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B008 SpaceStation & SpaceCom Operating Manual
B008 SpaceStation & SpaceCom Operating Manual
and SpaceCom
2
Contents
3
PATIENT SAFETY
PATIENT SAFETY
Important Information and Notes for Patient Safety
a Read carefully Instructions for Use of the infusion pumps and infusion syringe
pumps used.
a Application of infusion and infusion syringe pumps only under regularly supervisi
on by specially trained staff.
a The user must make sure the pumps and other components of the system are
locked correctly.
a Do not deposit things on the pumps. Avoid leaning on the pumps!
a The connecting leads must be laid so that people do not stumble over them and
work with the Space System is not hampered.
a Do not place disposable near the connections of the pumps – use hose routings.
a Make sure the pumps are inserted and removed correctly.
Transport:
a With max. 4 pumps. Be especially careful when a patient is connected. Avoid
external mechanical action!
Only for use of:
a Infusomat® Space
a Infusomat® Space P
a Perfusor® Space
a SpaceControl
a SpaceCom
a Some components have further Instructions for Use or assembly instructions,
which need to be observed.
a Therapeutic or diagnostic conclusions must not be based exclusively on values
displayed on infusion pumps or data available via interfaces.
a The Space System should only be operated in areas which are well protected
against vibration, dust corrosive and explosive gases, extreme temperatures and
humidity. To guarantee sufficient air circulation for cooling the system, there
should be at least 5 cm of clear space around the system. Do not cover the
ventilation slots. The equipment must be free of condensate during operation.
a When equipment with high electro-magnetic radiation is used at the same time
(e.g. digital telephones, X-ray apparatus, MRI, etc.) interference may occur. This
may lead to display trouble or implausible values may be indicated. If these
problems are due to electro-magnetic interferences, the following measures may
help to avoid or solve them:
a Avoid using devices which are not necessary from the medical point of view
(e.g. mobile telephones).
a Extend distance between source of interference and the medical product.
a Alter position of power supply leads, connection leads and electrodes.
a The EMC-limits (electro-magnetic compatibility) according to IEC/EN 60601-1-2
and IEC/EN 60601-2-24 are maintained. If the equipment is operated in the
vicinity of other equipment which may cause high levels of interference (e.g. HF
surgical equipment, nuclear spin tomography units, mobile telephones) maintain
the recommended protective distances for these devices.
5
PATIENT SAFETY
a The Space System should not be exposed to excessive magnetic fields (e.g. in an
MRI room). If necessary, longer infusion lines can be used. When using a
defibrillator, precautions must be observed which can be found in the
documentation for the defibrillator.
a For the safe use of Space infusion pumps in MRI the SpaceStation MRI is
recommended.
a In any case of central alarm (e.g. from staff call) it is necessary to check which
infusion pump caused the alarm. Only the specified alarm caused by the infusion
pump is relevant for safety.
Direct contact of the connectors of the SpaceStation during operation can lead
to malfunction due to electrostatic discharge.
Parallel infusion:
Compared to single infusions increased bolus volumes and alarm delay times may
occur!
Therefore:
If possible, select low pressure settings.
Pay attention to bigger bolus volumes and alarm delay times.
When removing sealing, do not let the bolus reach the patient.
A bolus reduction may lead to an underdosage of the drug when starting the
infusion again.
Recommendation: bolus reduction by opening the outward conducting system.
The bolus reduction may lead to dosage variations.
Higher personal supervision with critical drugs.
Immediate reaction in case of alarm!
When switching off a pump temporarily bolus administration is possible due to
enrichment of concentration at reduced flow.
The Space System is flexible due to fast and space saving assembly and disassembly
as well as the possibility to use it as a mobile, wall or ceiling unit.
Fur further descriptions as well as assembly resp. disassembly please see this
Instructions for Use.
Transport damages:
Inspection on delivery. Despite careful packaging, the risk of transport damage
cannot be entirely prevented. Upon delivery, please check that nothing is missing.
Do not use a damaged device. Contact the service department.
Packaging:
Packages are designed in a way that:
electrostatic charges are prevented and
batteries on printed boards cannot be discharged.
7
THE SPACESTATION IN DETAIL
Chapter 1
Central loudspeaker,
only contained in
SpaceCover comfort
Lever to release
universal clamp
Rotary knob to
unlock single
pumps. Locking
happens automa-
tically when the
pump is pushed in.
9
THE SPACESTATION IN DETAIL
Chapter 1
The upper segment is pushed on the lower segment from the front and fixed with the
locking in the lower segment.
To release, move the locking button in the corresponding position and take out the
upper segment to the front.
Attention: Every single SpaceStation must be fixed to a fastening tube by
means of a fixation clamp.
10
THE SPACESTATION IN DETAIL
Chapter 1
11
THE SPACESTATION IN DETAIL
Chapter 1
Every single pillar must be covered with a SpaceCover standard or SpaceCover comfort.
If with a two or three pillars build up and only one SpaceCover comfort is used in this
combination all alarms and status information are displayed at this Cover. In case
every pillar is covered with a SpaceCover comfort the status and alarm information
are shown at the corresponding cover.
12
COMBINATION OF PUMPS WITHIN A SPACESTATION
Chapter 2
13
INSERTING AND REMOVING INDIVIDUAL PUMPS
Chapter 3
To release, turn the knob clockwise in the vertical position and remove the pump.
After release the pump is held in the SpaceStation by the guide rails, but can drop
easily due to strong vibrations or during transport.
Attention: If a SpaceStation is used to transport infusion pumps make sure that
the pumps are correctly seated in the system.
A combination of Space pump and SpaceControl is installed in the SpaceStation in
the same way. In this case pump and SpaceControl are automatically and individu-
ally locked. Before removal, first release the pump and then SpaceControl and then
remove both systems. For detailed information please refer the instructions for use of
SpaceControl.
Attention: After connecting a pump the blue LED starts flashing for a short time.
In case the blue LED is illuminated constantly, a non critical fault is detected. By dis-
connecting and connecting the pump again, the fault could disappear, observe blue
LED. If the blue LED stays illuminated please inform the technical service. The pump
can be used furthermore but the status is not shown at the SpaceCover comfort,
green/yellow/red LED at cover, and communication with external systems, PDMS,
SpaceOneView, or staff call, is not working anymore. Status information are only
shown at the pump directly.
14
SpaceCover Standard / SpaceCover Comfort
Chapter 4/5
SpaceCover Standard
The SpaceCover Standard does not contain any additional electronics. It protects the
upper connectors from humidity and damage and allows a single SpaceStation to be
used as a carrying unit.
Attention: Make sure that the SpaceCover is always correctly fixed. Please refer
also to the „Assembly and Disassembly Instructions” of the SpaceStation.
SpaceCover Comfort
Operating
elements and
status display on
SpaceCover
Status and
alarm display
15
SpaceCover Comfort
Chapter 5
Status display
for SpaceStation
and SpaceCover,
3-colour
Display of battery condition, 3-colour LED, green, yellow, red, for display of
green LED rechargeable battery condition
Maintenance required
Maintenance active (capacity > 75%) flashing
16
SpaceCover Comfort
Chapter 5
Battery pre- and end alarms can be acknowledged with the buttons of the volume
control “+” and “-“. Thereby the audible alarm is prevented, the optical alarm is still
displayed. Battery alarms are automatically acknowledged when the system is
reconnected to the mains.
18
Interfaces FOR Data Communication
Chapter 6
19
Interfaces FOR Data Communication
Chapter 6
Wireless LAN
(optional)
Status displays
for SpaceCom
Ethernet RJ 45
PS/2 Connection
RS232
USB Slave
USB Master
20
Interfaces FOR Data Communication
Chapter 6
Wireless LAN
(optional)
Status displays
for SpaceCom
Ethernet RJ 45
RS232
After starting the system the red LED must go out after approx. 60 sec. Should this
not be the case there is an error. Try to remedy the error by re-starting the system.
Should the red LED stay on please contact the B. Braun service.
21
Interfaces FOR Data Communication
Chapter 6
Attention: Make sure that the IP address used in SpaceCom is unique within the
hospital network and check the correct communication with the PDMS prior to clini-
cal use.
22
Interfaces FOR Data Communication
Chapter 6
Important: The browser must accept cookies and allow the execution of JavaScript.
Important: SpaceCom only supports Microsoft® Internet Explorer 7.0 or higher as
well as Firefox version 3 or higher.
6.6.2 Login
The following user names and passwords are predefined:
23
Interfaces FOR Data Communication
Chapter 6
Language Status of
setting connection
6.7 Status
The status display shows infusion pump data and the system status. The representa-
tion of the pumps corresponds with the topological configuration in the system. The
present status will be displayed according to the legend. If a pump is selected, de-
tailed information will be displayed on the right. Patient information will only be
displayed if it is also saved in the pump. This is available only with pump software
version G and higher. The data of the selected pump will be shown according to the
pump software version.
24
Interfaces FOR Data Communication
Chapter 6
6.8 Service
This page contains information about the individual pumps and the system.
6.9 Configuration
Under configuration user settings and configurations can be done.
25
Interfaces FOR Data Communication
Chapter 6
26
Interfaces FOR Data Communication
Chapter 6
PDM system.
27
Interfaces FOR Data Communication
Chapter 6
You also can setup a TCP/IP interface for the communication with SpaceCom via the
BCC protocol. In this case the port 4001 is used in SpaceCom. In this case the other
settings for the COM-Port are not used.
For further information how to configure the BCC protocol see the separate interface
description.
28
Interfaces FOR Data Communication
Chapter 6
29
Interfaces FOR Data Communication
Chapter 6
Load image
a. The module changes to “Update mode”
b. Press the button “Browse” and choose the desired image.
d. Wait about 10 minutes, until the image is loaded and the module has exited the
update.
31
Interfaces FOR Data Communication
Chapter 6
WLAN Security
Network authentication - Open
Encryption:
None
WEP 64 (5 alphanumeric / 10 hexadecimal character)
WEP128 (13 alphanumeric / 26 hexadecimal character)
Network Key
32
AutoProgramming
Chapter 7
AUTOPROGRAMMING
7.1 General
AutoProgramming offers the possibility to send an order/ a prescription to one or
more B. Braun Space infusion pumps placed in a SpaceStation. In case an order is
received by a pump it prompts the data and the user has to confirm all values of the
order before the infusion can be started. Order data has a lifetime of 5 minutes. Af-
terwards the data is deleted at SpaceCom and a delete event is sent to the pumps.
Attention: AutoProgramming is an additional feature to communicate data
generated in an electronic documentation system to the pumps. Before setting the
system into operation, please check the correct link of the documentation system
and the pumps. Before the data is activated at the pump the operator has to confirm
the correctness of the data by using a reference to the original data entered.
Attention: Before reactivation of a Piggyback drug the user has to check that all
parameters of the reactivated Piggyback drug are correctly displayed.
It is possible to send order data to a specific infusion pump by using the serial number
and type of pump within the data stream. Doing this the following sequence gets active.
AutoProgramming function is available for pumps with software version L03 or higher.
33
AutoProgramming
Chapter 7
In case any data are missing, e.g. patient weight, to start the infusion the pump will
request the missing data by opening the corresponding menus.
In case any data is missing, e.g. patient weight, to start the infusion the pump will
request the missing data by opening the corresponding menus.
In case not a specific pump is addressed and the order or a list of orders is sent to a
SpaceStation containing several pumps, all pumps within the system will start
signaling the availability of order data.
Note: In case the drug name exceeds the length of 8 character the short name is dis-
play or the drug name is truncated automatically. In this case the drug name (long)
can be displayed in the lower line of the pump display by scrolling up/down. Please
refer the instructions for use of the pumps.
34
AutoProgramming
Chapter 7
Order data are displayed according to the status of a pump. Details are listed below:
Stand by active Order data are In the upper line of the display
displayed Order data and the first entry of the
prescription list are shown. After
ending stand by the list can be
edited.
Pump is switch on but not Order data are List can be entered by pressing the
infusing displayed blue connect button m.
Infusing and no drug Order data are List can be entered by pressing the
name assigned displayed blue connect button m.
Pump is connected to Order data are List can be entered by pressing the
system while order data displayed blue connect button m.
are active
Infusing a drug but Order data are Only this drug is displayed in
infusion rate is changed displayed order list. Rate is adjusted after
in order list confirmation.
Note: It is recommended to switch off the feature “Use last therapy”. To do this
please use the Service Tool HiBaSeD.
The following additional options are available at the pump in case a pump is not
directly addressed by the sending system or several orders are in the prescription list.
35
AutoProgramming
Chapter 7
One of the menus is offers settings to delete the order list at this pump or force the
pump to stop signaling order data.
36
AutoProgramming
Chapter 7
LookUp
LookUp allows to link the received AutoProgramming order data with a data set of
the drug library within a pump in order to take over pre-defined therapy types
including its parameters, for example, default rate and soft/hard limits before star-
ting the infusion.
There are two different possibilities to link the received data to a drug data set of the
drug library:
1. via Drug Long Name and Concentration
2. via Drug ID
LookUp can be used for the therapy types Continuous and Dose Over Time (incl. Pig-
gyback) only. It must be enabled via the Service Tool HiBaSeD. Furthermore, it is pos-
sible to configure the LookUp function as mandatory within the AutoProgramming
process. For detailed information of the configuration please refer to the Service Tool
HiBaSeD instructions.
Piggyback
(valid for pump software version L04 or higher)
To program a Piggyback infusion in a single pump a second sending of data is ne-
cessary. Follow the defined workflow and send the primary infusion data. In case the
drug is defined within the drug library of Space as a Piggyback drug the pump will
prompt a question to select the secondary infusion out of the drug library. After the
second data stream has been received a dialog is shown to confirm the data.
In case the infusion is already running (pump started with primary infusion) a new
sent drug will automatically assigned as a secondary infusion and a dialog is shown
to confirm the data.
For more detailed information please refer the Auto-Programming Interface specifi-
cation.
Attention: The user has to ensure that all pumps of the same type used in a
wireless network have unique serial numbers.
37
AutoProgramming
Chapter 7
38
BARCODE READER
Chapter 8
BARCODE READER
SpaceCom allows to use a Barcode Reader to scan information from barcode labels
(medication or patient information) and to send the information to a specific pump
within the Space system.
Attention: Only the barcode reader provided by B. Braun is compatible with
Space. In case of any other hardware used a proper operation can not be guarantied.
Attention: The user must verify the data read in via a barcode reader at the
pump before confirmation. To allow a clear allocation of a drug to a patient it is re-
commanded to print the patient name on the barcode label.
The barcode reader is detected by SpaceCom automatically. Via the service program
HiBaSeD it is possible to set up the behavior of a pump in case a barcode reader is
connected. Since SW G or higher of the pump the following settings are possible:
HiBaSeD menu Others:
- Activation of barcode reader menu within „Special functions“
- Show barcode reader menu during the Start-up of the pump
HiBaSeD menu Barcode:
Authorized nurse ID scan: The nurse is asked to scan a nurse ID. The nurse ID is stored
in the history protocol of the pump and transferred via BCC protocol.
Patient ID matching: The user is ask to scan the patient ID. In this case the patient
ID must be included in the medication container label as well and the pump checks
if the patient ID (patient wrist band) matches to the ID coded on the medication
container label.
Sharing nurse ID: The scanned nurse ID is shared with all other pumps within the
system.
The duration of validity defines the time the information (Patient ID and Nurse ID)
are valid within the pump. After this time the data needs to be scanned in again in
case the barcode reader is used.
Look-up: The Look-up feature allows to link the information received via barcode
with the drug library of a pump. In case the drug name and the concentration of
a drug are in the drug data base of the pump the other information programmed
within the drug data base are added to the barcode information. In this case for exa-
mple the soft- and hard limit settings are active.
In case the Look-up feature is not used the information contained in the barcode are
displayed only. In this case a hand symbol is shown in front of the drug name displa-
yed at the pump.
For detailed information please refer the Barcode Interface Specification.
39
Service
Chapter 9
Service
The Space System is to be subjected to a Technical Safety Check with registration in
the Medical Device Book every 24 months.
The Technical Safety Checks may only be performed by technicians trained by
B. Braun or technical personnel of B. Braun Melsungen AG.
Individual agreements take into account the specific conditions of every hospital.
If required a complete Service Manual can be made available, this, however, only
combined with a technical training.
Note:
If the Space System is to be integrated in existing wall or ceiling supply systems,
please check whether this adaptation is permitted with the manufacturer of the
supply systems.
The infusion pumps Infusomat® Space and Infusomat® Space P as well as the infusi-
on syringe pump Perfusor® Space are to be submitted to a Technical Check with
registration in the Medical Device Book according to the checklist every 2 years.
This 2-year maintenance should be carried out by the service personnel of the
manufacturer B. Braun Melsungen AG, or technical staff trained by them.
The CE label confirms that this medical device corresponds to the „Directive of the
Council for Medical Products 93/42/EC” of June 14, 1993.
40
GUARANTEE
Chapter 10
GUARANTEE
B. Braun Melsungen AG puts a guarantee of 24 months on every SpaceSystem coun-
ted from the delivery date. For rechargeable batteries a guarantee of 12 months is
given.
This guarantee includes repair or replacement of defective parts due to constructio-
nal, manufacturing or material defects. The guarantee becomes void if the user or
third parties make changes to or repairs on the system. Excluded from the guarantee
are:
repairs of defects that can be attributed to incorrect manipulations, improper use
or normal wear.
The instructions for use of the Space System can also be reordered after the product
service life.
10.1 Maintenance
Operate the system only in accordance with the instructions for use.
Check, clean and disinfect the Space System at regular intervals.
Check for cleanliness, completeness and damages.
Only use original spare parts and accessories.
Carry out the Technical Safety Check or maintenance of the Space System with all
additional units connected (e.g. PC) every 24 months (see checklist attached).
41
GUARANTEE
Chapter 10
42
LABELING
Chapter 10
This table describes symbols in general but does not replace the
technical specification of the described product.
Symbol Explanation
Temperature Limit
Moisture Limit
Keep dry
Recycle
43
TECHNICAL DATA
Chapter 11
TECHNICAL DATA
11.1 B. Braun SpaceStation without B. Braun SpaceCom
Type of unit System rack for connection of up to
4 infusion pumps
Classification (acc. to IEC/EN 60601-1) Defibrillator–proof; CF equipment
Protective Class I
MDD Class IIb
Protection type IP 22 (drip protected)
Power supply Primary: 100 … 240V 50/60Hz
110V 0.46A / 220V 0.23A (mains fuse 2A
slow blow)
Secondary: 12V DC / 35W
(cooling: convection)
Duty cycle 100%
External low voltage supply 11 … 16V DC
(via Connection Lead SP 12)
Staff call max. 24V / 1A /24VA (via Connection Lead
for Staff Call)
floating output
Observe VDE0834
Pay attention to national requirements
Earth leakage current (incl. cabling) one station six stations
NC < 35 µA NC < 110 µA
SFC < 70 µA SFC < 220 µA
Patient leakage current < 1 µA
EMC acc. to IEC EN 60601-1-2:2001 +A1:2006
and IEC EN 60601-2-24:1998
Operation in ambulance cars acc. to 2009/19/EG(2004/104/EG)
Electronic with following functions
Protection of pump connector Release of power outlet only if pump is
seated in
Electronic fuse 12V/1,8A
Interface to SpaceCom optional device
Protection of SpaceCover Release of power outlet only if cover is
mounted
Electronic fuse 12V/1.5A
Configuration of SpaceStation Dynamic configuration depending of the
mounted SpaceStations
Addressing of pumps Dynamic addressing related to the position
of the pump within the system
Interfaces
Mains power inlet Standard cable
44
TECHNICAL DATA
Chapter 11
46
TECHNICAL DATA
Chapter 11
47
TECHNICAL DATA
Chapter 11
RF emissions Group 1 The Space System uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
Note: The optional WiFi modul (2,4GHz / 100mW)
can cause interference with devices in the vicinity.
Please observe the necessary minimum distance
requirements.
RF emissions Class B The Space System or any component is suitable for
CISPR 11 use in all establishments, including domestic
establishments and those directly connected to the
Harmonic only for SpaceStation public low-voltage power supply network that
emissions applicable supplies buildings used for domestic
IEC 61000-3-2 purposes.
Class A
IEC 61000-3-3
Note: Maximum emissions are measured with a complete system (SpaceStation and components).
48
TECHNICAL DATA
Chapter 11
< 5 % UT
(>95 % dip in UT )
for 5 sec
<5% UT
for 5 s
(>95% dip)
Power frequen- IEC 60601-2-24: Power frequency magnetic
cy (50/60 Hz) 400 A/m 400 A/m fields should be at levels
magnetic field characteristic of a typical
according IEC location in a typical commer-
61000-4-8 cial or hospital environment.
Note: Different test values of IEC 60601-2-24 are marked in the table. At this test values none
dangerous disturbances are allowed while at the lower test values of IEC 60601-1-2 no disturbances
are allowed.
49
TECHNICAL DATA
Chapter 11
Recommended
separation distance
radiated IEC 60601-1-2:
electromagnetic 3 Veff normal and d = 1,2 √P
HF fields 10Veff in ISM Field strengths should be less then
according frequency band 10V/m
IEC 61000-4-6
IEC 60601-2-24: 10Veff d = 1,2 √P
10 Veff 150 KHz to 80 MHz 80 MHz to 800 MHz
150 KHz to 80 MHz
10 V/m d = 2,3 √P
radiated 10 V/m 80 MHz to 3 GHz 800 MHz to 2,5GHz
electromagnetic 80 MHz to 2,5 GHz
HF fields where p is the maximum output
according power rating of the transmitter in
IEC 61000-4-3 watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
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.
NOTE 3: Different test values of IEC 60601-2-24 are marked in the table. At this test values none
dangerous disturbances are allowed while at the lower test values of IEC 60601-1-2 no disturbances
are allowed.
50
TECHNICAL DATA
Chapter 11
NOTE 1: For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the frequency
of the transmitter, where P is the maximum output power rating of the transmit-ter in watts (W)
according to the transmitter manufacturer.
NOTE 2: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the frequency range 0.15 MHz to 2.5 GHz to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently brought into
patient areas.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
51
GNU GENERAL PUBLIC LICENSE
Chapter 12
Preamble
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License is intended to guarantee your freedom to share and change free
software--to make sure the software is free for all its users. This
General Public License applies to most of the Free Software
Foundation’s software and to any other program whose authors commit to
using it. (Some other Free Software Foundation software is covered by
the GNU Lesser General Public License instead.) You can apply it to
your programs, too.
We protect your rights with two steps: (1) copyright the software, and
(2) offer you this license which gives you legal permission to copy,
distribute and/or modify the software.
Also, for each author’s protection and ours, we want to make certain
that everyone understands that there is no warranty for this free
52
GNU GENERAL PUBLIC LICENSE
Chapter 12
You may charge a fee for the physical act of transferring a copy, and
you may at your option offer warranty protection in exchange for a fee.
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GNU GENERAL PUBLIC LICENSE
Chapter 12
2. You may modify your copy or copies of the Program or any portion
of it, thus forming a work based on the Program, and copy and
distribute such modifications or work under the terms of Section 1
above, provided that you also meet all of these conditions:
b) You must cause any work that you distribute or publish, that in
whole or in part contains or is derived from the Program or any
part thereof, to be licensed as a whole at no charge to all third
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GNU GENERAL PUBLIC LICENSE
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3. You may copy and distribute the Program (or a work based on it,
under Section 2) in object code or executable form under the terms of
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The source code for a work means the preferred form of the work for
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58
ORDERING