Hoffrichter TREND II User Manual

Respiratory therapy device

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Quality makes the Difference

User´s Manual

CPAP - AUTO - BILEVEL - BILEVEL ST20

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Page 1 Quality makes the Difference User´s Manual CPAP - AUTO - BILEVEL - BILEVEL ST20...
Page 2 SERIAL NUMBER HOFFRICHTER GmbH delivers all its systems with a serial number in order to ensure traceability. The serial number is indicated on the type label on the bottom of the system. Please always specify the serial number in inquiries and complaints.
Page 3: Table Of Contents
General Remarks ..........14 TREND II CPAP ..........16 TREND II AUTO ..........17 TREND II BILEVEL ........... 19 TREND II BILEVEL ST20 ........20 Notes Prior to First Use ........22 Views ..............24 Front View ............24 Back View ............25 Scope of Delivery ..........
Page 4 Cleaning .............. 33 Cleaning the Mask ..........33 Cleaning of the Therapy Tube ......33 Cleaning the Device .......... 34 Cleaning the Head Gear ........34 Alarm Functions of the Device ......35 Power Failure ............ 35 Mask Alarm ............36 Pressure Alarm ..........
Page 5: Legend Of Symbols
LEGEND OF SYMBOLS Observe the accompanying documenta- tion Applied part type BF Electric safety class II (with protective insulation) CE Declaration of Conformity Manufacturer Observe the User´s Manual Do not dispose of the device with nor mal domestic waste. For information on the proper disposal of the device, please con- tact your responsible customer service.
Page 6: Safety Instructions
HOFFRICHTER GmbH is not liable for any damage and consequential damage nor for any effects on the safety, reliability and performance of the device, if: •...
Page 7 In order to prevent potential hazards, please fol- low the instructions below: • Exclusively use the device for your own therapy, which must have been prescribed by a physician. • Use accessories only which have been recom- mended and offered by your specialized dealer. •...
Page 8 • Mobile use of the device is permitted only in a parked vehicle. • Immediately see your physician if, while using the device, you develop one or more of the following symptoms: dryness of the mucous membranes in nose and throat, frontal sinus complaints, ear- ache, a running nose, hypersensitivity of the skin, oversensitiveness, loss of voice, disturbances of orientation or memory.
Page 9 To maintain electrical safety, please observe the following instructions: • Do not put the device into operation if its housing and/or cables are damaged. • Do not open the housing. Notify your specialized dealer of any disturbances and failures. • Protect the device from water and moisture.
Page 10: Power Supply
POWER SUPPLY TREND II has an internal switched mode power supply unit with a wide range input of 100 - 240 V~, 50 - 60 Hz. This allows connection to all energy supply networks in the world. It is also possible to operate the de vice with a direct voltage of 24 V DC, e.g.
Page 11: Standby Mode
The standby mode is indicated by the illuminated display showing date and time. Power consumption in this mode is approx. 5 W. In the standby mode, the device TREND II may remain continuously switched on without posing any risk. Standby Mode...
Page 12: Intended Use
INTENDED USE The TREND II is intended for treating breathing disfunc- tion especially for nighttime sleep apnea in patients with a weight of 30 kg and higher. The device generates a continuous positive airway pressure in order to keep the upper respiratory tract unobstructed.
Page 13: Contraindications
CONTRAINDICATIONS Respiratory therapy may be contraindicated in patients with the following preexisting diseases: • Bullous lung diseases • Pneumothorax • Very low blood pressure • Air accumulation after open craniocerebral trauma or other head injuries In case of an inﬂ ammation of the paranasal sinuses or the middle ear, it might be indicated to stop the ther- apy.
Page 14: Technical Description
TECHNICAL DESCRIPTION GENERAL REMARKS For all devices of the TREND II series the following characteristics apply. Air inlet To generate the necessary pressure, the device is pro- vided with an electronically controlled blower. In order to keep the stress for the patient as low as possible, the...
Page 15 AquaTREND uni a clip-on humidiﬁ er is available as accessory for all TREND II devices. If necessary, just click the humidiﬁ er onto the device. Remove it by pressing its release button.
Page 16: Trend Ii Cpap
TREND II CPAP The CPAP device is a therapy device for treating obstruc- tive sleep apnea. For this purpose the device provides a continuous positive air pressure. Apart from the con- ventional CPAP-mode the device offers a proportional increase in pressure in the FLEXLINE mode to the indi- vidual breath ﬂ...
Page 17: Trend Ii Auto
TREND II AUTO Within a certain pressure range the device automati- cally controls the therapy pressure depending on the occurrence of respiratory events. In sleep phases with no events the therapy pressure is lowered. Starting obstruc- tive events are treated effectively with a slight pressure increase.
Page 18 The combined analysis of all results facilitates a very precise differentiation between obstructive and cen- tral events. The device adjusts the therapy pressure according to the detected events as described below: • Increase of pressure for obstructive events • Decrease of pressure for central events and normal respiration In addition, the pressure increase can be adjusted in 5 levels according to special requirements and to...
Page 19: Trend Ii Bilevel
TREND II BILEVEL The device has two different adjustable pressure lev- els. A higher level for inspiration and a lower level for expiration. Trigger device The respiration trigger detects the patients efforts to breath in and out and signals these efforts to the con- trol device.
Page 20: Trend Ii Bilevel St20
TREND II BILEVEL ST20 The device has two different adjustable pressure lev- els. A higher level for inspiration and a lower level for expiration. Trigger device The respiration trigger detects the patients efforts to breath in and out and signals these efforts to the con- trol device.
Page 21 ST-mode Spontaneous breathing and Time – as long as the patient is breathing independently the device is oper- ating in the S-mode. Once the patient stops breathing the device automatically switches into the T-mode and provides respiration for the patient in the prescribed safety frequency.
Page 22: Notes Prior To First Use
NOTES PRIOR TO FIRST USE Never turn the device on if you kept it in a very cold environment. Wait for approx. 1 hour until its tempera- ture compensation is completed. Regularly check the air ﬁ lter cassette and regularly exchange it as described on page 32.
Page 23 Please strictly observe the following setup instructions: • Do not place the device in the vicinity of a heat- ing source. Air circulation – particularly that below and behind the device – must not be impaired by furniture, curtains or cushions. •...
Page 24: Views
VIEWS FRONT VIEW Program keys Filter cassette Display Heater LED Info key Heater key Release button for acces- sories Measuring tube connection Air outlet 10 Contact socket for humidiﬁ er 11 ON/OFF key Views...
Page 25: Back View
BACK VIEW 12 DC Input 24 V DC 13 RS232 interface 14 Power connection 230 V AC Views...
Page 26: Scope Of Delivery
SCOPE OF DELIVERY Therapy device User’s manual Power cord Therapy tube (1.80 m) incl. measuring tube Stoppers Carrier bag Replacement ﬁ lter cas- sette without frame cover Scope of Delivery...
Page 27: Optional Accessories
Art. - No.: TREND II CPAP ........0000 2061 TREND II AUTO ........0000 2062 TREND II BILEVEL ........0000 2063 TREND II BILEVEL ST 20 ......0000 2064 User´s manual ..........5000 0201 Power cord ..........3110 0015 Therapy tube, measuring tube and stoppers ...........0000 7116 Carrier bag ..........0000 2437...
Page 28: Use Of The Device
USE OF THE DEVICE After having set up the device properly, connect the device using the supplied power cord, with the socket outlet. 2. The device displays a welcoming message, the software version and the current number of treat- ment hours. Thereafter, the display shows the date and time.
Page 29 Place the tube such that it does not exert any pull- ing action on the mask while you are lying down. 8. Breathe deeply and calmly only through your nose. If you have activated the soft start function, the device initially reduces the pressure after comple- tion of the mask test and will then slowly increase the pressure automatically to the prescribed value, allowing you to fall asleep at a lower pressure.
Page 30: Use Of Oxygen
USE OF OXYGEN If you also have to inhale oxygen during your therapy, Mask please be absolutely sure to follow the instructions from the manufacturer or the dealer delivering the oxy- gen to you. If you supply the oxygen directly into the mask, please use a non-kinking tube that consists of a medically approved material.
Page 31 ATTENTION! If you are using oxygen together with the device, the oxygen supply must always be deactivated as long as the device is in the standby mode or while it is turned off. • Always turn on the device ﬁ rst and only then the oxygen supply.
Page 32: Filter Change
To set back the message proceed as described in the chapter “Patient-Menu” on page 46. NOTE: Never operate the device without ﬁ lter cassette. Only and exclusively use original HOFFRICHTER ﬁ lter cassettes. Otherwise, the warranty for the respiratory therapy device will become extinct. Filter Change...
Page 33: Cleaning
CLEANING CLEANING THE MASK For reasons of hygiene the mask must be cleaned on a daily basis: 1. Separate the mask from the therapy tube. 2. Use mild soap water (don´t use other additives) for cleaning, thoroughly rinse with clear water and let the mask dry in air, protected for direct sunlight.
Page 34: Cleaning The Device
NOTE: If water should stay in the measuring tube it could adulterate the pressure measuring or delay the control. Both could affect an optimal therapy. CLEANING THE DEVICE For reasons of hygiene the device must be cleaned on a weekly basis: 1.
Page 35: Alarm Functions Of The Device
ALARM FUNCTIONS OF THE DEVICE POWER FAILURE If a power failure at night would go unnoticed as a result the patient would breathe used air from the ther- apy tube all night. To avoid this the device is equipped with an alarm mechanism that warns you if power or a fuse fail at night.
Page 36: Mask Alarm
MASK ALARM This alarm function is activated only if the auto- 0' (.) MMMMMM<;0 matic function is turned to “OFF” or “Start”. If the $!' 0'H mask has slipped off your face or if the tube is pulled off the device, the device is not turned off automatically, but emits a visual and audible alarm..
Page 37: Wake Alarm
WAKE ALARM The device is provided with a comfortable integrated alarm clock. Using the program keys, you can activate and deactivate this alarm clock at any time. The alarm clock emits an alarm at the programmed wake time. Press the ON/OFF key once to stop the alarm for the next 5 minutes (can be set with the help of the PC soft- ware) and twice to deactivate it completely.
Page 38: Functions Of The Device
FUNCTIONS OF THE DEVICE You can program the functions of the device with the following three keys:  = program key  = program key  = enter key lar symbol  preceding the line indicates that this line The display has two lines. Using the  and  keys, you can select the line to be displayed.
Page 39: Info-Menu
The device has three different menus: 1. Info-Menu In this menu the set parameters can be displayed. 2. Patient-Menu In this menu the patient can change settings. 3. Clinic-Menu In this menu, only a physician or service techni- cians can change settings. Use the ...
Page 40 TREND II CPAP TREND II AUTO TREND II BILEVEL TREND II BILEVEL ST20 Therapy Therapy Therapy Therapy Filter Filter Filter Filter Ramp Ramp Ramp Ramp P-Ramp P-Ramp P-Ramp P-Ramp Mode Mode Mode Mode Pressure Pressure Pressure Pressure FLEX-Level FLEX-Level I-Pressure...
Page 41 Therapy Q$!.,5 MMMMMMMM<=>$ Shows the total therapy time of the device 4%/ !*1 Filter Q %(/!. MMMMMMMMMM<=>$ Shows the time since the last ﬁ lter change 4%/ !*1 Ramp Q), MMMMMMMMMMMM@;)%* Shows the remaining time of the soft start ramp 4%/ !*1 P-Ramp Q ), MMMMMM? @$...
Page 42 P-Min (only in mode APAP) Q * MMMMMMMM@ ;$ Shows the selected minimum pressure 4%/ !*1 P-Max (only in mode APAP) Q 4 MMMMMM<; ;$ Shows the selected maximum pressure 4%/ !*1 I-Pressure (only in modes S, T and ST) Q .!00 MM<;...
Page 43 E-Trigger (only in modes S and ST) .%##!. MMMMMMMMMM= Shows the selected expiration trigger threshold 4%/ !*1 Frequency (only in modes T and ST) Q .!-1!*5MM<=,) Shows the selected number of breaths per minute 4%/ !*1 Inspiration (only in modes T and ST) Q *0,%./%+*MM>>N Shows the ratio of inspiration time proportionate 4%/ !*1...
Page 44: Patient-Menu
Press and hold the enter key (at least 1 second) to move to the programming mode. The Patient-Menu will now appear on the display. TREND II CPAP TREND II AUTO TREND II BILEVEL TREND II BILEVEL ST20 Wake Time Wake Time Wake Time Wake Time Delete Filter...
Page 45 Wake Time In this menu item you can set and change the wake Q'! % )! MM;BL;; time. 4%/ !*1 After pressing the  key again the hour of the wake time will start ﬂ ashing. Now you can change it by using the ...
Page 46 Delete Filter In this menu item the ﬁ lter counter can be reset. Q !(!/! %(/!. This function should be used at every ﬁ lter change 4%/ !*1 so that always a current value is displayed. To reset the ﬁ lter counter, go to the Patient-Menu (press the ...
Page 47 Mask Q0' MMMMMMMMMMMMMM+0! (only in modus CPAP and APAP in TREND II AUTO) 4%/ !*1 In this menu item the type of mask can be cho- sen. This is important for the correct function of the therapy device It can be chosen between Nose and Nose/Mouth.
Page 48 Ramp Q), MMMMMMMMMMMM@;)%* Whenever the blower has been started, the micro- 4%/ !*1 controller of the device checks whether a soft start ramp has been programmed. While the programmed time elapses, the soft start function increases the pressure from an adjustable initial ramp pressure (P-Ramp) up to the pressure prescribed, thus allow- ing you to fall asleep more easily.
Page 49 TREND II CPAP, TREND II AUTO I-Pressure E-Pressure TREND II BILVEL, TREND II BILEVEL ST20 Functions of the Device...
Page 50 If the FLEXLINE mode is switched on, the pres- sure is raised by 1 hPa at FLEX-Level 1, 2 hPa at FLEX -Level and 3 hPa at FLEX-Level 3 (TREND II CPAP and TREND II AUTO). If the APAP mode is switched on, the pressure is raised to the max.
Page 51 Mask Test TREND II CPAP, TREND II AUTO Mask Test I-Pressure E-Pressure TREND II BILVEL, TREND II BILEVEL ST20 Functions of the Device...
Page 52 Automatic The automatic mode provides three settings (OFF, Start/Stop, Start). 1. Auto OFF (with mask alarm) 0' (.) MMMMMM<;0 If you set “Auto OFF” the device must be turned $!' 0'H on in the evening and off in the morning with the ON/OFF key.
Page 53 NOTES: The automatic function can be deactivated in the TREND II BILEVEL ST20 with the PC soft- ware from the medical staff. The device can be switched on or off in every mode by pressing the ON/OFF key. Brightness Q .%#$/*!00MM<;;N...
Page 54 Date Q /! MMMM=@ 5 ;D Use this menu item to set the date. 4%/ !*1 To do so go to the Patient-Menu (hold down the  key for approx. 1 second). Then select by using Date the keys  and . After using the  key the year will ﬂ...
Page 55 Time Q%)! MMMMMMMMMMMM<>L;; Use this menu item to set the time. 4%/ !*1 To do so go to the Patient-Menu (hold down the  key for approx. 1 second). Then select by using Time the keys  and . After pressing the  key the hour will ﬂ...
Page 56: Clinic-Menu
CLINIC-MENU In addition to the parameters in the Clinic-Menu, in the Clinic-Menu parameters relevant for the therapy can be set. This menu is used only by health and service professionals. In the Clinic-Menu the following patient and device rel- evant data can be shown and changed. Enter the PIN code for parameters, which are marked with a * shown on page 57 for prevention of wrong param- eter settings.
Page 57 TREND II CPAP TREND II AUTO TREND II BILEVEL TREND II BILEVEL ST20 * Mode * Mode * Mode * Mode * Pressure * Pressure * Pressure * Pressure * FLEX-Level * FLEX-Level * I-Pressure * I-Pressure * P-Start * E-Pressure * E-Pressure Ramp ...
Page 58 The device will then save the new mode. CPAP FLEX AUTO BILEVEL BILEVEL BILEVEL • • TREND II CPAP • • • TREND II AUTO • • TREND II BILEVEL • • • • TREND II BILEVEL ST20 Functions of the Device...
Page 59 Pressure (only in modes CPAP and FLEX) Q.!00 MMMMMMB @$ For changing the pressure go to the Clinic-Menu (hold 4%/ !*1 down the  key for approx. 1 second). Then select by using the keys  and . Press the Pressure ...
Page 60 For changing the FLEX-Level go to the Clinic-Menu (hold down the  key for approx. 1 second). Then select by using the keys  and . FLEX-Level Press the  key. Now the device will prompt you to enter the PIN. The ﬁ rst digit is ﬂ ashing. Enter the ﬁ...
Page 61 P-Min (only in mode APAP) Q * MMMMMMMM@ ;$ Press the  key. By using the keys  and  you 4%/ !*1 can now set the minimum pressure. Conﬁ rm with the  key. Next the parameter P-Max is set. P-Max (only in mode APAP) Q 4 MMMMMM<;...
Page 62 will ﬂ ash. Enter the second digit of the PIN with the help of the  and  keys, and proceed as described for the ﬁ rst digit. Enter the third digit accordingly. After entering the last digit of the PIN you can set the pressure by using the keys ...
Page 63 E-Slope (only in modes S, T and ST) (+,! MMMMMMMMMMMM>0 Time of pressure decrease from I-Pressure to 4%/ !*1 E-Pressure (pressure decrease rate) Press the  key. Now select the desired time by using the keys  and . Press  to conﬁ rm. I-Pressure E-Pressure 0.3s...
Page 64 I-Trigger (only in modes S, T and ST) Q .%##!. MMMMMMMMMM= The I-Trigger determines the trigger sensitivity for 4%/ !*1 detecting inspiration. It can be set to three levels. 10 ml 15 ml 25 ml Go to the Clinic-Menu to set the I-Trig- ger.
Page 65 Frequency (only in modes T and ST) Q .!-1!*5MM<=,) The frequency determines the breathes per minute. 4%/ !*1 Activate the Clinic-Menu to set the frequency. Then select by using the keys  and . Frequency Now the device will prompt you to enter the PIN. After entering the PIN set the desired frequency by using the keys ...
Page 66 Delay Time (only in mode ST) Q !(5 %)! MMMMMM>0 The delay time is the time after which the device 4%/ !*1 switches from S-mode into T-mode in the event of breath failure. Activate the Clinic-Menu to set the delay time. Then select by using the Delay Time keys ...
Page 67 P-Unit Q *%/MMMMMMMMMM). The device can show the pressure in the pressure 4%/ !*1 units hectopascal (hPa), millibar (mbar), and centi- meters of water (cmH O) . For changing the pressure unit go to the Clinic- Menu (hold down the  key for approx. 1 second). Then select by using the keys ...
Page 68 Turbine This menu item shows the total operating time of the turbine, the ﬁ lter, and the therapy time. Q1.%*! MMMMMMMM<=>$ Turbine 4%/ !*1 The counter indicates the total turbine running time. Filter Q %(/!. MMMMMMMMMM<=>$ The counter indicates the operating hours of the 4%/ !*1 ﬁ...
Page 69: Troubleshooting
TROUBLESHOOTING Problem Possible cause Remedy Pain in nose, paranasal Inﬂ ammation of the para- Stop therapy and contact sinuses or ears nasal sinuses or the middle your physician Unpleasent feeling of too Unwellness with prescribed If you think there is a high pressure high pressure values mistake, consult a physi-...
Page 70 Problem Possible cause Remedy Cold nose Room temperature too low Increase the room tempera- ture, run the tube under the blanket Running nose, urge to Reaction to the air ﬂ ow Increase the air humidity in sneeze the room or set the humidi- ﬁ...
Page 71 Problem Possible cause Remedy Very low air ﬂ ow Soft start function active Reduce soft start time Air ducts clogged Check the air inlet Blower constantly at maxi- Measuring tube not con- Check the measuring tube mum speed nected or clogged Device leaky Return the device to the service to have it checked...
Page 72: Display Messages
DISPLAY MESSAGES The sections below describe the most important dis- play messages. All further messages will be clear from their context. You have 45 sec left for seating the mask properly. Once C ;$ this time has elapsed, the device starts with the soft 0' !0/MMMMMMMM?@0 start function or the therapy.
Page 73 You have pressed the ON/OFF key and stopped the @ ;$ slumber phase. '! (.) You pressed the  key in the normal operating mode. .!00 E There will be a message that the alarm clock has been (.) (+' turned off.
Page 74 There has been an error during the system start after !)+.5 !"!/ switching on the voltage supply. Contact your dealer. The Clinic-Menu has been activated. (% *% !*1 /%2! The Patient-Menu has been activated. /%!*/ !*1 /%2! Change ﬁ lter. @ ;$ $*#! %(/!.
Page 75: Service
SERVICE Although all parts of the device have a very long service life, the device should be checked from time to time. We urgently recommend a technical service through our authorized customer service, since only they have the necessary tools and measuring instruments. In between service intervals you yourself can contribute to increasing the service life and to maintaining proper and reliable functioning.
Page 76: Preparing The Device Fora Different Patient
PREPARING THE DEVICE FOR A DIFFERENT PATIENT If the patient using the device changes, the device must be hygienically prepared by a specialized dealer or by the manufacturer. The necessary procedure is described in detail in the appropriate hygiene plan. Service...
Page 77: Disposal
DISPOSAL DEVICE For information on the proper disposal of the device, please contact your responsible customer service. PACKAGING You can return the packaging to your marketing part- ner or dispose it separately with your normal domes- tic waste. Disposal...
Page 78: Technical Data
TECHNICAL DATA Dimensions (W x D x H) 215 x 195 x 105 mm Mass approx. 2.3 kg Power supply 100 V ~ … 240 V ~, 50 ... 60 Hz, 24 V DC / 2.1 A Pressure range 4…20 hPa (mbar) 30 hPa (CPAP-APAP) Max.
Page 79 Air delivery volume > 170 l/min at 4 hPa therapy pressure > 160 l/min at 8 hPa therapy pressure > 150 l/min at 12 hPa therapy pressure > 130 l/min at 16 hPa therapy pressure > 120 l/min at 20 hPa therapy pressure Operating temperature + 5 °C ...
Page 80 HOFFRICHTER GmbH Mettenheimer Straße 12 / 14 19061 Schwerin Germany Phone: +49 385 39925 - 0 Fax: +49 385 39925 - 25 E-Mail: info@hoffrichter.de www.hoffrichter.de TREND II-eng-1009-04...

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Hoffrichter TREND II User Manual

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