Method and device combination for validating user input on a medical apparatus

The invention relates to a method for allowing operator input to a medical device that programs with selectable can perform program parameters, as well as a medical device, with such a process is executable.

Medical equipment, on which the inventive method is executable, in particular blood treatment device for extracorporeal blood treatment, and in particular dialysis devices, as described in EP 0 623 357 A1 or DE 197 42 633 C2 describes. Such devices have a computer screen and an input device with Buttons, switches, buttons or a keypad. The Input device may also be integrated in the screen when This is designed as a touch screen. allows the input device User inputs for selecting treatment modes for adjusting operating parameters or acknowledging an alarm.

In US 2003/0212314 A1 a medical device is described in which the presence of a person in front of the medical device by a Detector is detected. Let the parameters of the medical device only be adjusted when a person before the device is present. On this way, unintended movements caused by environmental factors can be prevented to a large extent.

In the field of device-assisted medical treatment is the Operator by selecting different Treatment programs, treatment parameters or Alarmquittierungsfunktionen one on the patient specially tuned performed treatment. The disadvantage of conventional operating devices, such. B. Touchscreens is that relatively accidental touches easily causes a change of programs or parameters can. For example, it is in the purification of the input device with unsure exclude a towel or cloth that unwanted contact occurs. In particular, because of the small Size of the control and display fields with touchscreen operator errors by accidental contact difficult to see what the case important parameter serious consequences for the treated can have patients.

The usual input fuses as password requests (DE 2146074) Identification cards with magnetic stripes (WO 87/02160) or Barcode scanning (US 5,384,756) have serious disadvantages for the user or treatment. The disadvantages of the password prompt are the large duration of the manual password entry, the restriction under on number codes and the possibility of incorrect entries of the password Stressful situations. Magnetic detection cards are subject to mechanical wear of the magnetic stripe while reading and mechanical stress on the map by careless handling. Optical scanning systems for bar code readers have similar drawbacks magnetic detection cards. In addition, they call for a direct Visual contact between transmitter and receiver.

WO 87/02160 describes a computer, the medical records of Patients contains. This is a system with limited access provided access for staff of different groupings. This System with restricted access only refers to the retrieval Data from the electronic file.

The invention is based on the object, a method for permission from Operator inputs to a medical device that is adapted to receive a medical treatment of the body of a patient according to predetermined conduct programs with selectable program parameters, indicate that allows people of different qualifications each be entrusted with certain tasks operator.

The inventive method is defined by claim. 1 These require that an operator identification into the medical device controlling computer is entered and that in Dependence different from the operator identification Access permissions for selecting programs and / or Modifying program parameters and / or for the input of Alarm acknowledgments are issued.

The invention offers the advantage that the access control with the unique operator identification in a multilevel hierarchy system can take place. The authorization to enter treatment parameters takes place in dependence on the operator identification of the respective Operator. The classification of the operator identifications could be in the way done that the nursing staff of the dialysis unit Access authorization for therapy-relevant parameters as therapy start or stop and alarm acknowledgment. Once the computer a Notes identify a person who belongs to the service staff (Service technician), it is given in addition to the admission of paramedical personnel the authorization, configuration and set service parameters. Thus, the invention allows different Access permissions to different programs or Functions and different permissions, these programs or to activate functions or to change.

In various treatments, such as dialysis, are for each treatment manually guided therapy protocols. The invention makes it possible to create such a protocol automatically. The medical device creates in its data storage a data structure the manually guided protocol corresponds. It stores all Patient data, such as name, number, weight and the set Therapy values, such as treatment time, ultrafiltrate order quantity, Conductivity of the dialysis fluid. In addition to the stored Data is stored the current operator identification that the The time of data input is transmitted from a reader unit. On Thus, the log contains information about the identity of the Operator who made the settings and the Treatment has monitored.

As media for the operator identification are customary Media such as magnetic cards, bar code media or smart card. It is also possible, the operator identification as a password or ID number provide that the operator manually in an input device is inputted. Preferably, the operator identification is in one of contain the operator carried transponder without contact with a reading unit of the medical device communicates. Such Transponder solution has the advantage of easy handling and a small time required for identification. A transponder is a device, the non-contact to a query by the computer connected reader responds and in response to such a query a digital signal, which identifies the person in question. Transponders do not require their own power supply generally. On Example of a transponder which a component compatibility Medical device ensures in DE 20113789 of the applicant described.

When using transponders include respective memory, is also the possibility, the respective protocol by the reading unit, which is then designed as a read-write unit into the transponder read. Thus, at the end of treatment, the protocol on the Transponder operator are saved to a later another computer system, also with a read unit for the Transponder is equipped to be supplied. Here is another Processing of data for documentation and Quality assurance purposes. The same can also be achieved when the medical device by means of data communication to another Computing system the protocol at the end of treatment or continuously during the treatment along with the operator identification transfers. The protocol can also on the medical device directly be printed.

There is also the possibility of the patient in each case a assign patient identification and each patient with a equip transponder in which this ID is stored. The Patient identification includes an indication that it is to a patient (and not a server-person) is. If the Transponder is provided with a sufficiently large memory, is the possibility of the treatment protocol in a patient transponder read, including the operator identification. In this manner, the patient's protocols prior treatments in the transponder themselves. In such a system it is also possible, on the Transponder already the treatment parameters for subsequent save therapies. This treatment data is immediately before of the next following treatment by the read unit of the medical read device and in the computer of the medical device adopted. The operator still has to be their Enter operator identification to start the treatment.

Hereinafter, a reference to the drawings Embodiment of the invention explained in more detail, these Explanations are not to be understood that they the restrict the scope of the invention. This is rather by the Claims determined.

Show it:

Fig. 1 is a schematic representation of a network to which several medical devices are connected, wherein each medical device having a reading unit for transponders and

Fig. 2 is a schematic representation of the data transmission between a transponder and the reading unit.

Fig. 1 shows a dialysis unit, which includes a data network 10 to the numerous medical devices 11 are connected, which are Here is dialysis machines. Each contains 11 medical device a computer 12 with software and data storage as well as a Input / output device 13, which is here with a screen Touchscreen function is.

With the computer 12, a write / read unit 14 is connected, the can communicate without contact with transponders 15th The transponder 15 containing a radio tag, which the radio waves with Write / read unit 14 communicates, and a data memory for Storing received data. Communication between Reading unit and radio tag is bidirectional.

On the network 10 also has a server 16 with screen 17 connected. The server 16 contains an extensive data storage, to the computer 12 of all devices can access 11th Of the Server 16 may in turn connected to a higher-level network be, for example, the Internet or an intranet.

In FIG. 2, the interaction of the reading unit 14 and transponder 15 shown. Both communicate via radio waves together. Of the Transponder 15 includes a power source 20, a controller 21 and a memory 22 in which inter alia the user identification ID of is the owner of the transponder. The memory 22 may also be used to store logs.

The write / read unit 14 includes an oscillator 25 for generating the Carrier frequency for data transmission and interfaces 26 and 27 for the communication with the computer 12th

The read / write unit 14 detects a located in their vicinity Transponder 15 and asks its stored identification ID. thereupon the transponder transmits the identification ID to the reader unit. The Identification ID includes an indication of the person in question, namely, whether the person nursing staff or the technical service personnel belongs. In both cases, different Access privileges to change or set up programs and program parameters on the screen. 13

There are also 15 Transponder for patients. These includes the Identification ID, an indication about the patient status of the owner. In the memory 22 can further personal data of the owner be stored as name, number, weight and. the like. In the memory can therapy values, such as treatment time, ultrafiltrate order quantity, Conductivity, etc. stored. At the end of the treatment can the protocol of the computer has 12 made of the treatment, in the transponder 15 of the operator and / or the transponder 15 the patient are stored back. In this manner, the Possibility the treatment protocol in a not to the data network 10 to transfer the attached computer.

In the computer 12 is based on the status information, the identification ID is associated with the admission of certain terminating Programs or program parameters set. The status indication stating whether the person nursing staff, the technical Service personnel or belongs to another group. The status indication may be part of the identification ID. On the other hand, it is also Possibility that a reference in the computer 12 or the server 16 stored list based on the identification ID is determined which is associated with the persons concerned. Here is also the possibility to check whether the person in question for the medical Device is approved. Here is a personal authorization in Computer system stores.

In Table 1 below is an example of various Access levels shown, each of a status of a possible associated operator. The "Einstellfreigaben" give those Settings to which the associated user is authorized. If the device has determined the status of the operator allows automatically the corresponding Einstellfreigaben.<tables><table><tgroup cols="3"><tbody><row><entry align="left"><b>access level</b></entry><entry align="left"><b>Einstellfreigaben</b></entry><entry align="left"><b>status</b></entry></row><row><entry align="left">0</entry><entry align="left">show, only actual</entry><entry align="left">patient</entry></row><row><entry align="left">1</entry><entry align="left">Control inputs and alarm acknowledgment</entry><entry align="left">caregivers</entry></row><row><entry align="left">2</entry><entry align="left">Treatment limits, operator inputs and alarm acknowledgment</entry><entry align="left">doctor</entry></row><row><entry align="left">3</entry><entry align="left">Machine configuration, service parameters, Treatment limits, operator inputs and alarm acknowledgment</entry><entry align="left">technical service staff</entry></row></tbody></tgroup></table></tables>

The term "machine configuration" includes information on Additional equipment and additional capabilities of the machine, such. B. Single-needle facilities. "Service parameters" are calibration values ​​and mechanical engineering limits.