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Lowenstein Medical prisma20C Service And Repair Manual
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Lowenstein Medical prisma20C Service And Repair Manual

Sleep therapy devices
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EN Service and repair manual for type WM 100 TD and WM 100 TH devices
prisma20C
prisma20A
prismaCR
prisma25S
prisma30ST
Sleep therapy devices
prisma25S-C
prisma25ST
prismaLAB
prismaAQUA
prisma30ST-C

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  • Page 1 EN Service and repair manual for type WM 100 TD and WM 100 TH devices prisma20C prisma25S-C prisma20A prisma25ST prismaCR prismaLAB prisma25S prismaAQUA prisma30ST prisma30ST-C Sleep therapy devices...
  • Page 2 Table of Contents Table of Contents 9.2 Service sets ..............61 10 Components and accessories ....63 1 Introduction ..........3 11 Required auxiliary equipment ....64 1.1 About this document ............3 11.1 Tools ................64 1.2 Navigation in this document ..........3 11.2 Test equipment .............
  • Page 3 1 Introduction 1 Introduction 1.1 About this document The aim of this service and repair manual is to familiarize you with the device in terms of function, technology, maintenance and repairs. This enables you to: • provide instructions for customers •...
  • Page 4 1 Introduction 1.3 Function 1.3.1 WM 100 TD therapy device The fan in the therapy device sucks ambient air in through a filter, compresses it, and routes it to the device outlet. From here, the air flows through the hose system and the mask to the patient.
  • Page 5 1.4 Warnings in this document The fan is a centrifugal fan with a precision-balanced fanwheel and a 3-phase motor with Hall effect sensors for continuous speed measure- ment. The fan is controlled from the mainboard, and the fan speed de- pends on the current pressure requirements and the current leakage.
  • Page 6 2 Product description 2 Product description 2.1 Therapy device overview 2-1 Therapy device Designation Description Cover Covers the humidifier connection when no respiratory air humidifier is connected. Unlocking button Allows the cover to be removed for connecting the humidifier prismaAQUA. Allows operation of the therapy device and the respiratory air humidifier.
  • Page 7 2.2 Display 2.2 Display The information shown on the display depends on the current status of the therapy device: • Standby mode (no therapy in progress) The clock is shown, as is the wake-up time if the alarm clock is set. •...
  • Page 8 2 Product description 2.2.2 Display in patient sector (Start screen in Therapy mode) 2-3 Start screen in Therapy mode Designation Description Clock Displays the current time. SD card symbol The SD card is in the therapy device. Info button Provides access to the info screen with detailed information on the therapy currently in progress. Alarm clock is set.
  • Page 9 2.2 Display 2.2.3 Display in the expert sector Please note that the screens may differ slightly depending on the set ventilation mode and device mode. 2-4 Display in expert sector (screen in BILevel ST mode in Therapy device mode) Designation Description PSG symbol prismaPSG module is not plugged in or there is no connection.
  • Page 10 2 Product description 2.3 Symbols on the display Symbol Designation Description Device status symbols (shown on the top line of the display) The expert sector is open and the parameters can be set. Access symbol The expert sector is open and the settings are locked. It is not possible to configure parameter settings.
  • Page 11 2.3 Symbols on the display Symbol Designation Description Alarm clock is set. Alarm clock symbol If no alarm clock symbol is shown: the alarm clock is off. Displays the respiration status: S=spontaneous T=timed Arrow pointing upward: Inspiration Respiration status symbol Arrow pointing downward: Expiration Apnea Mask position is good, no leaks...
  • Page 12 2 Product description 2.4 Components 2-5 Components Designation Description Respiratory mask Supplies the respiratory air to the patient. Power supply unit with connection Supplies power to the device. cable Connects the power supply unit to the therapy device. Power supply cable Connects the power supply unit to the power socket.
  • Page 13 2.5 Accessories 2.5 Accessories 2-6 Accessories Designation Description Breathing tube with 15 mm Connects the therapy device to the respiratory mask. diameter Filters the suctioned respiratory air and prevents the ingress of fine dust particles, pollen and fungal Pollen filter (white filter) spores.
  • Page 14 2 Product description 2.6 Labels and symbols 2.6.1 Labels on the therapy device 2-7 Labels on the therapy device Symbol Description Type plate on the right side of the therapy device Serial number of the therapy device Year of manufacture Labels and symbols on the therapy device 2 , 8 Consult instructions for use...
  • Page 15 2.6 Labels and symbols Symbol Description Type plate on the underside of the therapy device TYPE: WM 100 TD Type designation of the therapy device 37 V DC IP protection class: Degree of protection against ingress of dangerous parts and solid foreign bodies. The IP21 device is protected against dripping water.
  • Page 16 2 Product description Symbol Description Respiratory air humidifier is heated. Do not touch the element! Labels and symbols on the underside Do not dispose of device in household waste CE mark (confirms that the product complies with the applicable European directives) 32 V DC 32-volt direct current Degree of protection against electric shock: Type BF device...
  • Page 17 2.6 Labels and symbols 2.6.4 Labels on the therapy device packaging Symbol Description Permissible storage temperature: -25°C to +70°C °C Permissible storage humidity: 15% to 93% relative humidity 2.6.5 Labels on the breathing tube packaging Symbol Description For use on one patient only! 2.6.6 Viewing the therapy data and device information in the Expert Info menu In the Expert Info menu you can view information about the therapy...
  • Page 18 2 Product description 4. Select the required period. 5. Navigate back with the arrow key. 6. To view detailed information about the leakage, press the Leakage field. 7. To view detailed information about the apnea–hypopnea index (AHI) and respiratory parameters, press the AHI field. 8.
  • Page 19 2.6 Labels and symbols Abbreviation Description Device version Serial number Hardware version Firmware version Not relevant, internal developer information Not relevant, internal developer information System identification of the device Therapy hours without artifacts or open mask. This counter is reset when therapy data in the device are deleted or the device is reset to the factory settings.
  • Page 20 3 Maintenance 3 Maintenance 3.1 General information Maintenance, safety checks, inspections and repairs must only be carried out by the manufacturer or a technician specifically authorized by the manufacturer. 3.2 Intervals The therapy device is designed to have a useful service life of 6 years. Once these 6 years have elapsed, a complete final test must be performed (see "5 Final test", page...
  • Page 21 3.3 Changing the filter Resetting the maintenance counter Only applies if the maintenance counter is active: You need to reset the maintenance counter after every service and every hygienic preparation in order to return the hour counter to zero. 1. Switch on the therapy device. 2.
  • Page 22 4 Hygienic preparation 4 Hygienic preparation 4.1 General information • This product may contain disposable items. Disposable items are intended to be used only once. Use these items only once and do not reprocess them. Reprocessing disposable items may impair the functionality and safety of the product and lead to unforeseeable reactions as a result of aging, embrittlement, wear, thermal load, the effects of chemical processes, etc.
  • Page 23 4.2 Hygienic preparation of the therapy device 4.2.3 Hygienic preparation during patient change 1. Wipe-disinfect the following parts: • Housing • Power supply cable • Power supply unit 2. Replace the following parts: • Breathing tube WM 24445 • Respiratory mask with headband •...
  • Page 24 4 Hygienic preparation 8. Pull out the fan 47 together with the membrane 36 from the central part of the housing 2. 9. Remove the fan 47 from the membrane 36. 10.Detach the decoupling hose 7 and spacer 48 from the fan 47. WM 100 TD and WM 100 TH Back Forward...
  • Page 25 4.2 Hygienic preparation of the therapy device 11.Undo and remove 3 screws 50 on the fan 47. 12.Remove the fan cap 49 from the fan 47. 13.Wipe-disinfect the following parts: • Fan body • Fan cable 14.Immerse the fan in disinfectant 47: •...
  • Page 26 4 Hygienic preparation 16.Replace the fan cap on the fan 47. When doing so, pay attention to the correct positioning. 17.Secure the fan cap 49 in position with the 3 new screws 50. 18.Secure the new decoupling hose 7 and new spacer 48 on the disinfected fan 47.
  • Page 27 4.2 Hygienic preparation of the therapy device 20.Insert the fan 47 with the membrane 36 into the central part of the housing 2. 21.Insert the decoupling hose 7 and the cable bushing into the central part of the housing 2. Note: The decoupling hose must not be kinked or trapped.
  • Page 28 4 Hygienic preparation 4.3 Hygienic preparation of the respiratory air humidifier 4.3.1 Hygienic preparation during use Please observe the instructions for use of the therapy device. 4.3.2 Hygienic preparation during patient change Requirement The therapy device was used without a bacteria filter previously. •...
  • Page 29 5 Final test 5 Final test 5.1 General information The therapy device has a programmed step-by-step test to simplify the test procedure. This is available when the Service mode is active (see " Perform the step-by-step test", page 33). The step-by-step test includes all the test steps which are necessary for checking the proper functioning of the therapy device.
  • Page 30 5 Final test Function Parameter Description Settings option Device type Shows which modes are available Device serial Shows the serial number of the therapy One-off input of serial number if current number device. serial number is "0". SNs, types Mainboard serial One-off input of serial number if current Shows the serial number of the mainboard.
  • Page 31 5.2 Service mode Function Parameter Description Settings option RTC current date/ Shows the current setting of the real time Date, time time (UTC) clock. Time zone Shows the current setting of the time zone. Time zone Date, time Daylight saving Summer/winter time changeover Press the On/Off button.
  • Page 32 5 Final test 5.3 Preparation for testing 1. Connect the power supply unit to the therapy device and switch on the power supply (see instructions for use for the therapy device). 2. Connect up the breathing tube. 3. Connect up the respiratory mask. 5.3.1 Checking the housing 1.
  • Page 33 5.4 Performing a function check Perform the step-by-step test 1. Activate the Service mode: Connect the service connector WM 29917 to the system interface. The Service menu opens after approximately 5 seconds. 2. Press the Step-by-step test field. 3. Step 1: Compare the date and time with a reference clock. Requirement: The date and time are correct.
  • Page 34 5 Final test 11.Step 4: Checking the SD card. Requirement: • Display: SD card test status -> Passed (if SD card is in the device) • Display: SD card test status -> SD card not recognized (if no SD card is in the device) 12.If no SD card is in the device: Insert SD card and press Start again.
  • Page 35 5.4 Performing a function check 25.Step 8: Check the flow values 26.Press the 2 buttons for the different speeds one after the other and read off the displayed flow. Requirement: The displayed flow values are within the tolerance specified in the test record.
  • Page 36 5 Final test 5.5 Checking the display and the function of the keys 1. Connect the therapy device to the power supply. 2. Switch the therapy device on with the On/Off button 5.6 Checking the SD card 1. Insert the SD card 61 into the SD card slot. Requirement: The SD card symbol is shown on the display.
  • Page 37 6 Faults 6 Faults If you are unable to eliminate faults immediately with the help of the table, contact the manufacturer. To avoid exacerbating the damage, do not continue operating the device. Fault Cause Rectification Check that the power supply cable is connected properly. Check the function of the socket-outlet.
  • Page 38 6 Faults 6.3 Error memory The therapy device has an internal error memory with space for up to 100 error entries. Once the maximum number of entries is reached, the oldest entry is overwritten. 6.3.1 Opening/deleting the error memory 1. Activate Service menu (see 5.2) 2.
  • Page 39 6.3 Error memory Error Error memory designation Description Cause Remedy number ERR_MC_DONT_STARTS_IN_GIVEN Controller error Mainboard defective Replace mainboard _TIME ERR_MC_BOOTLOADER_ERROR Controller error Mainboard defective Replace mainboard Send therapy device to the ERR_COULD_NOT_START_APPLICATIO Initialization error Further investigation necessary manufacturer or replace mainboard Send therapy device to the ERR_CLEAN_AND_PREPARE_UBI_...
  • Page 40 6 Faults Error Error memory designation Description Cause Remedy number Connect respiratory air Respiratory air humidifier or humidifier or cover cover not correctly connected correctly Mainboard defective Replace mainboard Error in pressure ControlPressureSensorLowError Pressure-measurement hose Connect pressure- measurement line not connected measurement hose Check position of pressure- Pressure-measurement hose...
  • Page 41 7 Repairs 7 Repairs 7.1 General information • When carrying out repairs, please refer to the instructions for use and the service and repair manual. In particular, you should observe the safety information contained in the instructions for use. • Repairs should only be carried out at an ESD workstation! •...
  • Page 42 7 Repairs 2. Pull off the device outlet 60. 3. Place the therapy device on its front 3 on a table, and unscrew the 2 screws 22. 4. Fold up the back of the housing 1 and place it on the table carefully. 5.
  • Page 43 7.3 Closing the therapy device 7.3 Closing the therapy device 1. Place the front of the housing 3 on the top edge of the fan box. Note: The recesses must face downwards and the display 20 backwards. 2. Connect the fan connector to connection X200. 3.
  • Page 44 7 Repairs 7. Insert device outlet 60 in the therapy device. 8. Insert the cover/respiratory air humidifier. 7.4 Replacing the mainboard 7.4.1 Removing the mainboard 1. Remove the SD card 61 from the SD card slot. 2. Open the therapy device (see "7.2 Opening the therapy device", page 41) WM 100 TD and WM 100 TH...
  • Page 45 7.4 Replacing the mainboard 3. Remove the connection cable of the respiratory air humidifier 9 from the holding bracket. 4. Disconnect the connection X600 from the mainboard. X600 5. Disconnect the connection X701. X701 6. Remove the pressure-measurement hose 10 with the elbow from the connection on the pressure sensor.
  • Page 46 7 Repairs 7. Undo the lock on the ribbon cable for the display 8. Note: The black clip must be clicked upwards. 8. Remove the ribbon cable for the display 8. 9. Unscrew the 3 screws 25. 10.Remove the mainboard from the front of the housing 3 by lifting the mainboard slightly on one side and then pulling it out diagonally upwards.
  • Page 47 7.4 Replacing the mainboard 4. Insert the ribbon cable for the display 8 in the recess X100 and secure it in place. X100 Note: • The blue stripe must point upwards. • The black clip must be clicked downwards. 5. Secure the elbow of the pressure-measurement hose 10 in place on the pressure sensor.
  • Page 48 7 Repairs 9. Close the therapy device (see "7.3 Closing the therapy device", page 43) If necessary If the message Code 113 appears on the therapy device after the mainboard has been changed, the following steps must be taken: 1. Activate the Service mode: Connect the service connector WM 29917 to the system interface.
  • Page 49 7.5 Replacing the display 7.5 Replacing the display 7.5.1 Removing the display 1. Open the therapy device (see "7.2 Opening the therapy device", page 41). 2. Remove the mainboard (see "7.4.1 Removing the mainboard", page 44). 3. Undo the lock on the ribbon cable for the display 8. Note: The brown clip must be clicked upwards.
  • Page 50 7 Repairs 7.5.2 Installing the display 1. Insert the new display 20 in the display frame 21. 2. Insert the display frame 21 with the new display 20 in the front of the housing 3. 3. Secure the display frame 21 in place with the 4 screws 25. 4.
  • Page 51 7.6 Replacing the fan 7.6 Replacing the fan 7.6.1 Removing the fan 1. Open the therapy device (see "7.2 Opening the therapy device", page 41). 2. Place the therapy device on its back on a table. 3. Undo and remove 2 screws 23. 4.
  • Page 52 7 Repairs 6. Pull out the fan 47 together with the membrane 36 from the central part of the housing 2. 7. Remove the fan 47 from the membrane 36. 8. Detach the decoupling hose 7 and spacer 48 from the fan 47. WM 100 TD and WM 100 TH Back Forward...
  • Page 53 7.6 Replacing the fan 7.6.2 Installing the fan 1. Secure the new decoupling hose 7 and new spacer 44 on the new fan 47. When doing so, pay attention to the correct positioning. 2. Insert the fan 47 in the membrane 36. Note: The marks on the membrane must be aligned with the screws on the fan.
  • Page 54 7 Repairs 3. Insert the fan 47 with the membrane 36 into the central part of the housing 2. 4. Insert the decoupling hose 7 and the cable bushing into the central part of the housing 2. Note: The decoupling hose must not be kinked or trapped. 5.
  • Page 55 7.7 Replacing the parts of the housing 7.7 Replacing the parts of the housing 7.7.1 Replacing the front of the housing 1. Open the therapy device (see "7.2 Opening the therapy device", page 41). 2. Remove the mainboard (see "7.4.1 Removing the mainboard", page 44).
  • Page 56 7 Repairs 7. Insert the seal for the system interface 42 into the new front of the housing 3. 8. Insert the new seal for the SD card slot 43 into the new front of the housing 3. 9. Insert the new connection cable for the hose heater 5 into the new front of the housing 3 (only applies to devices as of serial number 5.000).
  • Page 57 7.7 Replacing the parts of the housing 7.7.2 Replacing the central part and back of the housing 1. Remove the fan (see "7.6.1 Removing the fan", page 51). 2. Unscrew and remove the 2 screws 22 of the connection cable for the power supply unit 4 on the back of the housing 1.
  • Page 58 7 Repairs 7.8 Replacing the battery on the mainboard 1. Open the therapy device (see "7.2 Opening the therapy device", page 41). 2. Depress the contact tab of the battery holder and remove the battery 56 with the help of plastic pliers or tweezers. 3.
  • Page 59 8 Storage and disposal 8 Storage and disposal 8.1 Storage 8.1.1 General information Store the device under the specified ambient conditions (see chapter "Technical data"). 8.1.2 Storing the therapy device 1. Switch off the therapy device. 2. Disconnect the therapy device from the power supply. 3.
  • Page 60 WM 29938 Hose nozzle WM 29968 PCBs prisma20A mainboard WM 35015 Zubehörteil mainboard WM 35016 prismaLAB mainboard WM 35017 prisma20C mainboard WM 35018 prisma25S mainboard WM 35025 prisma25S-C mainboard WM 35026 prisma25ST mainboard WM 35027 prisma30ST mainboard WM 35028 prisma30ST-C mainboard...
  • Page 61 9.2 Service sets Item Designation Article number On/Off button, complete, prisma20C WM 29913 On/Off button, complete, prismaLAB WM 29914 On/Off button, complete, prisma25S WM 29903 On/Off button, complete, prisma25S-C WM 29909 On/Off button, complete, prisma25ST WM 29923 On/off button, complete, prisma30ST...
  • Page 62 9 Replacement parts Item Designation Article number WM 100 TD patient change set WM 29973 Air filter WM 29651 Spacer WM 29604 Label, patient change set WM 77160 O-Ring 37x3 WM 1145/14 WM 100 TH patient change set WM 29974 Humidifier insert WM 29683 Base of humidifier...
  • Page 63 10 Components and accessories 10 Components and accessories Designation Article number Breathing tube with 19 mm diameter WM 24445 Breathing tube with 19 mm, autoclavable WM 24667 Breathing tube with 15 mm diameter WM 29988 Bacteria filter WM 24476 Set, 12 pollen filters WM 29652 prismaBAG basic WM 29659...
  • Page 64 11 Required auxiliary equipment 11 Required auxiliary equipment 11.1 Tools • Torx screwdriver Size T 20 • Torx screwdriver Size T 9 • Torx screwdriver Size T 8 • ESD workstation 11.2 Test equipment • Portable pressure measuring device Measuring range 0-40 hPa •...
  • Page 65 12 Technical data 12 Technical data 12.1 Technical data of therapy device Specification Therapy device Product class according to 93/42/EEC Dimensions W x H x D in cm 17 x 13.5 x 18 Weight 1.4 kg Temperature range Operation +5°C to +40°C Storage -25°C to +70°C Permissible humidity during operation and storage...
  • Page 66 12 Technical data Specification Therapy device < 20 hPa: ± 0.6 hPa Pressure accuracy >20 hPa: ± 0.8 hPa P Lim (maximum pressure in case of error) < 40 hPa It is not possible to set a target volume for the AcSV mode. The pressure control Target volume in AcSV mode stabilizes the volume at the respective current level.
  • Page 67 12.1 Technical data of therapy device Specification Therapy device Peak flow as per ISO 80601-2-70 Pressure measured at the patient connection Average flow at the patient connection opening at a flow of 40 l/min opening [l/min] CPAP and APAP mode Test pressures: 4 hPa 4.0 hPa...
  • Page 68 12 Technical data Specification Therapy device Stability of the dynamic pressure (short-term accuracy) as per ISO 80601-2-70 in CPAP and APAP mode - when using the 19 mm hose 4 hPa p < 0.68 hPa Δ 8 hPa p < 0.58 hPa Δ...
  • Page 69 12.2 Technical data of power supply unit Specification Therapy device Pollen filter Filter class E10 down to 1 μm ≥ 99.5% down to 0.3 μm ≥ 85% Service life of pollen filter Approx. 250 hours Memory sizes of 256 MB to 8 GB can be used, interface compatible with SD physical SD card layer version 2.0 Tolerances for measurements...
  • Page 70 12 Technical data Specification prismaAQUA Classification as per DIN EN 60601-1: Operating mode Continuous operation Test parameters and limit values can be requested from the manufacturer if required. Electromagnetic compatibility (EMC) acc. to DIN EN 60601-1-2: EN 55011 B Radio interference suppression IEC 61000-4 Parts 2 to 6, Part 11, Part 8 Radio interference immunity IEC 61000-3 Parts 2 and 3...
  • Page 71 12.5 Pneumatic system diagram 12.5 Pneumatic system diagram pressure Flow regulator source Patient mask Nasal or full face mask Inlet for Respiratory ambient air Optional Optional O Optional Exhalation Air filter hose, humidifier safety valve bacteria filter system 1.8m Pressure sensor for patient pressure 12.6 Separation distances...
  • Page 72 13 Test record 13 Test record You can find a blank template for the test record on the following pages. The headings in the test record correspond to the headings in the chapter "Final test". WM 100 TD and WM 100 TH Back Forward Contents...
  • Page 73 Test record as per Service and Repair Manual WM 67971 Page 1 of 2 prisma20C prismaCR prisma20A prismaLAB Device type: prisma25S prisma25S-C prisma25ST prisma30ST prisma30ST-C Device description: Sleep apnea therapy device Serial no.: Manufacturer: Löwenstein Medical Technology GmbH + Co. KG...
  • Page 74 Test record as per Service and Repair Manual WM 67971 Page 2 of 2 Step 9 Check the humidifier interface (heating element) Actual Actual The voltage and current Voltage setting current voltage consumption displayed are 16 V > 0 A 15 - 17 V within the tolerance specified.
  • Page 76 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 5 47 02 - 100 F: +49 40 5 47 02 - 476 www.loewenstein-medical.com...

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