MAVIG PORTEGRA2i User manual
Instructions for Use - Portegra2i
with internal cabling
Rev.: POI02G04
Languages: English 2 - 18
Deutsch 19 - 35
MAVIG – INSTRUCTIONS FOR USE
Art.-Code: MA05107201
2
3
ENDE
Digital Manuals
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www.mavig.com/eifu
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4
Introduction
Dear Customer,
Thank you for purchasing a MAVIG Portegra2i suspension system or component.
Please read this document carefully and follow all directions, warnings, and notices.
Feel free to contact us with any questions or comments on our products.
Contact Information
For questions or comments, please see back of manual for nearest MAVIG contact.
Disclaimers
Considerable eort has been made to ensure that the contents of this manual are free from omissions
and inaccuracies. However, MAVIG makes no warranties with respect to the contents of this document
and disclaims any implied warranties.
Changes
MAVIG products are under continuous development. MAVIG reserves the right to modify the manual,
packaging, equipment or technical specications, and scope of delivery without prior notice.
Translations
The master document is in German. In case of translation, precedence remains with the German version.
Copyright and Trademarks
All rights reserved. These instructions/manuals are protected by copyright law. MAVIG and Portegra2i
are registered trademarks of the company MAVIG GmbH. All other trademarks mentioned in the manuals
are the property of the corresponding manufacturer.
© 05/2021 MAVIG GmbH
5
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Contents
Digital Manuals 03
Introduction 04
Contents 05
Use and ready availability of the instructions / Warranty 06
Initial use 09
3.1 Identication of the system/device 09
3.2 Intended use / Reporting requirements according to regulation (EU) 2017/745 09
3.3. Standards / CE-Marking 10
3.4 Precautionary measures 10
3.5 Working with the system 12-13
6.1 Cleaning 14
6.2 Disinfection 15
6
Use and ready availability of instructions for use • Warranty
This manual describes the use of the various components of the Portegra2i system manufactured by
MAVIG. The instructions apply to the Portegra2i systems.
The instructions for use are an integral part of the system/device and must be kept close at
hand at all times for ease of reference. The Portegra2i installation instructions must also be
kept close at hand as certain points raised in the instructions for use refer to them.
Do not pass the system/device on to third parties without the valid instructions for use.
Check the identity and version number of the system/equipment to ensure that an up-to-date
and valid set of instructions for use has been issued with the system/device.
MAVIG guarantees the safety and reliability of the system/device solely on the following basis:
• The system/device is used solely for its intended purpose and its operation complies with
the information provided in these instructions for use.
• Only original authorised replacement parts or accessories as specied by MAVIG are used.
The use of unauthorised parts holds unknown risks and must be avoided at all times.
• No structural changes are made to the device. Unauthorised changes or modications to
the system/device are prohibited for reasons of safety.
• The system/device is regularly inspected and serviced at the specied times.
ENDE
Symbols and Denitions
WARNING
Indicates that the information is a warning. Warnings advise you of circumstances that
could result in injury or death to the patient or operator. Read and understand the warnings
before installing or operating the system.
CAUTION
Indicates that the information is a caution. Cautions advise you of circumstances that
could result in damage to the device or improper functioning of the device. Read and
understand the cautions before installing or operating the system.
Provides usage tips and useful information.
WARNING
Indicates a possible electrical hazard, which can lead to severe injury or even death.
This symbol marks the points, where protective ground lines are attached.
This symbol represents to consult accompanying documents.
MAXIMUM WEIGHT LOAD SYMBOL
This symboly is combined with a weight in kilograms that shows the maximal weight
that the marked component can hold.
CE MARK
With this symbol, MAVIG declares that the products comply with the relevant regulati-
ons set forth in the applicable European Directives.
Collisions with other equipment can cause structural failure of the suspension arm,
resulting in operator or patient injury. If collision occurs, immediately have the arm
inspected by a qualied service technician.
MD SYMBOL
This symbol indicates that this is a medical device.
NOTE:
!
!
RECOGNISED UL COMPONENT
This component has been recognised by Underwriters Laboratories Inc. Representative
samples of this product have been reviewed by UL and comply. with the applicable
requirements.
Safety Instructions
All electrical, assembly and dismantling work on the system must be carried out by qualied technicians
specically trained to perform this work.
Only appropriately trained personnel may operate, clean, and disinfect the device.
BEWARE: The system has not been certied to DIN EN 60601-1 when live. The system must
therefore be certied again by an appropriately trained technician after installation
with injectors, wiring etc.
MAVIG is not responsible for unauthorised or inappropriate handling of or changes to the system.
Changes to the system require written authorisation by MAVIG as inappropriate changes may adversely
aect the smooth operation, safety, and reliability of the system.
Any changes made to the system render the CE certication awarded to MAVIG invalid.
Thereafter, new approval must be obtained by the operator in accordance with the relevant statutory
provisions.
Avoid collisions between the system and other devices, walls, ceilings, etc. as these might seriously
damage it.
Any disregard of these instructions exempts the manufacturer from all liability and/or warranty obligations.
When installing and adjusting the Portegra2i and/or associated components, ensure
to cut o the power supply to the entire system. Danger of Death!
The spring arm is always under tension. Before carrying out assembly or dismantling
work on the spring arm, always move it slowly to its upper limit.
There is otherwise a risk that the arm will suddenly shoot upwards when components
are removed. This could result in personal injury and/or damage to the system!
!
The manufacturer must be immediately informed of any damage caused to the system.
The system must not be used until the damage has been rectied. Disconnect the
system from the mains. Do not stand or work beneath the system.
!
Do not remove any covers, open any cable ducts, etc.!
!
ENDE
Operation
These instructions for use apply after initial use as specied. The system/device must be
thoroughly cleaned and disinfected prior to initial use (see section 6.0 Cleaning/disinfection).
The product can be clearly identied by using the type plate / product label attached on the
product. There you will nd at least the following information:
Name of the product, manufacturer and adress, serial number
Information on other available Portegra2 products can be found on our web page at:
http://www.mavig.com/system-solutions/portegra2/
The Portegra2i system is a spring-supported, rotating and swivelling load-bearing system that
allows payloads to be positioned in space in up to three dimensions. The use of Portegra2i
systems is intended for professional health care facilities such as clinics, hospitals and medical
practices of group 0, 1 or 2 according to DIN VDE 0100-710 or HD 60364-7-710. The monitor
carrier system can be used by medical personnel such as doctors, nurses and assistants.
Radiation protective shields are used for the stationary protection of medical personnel against
ionizing radiation. The product is designed for applications in air-conditioned health care
facilities such as clinics, hospitals and doctors’ surgeries. The product is used exclusively by
medical professionals such as physicians and assistants.
The carrier system is used to fasten monitor carrier to the ceiling.
It is the responsibility of the operator to ensure the device is safe for use and to provide the
user with due instruction in its operation and its use for the purpose intended.
In accordance with the relevant legal regulations, serious incidents that have occured in
connection with a MAVIG medical device must be reported to MAVIG and to the responsible
national authorities in the country in which the user is active. In this sense, incidents are
reportable if the use of the medical device directly or indirectly led, might have let or might
lead to the death or the temporary or permanent serious deterioration of a patient’s, user’s or
other person’s state of health.
10
Operation
Since the products are not a medical device in the sense of the EU Medical Device Regulation
2017/745 (MDR), there are also no statutory reporting obligations according to the EU Medical
Device Regulation 2017/745 (MDR).
IEC 60601-1:2005+A1:2012
If the product bears a CE mark, it complies with the requirements of the EU Medical Device
Regulation 2017/745 (MDR) or, as partly completed machinery, it complies with the relevant
provisions of EC Directive 2006/42/EC.
Observe the following when using the system/device after successful installation in accordance
with the Portegra2i installation instructions (POI03Oxx):
1. Avoid collisions with other devices, the walls, or the ceiling.
2. Stop using the system if there is a collision or any other damage to the system.
Do not stand or work beneath the system.
11
ENDE
Operation
12
Operation • Positioning of extension arm - spring arm
Fig. 1
1
Injector holder by way
of example
Fig. 2
Fig. 3
!
Ceiling Column Ceiling Column
x
13
ENDE
Operation • Positioning of extension arm - spring arm • Installation/Removal
All moving loints of the Portegra2i system are built with turning stops!
These turning stops prevent the internal cabling overturning.
3.5.1 Injector holder bar (Fig. 1)
Move the system only by the injector holder bar (1/Fig. 1).
The system can be moved in all directions by using the bar (1/Fig. 1) of the injector
mounting bracket.
Also see chapter 4.0, Positioning of extension arm - spring arm.
4.0.1 When the spring arm and the extension arm are positioned at 180° to each other (Fig. 2),
the attachment cannot be moved in the direction of the ceiling column. Repeated exertion
of force of > 25 N (acc. to DIN EN 60601-2-41) may cause damage to the attachment.
4.0.2 To move the attachment in the direction of the axis of suspension, the angle between the
extension and spring arms must be less than 180° (Fig. 3).
This applies to all attachments to ceiling and wall mountings (illustration is just one example).
The information required for installation and removal can be found in the Portegra2i installation
instructions provided (POI03Oxx). Only qualied personnel may carry out this work.
Only move the system by the dened points/handles. Always hold the system rmly
until you have nished moving it. Never allow movement to swing outwards in an
uncontrolled manner.
!
14
Cleaning / Disinfection
6.0
ATTENTION: Only trained personnel can clean and disinfect the system/equipment. The methods
used to clean and disinfect must comply with the applicable statutory provisions and
guidelines in regards to hygiene, disinfection, and explosion protection.
ATTENTION: The Portegra2i system/devices cannot be sterilised.
6.1.1 Follow the general safety instructions as stated in section 2.0.
6.1.2 Cleaning agents/aids and use
I. Clean the surfaces with a mild soap solution or a commercially available detergent.
To avoid damage to surfaces, do not use any scouring agents, bleaches, or abrasive, corrosive,
or acidic cleaning agents or polishes.
II. To wipe surfaces, use a soft cloth free of particles or debris of any kind. Use liquid sparingly
when cleaning and ensure that no moisture penetrates the system.
Only slightly dampen the cloth. If necessary, use a mild soap solution or commercially available
detergent. Rub the cleaned areas dry with a cotton cloth.
Extreme care must be taken when cleaning electrical devices. Danger of death!
1. Disconnect the device from the mains electricity before cleaning.
2. Wipe only. Use cleaning liquid and/or use wipe disinfectants sparingly.
Do not spray clean or use spray disinfectants.
3. No moisture should penetrate the system, e.g. the sockets, gas outlets,
or device apertures.
15
ENDE
Cleaning / Disinfection
6.0
6.2.1 Follow the general safety instructions as stated in section 2.0.
6.2.2 Disinfection procedures
I. Only use wipe disinfectants; do not use any spray disinfectants.
II. The procedures adopted must comply with the applicable statutory provisions and guidelines.
The operator must dene hygiene guidelines and the corresponding safety measures for the
disinfection procedures used.
III. If the system is contaminated with infectious or potentially infectious material (e.g. blood,
bodily uids, excrement), the relevant surfaces must be disinfected immediately.
IV. Surfaces should be routinely disinfected in accordance with the hygiene/disinfection system
established by the operator.
V. The combined use of dierent disinfectants and/or disinfectants and cleaning agents may
impair product performance or damage system surfaces.
VI. Always consider the material compatibility (e.g. stainless steel, aluminium, plastics, lead acrylic
glass, lead glass, PVC, silicon, natural or synthetic rubber, as well as chromed, painted or coated
surfaces).
VII. If unsure, apply the disinfectant on a small test area.
If disinfectants are used that form explosive gas mixtures, they pose a risk to life
and health because of the risk of explosion.
!
16
Servicing
Do not use any tools to check screws fastened with Loctite. Doing so could damage
the threadlocking adhesive.
!
If components have loosened or you are not sure whether the components are still in
good order, please advise the relevant service technician of the company responsible
for the installation.
Stop all use of the device until the damage is rectied:
Disconnect the system from the mains. Do not stand or work beneath the system.
!
Fig. 3
1
2
3
7.0.1 Check the system for external damage prior to use. Stop using a system/device if it is damaged.
7.0.2 Visual and performance checks for damage or stiness in the system must be carried out by
the user .
7.0.3 The following tests must be carried out by a qualied service technician every
. Refer to the information in the Portegra2i installation instructions
(POI03Oxx) where needed.
7.0.4 Check all connections of movable parts for performance
and smooth movement.
7.0.5 Perform a purely visual inspection of the items below.
All the screw heads must be rmly seated in the
components.
Check all swivel joints for looseness.
Check that the locking ring on the mounting pin (1/Fig. 3)
is still entirerly in the groove. (beneath the covering).
Check the screws (2/Fig. 3) at the 300° mounting
(beneath the covering).
Check the screws in the safety collars (3/Fig. 3).
To adjust the settings, such as the spring tension and the height of the spring arm,
please refer to the information in the Portegra2i installation instructions (POI03Oxx).
ENDE
Specications • Replacement Parts • Disposal
8.0.1 Climatic conditions
When in operation: 10°C to 40°C
20 - 75 % rel. humidity
70 - 106 kPa air pressure
Storage and transportation: -20°C to +70°C
max. 95 % rel. humidity
70 - 106 kPa air pressure
8.0.2 Service life
Portegra2i systems have successfully undergone tests of over 120,000 cycles in normal use.
This corresponds to a maximum life span of 10 years.
Due to the various MAVIG safety features, Portegra2i systems remain safe well beyond the
tested service life. Although the system’s performance can change due to normal mechanical
wear.
For an up-to-date list of replacement parts, please contact us at:
e-Mail or by telephone
10.0
The system/device must be disposed of in accordance with the nationally applicable provisions
at an appropriate recycling facility for electrical and electronic equipment.
If you have any questions, please contact us at: e-Mail
Phone
Notes
MAVIG – GEBRAUCHSANWEISUNG
Gebrauchsanweisung - Portegra2i
mit interner Verkabelung
MAVIG – GEBRAUCHSANWEISUNG
Rev.: POI02G04
Languages: English 2 - 18
Deutsch 19 - 35
Art.-Code: MA05107201
20
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