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Summary of Contents for Lowenstein Medical prisma SMART
- Page 1 EN Instructions for Use for devices of type WM 090 TD prisma SMART prisma SOFT Sleep therapy devices...
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Page 2: Table Of Contents
Contents Contents Introduction 1.1 Intended use ..................... 4 1.2 Description of function ................4 1.3 User qualifications ..................4 1.4 Indications ....................4 1.5 Contraindications ..................5 1.6 Side effects ....................5 Safety 2.1 Safety information ..................6 2.2 General information .................. 6 2.3 Warnings in this document ............... - Page 3 Contents Hygiene treatment 6.1 General information ................22 6.2 Cleaning intervals ................... 22 6.3 Hygiene treatment for device ..............23 6.4 Hygiene treatment for breathing tube ............. 25 Function check Troubleshooting 8.1 Device faults ................... 26 8.2 Display messages ..................27 Servicing 10 Storage 11 Disposal...
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Page 4: Introduction
CPAP therapy device for treating patients with obstructive sleep apnea with a constant pressure requirement. prisma SMART APAP therapy device for treating patients with obstructive sleep apnea with a variable pressure requirement. Therapy pressure adapts automatically to the patient's pressure... -
Page 5: Contraindications
1 Introduction 1.5 Contraindications The following contraindications are known - in the individual case, responsibility for deciding whether to use the device rests with the attending physician. Threatening situations have not ever been observed. Cardiac decompensation, severe cardiac arrhythmias, severe hypotension, especially in combination with intravascular volume depletion, severe epistaxis, high risk of barotrauma, severe lung disease (e.g. -
Page 6: Safety
2 Safety 2 Safety 2.1 Safety information 2.1.1 Handling the device, the components and the accessories If the device is damaged or its function is restricted, patients, users and people in the vicinity may be injured. ⇒ Only operate the device and its components if they are externally undamaged. ⇒... - Page 7 2 Safety • Have measures such as repairs, servicing and maintenance work carried out by the manufacturer or by specialists expressly so authorized by the manufacturer. • Connect only the devices and modules permitted in accordance with these Instructions for Use. The devices must meet the product standard applicable to them. Non-medical equipment should be positioned away from the patient's vicinity.
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Page 8: Warnings In This Document
2 Safety 2.3 Warnings in this document Warnings indicate information relevant to safety. Within procedures, you will find warnings in front of a step which contains a hazard to persons or objects. Warning! Indicates an unusually significant hazardous situation. If you ignore this instruction, severe irreversible or fatal injuries may result. -
Page 9: Product Description
3 Product description 3 Product description 3.1 Overview 1 Humidifier connection with cover 2 Release catch 3 Control panel with display 4 Interface for connecting the communication module 5 Handle 6 Filter compartment 7 Connection for power supply cable 8 Breathing tube with connection for mask... -
Page 10: Operating States
3 Product description 9 SD card slot 10 Power supply unit 11 SD card 12 Power cord 13 Device outlet port 3.2 Operating states • On: therapy is running. • Standby: blower is off, but immediately operational if the On/off key is pressed briefly. Settings can be made on the device when it is in standby mode. -
Page 11: Symbols In The Display
3 Product description The keys of the device may have different functions. If there is a symbol above the key in the display, the key adopts the function of the symbol in question. If there is no symbol above the key, the key retains its original function. 3.4 Symbols in the display SYMBOL DESCRIPTION... -
Page 12: Accessories
3 Product description 3.5 Accessories 1 Humidifier 2 Pollen filter (white) 3 12-24 V DC adapter... -
Page 13: Preparation And Operation
4 Preparation and operation 4 Preparation and operation 4.1 Set up and connect the device Risk of injury due to contaminated or infected patient circuit! A contaminated or infected patient circuit may transmit contamination or infections to the next patient. ⇒... - Page 14 4 Preparation and operation 2. Connect the power cord to the power supply unit and the socket. The operating hours of the device are displayed briefly. The device switches to standby. Risk of injury if breathing tube routed incorrectly! An incorrectly routed breathing tube may injure the patient. ⇒...
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Page 15: Start Therapy
4 Preparation and operation Risk of suffocation if full-face masks without an exhalation system are used! If full-face masks without an exhalation system are used, the CO concentration may rise to critical values and put the patient at risk. ⇒ Use full-face masks with an external exhalation system if there is no integrated exhalation system. -
Page 16: Performing The Mask Test
4 Preparation and operation 1. Start therapy (see "4.2 Start therapy", page 15). The humidifier switches on automatically. The humidifier symbol goes green 2. To increase the humidifier stage: press the key. 3. To decrease the humidifier stage: press the key. -
Page 17: Switch Softstart On And Off
4 Preparation and operation 4.6 Switch softSTART on and off Requirement Therapy is running. softSTART is activated by the physician. If the soft start is activated, the device automatically turns on every time therapy is started. 1. Press the softSTART key briefly to switch on softSTART manually. - Page 18 4 Preparation and operation 1. Push the SD card into the SD card slot until you hear it engage. The SD card symbol appears in the display. 2. To remove it, press the SD card briefly and remove the SD card. In doing so, please note: do not remove the SD card while the SD card symbol is flashing.
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Page 19: Menu Settings
5 Menu settings 5 Menu settings 5.1 Function of the keys The keys of the device may have different functions. If there is a symbol above the key in the display (e.g. above the softSTART key), the key adopts the function of the symbol in question. - Page 20 5 Menu settings FUNCTION KEY DESCRIPTION Scroll forward through menu Scroll back through menu Increase value Reduce value Confirm value Discard value Exit menu. Switch back to start screen. 5.2.2 Menu structure You can set the following parameters if your physician has enabled them for you. PARAMETER DESCRIPTION Here you can set the time for which ventilation pressure rises to...
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Page 21: Info Menu/Read Out Operating Hours
5 Menu settings 5.3 Info menu/read out operating hours Requirement The device is on standby. 1. Press the menu key 2. To call up the info menu: press 3. Navigate to the desired value with the keys: DISPLAY MEANING 0000 h Total operating hours of the device Operating hours for the last day. -
Page 22: Hygiene Treatment
6 Hygiene treatment 6 Hygiene treatment Risk of infection when the device is used again! If the device is used by several patients, infections may be transmitted to the next patient. ⇒ If the device is used again: have the device subjected to a hygiene treatment by the manufacturer or an authorized specialist dealer. -
Page 23: Hygiene Treatment For Device
6 Hygiene treatment 6.3 Hygiene treatment for device Risk of injury from electric shock! Ingress of liquids may lead to a short-circuit, injure the user and damage the device. ⇒ Disconnect the device from the power supply before the hygiene treatment. ⇒... - Page 24 6 Hygiene treatment 6.3.1 Clean air filter (gray filter) 1. Clean air filter 1 under running water. 2. Allow air filter 1 to dry. 6.3.2 Replace optional pollen filter (white filter) 1. Remove air filter 1 . 2. Replace white pollen filter 2 . 3.
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Page 25: Hygiene Treatment For Breathing Tube
7 Function check 6.4 Hygiene treatment for breathing tube Risk of material damage as a result of ingress of liquids! The device may be damaged by the ingress of liquids. ⇒ Use the breathing tube only when completely dry. 1. Subject the breathing tube to a hygiene treatment in accordance with the table below. -
Page 26: Troubleshooting
8 Troubleshooting 8 Troubleshooting If you are unable to remedy faults with the aid of the table, or in the event of unexpected operation or an incident, contact the manufacturer or your authorized specialist dealer. To avoid exacerbating the damage, do not continue operating the device. -
Page 27: Display Messages
8 Troubleshooting 8.2 Display messages If the message Err (xxx) appears in the display, look in the table for the error code displayed. Remedy the error in accordance with the description. ERROR CODE CAUSE REMEDY Device has lost the Contact specialist dealer and have device (108) saved time. -
Page 28: Servicing
9 Servicing 9 Servicing The device is designed for a service life of 6 years. If used in accordance with the intended use, the device requires no servicing during this period. If the device is used beyond this period, it needs checking by an authorized specialist dealer. -
Page 29: Appendix
12 Appendix 12 Appendix 12.1 Technical data 12.1.1 Device SPECIFICATION DEVICE Product class to 93/42/EEC Dimensions W x H x D in cm 17 x 13.5 x 18 Weight 1.34 kg Temperature range - operation +5 °C to +40 °C - storage -25 °C to +70 °C Rel. - Page 30 12 Appendix SPECIFICATION DEVICE Classification to DIN EN 60601- Continuous duty duty cycle Application part Breathing mask Test parameters and limit values can be obtained from Electromagnetic compatibility the manufacturer on request. (EMC) 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...
- Page 31 12 Appendix SPECIFICATION DEVICE Stability of dynamic pressure With breathing tube, with With breathing tube, (short-term precision) at 15 humidifier without humidifier breaths/min to ISO 80601-2-70 4 hPa Δ p ≤ 0.4 hPa Δ p ≤ 0.4 hPa Δ Δ 8 hPa p ≤...
- Page 32 12 Appendix Devices of the WM 090 TD type use the following open-source software: FreeRTOS.org The software of this device contains code which is subject to the GPL. You can see the GPL source code and the GPL on request. 12.1.2 Technical data for power supply unit SPECIFICATION POWER SUPPLY UNIT...
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Page 33: Marks And Symbols
12 Appendix 12.1.5 Safety distances RECOMMENDED SAFETY DISTANCES BETWEEN PORTABLE AND MOBILE HF TELECOMMUNICATION DEVICES (E.G. CELLPHONES) AND THE DEVICE Safety distance depending on transmission frequency in m Nominal capacity 150 kHz - 150 kHz - 80 MHz - 800 MHz - of HF device in W 80 MHz outside 80 MHz within... - Page 34 12 Appendix NO. SYMBOL DESCRIPTION Follow Instructions for Use Slot for the SD card USB connection (optional) On/off: indicates the On/off key DEVICE ID PLATE ON THE BOTTOM OF THE DEVICE Type designation of the device Degree of protection against solid foreign bodies. Device is protected IP21 against drips.
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Page 35: Scope Of Supply
12 Appendix 12.2.2 Markings on the device ID plate of the power supply unit SYMBOL DESCRIPTION INPUT Input voltage OUTPUT: Output voltage/direct voltage Only intended for indoor use. Degree of protection against electric shock: protection class II device Do not dispose of device in domestic waste. CE symbol (confirms that the product conforms to the applicable European directives) 12.2.3 Markings on the packaging of the device and accessories... -
Page 36: Accessories And Replacement Parts
12 Appendix 12.4 Accessories and replacement parts A current list of accessories and replacement parts can be ordered on the internet site of the manufacturer or through your authorized specialist dealer. 12.5 Warranty Löwenstein Medical gives the customer a limited manufacturer warranty on a new original Löwenstein Medical product and on any replacement part fitted by Löwenstein Medical in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of... - Page 40 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.de...
Need help?
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Questions and answers
how do I connect my prisma to a new mobile phone?
To connect the Löwenstein Medical SMART Prisma to a new mobile phone:
1. Make sure your therapy device is a Plus or Max variant, where Bluetooth is activated by default.
2. Press the menu button on the device.
3. Go to "Settings" using the right arrow button.
4. Navigate to the blue Bluetooth setting.
5. Use the plus and minus buttons to activate Bluetooth if it is not already on.
6. Ensure the Bluetooth symbol appears in the upper right corner of the display.
7. On your new mobile phone, open the Prisma app and pair it with the therapy device.
Bluetooth must be activated on both the device and your phone for pairing.
This answer is automatically generated
How to change the time
To change the time on the Lowenstein Medical SMART:
1. Enter the settings menu.
2. Use the plus (+) and minus (–) buttons to adjust the time.
3. Use the right arrow to switch between hours and minutes.
4. Press the forward key to confirm and move to the next setting.
5. To exit the settings menu, press the on/off button.
This answer is automatically generated
can i turn the airflow down
Yes, the Lowenstein Medical prisma SMART Auto CPAP offers the option of classic or dynamic pressure regulation for personalized respiratory therapy. This means the airflow can be adjusted based on the user's needs. Additionally, the pressure relief feature, softPAP, can be activated at any time.
This answer is automatically generated
What means err 826