SpaceStation - Frank`s Hospital Workshop
Contents
1. Outlet of mains voltage Connector for power supply of the next SpaceStations Pump connector 4 connectors F2A F2D for Infusomat or Perfusor Space Connection between modules Interconnection of several SpaceStation via plugs F3 and F4 Connection to periphery Connection of accessories PCA button SP Connection lead for Staff Call Connecting Lead SP 12 V Interface Lead SP via plug F3 Operating conditions Relative humidity Temperature Atmospheric pressure 30 90 without condensation BC 40 C 500mbar 1060mbar Storage conditions Relative humidity 20 90 without condensation Temperature 20 C 55 C Atmospheric pressure 500mbar 1060mbar Weight w o Cover with pole clamp 3 6 kg Dimensions W x H x D without Cover 290 x 327 x 160 mm Dimensions W x H x D with Cover 290 x 364 x 160 mm 11 2 B Braun SpaceStation with B Braun SpaceCom Like B Braun SpaceStation without B Braun SpaceCom with the following modifications Rated voltages Primary 100 240V 50 60Hz 110V 0 6A 220V 0 3A mains fuse 2A slow blow Secondary 12V DC 42W with forced ventilation turn on duration 100 Temperature controlled ventilator Ventilator powers up at 50 C Internal temperature Inserted SpaceCom Power consumption At 12V 2 5 to 4W depending on used accessories without battery charge ca 3W battery charge TECHNICAL D2. gt 50 Dz Maintenance active capacity gt 25 Dz Maintenance active capacity lt 25 E2 16 SPACECOVER COMFORT Kapitel 5 Rechargeable battery SpaceCom is only displayed when rechargeable battery is installed LED left LED middle LED right gt 75 capacity gt 50 capacity gt 25 capacity lt 25 capacity Battery flat switched over to SpaceStation battery Maintenance required Qo Maintenance active capacity gt 75 Maintenance active capacity gt 50 lt Maintenance active capacity gt 25 O BE Qo Maintenance active capacity lt 25 doollee o o Jobieien o cee Error change battery Rechargeable battery SpaceStation 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 5 1 2 Switching On Off The On Off switch is only operative in battery mode When the system is connected to the mains voltage the system is always activated A Attention When the system is not needed and not connected to the mains voltage the SpaceCover should be switched off To switch off the system the on off switch has to be pressed for three seconds The status LED is flashing for 5 seconds and
3. B Braun Space System is a flexible docking and communication system for the medical workplace in particular the intensive medical care which substantially contributes to the safety of its patients It serves the perspicuous accommodation of the infusion and infusion syringe pumps Infusomat Space Infusomat Space P and Perfusor Space whose concrete application is the medical professional decides on based upon guaranteed PATIENT SAFETY characteristics and technical data The pillar and mounting system synchronized system components enables the individualized workplace design 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 8 THE SPACESTATION IN DETAIL THE SPACESTATION IN DETAIL SpaceStation serves to accommodate up to four infusion and infusion syringe pumps The single SpaceStations can be assembled to form one or up to three pill
4. INDIVIDUAL PUMPS 14 Chapter 3 INSERTING AND REMOVING INDIVIDUAL PUMPS A Attention Before inserting a pump please ensure the vertical position of the side rotary knob The guide rails of the SpaceStation must engage in the guide grooves of the pump The pump is then pushed with light pressure into the Space Station The pump is automatically locked in the system The locking is to be recognized by the horizontal position of the side rotary knob 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 AN 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 individually lok ked 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 N 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 di sconnecting and connecting the pump again the fault could disappear observe blue LED If the blue LED stays illuminated please inform
5. 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 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 A Attention Make sure that the SpaceCover is always correctly fixed Please refer also to the Assembly and Disassembly Instructions of the SpaceStation SPACECOVER COMFORT SpaceCover Comfort offers a greater system functionality and operating facility Mounted on the front of the cover is a large and clearly visible status and alarm display All status and alarm conditions of the pumps within the system as well as of the pumps themselves are displayed The following conditions can be indicated m green gt OK at least one pump in operation m yellow gt prealarm of one pump in the system m red gt alarm of a pump in the system Details concerning the single prealarms and alarms are given in the corresponding instructions for use of the pumps In addition a rechargeable battery the same as with the pumps can be inserted in the SpaceCover Comfort This rechargeable b
6. 14 1993 GUARANTEE Chapter 10 GUARANTEE B Braun Melsungen AG puts a guarantee of 24 months on every SpaceSystem counted 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 constructional 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 10 2 Hygienics Disposal Clean the Space System with a mild soap sud Do not carry out disinfection by spraying at the mains connections Recommendation Disinfectant for disinfection by wiping from B Braun e g Meliseptol Let the unit dry for at least 1 minute before starting operation again Do not spray in system openings side openings for necessary cooling pow
7. ATA Chapter 11 Electrical isolation External interfaces have an electrical isolation of 4kV to the SpaceStation Spark protection acc to IEC EN 60601 1 2 1993 and IEC EN 60601 2 24 1998 EMC acc to IEC EN 60601 1 2 1993 and IEC EN 60601 2 24 1998 Internal interfaces Connection for battery pack Connection to electronics and interface to the pumps Compact Flash Slot for WLAN interface External Interfaces USB Master e g for memory sticks USB Slave for connection of aPC Ethernet for integration of network PS2 Interface for barcode reader Serial interface Optional battery for power supply of SpaceCom at power failure transport Type of battery NiMH battery pack Operating time of battery approx 2 h Charging time approx 6 h 11 3 B Braun SpaceCover comfort Pillar cover of the SpaceStation Covers outlet of mains voltage of SpaceStation below Makes comfortable carrying of a SpaceStation possible For central alarm of a SpaceStation For power supply of a SpaceStation at power failure transport Inserted electronics Power consumption At 12V approx 1W without battery charge approx 3W battery charge Loud speaker For central audible alarm for SpaceStation LED luminous fields For central optical display of status of SpaceStation Display and operating unit Display Status of Battery of Space Station Display Status of Battery of SpaceCom Display Mode of Operation Battery Mains operati
8. At the end of the list a special menu is shown where additional functions are selectable These are Stop signaling proposal data at this pump delete complete list of proposal data She E pergal PROPOSAL DATA Chapter 7 Selecting an entry In case you have selected the right medication from the list you can con an ode firm the correctness of the data by ZVI9 using the button e The entries are market with a check automatically At the end of the list you must confirm the correctness again by pressing the OK button In case a pump is already infusing the changes are set active after the confir mation with OK otherwise the pump has to be started manually by pressing The selected medication is deleted from the remaining proposal list and is not shown at other pumps anymore By pressing the Clear button the menu turns to the previous screen Unconfirmed changes are canceled Display of full drug name In addition to the display of the short drug name main display in big charac ters you can select within the lower display line the full name of the drug The content of the lower display line can be controlled by the up and down keys v 4 Please refer the Instructions for use of the pumps Example Display of long drug name 0 05 Adrenalin 25ma 50 mCaikaimm Attention The content of the drug name is depending of the linked PDMS Changes in proposal list In case changes in an alre
9. SpaceStation and SpaceCom Instructions for Use Valid for Software 695F B BRAUN CONTENTS Patient Safety Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Ordering The SpaceStation in Detail 1 1 Fastening a Single SpaceStation 1 2 Assembly and Disassembly of Pillars 1 3 Combining Individual SpaceStations Combination of Pumps within a SpaceStation ssecssscseesssecseessnees 13 Inserting and Removing Individual Pumpen 14 SpaceCover Standard EE 15 SpaceCover Comfort 5 1 Operating Elements and Status Display on the SpaceCover 5 1 1 Display of Battery Condition 5 1 2 Switching On Off 5 1 3 Volume Control 5 1 4 Brightness Sensor 5 1 5 Battery Maintenance Program 5 1 6 Status Display ae 51 7 Self Check during Startup aan ea 18 Interfaces for Data Communication BH Intended Use 6 2 The connectors of SpaceCom 6 3 Status Displays 6 4 Inserting and removing battery for SpaceCom 6 5 Configuration SpaceCom Interfaces 6 6 SpaceOnline the SpaceCom Web Server Application 6 6 1 Setting of a network connection 6 6 2 Login 6 9 1 User Settings 6 9 1 1 Change Password 6 9 1 2 Change Username 6 9 1 3 Change access authorization 6 9 2 WLAN and Ethernet Settings 6 9 3 BCC Protocol Settings 6 9 4 Battery Setting 6 9 5 Database Settings 6 9 6 T
10. ady active set of proposal prescription e g infusion rate are only displayed at the pump which is already operating this drug All other pumps will ignore the proposal list If additional data e g new medications are add to the already existing set of proposal data these data are only displayed at pump which do not have any drug name assigned at this moment In case a prescription is stopped at the PDMS the pump will not recognize this change automatically The drug delivery has to be stopped manually at the pump 29 PROPOSAL DATA 30 Chapter 7 Display of proposal data Proposal data are displayed according to the status of a pump Details are listed below Status of pump Signaling Content of proposal list Pump is switched off and Proposal data are In the upper line of the display Pro no drug name is shown in displayed posal data and the first entry of the the display usage of last prescription list are shown By swit therapy is disabled ching on the pump the list can be entered Pump is switched off and Only if drug in In the upper line of the display Pro a drug name is shown in the display Last therapy is enabled proposal list is matching the drug name at pump posal data and the first entry of the prescription list are shown By swit ching on the pump the list can be entered Stand by active Proposal data are displayed In the upper line of the display Pro posa
11. ange their status dynamically Should one of the two displays stay red for 15 20 sec an error is present and the displayed information is no longer up to date For details please see table below 23 INTERFACES FOR DATA COMMUNICATION 24 Chapter 6 Network connection Status Cause of Error green OK is are up to date red yellow OK data could not be updated Connection failed data not up to date Application failed Network connection failed check network and Space Com Space Online yellow green OK data is up to date OK data could not be updated Data from SpaceOnline have not yet been updated red OQ SpaceOnline failed data not up to date Internal error in SpaceCom try to solve by restarting 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 Important Changes and new settings only get active after a restart of SpaceCom The restart can be done via hardware reset or soft reset with the reboot button 6 9 1 User Settings Reboot SpaceCom It is possible to administer the password of individual logins configure the BCC protocol and determine the network settings The ward ID can also be set To restore the factory defaults listed in this Manual please select Set to factory default aft
12. 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 Z 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 International safety standards The Space System complies with IEC EN 60601 1 m IEC EN 60601 1 1 m IEC EN 60601 1 2 as well as IEC EN 60601 2 24 and is CE marked in compliance with EU Directive 93 42 B Braun Melsungen AG is certified according to DIN EN ISO 9001 and DIN EN ISO 13485 This certification also includes maintenance and service The visible LED s comply to class 1 LED products according to IEC EN 60825 1 The
13. ars which are separated from each other The individual pillars require their own mains supply and are interconnected with each other via special extension cables Every pillar must be closed with a cover SpaceCover Standard or Comfort to ensure safe and complete system functionality Connector for further SpaceStations or SpaceCover comfort F5 Connector for Space pump Data lines and 12 V voltage supply F2A to F2D Mains voltage outlet to the next SpaceStation F1B Guide rails for the individual pumps Central loudspeaker only contained in SpaceCover comfort Lever to release universal clamp Fixture of universal clamp SP rotatable for attachment to wall rails and infusion poles Mains power input FIA Connection for extension cable for further SpaceStation F4 Connection for staff call PCA button Connection Lead SP 12V and service cable F3 Attention Do not connect the Power Supply SP to this connector THE SPACESTATION IN DETAIL Chapter 1 Cover SpaceCover must always cover the uppermost segment Serves at the same time as carrying handle for a SpaceStation Rotary knob to unlock single pumps Locking happens automatically when the pump is pushed in Hose routings for infusion tubing Lock unlock of upper SpaceStation or Spac
14. ation SpaceCom will be installed laterally into a SpaceStation and functions as a central communication interface for all pumps in the system For further details about SpaceCom refer to the following paragraphs Detailed and supplementary information concerning the communication protocol BCC can be requested separately SpaceCom provides different interfaces like Ethernet RJ45 RS232 USB Master and Slave and a PS 2 for data communication and for the connection of accessories For wireless data transfer a Wireless LAN Adapter can be integrated into SpaceCom For central access to data of the infusion pumps a web server is integrated which can be accessed using a standard internet browser A Attention SpaceCom with software E is incompatible to Space pumps and SpaceCom with software version C or D This results in a faulty transfer of parameters in the BCC Protocol and the display in SpaceOnline Please ensure that only pumps with software version E are operated together with SpaceCom software version E 6 1 Intended Use SpaceCom is used to connect external devices for the data documentation in a Patient Data Management System PC or USB memory stick Therapeutic or diagnostic conclusions must not be based exclusively on values delivered by SpaceCom and their display on a Patient Data Management System or in the web application In particular the interpretation of alarms does not release the operator from observing the local alarms at the p
15. attery and fix it with the green hook The hook must be pressed upwards To remove the battery pull the hook down Battery operation of SpaceCom is only possible if an additional battery is used in SpaceCover comfort 6 5 Configuration SpaceCom Interfaces SpaceCom can be configured via a web access Default IP address for the Ethernet port is 192 168 100 41 The following parameters and settings can be adjusted Parameter Setting Settings ex works IP address Ethernet Static 192 168 100 411 DHCP Subnet mask 255 255 255 0 Gateway IP address WLAN Static 192 168 101 41 DHCP Subnet mask 255 255 255 0 Gateway Enoding WEP not active WPA not active TKIP not active Communication protocol BCC Version 3 25 RS232 Baudrate 9600 8N1 6 6 SpaceOnline the SpaceCom Web Server Application Additional access to the infusion pump data is possible via SpaceOnline A web server integrated in SpaceCom provides different web pages Access is protected by a password which offers personal or ward or hospital wide access control It is recommended to change the default login after installation Please refer chapter 7 5 2 for detailed information A Attention The data the values displayed on the web sites and in particular the infusion pump alarms do not release from observing the local alarm displays at the in fusion pumps Therapeutic and diagnostic decisions must not be made solely o
16. attery ensures complete system functionality in case of transport and even at an interruption of the voltage supply Furthermore a loudspeaker is integrated in the SpaceCover Comfort to output the alarms of the pumps The volume can be adjusted in nine steps via the operating elements Operating elements and status display on SpaceCover B BRAUN Status and alarm display 15 SPACECOVER COMFORT Chapter 5 5 1 Operating Elements and Status Display on the SpaceCover 9 step volume adjustment On Off switch for SpaceCover for SpaceCover Ki Display of battery condition 3 colour LED green yellow red for display of green LED rechargeable battery condition SpaceStation CO 7 Status display O e for SpaceStation d SpaceCover m En a 3 colour Space Com 5 1 1 Display of Battery Condition The display elements indicate the condition of the rechargeable battery in the SpaceCover and the SpaceCom The rechargeable battery for SpaceCom is available as an option The following conditions are indicated LED left LED middle LED right gt 75 capacity a ep o gt 50 capacity gt 25 capacity lt 25 capacity lt 30 min operating time lt 3 min operating time Maintenance required Maintenance active capacity gt 75 D4 doola e ololololoje a0 unen Maintenance active capacity
17. eCover A Attention Every SpaceStation or one pillar consisting of several SpaceStations must be covered with SpaceCover standard or comfort The SpaceCover protects the upper connections from humidity and damage and ensures perfect system functionality The SpaceStation and the individual pump are connected to each other via the connectors F2A to F2D The plugs are to be protected from damage and humidity 1 1 Fastening a Single SpaceStation Every single SpaceStation can be attached to infusion poles and vertical tubes e g pendants suspension as well as to horizontal wall rail systems according to EN 1789 without need of any further adapters or assembly auxiliaries The rear universal clamp can be rotated and has a quick action mechanism By pulling the release ring back the slide can be moved freely and prepositioned Now the SpaceStation can be definitely fixed by means of the set screw IN Attention Make sure that the SpaceStation is fastened correctly and safely after THE SPACESTATION IN DETAIL Chapter 1 I EN i By pulling the release ring back the slide can be moved Ny freely for prepositioning assembly Do not use tools to tighten the screw To release first loosen the clamp by turning the adjusting knob half and then pull the release ring in order to loosen the pole clamp using the quick gripping mechanism 1 2 Assembly and Disassembly of Pillars The upper segment is pushed on the
18. er reboot see picture An other option is the use of a USB I Setto factory default after reboot Memory Stick Create on a stick an empty directory with the name factorydefault Connect it to the USB Master port of SpaceCom and do a re boot be switching the mains power off and on again INTERFACES FOR DATA COMMUNICATION Chapter 6 6 9 1 1 Change password This menu allows to change the password for the user listed under chapter 6 6 2 Press change password to activate the new settings 6 9 1 2 Change user name The predefined user names can be changed in this menu However it is not possible to add new or to delete existing user names 6 9 1 3 Change access authorization The access authorization can be given for each individual user name The user access rights can be set and must be confirmed by an appropriate password Please entei Username and Password famin Username bss Password EEE New password KT Password confirmation Please enter Username and Password Fr Pe ord l New user name User name confirmation Change user name Please enter Username and Password admin Username F Password Access Rights R status KR Serice Configuration 25 INTERFACES FOR DATA COMMUNICATION 26 Chapter 6 6 9 2 WLAN and Ethernet Settings For further information how to configure the BCC protocol see the separate
19. er supply input interfaces etc Heed to the disposal and hygienic instructions Dispose of the system according to the country specific regulations Old units are taken back and removed by B Braun on request The connectors see Fig 3 3 system socket F 1 4 are regularly to be checked for contamination e g spilled fluid and cleaned if necessary For safety reasons the system must be disconnected from the mains while it is cleaned 33 GUARANTEE 34 Chapter 10 10 3 Rechargeable Batteries Charge the battery before initial start up The mean service life of the batteries is approximately 3 years Time of recharging typically 6 h NiMH In case of a power failure the system automatically switches over to the rechargeable battery if existing Charge and remove batteries out of the unit if the system is not used for a longer period of time storage time gt 2 weeks If the batteries are stored for longer time recharge at least once a year is recommended The service life of the batteries can be prolonged if they are regularly completely discharged and recharged at the mains Rechargeable batteries must be recycled special refuse 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 Je Defibrillator proof CF equipment Protec
20. gen 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 discuss 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 infusion 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 Responsibility of the Manufacturer The manufacturer person who assembles installs or imports the device can only be held responsible for the safety reliability and performance if mounting enhancements new settings changes or repairs are carried out by duly authorized persons the electrical installation in the respective room meets the requirements of the VDE 0100 0107 or IEC regulations the system is used in accordance with the instructions for use and the Technical Checks are carried out at regular intervals The CE label confirms that this medical device corresponds to the Directive of the Council for Medical Products 93 42 EC of June
21. goes out afterwards 5 1 3 Volume Control The volume of the loudspeaker installed in the SpaceCover can be controlled with the buttons and The setting is done in 9 steps after every new step a high beep signal with the new loudness is given If the maximum or minimum setting is reached a deep beep is given The last setting is saved when the system is switched off 5 1 4 Brightness Sensor Every SpaceCover Comfort is equipped with a brightness sensor that adapts the brightness of the alarm display in the cover to the environment The brightness cannot be adjusted manually 17 SPACECOVER COMFORT 18 Chapter 5 5 1 5 Battery Maintenance Program To guarantee maximum battery capacity and at the same time a long service life a so called battery maintenance program is integrated in the system The battery maintenance is displayed automatically dependent on the operation of the unit The battery maintenance program can only be initiated when the system is connected to the mains When the program is running the unit should not be used for transport purposes since otherwise the complete battery running time is not guaranteed The battery maintenance can be triggered separately for the battery of the SpaceCover and SpaceCom When maintenance is necessary the status diode green green yellow of the respective battery lights up The maintenance program is started by pressing the On Off button and the button for the SpaceCom
22. ime synchronization via SNTP 6 10 Wireless LAN Proposal data 7 1 General 7 2 Working with proposal dat ES Datalogger E Service Guarantee 10 1 Maintenance 10 2 Hygienics Disposal 10 3 Rechargeable Batteries Technical Data 11 1 B Braun SpaceStation without B Braun SpaceCom 11 2 B Braun SpaceStation with B Braun SpaceCom 11 3 B Braun SpaceCover comfort 11 4 B Braun SpaceCover standard PATIENT SAFETY PATIENT SAFETY Important Information and Notes for Patient Safety A Attention Consult accompanying documents Read Instructions for Use prior to use The user must check functional safety and integrity of the Space System Prior to use check functions of the Space System Valid only for Space System Functional tests and Technical Safety Checks have to be carried out separately for all additional connected devices Check and set up connections to mains and further plug connections Check if mains voltage corresponds to indication on the type plate When connected check staff call simulate alarm staff call must react Warnings Use of the Space System only by qualified staff Use Space System only when you are instructed to work with and familiar with it This Instructions for Use is part of the Space Systems necessary for proper use The Instructions for Use have to be available at the Space System Proper Use The modular Space System is made for treatment of a single patient I
23. interface description WLAN Settings MAC Address 00 13 10 Oa 4f a0 Ethernet Settings MAC Address 00 12 21 00 00 al C DHCP STATIC DHCP e STATIC 192 168 101 41 IP Address 92 168 100 41 IP Address 255 255 255 0 Subnetmask 255 255 255 0 Subnetmask IT Gateway IT Gateway ISpasscon Zem D Adhoc Disabled Encryption Open Authentication Network Key None 802 1x If SpaceCom is operated in DHCP mode you can assign a system name for every indivi dual SpaceCom to address it within your network SpaceCom DeviceName 6 9 3 BCC Protocol Settings SpaceCom provides different communication protocols for data exchange with Patient Data Management Systems For detailed information about compatible systems please refer to http www space bbraun com Interface TCPAP E The settings of the baud A E rate as well as parity a lt stopbits and databits Baudrate 57600 Baudrate 57600 comply with the requi Parity n Parity ks rements of the PDM sy h stert Stopbits ia Stopbits ME You also can setup a Databits BE Databits EZ 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 INTERFACES FOR DATA COMMUNICATION Chapter 6 6 9 4 Battery Settings Here you can determine when the battery maintenance prog
24. ion User Settings INTERFACES FOR DATA COMMUNICATION Chapter 6 6 7 Status Network connection Spacegnlin Status of connection __ PAREN DATA Patient rame Patient Wd Bed Room Stetion SpaceoOM Gender Patent weight Date o1 birth NEEN m secre Pow pata Drug name Rate inrused volume Remaining volume Time of infusion Remainng time Dose rete Drug concentration Sirine nane Syringe volume Profile type Status information Zem information m it The status display shows infusion pump data and the system status The representation of the pumps corresponds with the topological configuration in the system The pre sent status will be displayed according to the legend If a pump is selected detailed 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 A connection status display is integrated in the header Network connection SpaceOnline does is established show actual data Network connection i SpaceOniine IT a The network connection between PC or browser and SpaceOnline is shown and the status of SpaceOnline is monitored using the two status displays red yellow green The displays ch
25. l data and the first entry of the prescription list are shown After en ding stand by the list can be edited Pump is switch on but not infusing Infusing and no drug name assigned Proposal data are displayed Proposal data are displayed List can be entered by pressing the blue connect button List can be entered by pressing the blue connect button Infusing one of the drugs contained in the proposal list no display no display of proposal data only in case of change of infusion rate Pump is connected to sy stem while proposal data are active Infusing a drug but infu sion rate is changed in proposal list Proposal data are displayed Proposal data are displayed List can be entered by pressing the blue connect button Only this drug is displayed in propo sal list Rate is adjusted after confir mation Notification signal for proposal data It is possible to activate a notification signal which gives an audible signal in case of new proposal data are send to the Space system or a list of proposal data is not completely worn out This function can be enabled or disabled via the service tool HiBaSeD The notification is disabled by default DATALOGGER Chapter 8 DATALOGGER With software 695F010003 there is a data logger available which operated like a trip recorder in your car The data logger stores the most important data generated by a pump on SpaceCom f
26. 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 1 3 Combining Individual SpaceStations To mount one or multiple pillars the single SpaceStations can be assembled easily and without any difficulties without requiring any special assembly tools The admissible combinations are listed in the following table 10 THE SPACESTATION IN DETAIL Chapter 1 1 Pillar 2 Pillars 3 Pillars A A B A B C SpaceCover Comfort 1 1 1 1 1 1 SpaceCover Standard 1 1 1 1 1 1 SpaceStation 1 5 1 5 ee WA AIEA ler Restriction A lt 6 YA B lt 6 XYA B C lt 6 x alternative usage possible A B C number of SpaceStation in one pillar A Attention Other configurations such as more than three pillars or exceeding the number of SpaceStations within a pillar are not permitted and result in configuration error If a system consists of several pillars these should be arranged logically and physically from left to right Pillar 1 A Pillar 2 B Extension lead SP 60 or 120 cm The lead is connected to F4 in pillar 1 and then to F3 in pillar 2 A Attention If the pillars will not be connected as described above inter changing F4 and F3 there is a wrong topol
27. n the basis of the displays of the web application 21 INTERFACES FOR DATA COMMUNICATION 22 Chapter 6 SpaceOnline offers different Micro Sites upon which different data or configurations are possible 6 6 1 Setting of a network connection To set a network connection on your PC or PDMS Client System please contact the administrator or the manufacturer of the PDMS Please set up the network address of SpaceCom via the Web application Start a browser MS Internet Explorer or similar on your PC and fill in the default address or the newly determined IP address in the address field Hint Always use http when accessing SpaceOnline As an alternative to the IP address a name in the file hosts can be saved in the client system Please see the documentation of your client system for details Adresse http 192 168 100 41 m Important The browser must accept cookies and allow the execution of Java scripts Important SpaceCom only supports Microsoft Internet Explorer 6 0 or higher 6 6 2 Login The following user names and passwords are predefined user name password Activated for status status Status page service service Service page config config Configuration page In order to prevent unauthorized access you are recommended to change the individual passwords after first start up For further information regarding configuration please refer to the chapter Configurat
28. ogical representation in SpaceOnline and wrong addressing in the BCC protocol THE SPACESTATION IN DETAIL Chapter 1 12 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 Pillar 1 A Pillar 2 B Pillar 3 C Extension lead SP 60 or 120 cm The lead is connected to F4 in pillar 1 and then to F3 in pillar 2 Pillar 2 and 3 are interconnected with each other via F3 and F4 COMBINATION OF PUMPS WITHIN A SPACESTATION Chapter 2 COMBINATION OF PUMPS WITHIN A SPACESTATION The following pumps and modules can be combined within a SpaceStation 4 pumps Infusomat or Perfusor Space and optional SpaceCom 3 Space pumps and 1 SpaceControl and optional SpaceCom 2 Space pumps and 2 SpaceControl and optional SpaceCom 4 Space pumps and 1 SpaceControl attached to the lowest pump in the system and optional SpaceCom A Attention Danger of tipping An operation as tabletop unit is not allowed Operation is only allowed if mounted on a stable infusion pole N Attention The operation of a fifth pump mounted under the lowest pump in the system is not allowed 13 INSERTING AND REMOVING
29. on Switch on off of the SpaceStation in battery mode Display of failures Release battery maintenance 37 TECHNICAL DATA 38 Chapter 11 Internal Interfaces Interface to battery Interface to display and operating unit External Interface Optional battery for power supply of the SpaceStation at power failure transport Type of battery pack Interface to SpaceStation NiMH battery pack Operating time of battery approx 2 h with SpaceCom approx 10 h without SpaceCom Charging time approx 6 h Weight 0 9 kg Dimensions W x H x D 261 x 82 x 160 mm 11 4 B Braun SpaceCover standard Pillar cover of the SpaceStation Covers outlet of mains voltage of SpaceStation below Makes comfortable carrying of a SpaceStation possible Weight 0 6kg Dimensions WxHxD 261 x82 x 160 mm ORDERING Braun SpaceStati r sccesieecectecedsececsesecyitcecscesogstecsuaecpateccuveccastecouseccasshcouseeasfertaned 871 3140 Braun Perfusor Space 871 3030 Braun Infusomat Space 871 3050 B B B B Braun SpaceControl 871 3090 RB Braun SPACE COM u neuerer 871 3160 B Braun SpaceCover standard EENEG 871 3147 B Braun Spaeetovet Gpmfort geriet 871 3145 B Braun SpaceStation with SpaceCom integrated 871 3142 Recommended accessories for B Braun SpaceStation fm mobil 872 1106 Battery Pack SP NiMH 871 3180 PCA Button SP 871 3190 Exten
30. or the button for the SpaceCover simultaneously During maintenance all green LEDs are flashing and go out when the capacity reduces When the maintenance program is completed the batteries are recharged IN Attention When battery maintenance is carried out the unit should not be used for transport purposes since otherwise the complete battery running time is not guaranteed 5 1 6 Status Display green gt The system is operated with mains voltage yellow gt The system is operated by battery flashing red gt Wrong configuration check the system setup red gt Unrecoverable error exchange cover LED in front is flashing also 5 1 7 Self check during start up During the start up of the SpaceCover comfort a self check is started automatically The three LED at the front side are tested in the order red yellow green and after this the status indicators of SpaceStation and SpaceCom are tested All green yellow and red according to Display of battery condition If one of the front side alarm indicator is defect the red alarm LED and the lateral red status LED are illuminated see 5 1 6 INTERFACES FOR DATA COMMUNICATION Chapter 6 INTERFACES FOR DATA COMMUNICATION The SpaceStation does not provide an interface to connect the system into Patient Data Management Systems PDMS For the external communication SpaceCom can be used optionally SpaceCom can be upgraded or ordered ex works as one unit with SpaceSt
31. or up to 8 hours Only data of pump directly connected to Space Com are stored Historical data from the pump e g from transport are not down loaded to SpaceCom afterwards The memory is cleared in case SpaceCom is switched off The documentation is related to the drug name delivered from the pump In case no drug name is assigned the data are stored with type and serial number of the corre sponding pump If a drug name is assigned afterwards the documentation is conti nued with the new drug name The data can be request with a normal browser by ttp IP_og_SpaceCom validate asp By clicking on the drug name a list with detailed information is displayed on the left side Actual medication Drug name Slot Last event Arterenol 4mg 50 3 Start Dosisrate 0 01 ug kg min Ciprobay 400 mg ml 2 Start Rate 1 ml h History of medication Drug name Last event Ciprobay 0 2 100 Drug changed Disoprivan 20mg Drug changed Perfusor 1815 Drug changed Perfusor 1827 Drug changed Here are all medication listed which are not active any more The data are cleared after 8 hours 31 SERVICE 32 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 Melsun
32. ram should be activated It is given in days and only valid for the SpaceCom battery integrated in the rear panel of the SpaceStation The settings for the batteries of the pumps and of the SpaceCover comfort are made separately using the service program HiBaSeD For further information please refer to chapter Battery Maintenance Program 6 9 5 Database settings The ward ID is a feature unique to your system which appears both in the BCC SpaceCOM Bed ID protocol and on the SpaceOnline display The ward ID can have up to 15 characters Here you can start and stop applications of Applications SpaceCom also Normally all applications Serim exe 04 0 0004 Run are set active Changes should be done by Databaseexe 02 0 0123 Run service only the function of SpaceCom is BCCProtocol exe 03 1 0205 Run Stop effected by this settings DB2XML exe 010 0016 Run Stop Datalogger exe 03 0 0007 Run Stop 7 BCCProtocol exe stop or run the external interface for Patinet data Management Systems BCC protocol DB2XML exe stop or run SpaceOnline Datalogger exe stop or run the internal data logger of SpaceCom see chapter 8 6 9 6 Time synchronization via SNTP To synchronize the time stored in SpaceCom you can link SpaceCom to a time server in your network Fill in the required information and restart SpaceCom f 92 53 103 103 SNTP Server ben SNTP Refresh intervall seconds GMT 01 00 Amsterdam Be
33. rlin Bern Rome Stockholm Vienna Timezone 6 10 Wireless LAN A A Attention The optional WLAN card 2 4GHZ 100mW can cause interference with devices in the vicinity Please observe the necessary minimum distance requirements When using WLAN the encoding should be activated in order to protect the data connection The card provides WEP Wireless Equivalent Privacy and WPA WI FI Protected Access encoding for this purpose For more detailed information about the WLAN operation please see the documentation delivered with the upgrade kit WLAN 27 PROPOSAL DATA 28 Chapter 7 PROPOSAL DATA 7 1 General The optional function Proposal Data is available since software version 68xF030003 or higher versions On SpaceCom software 695F010003 or a later version is required The function Proposal data requires a PDMS which is supporting this function A proposal list is a list of medication with up to 24 medications and the corres ponding infusion rate 7 2 Working with proposal data L france Fonten The availability of proposal data are displayed at all pumps at the same time In the upper part of the display FMH at a pump the hint Proposal and the first entry of the prescription list is shown By pressing the blue Connect button at the pump the prescription list can be entered Navigation within the proposal list Via the keys 4 gt you can scroll through the proposal list
34. sion lead SP 60 CM 2 2222 871 3210 Extension lead SP 120 Cm EENS 871 3215 Extention lead SPIOM dutian aaeeea a EEE a 871 3315 Exte tion lead SP15 Mi nennen 871 3415 Connection Lead SP 12V 871 3231 Connection Lead for Staff Call SP 871 3232 Recommended accessories for B Braun SpaceCom Battery Pack SP NiMH v sssssscsssssssssssssssssseessssssccsssssesssssssssssssseessssseessssnseeesssses 871 3180 RS232 cross over cable SP 871 3237 RS232 connector converter er Eeer 871 3238 WLAN card for SpaceComs 2 een 871 3184 Availability only on request 39 B BRAUN Manufactured by B Braun Melsungen AG B Braun Melsungen AG Sparte Hospital Care 34209 Melsungen Germany 34209 Melsungen Germany Tel 49 0 56 61 71 0 e1449 0 Tel 49 0 56 61 71 0 Fax 49 0 56 61 71 20 44 Material No 38917302 e Drawing No M690700200F04 d 0208 e Printed on pulp bleached 100 chlorine free www bbraun com
35. t is especially designed for use on Intensive Care Units and Operating Theatres The Space System is used in hospital Operation mainly by physicians and medically qualified nursing staff Check if the current software and hardware version of the components of the Space System are the same as this Instructions for Use refers to At fm mobil accessory for mobile use it is not permitted to use short stands as the centre of gravity of the Space System may change Insert receptacle suspension of the fm mobil before transport Check stability and secure position especially when fastening the system to the fm mobil Prevent the fm mobil from rolling away on horizontal surfaces by using the locking device If there is an incline of more than 5 additional locking is necessary When the pumps in the Space System are switched off the control systems are not active Therefore close roller clamp or selector valve at the connection point to prevent uncontrolled backflow Do not plug the power supply lead into the socket before the whole system is built up The Space System is designed for operation with a single power supply connection per pillar All configurations must comply with IEC EN 60601 1 1 Possible explosion hazard if used in presence of flammable anesthetics Use only compatible combinations of equipment accessories working parts and disposables Use only original spare parts Functional safety is only guaranteed if by the manufac
36. the system Do not cover the ventilation slots The equipment must be free of condensate during operation 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 m Avoid using devices which are not necessary from the medical point of view e g mobile telephones m Extend distance between source of interference and the medical product Alter position of power supply leads connection leads and electrodes 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 6 PATIENT SAFETY m 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 m For the safe use of Space infusion pumps in MRI the SpaceStation MRI is recommended m In
37. tive Class MDD Class Ilb 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 lt 0 1 pA NC lt 0 1 pA SFC lt 30 pA SFC lt 100 pA Patient leakage current lt 1yA Spark protection acc to IEC EN 60601 1 2 2001 and IEC EN 60601 2 24 1998 EMC acc to IEC EN 60601 1 2 2001 and IEC EN 60601 2 24 1998 Operation in ambulance cars acc to 95 54 EG Electronic with following functions Use in cars is allowed 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 35 TECHNICAL DATA 36 Chapter 11 Addressing of pumps Dynamic addressing related to the position of the pump within the system Interfaces Mains power inlet Standard cable
38. turer recommended resp compatible disposables are used PATIENT SAFETY m Read carefully Instructions for Use of the infusion pumps and infusion syringe pumps used Application of infusion and infusion syringe pumps only under regularly supervision by specially trained staff m The user must make sure the pumps and other components of the system are locked correctly m Do not deposit things on the pumps Avoid leaning on the pumps m The connecting leads must be laid so that people do not stumble over them and work with the Space System is not hampered p Do not place disposable near the connections of the pumps use hose routings m Make sure the pumps are inserted and removed correctly Transport m With max 4 pumps Be especially careful when a patient is connected Avoid external mechanical action Only for use of m Infusomat Space Infusomat Space P Perfusor Space SpaceControl SpaceCom Some components have further Instructions for Use or assembly instructions which need to be observed Therapeutic or diagnostic conclusions must not be based exclusively on values displayed on infusion pumps or data available via interfaces 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
39. umps It is recommended that you connect only devices which conform to IEC950 or IEC1010 or use accessories specified by B Braun 119 INTERFACES FOR DATA COMMUNICATION 20 6 2 The connectors of SpaceCom Wireless LAN optional Status displays for SpaceCom Ethernet RJ 45 PS 2 Connection for Barcode reader RS232 USB Slave USB Master The RJ45 plug of the Ethernet socket is protected against unintentional removing by a mechanical lock To remove the plug slightly press the cap of the plug cover against the plug This opens the mechanical lock and the plug can be removed 6 3 Status Displays In SpaceCom there are two status displays showing the operating status The green LED signals the operating status The red LED shows errors For status indications please refer to the following table green LED red LED System starting not yet ready a gt ch SpaceCom is ready gt Cc Error during operation CC 5 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 INTERFACES FOR DATA COMMUNICATION Chapter 6 6 4 Inserting and removing battery for SpaceCom The cover of battery compartment can be opened with i e a little coin Place the b
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