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

p0001The invention relates to a method for allowing operator input on a medical device that can carry out programs with selectable program parameters, as well as a medical device with which such a method is feasible.

p0002Medical equipment, on which the inventive method can be carried out, in particular blood treatment device for extracorporeal blood treatment, and especially dialysis machines, as in <patcit id="pcit0001" dnum="EP0623357A1"><text>EP 0623357 A1</text></patcit> or <patcit id="pcit0002" dnum="DE19742633C2"><text>DE 197 42 633 C2</text></patcit> are described. 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 constructed as a touch screen. The input device allows user inputs for selecting treatment modes for setting operating parameters or acknowledging an alarm.

p0003In <patcit id="pcit0003" dnum="US20030212314A1"><text>US 2003/0212314 A1</text></patcit> is a medical device is described in which the presence of a person in front of the medical device is detected by a detector. The parameters of the medical device can be adjusted only when a person is in front of the device is present. In this way, unintended movements can by environmental influences to a large extent verhin be changed.

p0004In the field of device-assisted medical treatment, the patient specifically tailored treatment is carried out by the operator by selecting different treatment programs, treatment parameters or Alarmquittierungsfunktionen. The disadvantage of conventional operating units, such. As touchscreens is that relatively easily a change of programs or parameters can be caused by accidental contact. For example, it is not safe to exclude in the purification of the input device with a towel or cloth that an undesired contact occurs. In particular, operating errors by accidental contact are due to the small size of the control and display fields at Touchscreens be difficult to see, which in the case of important parameters can have serious consequences for the patients.

p0005The usual input fuses as password requests (<patcit id="pcit0004" dnum="DE2146074"><text>DE 2146074</text></patcit>), Recognition cards with magnetic stripes (<patcit id="pcit0005" dnum="WO8702160A"><text>WO 87/02160</text></patcit>) Or barcode scanning systems (<patcit id="pcit0006" dnum="US5384756A"><text>US 5,384,756</text></patcit>) Have serious disadvantages for the user or the treatment. The disadvantages of the password prompt, the large duration of the manual password entry, the restriction on number codes and the possibility of incorrect entries of the password under stressful situations. Magnetic detection cards are subject to mechanical wear of the magnetic stripe reading and the mechanical stress on the map by careless handling. Optical scanning systems for bar code readers have similar drawbacks as magnetic detection cards. In addition, they require a direct line of sight between transmitter and receiver.

p0006<patcit id="pcit0007" dnum="WO8702160A"><text>WO 87/02160</text></patcit> describes a computer containing medical records of patients. Here, an access system is provided with restricted access for staff of different groupings. This system with restricted access only refers to the retrieval of data from the electronic file.

p0007A process which substantially corresponds to the preamble of claim 1 is described in <patcit id="pcit0008" dnum="US20020038392A1"><text>US 2002/0038392 A1</text></patcit>, This method provides for the allocation of identification devices to the doctor and the patient. The Identifizierungsvorrichten are transponders that communicate wirelessly with a controller that controls a medical infusion device. There are different degrees of authorization, which authorizes the person carrying the device identification relating to the execution of different actions. To the contents of the operator transponder include a patient information and details about the IV medication and medication report components.

p0008In <patcit id="pcit0009" dnum="US20040039257A1"><text>US 2004/0039257 A1</text></patcit> described a computerized infusion system having user-specific additional authorization levels. A distinction is made between medical care personnel and technical service personnel, only the operator identification of the service staff allows you to change the machine configuration and service parameters.

p0009A device configuration that allows only qualified personnel to acknowledge alarms in a medical device, is described in <patcit id="pcit0010" dnum="WO9910029A"><text>WO 99/10029</text></patcit>,

p0010The invention is based on the object, a method for allowing operator input on a medical device that is capable of performing a medical treatment of a patient's body to predetermined programs with selectable program parameters to specify.

p0011The inventive method is indicated by the claim. 1

p0012The invention offers the advantage that the access control can be performed in a multi-level hierarchy system with the unique operator identification. The authorization to enter treatment parameters is effected in dependence on the operator identification of the respective operator. The classification of the operator identifications could be done in such a way that the nursing staff of a dialysis station has access authorization for therapy-relevant parameters, such as start or stop therapy and alarm acknowledgment. When the computer detects an identification of a person who belongs (service technician) to the service personnel, it is given in addition to the admission of the paramedical personnel permission, configuration and service parameters set. Thus, the invention allows different access permissions to different programs or functions and different permissions, to enable these programs or functions or to change.

p0013In various treatments, such as dialysis therapy protocols to be manually performed for each treatment. The invention makes it possible to create such a protocol automatically. The medical device created in its data storage a data structure that corresponds to the manually guided protocol. It stores all patient data, such as name, number, weight and the set therapy values, such as treatment time, ultrafiltrate purchase quantity, conductivity of the dialysis fluid. In addition to the data stored in the current operator identification is stored, which is transmitted at the time of data input from a reading unit. In this way, the log contains information about the identity of the operator who made the settings and monitors the treatment.

p0014The operator identification is contained in a transponder carried along by the operator which communicates contactlessly with a reader unit of the medical device. Such transponder solution has the advantage of easy handling and a low time required for identification. A transponder is a device that responds contactlessly to a query by the computer connected to the reader unit and in response to such a query provides a digital signal which identifies the person in question. Transponders do not require their own power supply generally. An example of a transponder, which ensures the compatibility of the components of a medical device, is in<patcit id="pcit0011" dnum="DE20113789"><text>DE 20113789</text></patcit> the applicant.

p0015By the use of transponders include respective memory, it is also possible to read the respective protocol by the reading unit, which is then designed as a read-write unit into the transponder. Thus it can be stored on the transponder of the operator at the end of treatment, the protocol to be later another computer system, which is also equipped with a read unit for the transponder supplied. Here is a further processing of data for documentation and quality assurance purposes. The same can also be achieved if the medical device to another computing system transfers via data communication protocol at the end of treatment or continuously while the treatment with the operator identification. The log can be printed out directly also on the medical device.

p0016The invention provides to assign a respective patient identification and the patient to provide each patient with a transponder, in which this ID is stored. The patient identification includes an indication that it is a patient (and not a server-person) is. Since the transponder is provided with a sufficiently large memory, the treatment protocol is read in a patient transponder, including the operator identification. In this way, the patient takes the logs of previous treatments in the transponder itself. In such a system there is also the possibility, already store to the transponder the treatment parameters for subsequent therapies. This treatment data are read immediately prior to the next treatment of the read unit of the medical device and transferred to the computer of the medical device. The operator must then enter their operator identification to start the treatment.

p0017In the following an embodiment of the invention is illustrated with reference to the drawings, these explanations are not to be construed as limiting the scope of the invention. This is rather determined by the claims.

Show it:

p0018<figref idrefs="f0001">Fig. 1</figref> , Each medical device having a schematic representation of a network to which a plurality of medical devices are connected to a read unit for the transponder, and

p0019<figref idrefs="f0001">FIG. 2</figref> a schematic illustration of data transmission between a transponder and the reading unit.

p0020<figref idrefs="f0001">Fig. 1</figref> shows a dialysis unit, which includes a data network 10, are connected to the various medical devices 11, in which this is to dialysis machines. Each medical device 11 includes a computer 12 with software and data storage as well as an input / output device 13, when this is a screen with touchscreen feature.

p0021With the computer 12, a write / read unit 14 is connected, capable of communicating contactlessly with transponders 15th The transponder 15 includes a radio tag, which communicates via radio waves with the write / read unit 14, and a data memory for storing received data. Communication between the reader and the radio tag is bidirectional.

p0022On the network 10 further includes a server 16 is connected with the screen 17th The server 16 contains an extensive data storage, to the computer 12 of all devices can access 11th The server 16 may in turn be connected to a higher-level network, such as the Internet or an intranet.

p0023In <figref idrefs="f0001">FIG. 2</figref> is depicted the interaction of the reading unit 14 and transponder 15th Both communicate via radio waves together. The transponder 15 includes a power source 20, a controller 21 and a memory 22 in which, inter alia, the operator identification is included ID of the owner of the transponder. The memory 22 can also be used to store logs.

p0024The write / read unit 14 includes an oscillator 25 for generating the carrier frequency for data transmission as well as interfaces 26 and 27 for communication with the computer 12th

p0025The read / write unit 14 detects a present in their vicinity transponder 15 and asks its stored identification ID. Then, 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 belongs to the nursing staff or the technical service personnel. In both cases, different access privileges to change or adjustment of programs and program parameters on the screen. 13

p0026There are also 15 Transponder for patients. In these, the identification ID contains an indication of the patients status of the owner. In the memory 22 other personal data of the owner may be stored as name, number, weight and. The like. In the memory can therapy values, such as treatment time, ultrafiltrate purchase quantity, conductivity, etc. are stored. At the end of treatment can be the protocol that the computer 12 made by the treatment can be stored back in the transponder 15 of the operator and / or the transponder 15 of the patient. In this way, it is possible to transfer the treatment protocol in a computer not connected to the data network 10th

p0027In the computer 12 the access authorization is based on the status information that is associated with an identification ID, set to adjust certain programs or program parameters. The status information indicates whether the person in question belongs to the nursing staff, the technical staff or any other group. The status information may be part of the identification ID. On the other hand there is also the possibility that it is determined from a list stored in the computer 12 or the server 16 based on the identification ID, which status is assigned to the person concerned. Here is also the possibility to check whether the person is authorized for the particular medical device. Here, a personal authorization is stored in the computer system.

p0028In Table 1 below is an example of various levels of access is shown, which are each associated with a status of a possible operator. The "Einstellfreigaben" specify those settings to which the assigned operator is authorized. If the device has determined the status of the operator, it automatically enables the corresponding Einstellfreigaben.<tables id="tabl0001" num="0001"><table frame="all"><title><b>Table 1</b></title><tgroup cols="3"><colspec colnum="1" colname="col1" colwidth="27mm" /><colspec colnum="2" colname="col2" colwidth="93mm" /><colspec colnum="3" colname="col3" colwidth="46mm" /><thead valign="top"><row><entry><b>access level</b></entry><entry><b>Einstellfreigaben</b></entry><entry><b>status</b></entry></row></thead><tbody><row><entry>0</entry><entry>show, only actual</entry><entry>patient</entry></row><row><entry>1</entry><entry>Control inputs and alarm acknowledgment</entry><entry>caregivers</entry></row><row><entry>2</entry><entry>Treatment limits, operator inputs and alarm acknowledgment</entry><entry>doctor</entry></row><row><entry>3</entry><entry>Machine configuration, service parameters, Treatment limits, operator inputs and alarm acknowledgment</entry><entry>technical service staff</entry></row></tbody></tgroup></table></tables>

p0029The term "machine configuration" includes information on additional equipment and additional capabilities of the machine, such. As single-needle facilities. "Service parameters" are calibration values ​​and machine-technical limits.