HOFFRICHTER DATA box

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1 HOFFRICHTER DATA box Operating Instructions

2 Serial Number Each HOFFRICHTER device is provided with a serial number which guarantees the product can be traced back. The serial number is on the type identification plate to be found on the reverse of the device. In case of any query or complaint, please always state the serial number. Conformity The device complies with the requirements of the directives 93/42/EWG. 2 DATA box

3 Contents Contents Legend of Symbols Safety instructions Intended Use Description of the Device Function of the Device Cleaning and Disinfection Technical Data DATA box 3

4 Legend of Symbols Legend of Symbols: Please observe the Documents Please observe the Operating Instructions Manufacturer CE-declaration of conformity Do not dispose of the device with normal domestic waste. For information on the proper disposal of the device, please contact your responsible customer service. SD-Card slot 4 DATA box

5 Safety Instructions Before first use of your DATA box, please read this manual thoroughly. Keep the manual in a safe place, so that you will be able to consult it whenever necessary. For the period stipulated by law, HOFF- RICHTER GmbH warrants that the product is free from any defects provided it is used as intended. Attention! HOFFRICHTER GmbH shall not be held liable for any damages or consequential damages, consequences for safety, reliability and performance of the device in case of: Tampering, modifying, adding expansion features, adjustment, repair and maintenance executed by persons who have not been authorized by HOFFRICHTER. Building in accessory and spare parts which have been fabricated by other manufactures and not been released by HOFFRICHTER for use in the DATA box. DATA box 5

6 Safety Instructions Always have the Operating Instruction ready at hand. It is part of DATA box and a requirement for intended use. The manufacturer shall consider himself responsible for the safety, reliability and operability of the system only if: the device is used in accordance with the Operating Instructions. installation, repair, maintenance and modification work is only carried out by persons authorized to do so. the regulations for quality assurance and traceability are adhered to. The housing of the device does not provide any protection against ingress of water. Never try to open the housing of DATA box. Never expose the device to rain, moisture or humidity. Malfunctions, damage and electric shocks can occure as a result. Never place the DATA box in the vicinity of other equipment or devices, such as defibrillators, diathermy equipment, mobile phones, microwave equipment, remote controlled toys, etc. 6 DATA box

7 Safety Instructions If temperatures fall below 5 C or rise above + 40 C, proper functioning of DATA box may be impaired. The system must not be exposed to direct solar radiation. Do not use the device if there is visible damage to it. Accidents, fires and electric shocks can occure as a result. DATA box 7

8 Intended Use The DATA box is an accessory device which can be used in connection with the respiratory therapy series TREND II, VECTOR et, CARAT et and point. It contains a removable memory card and serves to summarise and store the independent transfer of device and therapy data. Exchange of data between patient and medical personnel The memory card can be sent to the sleep laboratory or doctor in charge by the patient, independent of the therapy device. After successful data assessment by medical personnel, the e.g. modified therapy parameters can be copied on the memory card with the help of the DATA box and finally send to the patient again. This data can be sent directly via the DATA box and transferred again to the therapy device. 8 DATA box

9 Intended Use Summary and storage of additional data If the DATA box is connected to the respiratory therapy device, summary and storage of the additional data is possible in the device by default. Oxygen saturation of the patient can be recorded and stored by a connection with a pulse oxymeter. This enables the medical personnel to analyse the success of the therapy. DATA box 9

10 Discription of the Device 2 3 Port: CPAP Port: PC Port: SpO2 5 1 RJ 11 plug socket for the connection to the therapy device (Port: CPAP) 2 LED (green - red) 3 USB plug socket Type B for the connection with a PC (Port: PC) 4 4 SD-Card slot 5 Optional SubD 9-plug socket for a Pulse Oxymeter 10 DATA box

11 Function of the Device Connect the DATA box with the therapy device. Use the accompanying interface cable for this. The device automatically starts the communication with the therapy device as soon as the devices are connected and an SD card is inserted into the card slot. First, check the device and see whether the file with new therapy or patient data is located on the SD card. If this is the case, the new settings will be transferred onto the therapy device. The memory content of the therapy device will subsequently be stored on the SD card. The LED flashes green in order to display the storage process. The LED illuminates green constantly after completion of the storage. If you do not want to use the device for storing further therapy data during therapy, separate it from the therapy device. When using DATA box to record further therapy data and perhaps oxymetry data, the DATA box must be connected by the interface cable which is connected to the therapy device during the complete therapy. The LED is illuminated green during therapy and a short, periodic blinking of the LED signals storage processes onto the SD card. After completion of therapy, the therapy memory on the device is read and stored. The process can take several minutes depending on the size of the memory. The following table displays the recorded data. DATA box 11

12 Function of the Device Device VECTOR et CPAP CARAT et CPAP TREND II CPAP VECTOR et Auto CARAT et Auto TREND II Auto VECTOR et Bilevel /ST20 CARAT et Bilevel /ST20 TREND II Bilevel/ST20 point 12 Mode (adjusted) CPAP FLEXLINE CPAP/Auto FLEXLINE all Modes CPAP Central Apnea Obstructive Apnea Mixed Apnea Hypopnea Airway Constriction Snoring Mode Adjustment Leakage Hyperventilation Mouth Exhalation Basic Pressure Pressure Breathing Flow Average System Flow Rel. Respiratory Volume Oxygen Pulse DATA box allways available only available, if DATA box is connected available, if DATA box is used together with Oxygen-Kit

13 Function of the Device Do not separate the DATA box during therapy and storage of data (displayed by blinking green LED) from the therapy device. Display of the LED The LED signals the following operational conditions: Illuminated green device is operational Blinking green data exchange between devices Blinking red Illuminated red Illuminated orange An error has occurred (see chart from page 14) DATA box 13

14 Function of the Device Problem Possible Cause Remedy LED illuminates orange SD card not recognised Repeat process several times if necessary. Wait 5 seconds after inserting the SD card. If no change occurs: exchange DATA box LED blinks red first and then illuminates red Data storage error has occurred Error in communication with the therapeutic device has occurred Use another SD card Check the cable connections 14 DATA box

15 Function of the Device Problem Possible Cause Remedy LED blinks red Error in data program storage Replace DATA box detected An unsupported therapy device has been connected Incorrectly formatted SD card recognised Therapy device has no serial number. A clear allocation of the data is not guaranteed Connect only the therapy devices mentioned on page 8 Format SD card with TRENDset Have a serial number programmed by service technician DATA box 15

16 Function of the Device SD card Only use SD cards with a storage capacity of at least 128 MB and at most 2 GB. A new SD card must be formatted by the TRENDset software before it can be used. SD cards which are not supported by the DATA box will be distinguished by a blinking red LED. The card holder is a Push-Push-holder and therefore the card is ejected again little by little by putting pressure on the card slot in the direction of the card. When inserting the card, a click signals the maximum slot position. False insertion of the card is prevented by the design and customised intake. Optional pulse oxymeter The optional installation of a pulse oxymeter for recording and storage of oxygen saturation and pulse enables a further analysis of therapeutic devices by the attending medical personnel. 16 DATA box

17 Cleaning and Disinfection Safety instructions: - Do not use any volatile substances, such as solvents, to aviod damaging of the surface. Clean the device only using a soft, dry cloth. - Do not immerse the device in water or solvent - Make sure that no water or other fluids can penetrate into the device trough opening or venting slots. This could lead to short circuits, damage, electric shocks and fires. Device surface Use a cloth moistened with soap water to clean the external surfaces of the device. Then wipe the device with clear water to remove residual cleaning agent. The devices surfaces should be disinfected at regular intervals and in case of suspected contamination. We recomend SAGROTAN Med for disinfecting the external surfaces of the device. Disinfectants which are recognized according to the RKI Guideline can also be used. Before being put into operation, the device should be completely dry. DATA box 17

18 Techncal Data Specifications and Performance Dimensions: 115 x 84 x 25 mm Weight: 110 g Operating conditions Operating temperature: + 5 C to + 40 C Relative air humidity: 10 % to 95 % Storage conditions - 40 C to + 70 C (Store in a dry, vibration free position; store device and accessories in their original packaging) Data subject to technical modification 18 DATA box

19 Notes DATA box 19

20 Manufacturer: HOFFRICHTER GmbH Mettenheimer Straße 12/ Schwerin Tel.: Fax: Mail: URL: DATAbox-eng

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