Medical electrical equipment needs special precautions regarding electromagnetic compatibility emc and needs to be installed and put into service according to the emc information provided in pages 4448 of this manual. Essentially all medical devices used in hospitals come with a user instruction manual, commonly called instructions for use ifu or directions for use. Remove the protective sheet from the monitor screen. The device and battery unit are supplied separately in a nonsterile state.
Creating instructions for use ifu for medical devices requires quite a lot of responsibility in fact, you need to combine your techcomm skills with project management, administrative and legal skills. The beginners guide to design verification and design. Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. User manual contraindications, warnings, cautions, notes and symbols 7 of 44 2 contraindications, warnings, cautions, notes and symbols your device was designed and built with safety in mind. When a products user manual lists an author, list the author of the manual in place of the company name in your reference list citation. Ifu medical devices template to comply with regulation eu. Turn your medical devices user manual into an online. Technical writing sample medical device user manual free download as pdf file. The ifu medical devices template is an ms word template, that contains all mandatory elements to create your own information for use for medical devices. User manual and medical device booklet magnifying aids.
Or, is the intended use a very general statement, and could even be derived from a gmdn code, or. If a manual is wellwritten, however, you should consider giving the manual a more prominent treatment on your website and using it as a marketing tool. Please visit the coolpad americas official website at for more information on supported product models. The device should provide reliable service and high quality patient care. This device is restricted to sale by or on the order of a physician. Typically an ifu includes basic operational how to information as well as pages of warnings, cautions, and other general or devicespecific information beyond simply how to operate the device. Medical device marketers spend countless hours developing slick brochures, pamphlets, and web copy, but physicians often require more indepth information than can be conveyed in a brochure. A guide to developing usable instructions for use for. The user can determine this quantity according to a products characteristics and frequency of use in your hospital. If the device is to be used by multiple patients a main flow bacteria filter should be installed inline between the device and the breathing circuit tubing to prevent contamination. It is the responsibility of an economic operator usually the manufacturer to verify if ce marking directives relevant to its product contain mandatory.
In the event of signs of damage, do not use the device and inform your aircraft medical agent or distributor. Since some institutions and individuals will embrace computerbased learning more readily than others, device manufacturers will be challenged to make their transition to a. August 27, 2019 this is a functional instruction of ubiomacpa pro software. Ce requirements for user manual certification company. Ghtf sg1 label and instructions for use for medical.
If the setup of the electronic magnifier in the proximity of medical, analogical measuring devices cannot be avoided, the operator of these devices has to be. Here are some critical factors to consider when developing effective ifus. Eceu mdd class iia per 9342eec annex ix rule 15 device is intended to disinfect medical devices. Acceptable media for electronic product user manuals.
Label and instructions for use for medical devices study group 1 final document ghtfsg1n70. As with any prescription medical device, failure to follow product instructions or changing settings and performing therapy applications without the express direction andor supervision of a trained clinical caregiver may lead to improper product performance and the potential for serious or fatal injury. Unpack the device and check for any visible signs of damage that may have occurred during shipment. This guidance document applies to all medical devices, except. How to cite a user manual in a paper pen and the pad. A medical device user manual coauthored by technical writer and journalist john melendez. In fact, medical device salespeople frequently encounter customersthe chair of a hospitals device selection committee, for examplewho insist on judging a product based on how easy it is to use without any training, assistance, or referrals to the user manual. Fda approved the use of electronic labelling for prescription medical devices intended for use in u. Technical writing sample medical device user manual. The optoelectronic reading device is suited for use in all setups including domestic use as it can be connected directly to a public mains supply that powers buildings for residential purposes.
Periodically inspect laser eyewear for pitting and cracking. User manual instruction guide for visual coaching device vcd vcdt711n varian medical systems, inc setup instructions, pairing guide, and how to reset. Software user interface requirements for medical devices. The personal protective equipment ppe directive annex i, paragraph 1. The technical construction file defines the product design and the conditions for safe usage.
Information contained in the owners manual typically includes. User manuals, philips medical equipment operating guides and service manuals. User manuals, medtronic medical equipment operating guides and service manuals. As a result of this emerging multimedia approach, the hardcopy medical device user manual is swiftly evolving toward a system of both print and electronic components. Preface the document herein was produced by the global harmonization task force, a voluntary group of representatives from medical device regulatory authorities and the regulated industry. Wound treatment system users manual infiniti medical.
Use the intended use statement and product labelling e. Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law. For machinery and installations user manual requirements are mentioned in the machinery directive 200642ec under annex i, paragraph 1. However, there is no replacement for care providers being attentive. Instructions for use ifu are therefore considered part of the product user interface. The file contains information such as drawings, certificates, test reports, calculations, the user manual, part lists etc. However, only one person can use the device at a time. The user manual can usually answer these questions and boost a clients interest in the product. The technical file is kept by the manufacturer, which keeps it available for competent national authorities. Varian medical systems vcdt711n visual coaching device.
Medtronic medical equipment user manuals download manualslib. Philips medical equipment user manuals download manualslib. Dec 4, 2015 user manuals available for medical devices including baseline hydraulic hand dynamometers, digital inclinometers, jtech commander echo series, hand held dynamometers, and pinch gauges. Medical device marketers should take time to evaluate the devices manual before devoting too much website real estate. If a user manual is published by an outside publisher, that publisher information is listed in place of the company information under. Design validation must include packaging and labeling. Download 152 medtronic medical equipment pdf manuals. Music 3s user manual details for fcc id 2akztdmvme03s made by smart medical device co. Setup instructions, pairing guide, and how to reset.
This guidance is to be used in the preparation of labelling material for non in vitro diagnostic devices. Garrett recognizes that certain medical devices may have additional requirements which may require special care. The device is intended for use by operators trained or experienced in similar equipment. If a user is not selected within the first 5 seconds, the device will default to function and store information for the last user. Like design verification, it is important to plan design validation and to. For questions regarding this document, contact bob doyle at 3017965863 or via email. John melendez is a freelance technical writer reporting on high tech, the environment, sustainability, alternative energies and green issues. Any recommendations or directives issued by personal physicians or medical device manufacturers should be followed. List of user manual and guidance document medical device.
The instructions in this manual are not intended to supersede established medical protocols. The optoelectronic reading device is designed for use in the indicated electromagnetic environment. Products or services of the vendor or carrier are subject to change within this user guide without prior notice. Requirement for a printed copy of the user manual with a. An owners manual, also called as operating instruction or users guide, is an instructional book or booklet that is supplied with almost all technologically advanced consumer products such as vehicles, home appliances and digital devices. Transcend 3 minicpap user manual page 8 the transcend 3 minicpap is not defibrillation proof. Alerts the user to the possibility of a problem with the device associated with its use or misuse, such as device malfunction, device failure, damage to the device, or damage to other property. The operator must read, understand, and follow all instructions in the accompanying document including all warnings, cautions, and precautions before using this medical device. We offer selfservice for our smart terminal device users. After cold storage, allow the device to reach room temperature before programming or inserting the device because cold temperature may affect initial device. Medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations. It is not intended to be reprocessed and used again. After the device has been turned on, select user 1 or user 2 by pressing the updown button respectively.
This manual describes the components, setup, maintenance, accessories, and technical data of the merlin pcs. Safety communications, recalls, letters to health care providers, reporting adverse. Luckily, what needs to be included in the instructions for use for medical devices has been determined in relevant legislation. You can use the template to create instructions that comply with the ce marking requirements, the medical device regulation eu 2017745. Ubiomacpa medical device ubiomacpa pro user manual.
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