| Doc. No. | Date of First Issue | Last Issue No. | Last Issue Date |
|---|---|---|---|
| 15-01 | 23 Oct 2019 | Rev3 | 19 May 2022 |
A physical copy of this document should be regarded as an "uncontrolled copy". The holder of an uncontrolled copy is responsible for checking the accuracy of the document. Muntra's internal handling and review of documents is only done in the electronic version.
Publication date: 2022-05-19
Revision number: Rev3
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MPMS is a medical device, CE-marked according to the directive 93/42/EEC. |
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Manufacturer: Muntra AB Katarinavägen 15 116 45 Stockholm Sweden Phone: +46 (0)8-40 90 68 90 E-mail: [email protected] Website: https://about.muntra.se The date of manufacture is shown in the software. |
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Read all instructions before use! |
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The catalog number is MPMS Rev2. Current product version is shown in the software (Version x.y.z). |
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W A R N I N G ! This symbol alerts the user to the risk of possible injury, death or other serious adverse reactions. |
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C A U T I O N ! This symbol alerts the user to the risk of possible injury, death or other serious adverse reactions. |
- The product must be installed properly before being put into clinical use.
- The product may only be used by authorized personnel.
- The product may only be used in accordance with its intended use.
- Read the Instructions For Use before using the product and follow all safety precautions.
- Any incident or harm to a patient or operator that might be caused by the product must be reported to the manufacturer or distributor.
MPMS is available in two variants.
- Version 1 is available through the browser.
- Version 2 is a so-called desktop application.
The desktop application is developed with the same code base as version 1.
The purpose of the desktop application is to enable MPMS to communicate with X-ray sensors and/or image management software on the user's computer.
MPMS is a Class IIa medical device, CE-marked according to the directive 93/42/EEC. The product is in compliance with European standards according to table 2.
Table 2. Compliance with European standards
| Standard | Name/Description |
|---|---|
| IEC 62304:2015-06 | Medical device software – Software life cycle processes |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO 13485:2016 | Quality management systems – Requirements for regulatory purposes |
| ISO 14971:2019 | Medical Devices – Application of Risk Management to Medical Devices |
| IEC 80001-1:2010-10 | Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities |
| ISO 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| MEDDEV 2.12/2 rev2 | Post-market Clinical Follow-up Studies |
| MEDDEV 2.7/1 revision 4 | Clinical Evaluation: A Guide for Manufacturers and Notified Bodies |
| 93/42/EEC | Medical Devices Directive |
The intended use can be found in Muntra's intended use
MPMS is intended to be used by licensed dentists, licensed dental hygienists, dental practitioners and other practitioners assisting the caregiver. For further information, see Intended use and usage.
MPMS is applicable to all types of dentistry patients. The intended purpose of the product is applicable regardless of age, gender, weight and health condition. Muntra does not apply any limitations to the patient target group.
When used for diagnostic purposes, the device will be used to diagnose and document diseases and conditions such as dental caries, periodontal disease, tooth and jaw injuries, in orthodontic treatment and other conditions that are encountered by general practitioners and specialists in the dental care field.
There are no known contraindications.
The primary undesirable side effect is a faulty diagnosis that leads to incorrect treatment and / or medication. No events of these potential side-effects have been recorded during the clinical trial, nor during the post-market clinical follow-up trial to date. The undesirable side-effects are considered acceptable.
MPMS is not a consumable device and thus has no shelf lifetime. The device lifetime is ongoing as long as the technology is applicable for the clinical need.
Before the product may be put to clinical use, it must be installed properly according to the installation instructions.
Installation is performed on one or several computers in a network. All computers may or may not connect to a common server that stores the X-ray software's database with patient information and images. Each computer in a treatment room is a workstation with connected equipment such as sensors and cameras as well as third party software such as drivers. In Muntra, settings are stored centrally. Each workstation may have additional settings that may be different between computers.
When installing a workstation, the correct plugins needed for the attached equipment are selected. The drivers for the equipment as well as the plugin may contain additional settings, e.g. for image enhancement. Adjustment of these settings, calibration of the X-ray imaging system and monitor calibration must be performed according to the installation instructions before clinical use takes place.
Refer to the instructions on installation, clinic settings and user settings for further details.
Backups are currently not performed in real time, but every night.
Below is a presentation of the basic functionality of the software. Please note that the appearance and functionality may differ depending on current settings and connected equipment. All patient information in the examples below is fictitious.
MPMS supports management of patient records and personal data. The user is able to create a new patient, find patients, edit personal information and more.
Refer to the instructions on patient data management for further details.
MPMS’ time management functionality covers tactical planning, scheduling of patient treatments, appointment management and appointment reminders. This includes e.g.
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- setting post-treatment appointment reminders for the patient
- creating, editing and deleting patient appointments
- creating and scheduling emails, text messages and mail to maximize the chance that the patient appears for the appointment
MPMS’ treatment functionality encompasses a wide variety of treatment-related processes covering planning, execution and follow-up.
MPMS’ treatment planning functionality aims to enable the formulation of a plan for improving the patient’s health status. This includes defining an easy-to-understand patient document describing the proposed treatment procedure. It includes planning and hence also relates to claims management.
Refer to the instructions on treatment planning for further details.
MPMS’ provides support for caregivers to define, store, edit and remove medical records in accordance with applicable laws and regulations.
Refer to the instructions on medical records management for further details.
MPMS’ e-prescription module enables the caregiver to create and send an electronic prescription that can instantly be expedited at any local pharmacy (selected markets apply).
Refer to the instructions on medical prescription for further details.
MPMS’ referral module enables the caregiver to instantly share referrals with any caregiver registered in MPMS. This includes secure, mutual consultation responses between e.g. general and specialist caregivers.
Refer to the instructions on referrals for further details.
MPMS integrates seamlessly against applicable X-ray software solutions. Also, MPMS has its own image capture and image handling functionality.
Refer to the instructions on x-ray for further details.
MPMS file storage capabilities enable caregivers to quickly and securely save and back up documents. This can relate to e.g. treatment history, financials and government communication.
Refer to the instructions on file handling for further details.
MPMS’ facilitates handling of claims, invoices and payments. All financial transactions are reflected in each organization’s accounting and reporting.
MPMS’ enables caregivers to make claims against government authorities, to ensure applicable subsidies are reimbursed correctly and securely.
Refer to the instructions on claims handling for further details.
MPMS’ invoicing functionality includes both direct patient payments and regular invoices. It enables a number of different features to create customer receivables, handle advance and up-front payments, and ensure the clinic is reimbursed effectively.
Refer to the instructions on invoicing for further details.
MPMS has full support for generating bookkeeping for the organization, in line with local laws and regulations.
Refer to the instructions on accounting for further details.
Caregivers are able to improve performance for the organization and clinic, using simple and transparent reports.
Refer to the instructions on reporting for further details.
Caregivers using MPMS gain access to Muntra partners that provide additional value-adding services. This includes e.g. payment and invoice service providers. MPMS’ sourcing module enables the management of these partners.
Refer to the instructions on sourcing for further details.
If an accident or incident occurs when MPMS is used, with injury to a patient or a user, or if a situation occurs where injury or malpractice could have occurred, Muntra AB must be notified immediately in order to investigate the event and to report the incident to the authorities.
The purpose of these instructions for use is to provide a sufficient description of the product to be put to its intended use in a safe and efficient way. It is important that all users of the system have read the instructions for use and follow all safety precautions. If errors or omissions are discovered in the instructions for use, kindly notify Muntra AB.
User support is primarily provided by Muntra AB via telephone, e-mail, chat messaging or remote connection to solve problems.
A variety of equipment from other vendors can be connected to Muntra, such as sensors and cameras. If the equipment cannot be connected or is not working properly, first check that it is supported by MPMS and that it has been properly installed according to the installation instructions. Then contact the distributor who supplied or installed the equipment for troubleshooting. If the problem seems to be due to an error in the application, contact Muntra AB.
If an application error occurs in MPMS, a special error message with an error code is displayed. It is important to notify Muntra AB for troubleshooting so the product can be improved. All application errors are stored in a log.
Additionally, the most common errors are explained and if possible resolved in Muntra's error handling.