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Lowenstein Medical 09382-03, User Manual

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Lowenstein Medical 09382-03 User Manual Download Page 21

Chapter 

3 

Device overview 

Identification and labelling 

 

 

LM 2000 - 06.05.2021 - 09382-03 

21 

Table 6: Icons/labels 

 

Class II device 

 

Protection class of the device housing (against the ingress of foreign 

bodies from a size of 2.5 mm and against the vertical falling of water 

droplets) 

 

The device complies with Directive 93/42/EC “Medical devices”. 
The device meets the requirements of EU Directive 93/42/EEC/Appendix II. 

Monitoring is carried out by TÜV Rheinland LGA Products GmbH, 

Nuremberg. 

 

F 1.6AL, 250V 

Fuse 

 

Plug for heating cable 

 

Plug for temperature sensor cable 

  Alternating current 

  The type plate contains, among other things, the serial number, mains 

connection and fuse data. 

Identification and labelling 

 

 

 

 

 

IP31

Summary of Contents for 09382-03

Page 1: ...Respiratory humidifier User manual Rev 09382 03 06 05 2021...

Page 2: ...n Medical SE Co KG Subject to change 06 05 2021 L wenstein Medical SE Co KG Arzbacher Stra e 80 56130 Bad Ems Germany 49 2603 9600 0 49 2603 9600 50 loewensteinmedical com User manual LM 2000 Order no...

Page 3: ...in this manual are intended for the basic understanding and may differ from the actual design Customer service Please contact our customer service with the following contact details Contact type Cont...

Page 4: ...ity and guarantee 16 3 Device overview 17 Scope of delivery 17 Device description 17 Level sensor 18 Icons 19 Identification and labelling 21 4 Configuration Service 22 Cable 22 Neonate configuration...

Page 5: ...sation 50 Cleaning and disinfecting the humidifier 50 Cleaning and disinfecting the heating cable and power cable 51 Cleaning and sterilising the heating cable and power cable 52 Cleaning and disinfec...

Page 6: ...cables of the heated ventilation tube Heating plate LM 2000 element for supplying the water chamber with thermal energy Mains cable Cable connecting the humidifier with a power source Stand by The de...

Page 7: ...instruction manual To indicate instructions for action result descriptions lists references and other items the following symbols and highlighting are used in this instruction manual 1 Indicates step...

Page 8: ...e reduce the formation of condensate Check several times daily that no condensation forms inside the ventilation system The formation of condensate can cause an increased in flow resistance influence...

Page 9: ...with high electromagnetic fields The operation of high frequency short wave or microwave surgical equipment in the vicinity of the humidifier may affect its operation In this case the humidifier near...

Page 10: ...bles Make sure that the power source characteristics are compatible with the label of the humidifier Pay attention to the positioning of the cables and ventilation tubes If they are placed around the...

Page 11: ...d the humidifier must be switched off When air oxygen mixtures are introduced into the heated tubes and humidification chamber installed in combination with the LM 2000 the concentration of the mixtur...

Page 12: ...emissions Interference emissions test Conformity Guidelines on the electromagnetic environment High frequency interference emission test CISPR11 Group 1 The LM 2000 system uses high frequency energy o...

Page 13: ...or mains No signal lines available The quality of the supply voltage should correspond to that of a typical business or hospital environment Surges in accordance with IEC 61000 4 5 1 kV push pull volt...

Page 14: ...tective distance in metres m At all frequencies the field strength of stationary radio transmitters should be lower than the compliance level in accordance with an on site examination Interference is...

Page 15: ...nications equipment Table 5 Protective distance depending on the transmitter frequency Rated power of the transmitter W Protective distance depending on the transmitter frequency m 150 kHz 80 MHz 80 M...

Page 16: ...uately addressed during training Laypersons should be instructed to contact the technical customer service in the event of any changes in humidifier performance Password The responsible and authorised...

Page 17: ...d in both invasive and non invasive ventilation thanks to the possibility of regulating the temperature of the inhaled gases The LM 2000 humidifier automatically controls the temperature and humidity...

Page 18: ...ber is between 1 C and 4 C The graphic representations of the humidifier are indicative and only serve to facilitate its possible installation The choice of ventilation system is the sole responsibili...

Page 19: ...not approved by L wenstein Medical may affect performance or safety for example the humidifier may not immediately signal that the maximum safety level of water in the water chamber is exceeded Clini...

Page 20: ...urer Do not use hooks This side up Batch code Product code Serial number Sensitive to moisture Sensitive toheat Temperature limits Fragile The device must be disposed of in accordance with EU Directiv...

Page 21: ...alling of water droplets The device complies with Directive 93 42 EC Medical devices The device meets the requirements of EU Directive 93 42 EEC Appendix II Monitoring is carried out by T V Rheinland...

Page 22: ...asuring the temperature at the outlet of the water chamber 3 Sensor to detect the temperature near the patient Single heating cable 1 Plug for connection to the humidifier red 2 Plug for connection to...

Page 23: ...esented by block V the humidifier by block U and the patient by block P 1 Water chamber 2 Temperature sensor cable 3 Temperature sensor at the outlet of the water chamber 4 Sensor to detect the temper...

Page 24: ...bes The dotted arrows indicate the direction of gas flow with the ventilator represented by block V 1 Water chamber 2 Temperature sensor cable 3 Temperature sensor at the outlet of the water chamber 4...

Page 25: ...Position the water chamber on the heating plate and exert light pressure to ensure its correct seat If seated correctly it will engage with an audible click For inhalation only use USP grade sterile w...

Page 26: ...and the dual heating cable if the expiration tube is also heated 5 Connect the plug like the sensor cable to the socket of the humidifier until you hear a click and align the guide arrows on the cabl...

Page 27: ...simultaneously disconnect all poles of the device s circuits from the mains 6 Operation The Neonate configuration differs graphically from the Adult configuration by the breathing circuit displayed o...

Page 28: ...een LED on the device will flash The temperature measured by the temperature sensor near the patient is displayed in white on the operating screen below the patient connection socket To access the tem...

Page 29: ...by increasing the set value with the button and decreasing it with the button The control temperature at the outlet of the water chamber can be set between 29 and 37 C while the control temperature ne...

Page 30: ...cedure Ensure that the temperature sensor near the patient is located outside the incubator Change the control temperatures lowering the temperature at the chamber outlet and or increasing the tempera...

Page 31: ...after entering the password Password 1234 If you enter an incorrect password an error message is displayed Pressing the Delete button allows you to delete the entered numbers and re enter the password...

Page 32: ...s Activation time of the screen saver In the Settings menu you can also enable the display setting of the current temperature measured by the sensor at the outlet of the water chamber Chamber temperat...

Page 33: ...atient Tap the screen to exit the screen saver and return to the operating screen The screen saver is automatically disabled when an alarm state is triggered N Alarm screen The LM 2000 has an alarm sy...

Page 34: ...emains unchanged if the alarm state persists In some alarm states the corresponding audible alarm signals cannot be interrupted Alarms p 43 In the event of a second level alarm the LED on the device f...

Page 35: ...for humidifier in a configuration with heated inspiration tube only If the humidifier is set to heat both tubes an alarm screen will indicate a disconnected heating cable of the expiration tube Pressi...

Page 36: ...by pressing the START button for about half a second The LED on the device lights up continuously in blue when humidification is paused A Temperature control screen Patient hazard Inadequate oxygen s...

Page 37: ...cified in the technical data Technical data p 56 Press the button you want to select for about half a second Then confirm by pressing the OK button for about half a second Press the Cancel button to r...

Page 38: ...reen Press the reset button to reset the temperatures to the default setting The predefined temperatures at the outlet of the chamber and near the patient are 37 and 39 C respectively The activation o...

Page 39: ...fter entering the password Password 1234 If you enter an incorrect password an error message is displayed Pressing the Delete button allows you to delete the entered numbers and re enter the password...

Page 40: ...saver In the Settings menu you can also enable the display setting of the current temperature measured by the sensor at the outlet of the water chamber Chamber temperature button and enable or disabl...

Page 41: ...urn to the operating screen The screen saver is automatically disabled when an alarm state is triggered A Alarm screen The LM 2000 has an alarm system that can indicate a potential or actual danger an...

Page 42: ...alarm state persists In some alarm states the corresponding audible alarm signals cannot be interrupted Alarms p 43 In the event of a second level alarm the LED on the device flashes yellow while in...

Page 43: ...cond level alarms Text colour Alarm level Audible signal Red First level Continuous Yellow Second level Interrupted When an alarm state is triggered the alarm buttons are displayed at the top of the o...

Page 44: ...hamber Interrupt ventilation and replace the chamber Possible hardware error Contact the technical customer service E0003 Yes 10 seconds Patient s inspiratory temperature too high The temperature at t...

Page 45: ...The heating plate temperature has exceed 95 C Check for correct insertion of the water chamber E0012 Yes 5 seconds Humidifier overheated The internal temperature of the LM 2000 has exceeded 70 C Wait...

Page 46: ...oes not detect the connection of the temperature sensors Check for correct installation of the temperature sensor cable Possibly defective temperature sensor cable E0007 Yes 10 seconds Temperature sen...

Page 47: ...tory temperature at the patient Alarm The temperature at the patient is low compared to the desired value Check that the gas flow is within permissible operating limits Check for correct installation...

Page 48: ...le 10 Testing the functionality of the alarm system Test sequence Alarm codes shown on the display State triggering the alarm Alarm system delay Steps to clear the alarm Start humidifier without inser...

Page 49: ...ventilation system Start up p 25 The annual tests may only be carried out by competent and authorised certified personnel in accordance with the maintenance manual of L wenstein Medical L wenstein Med...

Page 50: ...wenstein Medical has approved the following methods for cleaning disinfection or sterilisation These methods do not impair the integrity and function of the humidifier and accessories The validation o...

Page 51: ...disinfectant manufacturer s instructions to ensure effective disinfection Notes on avoiding damage to or malfunction of the device Do not use alcohol solvents or scouring agents These substances coul...

Page 52: ...midifier and the supplied cables must be regularly disinfected immediately after use by one patient and before use by another patient in accordance with medical instructions Follow the disinfectant ma...

Page 53: ...rse the temperature sensors in microfiltered sterile water and remove visible contaminated residues with a small brush Ensure that the electrical connector plug is not immersed in the water 2 Dry the...

Page 54: ...7117 Disposable water chamber with automatic filling 0217117 1 Water chamber with automatic filling including non return valve Leonie p180v2c Heated dual circuit for Children with water chamber with a...

Page 55: ...Dual heating cable for LM 2000 0217140 AC power cable with angled IEC socket and safety plug 0217141 AC power cable with angled IEC socket and BS 1363 plug 0217142 AC power cable with angled IEC sock...

Page 56: ...m operating pressure Follow the user manual for the water chamber and the ventilation tubes Heating time 20 minutes Ensure that the power source characteristics are compatible with the label of the hu...

Page 57: ...e 10 years The applied parts heating cable temperature sensor cable and power cable must be checked regularly in accordance with the service manual Should the applied parts prove no longer suitable du...

Page 58: ...ubject to change As at 06 05 2021 L wenstein Medical SE Co KG Arzbacher Stra e 80 56130 Bad Ems Germany 49 2603 9600 0 49 2603 9600 50 loewensteinmedical com User manual LM 2000 Order no gba10450en201...

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