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Biegler RESPIFIT S Скачать руководство пользователя страница 26

RESPIFIT S

26

11 ELECTROMAGNETIC COMPLIANCE

11.1 Emissions

Test

Limits

Conducted emissions

CISPR 11, Group 1, Class B

Radiated emissions

CISPR 11, Group 1, Class B

Harmonic current
emissions
(IEC 61000-3-2)

IEC 61000-3-2, Class A

Voltage changes and
flicker
(IEC 61000-3-3)

IEC 61000-3-3, complies with requirements

11.2 Immunity test level

Test

Test level

Electrostatic discharge
(ESD)
(IEC 61000-4-2)

Contact discharge: ± 8 kV
Air discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV

HF radiated disturbances
(IEC 61000-4-3)

80

–2700 MHz; 1kHz AM 80%; 3 V/m

Proximity fields from HF
wireless communications
equipment
(IEC 61000-4-3)

385 MHz;
Pulse modulation: 18 Hz; 27 V/m

450 MHz,
Pulse modulation: 18 Hz: 1 kHz Sinus;
28 V/m

710, 745, 780 MHz;
Pulse modulation: 217 Hz; 9 V/m

810, 870, 930 MHz;
Pulse modulation: 18 Hz; 28 V/m

1720, 1845, 1970 MHz;
Pulse modulation: 217 Hz; 28 V/m

2450 MHz;
Pulse modulation: 217 Hz; 28 V/m;

5240, 5500, 5785 MHz;
Pulse modulation: 217 Hz; 9 V/m

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Содержание RESPIFIT S

Страница 1: ...Instructions for use Patients RESPIFIT S Inspiratory Muscle Training Device Edition 2021 05 18 40 246 03 Sales Manufacturer ENG ...

Страница 2: ... this device it is essential that the instructions for use including safety instructions and warnings are read and complied with prior to commissioning It is the user s responsibility to fully familiarise themselves with how to operate the device correctly Target group These instructions for use are aimed at patients who use the RESPIFIT S More information on the settings and functions is availabl...

Страница 3: ...RAINING 12 4 TRAINING WITH THE RESPIFIT S 13 4 1 THE STRENGTH EXERCISE 13 4 2 THE ENDURANCE EXERCISE 16 4 3 RESULTS DISPLAY 19 4 4 DECOMMISSIONING 19 5 CLEANING 20 6 MAINTENANCE 22 6 1 TROUBLESHOOTING 22 6 2 PERIODIC INSPECTIONS 22 7 RETURNING DEVICES OR ACCESSORIES 23 8 DISPOSAL 23 9 MANUFACTURER LIABILITY 24 10 WARRANTY CONDITIONS 24 11 ELECTROMAGNETIC COMPLIANCE 26 11 1 EMISSIONS 26 11 2 IMMUNI...

Страница 4: ...gth and endurance of the respiratory muscles Integrated functions can also determine the capacity of the inspiratory muscles i e the strength and endurance of this muscle group An essential component of the device is the graphical representation of the exercise sequence which shows the patient whether he she is actually complying with the required training intensity The patient s individual exerci...

Страница 5: ...is Kyphoscoliosis or diaphragm dysfunction Pre and post operatively in thoracic procedures Chronic heart failure 1 4 Contraindications Any acute disease Any acute change in condition also as part of a chronic underlying condition Any chronic underlying condition that is not sufficiently controlled with treatment e g arterial hypertension or diabetes 1 5 Scope of delivery Number Description Catalog...

Страница 6: ... disconnect from the mains power supply Only plug the power supply unit into sockets that are easily accessible so they can be disconnected quickly if necessary The power supply unit must not be brought into contact with any liquids It is prohibited to use the RESPIFIT S in extension cable connectors The power supply unit must not be covered while in operation and must not be operated in immediate...

Страница 7: ...ons to the RESPIFIT S RESPIFIT S and its accessories must not be sterilised with steam or by thermochemical methods and must not be immersed in liquid The handheld patient module may be immersed in liquid when being cleaned as described in Section 5 It is absolutely essential that the periodic technical safety inspections see Section 6 2 are carried out and that the relevant inspection date is doc...

Страница 8: ...or functions in a way other than described in the instructions for use stop using the device immediately and return it to the service centre 3 INITIAL OPERATION AND USE Consult the instructions for use Users must thoroughly familiarise themselves with the contents of these instructions before putting the system in operation RESPIFIT S may only be used under the direction of the treating physician ...

Страница 9: ...leaning instructions in Section 6 Important The maximum service life of the handheld patient module is three months The handheld patient module therefore has to be disposed of after no more than three months and a new patient module used To calculate the resistance RES three different aperture diameters are available to the treating physician therapist A B or C ...

Страница 10: ...he patient Thereafter the adjustment mechanism can no longer be released When purchasing a new handheld patient module please ensure that the treating physician therapist makes the patient specific adjustments once again and subsequently locks the adjustment mechanism Moreover for each aperture you can select strength exercise or endurance exercise by rotating Figure 3 Strength endurance exercise ...

Страница 11: ... handheld patient module 3 2 Datakey Before the patient starts therapy with the RESPIFIT S the patient specific settings must be determined under the direction of the treating physician therapist and stored on the datakey Figure 5 Insert the datakey into the back of the device Insert the datakey into the device at the position indicated If the device is plugged in without the datakey inserted DATA...

Страница 12: ... the mains power Connect the connection tube to the handheld patient module and the device with Luer connectors Figure 7 Connecting the handheld patient module to the device Figure 8 Patient module in use 3 4 Setting up before training Before training the treating physician therapist adjusts the device one single time to the needs of the patient As training advances the treating physician therapis...

Страница 13: ...les in particular the diaphragm are under maximum strain In the strength exercise the cross section of the air duct is reduced to such an extent that only a minimum volume of air can be aspirated Each inspiratory manoeuvre will start from a state of maximum exhalation residual volume During inhalation the dumbbell the icon for the strength exercise is raised in accordance with the negative pressur...

Страница 14: ...ds is stipulated The device is subsequently ready for the next individual exercise For the strength exercise the following parameters must be set in advance by the treating physician therapist Minimum strength value Number of strength exercises per exercise block Number of failed attempts per exercise block Pause time between the individual exercises Before starting the exercises the arrow on the ...

Страница 15: ...rent actual pressure attained is displayed The number of individual exercises is displayed next to the exercise icon This number goes down with each successfully completed individual exercise The number of failed attempts that are permitted for each exercise block is displayed next to the failed attempt icon This number goes down with each failed attempt After each individual exercise a separate s...

Страница 16: ...thing For the endurance exercise inhalation is carried out against a pre established resistance The cross section of the air duct is reduced by the set aperture A B or C Inhaling and exhaling through the handheld patient module at normal breathing rate tidal breathing frequency moves the balloon up and down on the screen The balloon moves up with each inhalation and drops back during exhalation Th...

Страница 17: ...dule must point towards the balloon icon as shown on the screen Figure 17 Endurance training screen display Figure 18 The arrow on the handheld patient module points towards the balloon Press the button to access the training screen for the endurance exercise The training screen for the endurance exercise is structured as follows Figure 19 Endurance exercise training screen The balloon rises and f...

Страница 18: ...ailed attempt After each individual exercise a separate screen indicates whether the exercise has been carried out correctly or not A smiling face is displayed if the exercise was successful and a sad face is displayed after a failed attempt An hourglass shows how long the patient should pause between two exercises Figure 20 Exercise successful Figure 21 Exercise failed The endurance training is c...

Страница 19: ... The results of the exercises performed are displayed along with any stops during the training session The settings made by the treating physician therapist are also shown in the display under INFO Figure 25 Display order of results The next display is opened by pressing the button 4 4 Decommissioning Unplug the power supply unit to shut down the device ...

Страница 20: ...es whether the handheld patient module is to be cleaned with or without subsequent disinfection The handheld patient module must be cleaned without the connecting tube since any moisture remaining in the tube can damage the pressure sensor in the device Cleaning The handheld patient module must be disassembled and completely immersed in warm water with a little washing up liquid added to it It sho...

Страница 21: ...openings face downwards or to the side while drying Turn the current aperture setting A B C on the handheld module to the position to ensure that any liquid will run out through the opening Disassemble and reassemble as depicted in this diagram Figure 26 Connecting the handheld patient module Ensure that the membrane on the valve seat of the Y piece is handled with the utmost care during cleaning ...

Страница 22: ...o the service centre 6 1 Troubleshooting Errors Possible cause Solution Display is blank No power supply Insert the mains plug If the error persists send the device for servicing DATAKEY Datakey is not inserted or datakey is inserted incorrectly or datakey is defective Insert datakey If the error persists the datakey may be incorrectly inserted or faulty If the datakey is faulty request a new one ...

Страница 23: ...unction is discovered during the periodic inspection suitable warning signs should be attached to the device to ensure that it is not used before the required service and repair work has been carried out It must be returned for repair to the manufacturer or service centres expressly authorised by the manufacturer 7 RETURNING DEVICES OR ACCESSORIES Devices or accessories must be carefully cleaned b...

Страница 24: ...annot be accepted The warranty period is 24 months The manufacturer guarantees that all material and manufacturing defects which arise within 24 months of the date of purchase will be repaired free of charge Claims are only accepted under the following terms The manufacturer and or supplier is informed immediately of the fault for which the warranty claim is being made The instructions of the manu...

Страница 25: ...he manufacturer or supplier If the manufacturer is required to meet a warranty claim in accordance with these terms the customer shall bear the costs and risks of transport of the device from and to the place of use The manufacturer and or supplier shall under no circumstances assume liability for slight negligence Compensation for lost earnings and profits is likewise excluded ...

Страница 26: ...rostatic discharge ESD IEC 61000 4 2 Contact discharge 8 kV Air discharge 2 kV 4 kV 8 kV 15 kV HF radiated disturbances IEC 61000 4 3 80 2700 MHz 1kHz AM 80 3 V m Proximity fields from HF wireless communications equipment IEC 61000 4 3 385 MHz Pulse modulation 18 Hz 27 V m 450 MHz Pulse modulation 18 Hz 1 kHz Sinus 28 V m 710 745 780 MHz Pulse modulation 217 Hz 9 V m 810 870 930 MHz Pulse modulati...

Страница 27: ...iations IEC 61000 4 11 0 UT for 0 5 cycles at 8 phase angles 0 UT for 1 cycles at 0 70 UT for 25 30 cycles at 0 0 UT for 250 300 cycles at 0 12 SYMBOLS Certifies compliance with the Directive 93 42 EEC Medical device Serial number Consult instructions for use Follow the instructions for use Manufacturer Manufacturing date ESC button for exiting the relevant menu Button for confirming a selection B...

Страница 28: ...atedly by a single patient refer to cleaning instructions Batch number Catalogue number 13 OPERATING AND STORAGE CONDITIONS The RESPIFIT S is intended for use in the following facilities Medical establishments incl on site examination rooms general practices and therapy rooms Home use Permissible environmental conditions for the device and accessories Transport and storage Operation Temperature 25...

Страница 29: ...ype Does not apply to the power supply unit IP21 Protected from touch by fingers and from vertically dripping water Device weight 240 g Handheld module weight 61 g Classification IIa according to Rule 9 Device dimensions W x D x H 141 x 81 x 65 mm Dimensions of handheld module W x D x H 60 x 140 x 162 mm Pressure measurement Measuring range 180 mbar Resolution 1 mbar Precision 4 RESPIFIT S product...

Страница 30: ...el 43 1 979 21 05 Tel 43 1 577 35 60 Fax 43 1 979 21 05 16 Fax 43 1 577 35 60 33 office biegler com office eumedics at www biegler com www eumedics at 16 MANUFACTURER S DECLARATION The inspiratory muscle training device RESPIFIT S is a medical device as defined by Directive 93 42 EEC This is documented through the CE mark Notified Body TÜV SÜD Product Service GmbH Approval number ...

Страница 31: ...RESPIFIT S 31 NOTES ...

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