Logging with timestamped source validation, Sentry monitoring |
| Weak authentication or impersonation | Spoofing / Information Disclosure | Bypass of security controls or unauthorized access | Strong credential handling, 2FA, certificate pinning, no USB debug |
| Analytics or error reporting unavailability | Denial of Service | Temporary loss of insights or usage data | Does not affect patient care; app continues operating normally |
NOTE: Even in the case of full IT-NETWORK failure, the MESI mTABLET remains operational in standalone mode. All locally stored patient data and test results remain accessible directly on the device, ensuring uninterrupted use at the point of care.
Troubleshooting
10.1 CHARGING THE BATTERY AND STORING
If you wish to use the device on battery power, you must ensure that the battery is charged regularly. Between use the MESI mTABLET UNIT should be placed on the MESI mTABLET WI-FI DOCKING UNIT to charge its battery.
If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely worn out and you should contact your dealer or the manufacturer about replacing the battery.
When the device is charging the display on MESI mTABLET UNIT will be displaying charging status.
10.2 CLEANING INSTRUCTIONS
Cleaning the device regularly with a soft, dry or slightly damp cloth – is recommended. Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device.
10.3 PRODUCT LIFE AND STORAGE
If correctly used and maintained the device will have a minimum service life of 5 years. The device can be stored under suitable conditions for a maximum of 5 years. When using the device after storage, we recommend that you carry out a thorough maintenance check on the device.
10.4 NETWORK CONNECTIVITY AND INTEGRATION REQUIREMENTS
The mTABLET may be connected to an IT-NETWORK (e.g., hospital network or cloud infrastructure) to support integration with healthcare information systems, secure data transmission, and remote service access. This section outlines the technical and procedural requirements for safe and effective network integration.
a) Purpose of the mTABLET connection to an IT-NETWORK
The mTABLET connects to an IT-NETWORK to:
Synchronize data with cloud services (optional)
Exchange patient and measurement data with hospital information systems (HIS/EHR)
Enable secure remote maintenance and software updates (where applicable)
b) Required characteristics of the IT-NETWORK
The IT-NETWORK must fulfill the following characteristics:
Support for standard TCP/IP communication
2.4GHz or 5GHz Wi-Fi or Ethernet (mTABLET dock)
WPA2 or WPA3 encryption (Enterprise or PSK)
Sufficient bandwidth for low-latency medical data transmission
c) Required configuration of the IT-NETWORK
The IT-NETWORK should be configured with:
DHCP or Static IP assignment
Open ports for HTTPS (443), and DNS (53)
Allowed outbound access to MESI cloud services (if cloud is used)
Correct certificate and identity management (if WPA2-Enterprise or EAP is used)
d) Technical specifications of the network connection, including security specifications
Transport protocols: HTTPS over TLS 1.2 or higher
Application protocols: REST API, GDT, HL7, DICOM, XML, JSON or proprietary integration formats
Data encryption: all transmitted patient and system data is encrypted in transit
e) Intended information flow
| Source | Destination | Data Type |
|---|---|---|
| mTABLET | EHR/HIS systems | Patient data, test results |
| mTABLET | Cloud (MESI) | Patient data, test results |
| Cloud (MESI) | mTABLET | Device sync, software updates |
| HIS/EHR | mTABLET | Patient demographics, worklist |
Information is routed via secure channels and does not traverse public networks unless explicitly configured for cloud operation.
f) Hazardous Situations from IT-NETWORK Failures
The following hazardous situations may arise if the IT-NETWORK does not meet required characteristics:
Loss or delay of critical medical data
Incomplete synchronization leading to outdated records
Unauthorized data access due to misconfigured firewalls or certificates
Network downtime causing delayed diagnostics or workflow disruptions
NOTE: In the event of IT-NETWORK failure, the mTABLET continues to operate in standalone mode. All locally stored measurement results and patient data remain accessible to the user directly on the device, ensuring continuity of care even when network connectivity is lost.
Information for the Responsible Organization
The responsible organization (e.g., hospital IT department) is accountable for ensuring that the network environment where the mTABLET operates complies with the following:
Proper segmentation and access control for medical devices
Secure and reliable wireless or wired infrastructure
Routine patching and monitoring of the network and access points
Risk assessment when modifying the network or adding new devices
Changes to the network that may impact device performance include:
Reconfiguration of switches, firewalls, or Wi-Fi access points
Network topology changes or bandwidth limitations
Introduction of new connected devices that may overload the infrastructure
NOTE: The mTABLET is validated by the MANUFACTURER for operation over standard networks but is not validated for all possible IT-NETWORK configurations. The f inal network design and integration remain under the responsibility of the healthcare organization or integrator.
Summary of Network Risks
The MESI mTABLET system depends on secure network communication for functions such as cloud synchronization, analytics, remote configuration, and integration with third-party systems. The following network-related risks have been identified during the cybersecurity threat modeling process:
| Risk | Threat Category | Potential Impact | Mitigation Type |
|---|---|---|---|
| Loss or delay of data transmission | Denial of Service | Delayed synchronization or data upload systems | Local caching of data, retry mechanisms, |
| Incomplete data transfer or interrupted workflows | Denial of Service | Temporary loss of remote features (e.g., cloud backup, PDF export) | Device retains full functionality and data access offline |
| Unauthorized access to network endpoints | Spoofing / Elevation of Privilege | Potential for data leakage or control hijacking | TLS 1.2+ encryption, JWT token expiration, API key authentication |
| Data interception or tampering | Tampering / Information Disclosure | Compromised data integrity during transmission | HTTPS for all traffic, hashing, replay protection, CSRF mitigation |
| Audit trail or log integrity compromise | Repudiation | Difficulty tracking incidents or user actions | Logging with timestamped source validation, Sentry monitoring |
| Weak authentication or impersonation | Spoofing / Information Disclosure | Bypass of security controls or unauthorized access | Strong credential handling, 2FA, certificate pinning, no USB debug |
| Analytics or error reporting unavailability | Denial of Service | Temporary loss of insights or usage data | Does not affect patient care; app continues operating normally |
NOTE: Even in the case of full IT-NETWORK failure, the MESI mTABLET remains operational in standalone mode. All locally stored patient data and test results remain accessible directly on the device, ensuring uninterrupted use at the point of care.
Warranty information
Podjetje MESI d.o.o. za sisteme THERMOSYS, kupljene od 1. aprila 2026 dalje, zagotavlja garancijsko dobo do dveh let, ki se začne z datumom nakupa (datum dobave, ki je naveden na računu). Garancija velja z računom ali kopijo računa. Podjetje MESI d.o.o. zagotavlja tudi, da je sistem THERMOSYS, ki ste ga kupili, brez napak v materialih in da je izdelan iz ustreznih materialov. Podjetje MESI d.o.o. med garancijsko dobo zagotavlja brezplačno popravilo okvarjene naprave ali delov, za katere velja ta garancija. Če okvarjene naprave med garancijsko dobo ni mogoče popraviti, bo zagotovljena brezplačna zamenjava. Podjetje MESI d.o.o. bo zagotavljalo vzdrževanje in dobavo nadomestnih delov za obdobje desetih let od datuma nakupa, dokler so nadomestni deli na voljo pri dobaviteljih.
Garancija ne velja za:
stroške popravil in/ali škode, ki jih povzroči nepooblaščena oseba. Če želite vložiti garancijski zahtevek, se obrnite na lokalnega distributerja ali proizvajalca sistema THERMOSYS - kontaktni podatki so na voljo na spletnem mestu podjetja;
redne preglede (na zahtevo kupca) in/ali vzdrževanje (zamenjava obrabljenih delov);
obrabo oziroma poslabšanje delovanja dodatne opreme in drugih dodatkov, ki niso glavna naprava;
stroške, ki nastanejo zaradi nestrinjanja z garancijskimi pogoji (stroški bodo zaračunani);
poškodbe, ki jih povzročijo nesreče, nepravilna uporaba, malomarnost, abrazija, izpostavljenost ekstremnim temperaturam, topilom, kislinam ali vodi, normalna obraba ali poškodbe pri prevozu, kraja ali izguba;
uporabo naprave za namene, ki niso predvideni;
škodo, ki jo povzroči neustrezno ravnanje letalske družbe ali prevoznega podjetja;
nepravilno uporabo ali zlorabo sistema THERMOSYS, med drugim vključno z uporabo tega izdelka v nasprotju z običajnim namenom uporabe ali navodili podjetja glede uporabe in vzdrževanja;
okvare, ki so posledica uporabe izdelka v povezavi z dodatno opremo, ki je podjetje MESI d.o.o. ni odobrilo za uporabo s sistemom THERMOSYS;
okvare ali pomanjkljivosti sistema THERMOSYS, ki izhajajo iz nepravilne namestitve ali uporabe, ki ni skladna z navodili in tehničnimi ali varnostnimi standardi, predpisanimi v uporabniškem priročniku za napravo;
posledice nesreč, višje sile, strele, vode, požara, kršenja javnega reda, nepravilnega prezračevanja, napetostnih nihanj ali katerega koli vzroka, na katerega podjetje MESI d.o.o. ne more vplivati;
poškodbe baterije zaradi nerednega polnjenja prazne baterije ali uporabe v nasprotju z navodili v uporabniškem priročniku;
zamenjavo ali popravilo okvarjene naprave ali njenih delov, če je serijska številka izdelka spremenjena, izbrisana, odstranjena ali neberljiva.
| Column A | Column B |
|---|---|
| Deli, ki so vključeni v dvoletno garancijsko dobo | Infrardeča/brezkontaktna enota za merjenje temperature, sonda/kontaktna enota za merjenje temperature |
| Deli, ki so izključeni iz garancije | embalaža, ščitniki kontaktne sonde |
Vse zgoraj navedeno je edina in izključna garancija za sistem THERMOSYS.
Izjavljamo:
da bo sistem THERMOSYS med garancijsko dobo deloval brezhibno, če bo ravnanje z njim skladno z navodili za uporabo in če bo redno vzdrževan;
da se garancijska doba začne na dan nakupa;
da bomo med garancijsko dobo na lastne stroške odpravili napake in tehnične pomanjkljivosti sistema THERMOSYS, ki nastanejo med običajno uporabo;
da bo sistem THERMOSYS deloval pravilno, če bodo vzpostavljeni optimalni pogoji za njegovo delovanje: temperatura 16-40 °C, največ 75-odstotna vlažnost brez kondenzacije ter odsotnost čezmernih količin prahu in umazanije;
da garancija ne velja za primere, ki niso povezani z napakami v materialu in izdelavi;
da garancija preneha veljati, če se sistem THERMOSYS najame in se pri tem poškoduje;
da popravilo ali zamenjava skladno s pogoji te garancije ne zagotavlja pravice do podaljšanja ali obnovitve garancijske dobe;
da garancija preneha veljati, če podjetje MESI d.o.o. ne prejme plačil v obdobju po poteku katerega koli dogovorjenega plačilnega roka.
Opis postopka vložitve garancijskega zahtevka:
Garancija je veljavna samo, če se sistem THERMOSYS in njegovi deli vrnejo med veljavno garancijsko dobo, skupaj z originalnim računom ali njegovo kopijo, ki jo izda proizvajalec naprave. Po potrebi opišite težavo. Če račun ni predložen, si podjetje MESI d.o.o. pridržuje pravico do razveljavitve garancije.
Errors
10.1 CHARGING THE BATTERY AND STORING
If you wish to use the device on battery power, you must ensure that the battery is charged regularly. Between use the MESI mTABLET UNIT should be placed on the MESI mTABLET WI-FI DOCKING UNIT to charge its battery.
If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely worn out and you should contact your dealer or the manufacturer about replacing the battery.
When the device is charging the display on MESI mTABLET UNIT will be displaying charging status.
10.2 CLEANING INSTRUCTIONS
Cleaning the device regularly with a soft, dry or slightly damp cloth – is recommended. Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device.
10.3 PRODUCT LIFE AND STORAGE
If correctly used and maintained the device will have a minimum service life of 5 years. The device can be stored under suitable conditions for a maximum of 5 years. When using the device after storage, we recommend that you carry out a thorough maintenance check on the device.
10.4 NETWORK CONNECTIVITY AND INTEGRATION REQUIREMENTS
The mTABLET may be connected to an IT-NETWORK (e.g., hospital network or cloud infrastructure) to support integration with healthcare information systems, secure data transmission, and remote service access. This section outlines the technical and procedural requirements for safe and effective network integration.
a) Purpose of the mTABLET connection to an IT-NETWORK
The mTABLET connects to an IT-NETWORK to:
Synchronize data with cloud services (optional)
Exchange patient and measurement data with hospital information systems (HIS/EHR)
Enable secure remote maintenance and software updates (where applicable)
b) Required characteristics of the IT-NETWORK
The IT-NETWORK must fulfill the following characteristics:
Support for standard TCP/IP communication
2.4GHz or 5GHz Wi-Fi or Ethernet (mTABLET dock)
WPA2 or WPA3 encryption (Enterprise or PSK)
Sufficient bandwidth for low-latency medical data transmission
c) Required configuration of the IT-NETWORK
The IT-NETWORK should be configured with:
DHCP or Static IP assignment
Open ports for HTTPS (443), and DNS (53)
Allowed outbound access to MESI cloud services (if cloud is used)
Correct certificate and identity management (if WPA2-Enterprise or EAP is used)
d) Technical specifications of the network connection, including security specifications
Transport protocols: HTTPS over TLS 1.2 or higher
Application protocols: REST API, GDT, HL7, DICOM, XML, JSON or proprietary integration formats
Data encryption: all transmitted patient and system data is encrypted in transit
e) Intended information flow
| Source | Destination | Data Type |
|---|---|---|
| mTABLET | EHR/HIS systems | Patient data, test results |
| mTABLET | Cloud (MESI) | Patient data, test results |
| Cloud (MESI) | mTABLET | Device sync, software updates |
| HIS/EHR | mTABLET | Patient demographics, worklist |
Information is routed via secure channels and does not traverse public networks unless explicitly configured for cloud operation.
f) Hazardous Situations from IT-NETWORK Failures
The following hazardous situations may arise if the IT-NETWORK does not meet required characteristics:
Loss or delay of critical medical data
Incomplete synchronization leading to outdated records
Unauthorized data access due to misconfigured firewalls or certificates
Network downtime causing delayed diagnostics or workflow disruptions
NOTE: In the event of IT-NETWORK failure, the mTABLET continues to operate in standalone mode. All locally stored measurement results and patient data remain accessible to the user directly on the device, ensuring continuity of care even when network connectivity is lost.
Information for the Responsible Organization
The responsible organization (e.g., hospital IT department) is accountable for ensuring that the network environment where the mTABLET operates complies with the following:
Proper segmentation and access control for medical devices
Secure and reliable wireless or wired infrastructure
Routine patching and monitoring of the network and access points
Risk assessment when modifying the network or adding new devices
Changes to the network that may impact device performance include:
Reconfiguration of switches, firewalls, or Wi-Fi access points
Network topology changes or bandwidth limitations
Introduction of new connected devices that may overload the infrastructure
NOTE: The mTABLET is validated by the MANUFACTURER for operation over standard networks but is not validated for all possible IT-NETWORK configurations. The f inal network design and integration remain under the responsibility of the healthcare organization or integrator.
Summary of Network Risks
The MESI mTABLET system depends on secure network communication for functions such as cloud synchronization, analytics, remote configuration, and integration with third-party systems. The following network-related risks have been identified during the cybersecurity threat modeling process:
| Risk | Threat Category | Potential Impact | Mitigation Type |
|---|---|---|---|
| Loss or delay of data transmission | Denial of Service | Delayed synchronization or data upload systems | Local caching of data, retry mechanisms, |
| Incomplete data transfer or interrupted workflows | Denial of Service | Temporary loss of remote features (e.g., cloud backup, PDF export) | Device retains full functionality and data access offline |
| Unauthorized access to network endpoints | Spoofing / Elevation of Privilege | Potential for data leakage or control hijacking | TLS 1.2+ encryption, JWT token expiration, API key authentication |
| Data interception or tampering | Tampering / Information Disclosure | Compromised data integrity during transmission | HTTPS for all traffic, hashing, replay protection, CSRF mitigation |
| Audit trail or log integrity compromise | Repudiation | Difficulty tracking incidents or user actions | Logging with timestamped source validation, Sentry monitoring |
| Weak authentication or impersonation | Spoofing / Information Disclosure | Bypass of security controls or unauthorized access | Strong credential handling, 2FA, certificate pinning, no USB debug |
| Analytics or error reporting unavailability | Denial of Service | Temporary loss of insights or usage data | Does not affect patient care; app continues operating normally |
NOTE: Even in the case of full IT-NETWORK failure, the MESI mTABLET remains operational in standalone mode. All locally stored patient data and test results remain accessible directly on the device, ensuring uninterrupted use at the point of care.
Standard compliance
The provisions of the Council Directive 93/42/EEC concerning medical devices were complied with. The standards in the table below were complied with.
| Reference number | Description |
|---|---|
| EN 60601-1:2006/ A1:2013 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-6:2010/ A1:2015 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 80601-230:2010/A1:2015 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| EN 10603:1997+A2:2009 | Non-invasive sphygmomanometers. Supplementary requirements for electromechanical blood pressure measuring systems |
| EN 1060-4:2004 | Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers |
| EN ISO 152231:2016 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements |
| EN 303 446-1:2017 | Electromagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 1: Specific conditions for equipment in residential locations. |
| EN 62366:2008 | Medical devices - Application of usability engineering to medical devices |
| EN 62304:2006/ A1:2015 | Medical device software - Software lifecycle processes |
| EN ISO 109931:2009/AC:2010 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices – Application of risk management to medical devices |
| EN ISO 13485:2016 | Medical devices – Quality management systems – Requirements for regulatory purposes |
11.1. MANUFACTURER DECLARATION ON EMC
MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
| Emissions test | Compliance | Electromagnetic environment - guidance |
|---|---|---|
| RF emissions CISPR 11 | Group 1 | The above listed models use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RF emissions CISPR 11 | Class B | MESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Harmonic emissions IEC 61000-3-2 | N/A | MESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Voltage fluctuations / flicker emissions IEC 61000-3-3 | Complies | MESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
Patient coupling PORT
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) according to IEC 61000-4-2 | ± 8 kV Contact ± 2, 4, 8, 15 kV Air | ± 8 kV contact discharge ± 2, 4, 8, 15 kV air discharge | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Conducted RF induced by RF fields IEC 61000-4-6 (a) | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | Exempt from this requirement - cable length is less than 3 m | - |
Comment: *Not applicable, unit, without Signal input/output parts PORT
a) SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.
b) This test applies only to output lines intended to connect directly to outdoor cables.
c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
Enclosure Port
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | ±,8 kV Contact ± 2, 4, 8, 15 kV Air | ±8 kV Contact ± 15 kV Air* | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 3 V/m 80 MHz – 2.7 GHz 80% AM 1 kHz | 3 V/m 80 MHz – 2.7 GHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 385 MHz (18Hz Pulse Modulation) | 27 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 450 MHz (FM+/-5 KHz deviation 1 kHz sine or 18 Hz Pulse Modulation) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 710 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 745 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 780 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 810 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 870 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 930 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1720 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1845 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1970 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 2450 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5240 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5500 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5785 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| RATED power frequency magnetic fields IEC 61000-4-8 | 50 Hz or 60 Hz | 30 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Input a.c. power PORT
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrical fast transient/bursts IEC 610004-4 | ± 2 kV 100 kHz Repetition frequency | ± 2 kV | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Surges IEC 61000-4-5 | ± 0.5 kV, ±1 kV line(s) to line(s) ± 0.5 kV, ±1 kV , ± 2 kV line(s) to ground (a) | ± 1 kV Differential mode | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Conducted RF induced by RF fields IEC 61000-4-6 | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | 0% UT; 0°.45°, 90°, 135°, 180°, 225°, 270°, 315° 0% UT; 0° 0% UT; 70% 0% UT; 0% | 0.5 Cycles 1 Cycle 25/30 cycles (50/60 Hz) 250/300 Cycles (50/60 Hz) (5 s) | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. If the user of the above listed models requires continued operation during power mains interruptions, it is recommended that MESI mTABLET ABI is powered from an uninterruptible power supply or battery |
Comment:
a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.
b) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
Signal input/output parts PORT
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | ±,8 kV Contact ± 2, 4, 8, 15 kV Air | ±8 kV Contact ± 15 kV Air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical fast transient/bursts IEC 610004-4 (a) | ± 1 kV 100 kHz Repetition frequency | ± 1 kV | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Surges IEC 61000-4-5 (b) | ±2 kV line(s) to ground | Not applicable. | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Conducted RF induced by RF fields IEC 61000-4-6 (a) | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
Comment:
a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.
b) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Guidance and manufacturer’s declaration - electromagnetic immunity
MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
| Immunity test | IEC 60601 Test level | Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Conducted RF induced by RF fields IEC 61000-4-6 Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 3 V/m 80 MHz – 2.7 GHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 3 V/m | Portable and mobile RF communications equipment should not be used no closer to any part of the above listed models, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz - 800 MHz d = 2.3√P 800 MHz – 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range. (b) Interference may occur in the vicinity of equipment marked with the following symbol: |
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered. If the measured field strength in the location in which MESI mTABLET ABI is used, exceeds the applicable RF compliance level above, the above listed models should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the above listed models.
b) Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
MESI mTABLET ABI is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the above listed models can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the above listed models as recommended below, according to the maximum output power of the communication equipment.
Separation distance according to frequency of transmitter m
| Rated maximum output power of transmitter W | 150 kHz to 80 MHz d = 1.2√P | 80 MHz to 800 MHz d = 1.2√P | 800 MHz to 2.5 GHz d = 2.3 √P |
|---|---|---|---|
| 0.01 | 0.12 | 0.12 | 0.23 |
| 0.1 | 0.38 | 0.38 | 0.73 |
| 1 | 1.2 | 1.2 | 2.3 |
| 10 | 3.8 | 3.8 | 7.3 |
| 100 | 12 | 12 | 23 |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
11.2 ESSENTIAL PERFORMANCE
MESI ABI MODULE is a part of MESI mTABLET ABI whose essential performance is performing an ABI measurement in specified operating conditions. The measurement is defined as measurement process and data storage to MESI mTABLET.
Due to the devices high sensitivity, intended use and operating modes the device is susceptible to EM interferences. If the device essential performance is degraded, the device will notify operator with error messages of any issues, while the cuffs (if in use during the event) will deflate and cause no harm to the patient.
Important labels
Warranty information
Podjetje MESI d.o.o. za sisteme THERMOSYS, kupljene od 1. aprila 2026 dalje, zagotavlja garancijsko dobo do dveh let, ki se začne z datumom nakupa (datum dobave, ki je naveden na računu). Garancija velja z računom ali kopijo računa. Podjetje MESI d.o.o. zagotavlja tudi, da je sistem THERMOSYS, ki ste ga kupili, brez napak v materialih in da je izdelan iz ustreznih materialov. Podjetje MESI d.o.o. med garancijsko dobo zagotavlja brezplačno popravilo okvarjene naprave ali delov, za katere velja ta garancija. Če okvarjene naprave med garancijsko dobo ni mogoče popraviti, bo zagotovljena brezplačna zamenjava. Podjetje MESI d.o.o. bo zagotavljalo vzdrževanje in dobavo nadomestnih delov za obdobje desetih let od datuma nakupa, dokler so nadomestni deli na voljo pri dobaviteljih.
Garancija ne velja za:
stroške popravil in/ali škode, ki jih povzroči nepooblaščena oseba. Če želite vložiti garancijski zahtevek, se obrnite na lokalnega distributerja ali proizvajalca sistema THERMOSYS - kontaktni podatki so na voljo na spletnem mestu podjetja;
redne preglede (na zahtevo kupca) in/ali vzdrževanje (zamenjava obrabljenih delov);
obrabo oziroma poslabšanje delovanja dodatne opreme in drugih dodatkov, ki niso glavna naprava;
stroške, ki nastanejo zaradi nestrinjanja z garancijskimi pogoji (stroški bodo zaračunani);
poškodbe, ki jih povzročijo nesreče, nepravilna uporaba, malomarnost, abrazija, izpostavljenost ekstremnim temperaturam, topilom, kislinam ali vodi, normalna obraba ali poškodbe pri prevozu, kraja ali izguba;
uporabo naprave za namene, ki niso predvideni;
škodo, ki jo povzroči neustrezno ravnanje letalske družbe ali prevoznega podjetja;
nepravilno uporabo ali zlorabo sistema THERMOSYS, med drugim vključno z uporabo tega izdelka v nasprotju z običajnim namenom uporabe ali navodili podjetja glede uporabe in vzdrževanja;
okvare, ki so posledica uporabe izdelka v povezavi z dodatno opremo, ki je podjetje MESI d.o.o. ni odobrilo za uporabo s sistemom THERMOSYS;
okvare ali pomanjkljivosti sistema THERMOSYS, ki izhajajo iz nepravilne namestitve ali uporabe, ki ni skladna z navodili in tehničnimi ali varnostnimi standardi, predpisanimi v uporabniškem priročniku za napravo;
posledice nesreč, višje sile, strele, vode, požara, kršenja javnega reda, nepravilnega prezračevanja, napetostnih nihanj ali katerega koli vzroka, na katerega podjetje MESI d.o.o. ne more vplivati;
poškodbe baterije zaradi nerednega polnjenja prazne baterije ali uporabe v nasprotju z navodili v uporabniškem priročniku;
zamenjavo ali popravilo okvarjene naprave ali njenih delov, če je serijska številka izdelka spremenjena, izbrisana, odstranjena ali neberljiva.
| Column A | Column B |
|---|---|
| Deli, ki so vključeni v dvoletno garancijsko dobo | Infrardeča/brezkontaktna enota za merjenje temperature, sonda/kontaktna enota za merjenje temperature |
| Deli, ki so izključeni iz garancije | embalaža, ščitniki kontaktne sonde |
Vse zgoraj navedeno je edina in izključna garancija za sistem THERMOSYS.
Izjavljamo:
da bo sistem THERMOSYS med garancijsko dobo deloval brezhibno, če bo ravnanje z njim skladno z navodili za uporabo in če bo redno vzdrževan;
da se garancijska doba začne na dan nakupa;
da bomo med garancijsko dobo na lastne stroške odpravili napake in tehnične pomanjkljivosti sistema THERMOSYS, ki nastanejo med običajno uporabo;
da bo sistem THERMOSYS deloval pravilno, če bodo vzpostavljeni optimalni pogoji za njegovo delovanje: temperatura 16-40 °C, največ 75-odstotna vlažnost brez kondenzacije ter odsotnost čezmernih količin prahu in umazanije;
da garancija ne velja za primere, ki niso povezani z napakami v materialu in izdelavi;
da garancija preneha veljati, če se sistem THERMOSYS najame in se pri tem poškoduje;
da popravilo ali zamenjava skladno s pogoji te garancije ne zagotavlja pravice do podaljšanja ali obnovitve garancijske dobe;
da garancija preneha veljati, če podjetje MESI d.o.o. ne prejme plačil v obdobju po poteku katerega koli dogovorjenega plačilnega roka.
Opis postopka vložitve garancijskega zahtevka:
Garancija je veljavna samo, če se sistem THERMOSYS in njegovi deli vrnejo med veljavno garancijsko dobo, skupaj z originalnim računom ali njegovo kopijo, ki jo izda proizvajalec naprave. Po potrebi opišite težavo. Če račun ni predložen, si podjetje MESI d.o.o. pridržuje pravico do razveljavitve garancije.
