baaske e-medic User manual

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Baaske Medical GmbH & Co. KG Made in Germany ISO 9001

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// Contents
1. Safety instrucons
Electrical safety and conformity
Inial operaon
Purpose and mode of operaon
Connecon of peripheral devices
Upgrade and installaon of components
Acon with ingress of foreign bodies and uids
Acon with the ingress of foreign objects and liquids
Adherence to physical limit values
Temperature uctuaons and condensaon
Choice of locaon
2. Paent environment
e-medic Pro-Line M II Computer (Medical)
e-medic Pro-Line II Computer
Combinaon with acve medical products in the paent environment
Safety instrucons for operaon in the paent environment
3. Integraon in a medical system
4. Operaon in a network
5. Safe operaon
Data protecon
Protecon from power outages
Care and maintenance
e-medic air lter inspecon or exchange
Cleaning the housing
6. Liability and warranty
Contact and Service Hotline
Disclaimer
Notes
7. Technical data
Connecon diagram
Data sheet
Accessories and add-on cards
Declaraon of conformity
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Dear customer,
Thank you very much for deciding on a high quality e-medic product.
Our e-medic Computers are developed and manufactured in Germany following the strict
guidelines of ISO9001 Quality Management. You have thus bought a quality product with a
high manufacturing standard and high life expectancy and have, at the same me, suppor-
ted Germany as the country of origin for high quality products.
We have developed and produced your e-medic Computer with the best possible compo-
nents to allow you many years of smooth operaon. For this reason our products come
with a long-term availability guarantee for spare parts as well as with a warranty of up to
5 years*.
To ensure long-term stability the AirBalanced housing and the three-stage e-medic air lter
have been developed for the e-medic Pro-Line II range. The three-stage e-medic air lter
consists of a replaceable an-bacterial Qualitex® ne parcle felt lter (stage 1) and two
permanent parcle lters. The permanent lters are an anstac plasc lter (stage 2) and
a high voltage discharge, interference impulse resistant stainless steel lter (stage 3). At the
same me the three-stage air lter provides a high air ow and small ow resistance due to
its large surface area of approximately 28,8 cm2. These are all important features to gua-
rantee long maintenance intervals. Our clear goal: low maintenance, long-term operaons
so that you can concentrate on your day-to-day business and, in the best case, not noce
your computer. It’s there, and works.
We wish you a lot of enjoyment with your e-medic Computer and thank you once again for
choosing us as your partner.
Your e-medic Team
*Opon with addional charge
// Foreword
Note
To avoid the risk of possible electric shock this unit must only
be connected to a mains power supply with an earth conductor
protecon.
!

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// 1. Safety instrucons
<< Read carefully prior to inial operaon start-up!!! >>
Electrical safety and conformity
The Pro-Line II PC must only be installed and brought into operaon by qualied personnel.
The opening of the housing is also only to be carried out by qualied personnel. The Pro-
Line II PC must only be powered by a 230/240V mains supply with an aached protecve
earth conductor. The mains supply must conform to DIN 0100 part 710. The computer is
also sll connected to the mains supply when it is in a switched o condion. Only through
unplugging the computer will it be separated from the mains supply. The operaonal area
must comply with the requirements of EN/IEC 60601-1 or EN/IEC 60950-1. The unit must
only be operated using the original mains cable provided. An extension of the power sup-
ply connecng cable is not permied. If the original mains cable has to be replaced with
another cable or a longer cable, then only a cable validated by us may be used. With visible
damage to a power line this must be replaced immediately with a perfect mains cable that
has been validated by us. With transfer or resale of the unit this handbook must be passed
on with it.
! If these instrucons are not complied with the unit loses its conformity and there is a
danger to life for users, paents and third persons.
Inial operaon
When your Pro-Line II PC has just been delivered do not under any circumstances connect
it straight away! First unpack your new computer very carefully and remove the protecve
foil. Then leave the PC standing in the room in which it is to be used for at least 2 hours so
that the computer can assimilate the room temperature and any possible condensaon
moisture that has accrued can dissipate. If moisture has built up on the housing wipe this
o with a clean, anstac cloth. As long as there is moisture on the housing the computer
must not be connected to the mains supply.
Purpose and mode of operaon
This unit is suitable for the storage and processing of data. This unit is developed for long-
term use in intermient operaon.

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Connecon of peripheral devices
Read the operang instrucons of the devices to be connected very carefully and follow
the installaon instrucons of the respecve products. The cable lengths of the devices
connected must not exceed 3m, otherwise correct operaon cannot be guaranteed. En-
sure the connectors are seated properly. If you have bought your Pro-Line II PC with an
addional graphic card the display connecons on the mother board are disconnected.
Connect the monitor to be used to one of the horizontally lying graphics card connectors.
These are to found in the lower area at the back of the computer. With connecon to the
motherboard sockets for the built in graphic device your monitor will not funcon.
! Warning: With devices that provide the Pro-Line II with addional power via the con-
necng plug, the supply unit must also be checked according to EN60601-1.
Upgrade and installaon of components
<< Remove the mains supply plug before opening the housing! >>
Any opening of the housing is solely permied by one of our authorised company’s resp.
technicians. Aer opening the unit, and according to applicable legal requirements, a new
safety test must be carried out in accordance with EN60601-1.
Before opening the housing it is imperave to remove the mains supply plug and to wait for
approx. 1 minute unl all electrical current inside the unit has dissipated. Otherwise there
will be a danger to life!!! A subsequent change to the conguraon of the unit requires
authorisaon by e-medic Support and only components that have been tested and valida-
ted by us may be used. An unauthorised change to the unit conguraon will result in an
immediate loss of conformity and can lead to a danger to the health of the user and / or the
paents and other people as the electrical safety can no longer be guaranteed!
Acon with the ingress of foreign objects and liquids
With the inadvertent ingress of foreign objects, liquids or with the development of conden-
saon on the unit it must immediately be separated from the mains supply by removing
the plug. Under no circumstances switch the unit on again and contact the in-house tech-
nician, resp. your e-medic dealer or contact our Support team.

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Adherence to physical limit values
In accordance with the technical data maintain the specied permissible operang values
for temperature, humidity and air pressure without fail as the Pro-Line II PC would other-
wise be run outside its specicaons and safe operaon can no longer be guaranteed. If
the limits of the values for operaon exceed or are below those stated the unit must be
immediately switched o and the mains supply plug removed.
Temperature uctuaon and condensaon
If the unit is exposed to large temperature uctuaons, such as those that can occur
through transportaon or storage in an unheated locaon, under no circumstances con-
nect the unit straight away as condensaon moisture can accumulate internally. Wipe o
visible external condensaon with a clean, anstac cloth and in such a case leave it stan-
ding without packaging material for at least 2 hours before connecng the Pro-Line II PC
to the mains supply. The unit can only be connected when no further condensaon forms.
Choice of locaon
The Pro-Line II PC must be placed in a dust free, vibraon-free and dry locaon and must
not come into direct contact with liquids and combusble gases. Ensure that the computer
has a rm, horizontal and level plaorm. Make sure that the computer has enough room on
each side to prevent the build up of heat. Under no circumstances must the rear venlaon
grill be covered or blocked as the power supply unit will no longer be suciently cooled. If
other installaon opons are chosen it is to be ensured that nobody can be injured due to
inadequate xaon of the computer.

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// 2. Paent environment
To protect your paents from electrical inuences avoid simultaneous contact with the
paents and the computer housing.
a) e-medic Pro-Line M II Computer (Medical)
The Pro-Line M II is a so called „Medical PC“ and was developed and tested for use in the
vicinity of paents. It fulls the requirements of the EN/IEC 60950 and EN/IEC 60601-1-2
standards and the power supply fulls the requirements of EN / IEC 60601-1 standard with
respect to the electrical limit values.
b) e-medic Pro-Line II Computer
Pro-Line II model computers are only appropriate for use in the vicinity of paents in
conjuncon with a medical isolang transformer. The output of the isolang transformer
should be at least 450VA. We recommend the use of the MED N isolang transformers
that can be sourced through your e-medic dealer. In this conguraon a faultless funcon
is guaranteed. In the following table you can nd an overview of recommended isolang
transformers.
Recommended isolang transformers for Pro-Line II
Output Model name
600VA MED N 600 VA
1000VA MED N 1000 VA
2000VA MED N 2000 VA
Electrical safety according to IEC / EN 60601-1
For the manufacture of a system consisng of computers of the Pro-Line (M) II series and
other electrical devices used in the medical eld, the requirements of the valid version of
IEC / EN 60601-1 resp. EN 60601-1-1 are to be taken into account.
Furthermore, it is the responsibility of the system manufacturer to market the complete
system according to the medical product guidelines 93/42 EWG resp. 2007/47/EG and,
as the case may be, to bring it into operaon in the framework of in-house producon
according to §12 MPG. Because by denion a computer system without medical soware
cannot be a medical product as dened by the guidelines of 93/42 EWG it is, therefore, a
new system made up of medical product and non-medical product.
Isolang transformer MED N 600 VA 230V

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The e-medic Pro-Line M II Computer was cered according to IEC / EN 60601-1-2 and the
power supply meets the requirements according to IEC / EN 60601-1. Compliance with the
limits of these standards allows the system manufacturer to carry out the (simplied) con-
formity assessment procedure according to the medical product guidelines.
Depending on the medical purpose of the overall system it may also be necessary to install
a so called galvanic separaon between an acve medical product and a computer system
for both Pro-Line and also Pro-Line M Computers to comply with the requirements of the
IEC / EN 60601-1. Galvanic separaon isolates the wanted signal of the respecve PC inter-
face, such as network (Ethernet), USB or DVI interfaces.
Listed in the following table are our recommended and tested isolators which can be sour-
ced through your e-medic dealer:
Data lines that may possibly be connected, e.g. network and ISDN cables, must also be
isolated. In the table below you will nd our recommendaons and these can be supplied
by your e-medic dealer.
USB 1.1 Med
MI-1005
Recommended isolators for Pro-Line II
Connecng cable
type
Model name
USB USB 1.1 MED
Serial RS-232 RS232 Isolator STD 2.5KV B 9Pin
LAN-Network MI-1005
BNC/S-VHS MED Video Isolator 1, 2, 4
DVI DVI-Isolator STD1, STD2, STD4
Recommended data cable isolators for Pro-Line II
Data cable type Model name
LAN-network MI-1005
ISDN ISODN ISDN Isolator

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Safety instrucons for operaon in the paent environment
In general the current valid naonal laws, standards and guidelines are to be complied
with. The Pro-Line II Computer may be used within the paent environment. In conjuncon
with acve medical products that were introduced according to the 93/42 EWG guidelines,
a new medical electrical system is created that must be re-evaluated. Peripheral devices
within the paent environment, such as printers or cameras, must also either comply with
the requirements of IEC 60601-1 and IEC60601-1-2 or be addionally equipped with a two-
stage protecon for the paents. This addional protecon can be ensured by the use of
isolang transformers or isolators in the connecng cable (see Point 2. “Paent environ-
ment” ). With non-compliance with the current regulaons you are acng with gross negli-
gence and place the lives of your paents and those of uninvolved third pares in possible
danger. If in doubt contact our e-medic Support in order to create a safe environment for
you and your paents. If you need further support, such as specialist literature or training,
you can also contact our e-medic Support Team. We will be happy to help you further in an
uncomplicated and unbureaucrac manner.
// 3. Integraon in a medical system
With the integraon of the Pro-Line II Computer in a medical electrical system the requi-
rements of the valid version IEC 60601-1 and possibly the requirements of the medical
product guidelines 93/42 EWG (2007/47/EG) are to be complied with. The Pro-Line II PC
must only be electrically connected to and operated with products and devices that comply
with the requirements of the standards EN/IEC 60601-1 or EN/IEC 60950-1. Before the in-
tegraon of the Pro-Line II PCs in a system, be sure to ask the manufacturer of the medical
system if this requirement for the operaon with a PC is specied. If operaon with a PC is
permied keep strictly to the system manufacturers recommended performance values for
the PC unit. Connected data cables must be separately isolated, where appropriate, as well
as the connecng cable between the Pro-Line II PC and other possible connected devices.
// 4. Operaon in a network
The Pro-Line II Computer may only be operated in a network that complies with the requi-
rements of EN 50173 resp. ISO/IEC 11801. We, as manufacturer of the e-medic computers,
will not be liable for transmission failures, data loss or electrical surges and short circuits in
your network structure that could occur due to non-standard installaon. Only allow the
installaon in your network to be carried out by the network administrator or a person
authorised by him.

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Do not carry out any changes to your network without the authorisaon of the network
administrator. In addion, in the case of use in the paent vicinity the instrucons listed
under Point 2. “Paent environment” are to be taken into account.
// 5. Safe operaon
Data protecon
Through the use of high quality components we have been able to develop a guaranteed
durable and stable plaorm for you. Please make sure, however, that your data is backed
up regularly because only you as the user of the computer are responsible for this. We
therefore recommend that you back up your data at regular intervals on an external data
carrier or, beer sll, on a Pro-Line II PC with two built in hard drives, this run in safe RAID1
array. In accordance with current legislaon we, as manufacturer, are not liable for dest-
royed data and their subsequent costs. Ask your e-medic dealer or our e-medic Support
Hotline for an appropriate soluon for secure data storage.
Protecon from power outages
So that no data loss occurs with mains supply failures and so that you can safely close
down your current applicaon we recommend the use of a medical UPS (Uninterrupble
Power Supply). These are available with dierent output sizes. The VA value given means
that with this VA performance decrease the UPS of the connected unit will supply electrical
power for approx. 4-6 minutes. Your Pro-Line II Computer has approx. 400VA power con-
sumpon at full load. A UPS with 420VA can supply your Pro-Line II Computer at full load
for 4-6 minutes. At half load, which corresponds to the normal operaon of a computer,
the PC will then be supplied for approx. 20 minutes. If you take a UPS with a higher VA
number then the supply me will be increased accordingly. The table below is intended
as a guide to make it easier for you to choose the appropriate UPS. Please remember that
your monitor should also be connected to the UPS so that your system remains operable
in an emergency.