SpaceStation - B.Braun Medical OÜ
Contents
1. PATIENT SAFETY PATIENT SAFETY Important Information and Notes for Patient Safety 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 Gilt nur f r das 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 m Check if mains voltage corresponds to indication on the type plate m Netzspannungsangabe auf Typenschild beachten m When connected check staff call simulate alarm staff call must react Warnings m Use of the Space System only by qualified staff m Use Space System only when you are instructed to work with and familiar with it m This Instructions for Use is part of the Space Systems necessary for proper use m The Instructions for Use has to available at the Space System Proper Use m The modular Space System is made for treatment of a single patient It 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 m 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 m2. A 0124 Restriction A lt 6 XA B lt 6 XA B C lt 6 x alternative usage possible A B C number of SpaceStation in one pillar Caution Other configurations such as more than three columns or exceeding the number of SpaceStations within a column are not permitted and result in configuration error If a system consists of several columns these should be arranged logically and physically from left to right Column 1 A Column 2 B Extension lead SP 60 or 120 cm The lead is connected to F4 in column 1 and then to F3 in column 2 J 11 12 Chapter 1 SPACE STATION IM DETAIL Every single column must be covered with a SpaceCover standard or SpaceCover com fort If a with 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 Column 1 A Column 2 B Column 3 C 1 foam DER Extension lead SP 60 or 120 cm The lead is connected to F4 in column 1 and then to F3 in column 2 Column 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. typically 6 h NiMH A longer recharging time does not have any negative effect In case of a power failure the system automatically switches over to the rechargeable battery if existing Remove batteries out of the unit if the system is not used for a longer period of time storage time gt 3 months 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 Chapter 9 TECHNICAL DATA UN TECHNICAL DATA 9 1 B Braun SpaceStation without B Braun SpaceCom Type of unit Type CF defibrillator proof Classification acc to IEC EN 60601 1 Protection class MDD Class II b Protection type IP 22 drip protected Power supply Primary 100 240V 50 60Hz 110V 0 46A 220V 0 2A3 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 Earth leakage current NC 10A SFC 20JA Patient leakage current NC 0 pA SFC 10uA spark protection acc to EN 60601 1 2 and EN 60601 2 24 EMC acc to EN 60601 1 2 and EN 60601 2 24 Electr
4. x 364 x 160 mm 9 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 approx 6 5W without battery charge ca 3W battery charge Electrical isolation External interfaces have an electrical isolation of 4kV to the SpaceStation Internal interfaces Connection for battery pack Connection to FM electronics with CAN interface to the pumps Compact Flash Steckplatz for WLAN interface External Interfaces 24 USB Master e g for memory sticks USB Slave for connection of a PC TECHNICAL DATA Chapter 9 Ethernet for integration of network PS2 Interface for barcode reader Serial interface Optional battery for power supply of the data module at power failure transport Type of battery NiMH battery pack 4 x 1 2V 1 9Ah Operating time of battery approx 1 5 h Charging time approx 6 h 9 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 F
5. 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 Caution This configuation is only permitted for one SpaceStation without integrated Spa ceCom An operation as gantry version is not allowed Danger of tipping Operation is only allowed if mounted at stabil infuison pole 13 Chapter 3 14 INSERTING AND REMOVING INDIVIDUAL PUMPS INSERTING AND REMOVING INDIVIDUAL PUMPS 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 Caution 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 locked Before removal first release the pump and then SpaceControl and then remove both systems For detailed information please re
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7. Atfm mobil accessory for mobile use it is not permitted to use short stands as the centre of gravity of the Space System may change m Insert receptacle suspension of the fm mobil before transport Check stability and secure position especially when fastening the system to the fm mobil m 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 m 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 m Do not plug the power supply lead into the socket before connecting all the other interfaces m The Space System is designed for operation with a single power supply connection per pillar m All configurations must comply with IEC EN 60601 1 1 Possible explosion hazard if used in presence of flammable anesthetics m Use only compatible combinations of equipment accessories working parts and disposables PATIENT SAFETY o Ba m Use only original spare parts Functional safety is only guaranteed if by the manufacturer recommended resp compatible disposables are used m Read carefully Instructions for Use of the infusion pumps and infusion syringe pumps used m Application of infusion and infusion syringe pumps only under regularly supervision by specially trained staff m The user mus
8. SpaceStation Instructions for Use XXXXXX KAKAK B BRAUN SHARING EXPERTISE CONTENTS AA ANA CONTENTS Contes Aero atten pandan aka e naen aaa ida cae cana aan nana an 3 Patient Na NG teste 4 Chapter 1 The SpaceStation in Det il un nn nn 1 1 Fastening a Single SpaceStation 1 2 Assembly and Disassembly of Columns 1 3 Combining Individual SpaceStations Chapter2 Combination of Pumps within a SpaceStation uunnemeemeemene 13 Chapter3 Inserting and Removing Individual Pumps neseosmeeee 14 Ch pter 4 SpaceCover Standard 15 Chapter5 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 5 1 7 Self check during start Up rasen 8 Chapter6 Interfaces and Data Communication 19 6 1 The Connections of SpaceCom 2 ana 9 Ch pter 7 SEIVICE nenne aeng aa 20 Ch pter 8 Guaranteed ERIEIEn 8 1 Maintenance 8 2 Hygienics Disposal 83 Rechargeable Batteries nu nee 22 Chapter9 Technical Data 9 1 B Braun SpaceStation without B Braun SpaceCom 9 2 B Braun SpaceStation with B Braun SpaceCom 9 3 B Braun SpaceCover comfort 9 4 B Braun SpaceCover Standard 1 nee en CEVA saia gah ewa ngagengang ikon aa nedi ganda gank aga nepak kanan ARE 27
9. aceCover without pole clamp 3 15 kg Weight without SpaceCover with pole clamp 3 544 kg Weight with SpaceCover Standard with pole clamp 4 08 kg Weight with SpaceCover Comfort incl battery with pole clamp 4 358 kg Pole clamp SP 0 360 kg SpaceCover Comfort with battery 0 847 kg SpaceCover Standard 0 573 kg ORDERING B Braun Perfusor Space 100 240 V csccccscsssssssssnsesssesessssssssessssssnsseess 871 B Braun Infusomat Space 100 240 V cssscsccsssssssssssnsssssssesesssssesssssnsees 871 B Braun SpaceConttol s n banana aana kananga bo aan angone kaayah anae aan odaia 871 B Braun SpaceCom s B Braun SpaceCover Standard 871 B Braun SpaceCover comfort sasasssrssnesa saeka aana anana ngenah ag anaa Ana agan gend 871 Recommended accessories for the B Braun SpaceStation Battery Pack SP NiMH ccccsssssssscccsccssssssecsccsssssseesessssseseessesnsssseeseeessuncenseseens 871 PEAButton Sparer E Re 871 Interface Lead CANI SP sssrin an ng ag aana nga agan Gae ena gana aaa h ena ngenang agaman anane 871 Interface lesd RS232 SP 122 22 ea 871 Connection Lead SP 12V 871 Connection Lead for Staff Call SPP 871 available as of 3rd Quarter 2004 3030 3050 3090 3160 3147 3145 27 B BRAUN SHARING EXPERTISE Manufactured by B Braun Melsungen AG B Braun Melsungen AG Sparte Hospital Care Postfach 1120 P 0 Box 1120 D 34209 Melsungen D 34209 Melsungen Tel 0 56
10. checklist every 2 years This 2 year maintenance should be carried out by the service personnel of the manufacturer B Braun Melsungen AG 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 14 1993 20 Chapter 8 GARANTIE IN 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 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 af
11. djusted in nine steps via the operating elements Operating elements and status display on SpaceCover B BRAUN Status and alarm display 15 Chapter 5 16 SPACECOVER COMFORT 5 1 Operating Elements and Status Display on the SpaceCover 9 step volume adjustment for SpaceCover On Off switch for SpaceCover 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 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 Rechargeable battery SpaceStation LED left LED middle LED right gt 75 capacity a gt 50 capacity Cy gt gt 25 capacity C S lt 250 capacity Cy Cy a lt 30 min operating time OO CO e lt 3 min operating time Cy Cy D5 Maintenance required Maintenance active capacity gt 75 ap Dz Maintenance active capacity gt 50 T a aD Maintenance active capacity gt 25 CD C aD Maintenance active capacity lt 25 E1 Kapitel 5 SPACECOVER COMFORT UN Rechargeable battery SpaceCom is only disp
12. eCover comfort Lever to release universal clamp Fixture of universal clamp SP rotatable for attachment to wall rails and infusion poles 100V to 230 V mains power input F1A 100V to 230 V mains voltage outlet to the next SpaceStation F1B Guide rails for the individual pumps Connection for extension cable for further SpaceStation F4 Connection for staff call PCA button Connection Lead SP 12V and service cable F3 Chapter 1 THE SPACESTATION IN DETAIL 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 SpaceCover Caution Every SpaceStation or one column consisting of several SpaceStations must be covered with a lid This lid 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 ceiling suspension as we
13. fer the instructions for use of SpaceControl Chapter 4 5 SPACECOVER STANDARD SPACECOVER COMFORT Ni 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 Caution 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 The cover is equipped on its front side with a large and very well readable 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 battery 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 a
14. is integrated in the SpaceCom to allow a wireless data transfer SpaceCom offers a central access to the data of the connected pumps via a standard internet explorer The information are handled by an integrated WEB Server application 6 1 The Connections of SpaceCom Status indicator of SpaceCom Ethernet RJ 45 PS 2 for bar code reader connection RS232 USB Slave USB Master 19 SERVICE Chapter 7 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 Service advice Tel Please insert your local telephone number Fax Please insert your local fax mail number 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
15. layed 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 Maintenance active capacity gt 75 Maintenance active capacity gt 50 Maintenance active capacity gt 25 Maintenance active capacity lt 25 ofen o book lololelelel o ooe Error change battery 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 Caution 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 1 seconds and 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
16. ll as to horizontal wall rail systems without need of any furt her 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 Caution Make sure that the SpaceStation is fastened correctly and safely after assembly Do not use tools to tighten the screw SPACE STATION IM DETAIL Chapter 1 By pulling the release ring back the slide can be moved freely for prepositioning 1 2 Assembly and Disassembly of Columns 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 Caution 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 columns 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 Chapter 1 SPACE STATION IM DETAIL UN 1 Column 2 Columns 3 Columns A A B A B SpaceCover Comfort 1 1 1 1 1 1 SpaceCover Standard 1 1 1 1 1 1 SpaceStation an IPS TaS 1724
17. onic 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 Outlet of mains voltage Connector for power supply of the next SpaceStations Pump connector 4 connectors F2A F2D for Infusomat or Perfusor Space 23 Chapter 9 Connection between modules TECHNICAL DATA Interconnection of several SpaceStation via plugs F4 and F5 Connection to periphery Connection of accessories PCA button PR lead Connecting Lead SP 12 V Interface Lead SP via plug F3 Operating conditions Relative humidity 30 90 without condensation Temperature 5 C 40 C Atmospheric pressure Storage conditions Relative humidity 500mbar 1060mbar 20 90 without condensation Temperature 20 C 55 C Atmospheric pressure 500mbar 1060mbar Weight w o Cover with pole clamp 3 544 kg Dimensions W x H x D without Cover 290 x 327 x 160 mm Dimensions W x H x D with Cover 290
18. or power supply of a SpaceStation at power failure transport Inserted electronics Power consumption At 12V approx 1W without battery charge approx 3 5W battery charge Loud speaker For central audiblec alarm for SpaceStation LED luminous fields For central optical display of status of SpaceStation Display and operating unit Display Status of Battery Cover battery Display Status of Battery Data module battery Display Mode of Operation Battery Mains operation Switch on off of the SpaceStation in batt ery mode Display of failures Release battery maintenance Internal Interfaces Interface to battery Interface to display and operating unit External Interface Interface to SpaceStation Optional battery for power supply of the SpaceStation at power failure transport Type of battery pack NiMH battery pack 4 x 1 2V 1 9 Ah Operating time of battery approx 1 h with SpaceCom approx 10 h without SPACEComdata module Charging time approx 6 h Weight 0 847 kg Dimensions W x Hx D 261 x 82 x 160 mm 25 Chapter 9 26 TECHNICAL DATA 9 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 0 573 kg Dimensions W x H x D 261 x 82 x 160 mm Single weights SpaceStation Weight without Sp
19. 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 bright ness of the alarm display in the cover to the environment The brightness cannot be adjusted manually 17 Kapitel 5 18 SPACECOVER COMFORT 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 main tenance 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 purpo ses 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 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 Caution When battery maintenance is carried out the unit should not be u
20. rm 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 m IEC EN 60601 1 IEC EN 60601 1 1 m IEC EN 60601 1 2 as well as IEC EN 60601 2 24 and is marked in compliance with EU Directive 93 42 EWG CE 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 B Braun Space System is a flexible filing 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 characteristics and technical data The column and mounting system synchronized system component
21. s enables the individualized workplace design PATIENT SAFETY nn aa 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 Instruc tions 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 Chapter 1 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 columns which are separated from each other The individual columns require their own mains supply and are interconnected with each other via special extension cables Every column 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 Central loudspeaker only contained in Spac
22. sed 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 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 INTERFACES AND DATA COMMUNICATION Chapter 6 INTERFACES AND DATA COMMUNICATION SpaceStation does only have a simple interface for integration of the system in Patient Data Management Systems PDMS For enhanced data communication SpaceCom is to be used SpaceCom can be retrofitted or ordered as one unit together with SpaceStation ex works SpaceCom is installed at the side of a SpaceStation and is used as a central communication interface for all pumps in the system Details on SpaceCom are given in the separate instructions for use SpaceCom is provided with different interfaces such as RJ45 RS232 and USB for data communication A Wireless LAN adapter
23. sible 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 m Alter position of power supply leads connection leads and electrodes m 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 equip ment nuclear spin tomography units mobile telephones maintain the recommended 5 6 PATIENT SAFETY protective distances for these devices 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 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 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 und ala
24. t make sure the pumps and other components of the system are locked correctly 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 m 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 exter nal mechanical action Only for use of m Infusomat Space Infusomat Space P Perfusor Space SpaceControl SpaceCom m Some components have further Instructions for Use or assembly instructions which need to be observed m Therapeutic or diagnostic conclusions must not be based exclusively on values displayed on infusion pumps or data available via interfaces m 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 m 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 implau
25. ter the product service life 8 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 8 2 Hygienics Disposal Clean the Space System with a mild soap sud Do not carry out disinfection b 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 power 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 21 22 Chapter 8 GARANTIE 8 3 Rechargeable Batteries Charge the battery before initial start up The mean service life of the batteries is approximately 3 years Time of recharging
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