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Chapter

Maintenance

Technical safety controls

LM 2000 - 06.05.2021 - 09382-03

8. Maintenance

Technical safety controls

Daily testing

The operator must visually inspect the humidifier to

check for the following:

▪

Integrity of the housing

▪

Integrity of the display

▪

Integrity of the sockets

▪

Integrity of the heating plate and connection

button of the water chamber

▪

Legibility of the type plate

▪

Integrity of the mains cable

If the integrity is compromised, the device must not be

used. Contact the technical customer service of

Löwenstein Medical.

Annual testing

Before you carry out the necessary annual tests,

install the 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

Löwenstein Medical. Löwenstein Medical accepts no

responsibility for the proper functioning and safety of

the LM 2000 humidifier if the annual tests required by

the maintenance manual have not been carried out

by competent and authorised/certified personnel.

The LM 2000 must undergo the following planned

annual tests every twelve months to maintain its

performance and safety.

Visual inspections

▪

Integrity of the housing

▪

Integrity of the display

▪

Integrity of the sockets

▪

Integrity of the heating plate

▪

Integrity of the attachment symbol of the water

chamber

▪

Legibility of the type plate

▪

Integrity of the mains cable

▪

Integrity of the heating cable

Содержание 09382-03

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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