LABORIE Solar Go Air Service & Installation Manual

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Solar Go Air

Service & Installation Manual

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Page 1 Solar Go Air Service & Installation Manual...
Page 2 180 International Drive Portsmouth, NH 03801 USA +1.800.522.6743 www.laborie.com Trademarks Solar Go Air is a registered trademark of Medical Measurement Systems B.V., Enschede, the Netherlands. © Copyright 2024 Laborie Medical Technologies Corp. Document Number: LBL-01683 Revision: B Release Date: 2024-05 Laborie Medical Technologies Corp.
Page 4: Table Of Contents
Safety Information ................18 Applied Parts .................. 18 Disposing of Product After Use/Environmental Consideration of Waste Disposal ..................18 1.10 Accessories for the Solar Go Air ............ 18 1.11 Troubleshooting ................18 1.12 Repairs ................... 20 1.13 Maintenance .................. 20 1.14 Technical Specifications ..............
Page 5 Explanation of Symbols ............61 Appendix C Electro Magnetic Compatibility ........... 69 Appendix D Software Messages .............. 77 Warranty for Solar Go Air Measurement System ........87 Index ....................... 91 Safety information Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 6 Solar Go Air Service & Installation Manual LBL-01683 [B] Safety information...
Page 7: Safety Information Solar Go Air
The instructions, precautions and warnings in this manual should be followed by the operator to ensure safe operation and to maintain the Solar Go Air measurement system in a safe condition. Therefore, the use of the Solar Go Air measurement system should be restricted to qualified personnel only.
Page 8 Electronic components are selected to cope with the specified conditions. The system can withstand the transport conditions provided it is clean, dry and protected by the manufacturer’s packaging. Before putting into storage, it must be clean, dry. Solar Go Air Service & Installation Manual LBL-01683 [B] Safety information...
Page 9 4 hours. All repairs, which are not performed by LABORIE personnel are for the responsibility of the hospital. LABORIE will not give any guarantee or take any responsibility for any part which has been opened, adjusted, or replaced by hospital personnel.
Page 10 Catheters and accessories WARNING Do not use the catheter if the package is damaged. CAUTION Always check the expiry date where applicable as this may affect the measurement results. Solar Go Air Service & Installation Manual LBL-01683 [B] Safety information...
Page 11 WARNING Do not use a defibrillator on a patient connected to the Solar Go Air or any patient modules. The Solar Go Air system does not contain defibrillation proof applied parts. Safety information Solar Go Air Service &...
Page 12 Do not use excessive amounts of water for cleaning the Solar Go Air measurement system to prevent damaging the electronics. CAUTION Never allow water to get inside the Solar Go Air system to prevent damage to the system. Repair (LABORIE qualified personnel only) WARNING...
Page 13 WARNING Before repair make sure that the Solar Go Air measurement system is not powered and remove the batteries. CAUTION Before repair always take antistatic precautions. Although precautions have been taken in this apparatus to prevent malfunctions due to abnormal environmental conditions and/or abnormal handling, such malfunctions can occur in some circumstances.
Page 14: Solar Go Air Measurement System
The Solar Go Air measurement system consists of a pressure and EMG interface module and a laptop. The Solar Go Air measurement system is a prescription device to be used only by physicians or individuals who have been trained and authorized by a physician or by a medical institution, under the supervision of a physician.
Page 15: Intended Use
Hardware and software changes After receiving new Solar Go Air manuals, always keep the old manuals as supplied with your system. Descriptions and images may be different because of Solar Go Air hardware and software changes.
Page 16: Performance Characteristics
Performance Characteristics NOTE To view the Performance Charateristics related to this product, consult the user manual that was supplied with your Laborie measurement system. Solar Go Air Service & Installation Manual LBL-01683 [B] Chapter 1...
Page 17: Configurations
Configurations 1.6.1 Introduction In this paragraph, you will find an illustration of the Solar Go Air measurement system. 1.6.2 Solar Go Air System The figure below shows an example of a Solar Go Air system meant for Anorectal Manometry investigations.
Page 18: Safety Information
Safety Information The Solar Go Air Service & Installation Manual is intended for all users who install, test and maintain the hardware and software. Before working with the Solar Go Air measurement system and its manuals, please take notice of the safety information as described at the beginning of this manual and in the chapters describing the individual modules.
Page 19 If your problem is not described or if you are not able to solve the problem with the descriptions, please contact your LABORIE representative. Solar Go Air Measurement System©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 20: Repairs
Technical specifications of the system can be found in the corresponding chapter. General specifications of the Solar Go Air measurement system are: • The Solar Go Air measurement system is designed in accordance to the IEC 60601-1 safety regulations. • For environmental conditions, see section called Safety Information Solar Go Air on page 7.
Page 21: 1.12 Laborie Software Program
1.12 LABORIE Software Program The LABORIE software program is provided on USB thumb drive and should be installed on the laptop to make the complete system function. For an overview of the software messages which require an action to resolve, see Appendix D.
Page 22: 1.13 Warranty
1.14 About the Manuals The Solar Go Air Service & Installation Manual is intended for all technical users who install, test and maintain the hardware and software. Information is accessible because each module is described in a separate chapter. Items like safety information, installation, block diagram, diagnostics and troubleshooting can be found.
Page 23 Solar Go Air Anorectal manometry system. Manual LABORIE document code Solar Go Air User’s manual Solar Go Air LBL-01682 Solar Go Air Service & Installation LBL-01683 manual (this manual) Solar Go Air Measurement System©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 24: Manual Conventions
Print report button. Choose Report > Print report means that you must click Print on the menu-bar and choose Print report. Press a key means pressing the key on the keyboard, e.g. the F1 key. Solar Go Air Service & Installation Manual LBL-01683 [B] Chapter 1...
Page 25 Member State where the incident occurred. North American Technical Support: Telephone: 1.800.333.1039 extension 1 or 1.800.522.6743 extension 1 Email: service@laborie.com Solar Go Air Measurement System©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 26: Installation
Installation Introduction In this chapter, you will find instructions for the installation of your Solar Go Air measurement system. Safety Information WARNING Connect only LABORIE T-DOC ARM (CAT003) catheters to the Solar Go Air measurement system. WARNING Safety can be violated if the Solar Go Air measurement system shows visible damage.
Page 27: Solar Go Air Systems
Solar Go Air Systems 2.3.1 Introduction The Solar Go Air system is a combination of laptop and the Solar Go Air module Figure 2.1 Solar Go Air Installation ©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 28: Laptop
Laptop Introduction The information in this chapter will help you to install the LABORIE software on the measurement laptop. Use the manuals supplied with your laptop to unpack and set up the laptop. Safety Information WARNING The computer and its peripherals, communicating to...
Page 29: Computer Requirements
3.4.1 Introduction The Solar Go Air measurement system is delivered with one USB thumb drive containing the LABORIE software and the Bluetooth software. Before you can work with the system, you must install the software, and the BT dongle. For installation of the software, see the LABORIE software installation manual, Document Code: LBL-02579).
Page 30 Protect personal data and privacy LABORIE systems using Bluetooth communications are designed to securely handle patient information. The LABORIE software on the computer initiates the contact with the Bluetooth devices. To disallow any BT device to connect to the computer, you have to disable this in the ‘Bluetooth devices’...
Page 31: Register Solar Go Air
Bluetooth USB dongleBLED112. For Bluetooth communication, you must proceed as follows: ▪ Install a fresh battery in the Solar Go Air module. ▪ Double-click the LABORIE Database icon ▪ From Login window, input Username and Password, then click OK button to start the LABORIE patient database program.:...
Page 32 Default, the entries last name and date of birth are obligatory. Choose Settings > System settings and the TAB Configure patient entry to select the entries patient number and date of birth. Solar Go Air Service & Installation Manual LBL-01683 [B] Chapter 3...
Page 33 Bluetooth is activated. For the Luna module, Bluetooth can be activated by pressing the Urge button on the Luna for 2 seconds. A flashing Bluetooth sign appears on the Luna LCD. Laptop ©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 34 Click on the field Bluetooth devices name to give the module a unique name, number or color coding, corresponding with a label on the module. ▪ Click the Close button to finish the registration. Solar Go Air Service & Installation Manual LBL-01683 [B] Chapter 3...
Page 35: Diagnostic Program
Diagnostic Program Refer to the manual of the computer manufacturer for diagnostic information. The diagnostic program in the laborie software can also give you some information concerning the computer and its connected devices. Troubleshooting Window does not start  Try to start Windows in Safe mode.
Page 36  The investigation file is probably corrupt. Check if you archived the patient and restore it.  If this is not the case, contact your LABORIE representative. In some cases, the file can be corrected by LABORIE. One of the messages ‘Protocol could not be found’, ‘Settings file not present’...
Page 37 ▪ Choose LABORIE Measurement & Analysis software. ▪ Click Shut Down. The message ‘Interface file "DBToExes.INI" not found is displayed  Start the measurement program from the LABORIE database only. The message ‘Not enough memory available. Cannot perform investigation.’ is displayed ...
Page 38: Bled112 Dongle
Please read the Safety information chapter at the beginning of this manual for additional information. Diagnostic Program You can test the Bluetooth Smart dongle with the remote control in the diagnostic program. Troubleshooting Refer to § 5.6 (Solar Go Air) for more information. Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 39: Technical Specifications
• . • Enclosure material: Black. • Wireless connection: Bluetooth ® 4.0 (Smart) technology. • For wireless Solar Go Air module. • Mounted in the USB port of the laptop. BLED112 Dongle ©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 40: Wireless Solar Go Air
Wireless Solar Go Air Introduction The Solar Go Air system is a wireless interface for measurement of 4 pressures and/or EMG. EMG stands for Electro MyoGraphy and can be used to measure the activity of the pelvic floor muscles with surface electrodes. The module can be used for anorectal manometry.
Page 41: Safety Information
Safety Information The Solar Go Air module complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Page 42: Installation
The Solar Go Air needs one battery type AA alkaline (1.5 Volt). Remove the rubber cover of the battery compartment (at the back of the Solar Go Air) by pressing on the cover, forcing the small tab upwards, which can be used to remove the cover.
Page 43 In the figure below the Solar Go Air is illustrated. Figure 5.3 Solar Go Air with its connectors Wireless Solar Go Air©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 44: Status Led
Install the Solar Go Air as follows: ▪ First insert a fresh the battery (§ 5.3.1) and register the Solar Go Air (§ 3.4.3). ▪ Connect the T-DOC transducers. ▪ Connect the EMG electrode leads to the Solar Go Air receptacles as...
Page 45: Connect Emg Cable
Connect EMG Cable The EMG electrode leads must be connected to the EMG receptacles on the Solar Go Air. It is possible to measure EMG using surface electrodes. The following types of EMG cables/leads and electrodes are recommended to use with the Solar Go Air: •...
Page 46: Test The Wireless Patient Unit
Green / Yellow 5.3.6 Test the Wireless Patient Unit The Solar Go Air can be tested in the measurement program if the system has been installed, registered and enabled in the protocol settings. The procedure is as follows: ▪ Double-click on the LABORIE Database button ▪...
Page 47: Diagnostic Program
The insulation barrier of Solar Go Air is BF according to the IEC 60601-1. Diagnostic Program You can test if the Solar Go Air is working properly in the diagnostic program. Choose from the main menu Utilities > Hardware test (USB) or Hardware test (BT) to display the diagnostic program.
Page 48 EMG signal corresponds. Test pressure channels The easiest way to test the Solar Go Air and the air-charged catheters is by using a water-column of at least 100 cm. The procedure is as follows: ▪...
Page 49 Applied pressure (cmH Allowed limits (cmH ± 2 cmH O ± deviation of catheter ± 2 cmH O ± deviation of catheter Wireless Solar Go Air©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 50: Troubleshooting
Troubleshooting Solar Go Air does not work and is not displayed in BT diagnostic program  Register the Solar Go Air (see § 3.4.3).  Replace the battery and check the status LED.  Contact your LABORIE representative. Error message ‘No Solar Go Air registered’...
Page 51 A question mark is shown where the pressure value should be  Is the catheter/transducer connected to the WPM?  Check if one of the cables, plugs or connectors is damaged. Wireless Solar Go Air©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 52: Technical Specifications
• Common mode rejection ratio: > 100 dB @ 50/60 Hz. • Update rate: 8 kHz (sample rate is 512 kHz or 2 kHz). • Receptacle 3 x 1.5 mm touch-proof connectors. Solar Go Air Service & Installation Manual LBL-01683 [B] Chapter 5...
Page 53 - BT environmental conditions - number and length of investigations o A good quality alkaline battery of 2600mAh will last 2 months, based on 75 investigations of 20 minutes per month. Wireless Solar Go Air©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 54: Maintenance
This can prevent problems occurring during an investigation. Preventive Maintenance With preventive maintenance, a regular check of the complete Solar Go Air measurement system is meant. LABORIE advises to perform preventive maintenance at least once a year. When malfunctions are found during the test procedures, refer to the Trouble shooting paragraphs to fix the module.
Page 55: Cleaning The System
LABORIE advises that cleaning of the whole system is performed on a regular base, for instance every month. Some parts need more frequent cleaning, daily or after each investigation to obtain a maximum hygienic Solar Go Air measurement system. Below we show the several parts with their cleaning instructions.
Page 56 • Re-usable EMG electrodes must be cleaned after each. Daily The cleaning instructions are as follows: • Clean and disinfect the Solar Go Air with isopropyl alcohol 70% (propanol) (low level disinfection). Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 57: Back-Up Patient Data
Query function. These patients can be saved to another medium. • Copy the complete MMS-win directory to another medium. This way also the measurement protocol settings are saved. Maintenance ©Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 58 APPENDICI, WARRANTY AND INDEX Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 60: Appendix A Cables
Appendix A Cables The following cables are described: • Solid state pressure transducer cable Solid state pressure transducer cable Function drive + sense - drive - sense + Lemo 4 connector TYPE: EPG.OB.304.HLN © 2013-2022 by LABORIE...
Page 61: Appendix B Explanation Of Symbols
Appendix B Explanati on of Symbols This appendix gives an explanation of the symbols on the Solar Go Air measurement system Follow instructions for use. Blue symbol Caution, consult instructions of use. Consult instruction for use for cautions and warnings Caution: Federal law restricts this device to sale by or on the order of a physician.
Page 62 The enclosure provides protection of solid foreign objects with a IP2X diameter of 12.5mm or more. Battery symbol. Rechargeable battery Nationally Recognized Testing Laboratories Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix B...
Page 63 Never put fingers or any other body parts in the pump while it is running! Symbol with red border Double insulated conform IEC 60601-1. Atmospheric pressure range 700 hPa to 1060 hPa. Operating Conditions: Temperature range +15°C to + 35°C. Operating Conditions: Relative humidity range 30% to 75%, non- condensing.
Page 64 This product is subject to WEEE directive 2012/19/EU. Contact your local authority for information about disposal and recycling. Energy source. Manufacturer. May be combined with manufacturing date. Keep dry. Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix B...
Page 65 Fuse. Equipotentiality. Protective earth. Earth (ground). Signal reference Class I equipment conform IEC 60601-1. Class II equipment conform IEC 60601-1. Explanation of SymbolsSolar Go Air Service & Installation Manual LBL-01683 [B]...
Page 66 Polarity of d.c. power connection USB port (upstream from U2M module to PC). Input Output Input/output Separating Transformer input and output voltage selection switch. Mass (including safe working load) in kilograms. Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix B...
Page 67 Catalogue number. Serial number. Quantity symbol: Numeral in symbol (in place of #) indicates the quantity of units in package. Explanation of SymbolsSolar Go Air Service & Installation Manual LBL-01683 [B]...
Page 68 4 digit incrementing unique number. Explanation of PE-number PEYY-FXXXXNNNN Peripheral Equipment. 2 digit manufacturing year number. Product group number. XXXX 3 or 4 digit unique module abbreviation. NNNN 4 digit incrementing unique number. Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix B...
Page 69: Appendix C Electro Magnetic Compatibility
• The equipment should be visually inspected regularly for damaged cables and connectors. Damaged cables should be replaced. • If the Solar Go Air system is used in a location near (e.g. less than 1,5 km from) AM, FM or TV broadcast antennas, it may be necessary to take preventive actions for reducing the EM interfering level (for instance by shielding the investigation room).
Page 70 The Solar Go Air measurement system is intended for use in the electromagnetic environment specified below. The customer or the user of the Solar Go Air measurement system should assure that it is used in such an environment. When the Solar Go Air system is exposed to electromagnetic (EM) disturbances, the system may show abnormal behaviour.
Page 71 The Solar Go Air measurement system is intended for use in the electromagnetic environment specified below. The customer or the user of the Solar Go Air measurement system should assure that it is used in such an environment. When the Solar Go Air system is exposed to electromagnetic (EM) disturbances, the system may show abnormal behaviour.
Page 72 The Solar Go Air measurement system is intended for use in the electromagnetic environment specified below. The customer or the user of the Solar Go Air measurement system should assure that it is used in such an environment. When the Solar Go Air system is exposed to electromagnetic (EM) disturbances, the system may show abnormal behaviour.
Page 73 Disturbance of the EMG trace is 450 MHz possible at and below the specified test level. It may be necessary to 9 V/m relocate the Solar Go Air or to 710/745/78 apply shielding. Field strengths from fixed RF 28 V/m...
Page 74 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Solar Go Air is used exceeds the applicable RF compliance level above, the Solar Go Air should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Solar Go Air.
Page 75 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Solar Go Air system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 76 Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix C...
Page 77: Appendix D Software
The Bluetooth USB Dongle might be turned off in case of a laptop Calibration is invalid. Calibration is invalid Retry calibration Cannot move a [Markername] marker Cannot move marker Marker is not movable Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 78 Cannot move a Pause marker (Display pause Cannot move marker Pause data is hidden data) Changes in marker data could not be written! Error during saving of marker data Contact your LABORIE Disk error representative Channel settings could not be written! Error during saving of channel...
Page 79 Luna P2 not present Luna channel expected but not Contact your LABORIE present representative Luna P3 not present Luna channel expected but not Contact your LABORIE present representative Software Messages Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 80 [ProtocolName], [TestName] Open Protocol fix this problem editor to fix this problem. Puller error Puller not running at correct speed Check puller or contact or not at all your LABORIE representative Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix D...
Page 81 The system is not powered. Please check the System is not powered Connect the power power connection The Solar Go Air [Name] has lost the connection Communication problems Contact your LABORIE representative There are more channels available in the...
Page 82 Contact your LABORIE Wireless patient module, Check the Bluetooth connected representative dongle or replace the batteries Solar Go Air not connected! Check the Range of Module expected but not Contact your LABORIE the Wireless patient unit, Check the Bluetooth connected...
Page 83 HIS export DLL could not be Contact your LABORIE initialized representative Incorrect version of the Borland database Incorrect version of the Contact your LABORIE engine installed. Application can not be Borland Database Engine representative Software Messages Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 84 System number is empty. Archive of patient Patient system number is Contact your LABORIE aborted empty representative System number is incorrect. Archive of Patient system number is Contact your LABORIE patient aborted incorrect representative Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix D...
Page 85 Pressure too High. The pressure release Contact your LABORIE valve if probably polluted. Release the tube representative from the water container and try to restart the pump. If the error remains, the system Software Messages Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 86 The system is not found. Please check the Communication problems Contact your LABORIE USB and power connection. representative The system is not powered. Please check Communication problems Contact your LABORIE the power connection representative Solar Go Air Service & Installation Manual LBL-01683 [B] Appendix D...
Page 87: Warranty For Solar Go Air Measurement System
Solar Go Air, are responsible for keeping current with developments in the literature on uro- dynamics or gastro-enterology. Please direct any questions or problems concerning uro-dynamics or gastro- enterology and the use of the instrument, or interpretation of data acquired from the Solar Go Air to the responsible physician(s).
Page 88 6. TERMINATION. This License is effective until terminated. This License will terminate automatically without notice from LABORIE if you fail to comply with any provision of this License. Upon termination you shall destroy the written materials and all copies of the SOFTWARE, including modified copies, if any.
Page 89 INCIDENTAL DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, AND THE LIKE) ARISING OUT OF THE USE OR INABILITY TO USE SUCH PRODUCT EVEN IF LABORIE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Page 91: Index
............................27 safety information ..........................26 Configurations Nexam .......................... 15 Database program ..........................19 Diagnostic program ..........................19 EMG cable Solar Go Air ............................43 Intended use ............................14 Laptop Solar Go Air Service & Installation Manual LBL-01683 [B]...
Page 92 ..........................45 install the battery ..........................40 protocol settings ..........................42 safety information ..........................39 status LED ............................42 technical specifications ........................49 test in measurement program ......................44 Solar Go Air Service & Installation Manual LBL-01683 [B] Index...
Page 93 ..........................47 System requirements ..........................27 Warranty ..............................85 Windows ..............................13 Index Solar Go Air Service & Installation Manual LBL-01683 [B]...

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LABORIE Solar Go Air Service & Installation Manual

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