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The ISO 80369-series replace Luer-connectors in five application areas to fight misconnections. Although the standard avoids the mechanical problem of misconnections, the design of products and packages remains arbitrary. So, packages and products with same functions but different connectors could have similar designs and hence could be mixed-up. To ascertain whether standardization is needed for marking non-distinguishable products and packages, a risk management and usability engineering process were carried out, partly. The ensuing risk analysis created nine unacceptable risks relating to non-distinguishable packages and lookalike-products. Based on this, risk control (standardization) is needed for lookalikes with the following proposed measures: colour allocation and haptic textures for products, colour allocation and symbols for packages. Furthermore, three scenarios were planned for summative evaluation. An additional consideration of the efficiency of proposed combinations of measures and products relying on measures would be helpful.

Der gesamte Produktlebenszyklus eines Medizinprodukts von der Entwicklungsinitiierung bis zur Abkundigung vom Markt wird wegen der spezifischen regulatorischen Anforderungen in verschiedene Phasen strukturiert und muss sehr weitgehend dokumentiert werden. Auserdem ist die Zulassung von Medizinprodukten weltweit nicht einheitlich geregelt. Innerhalb der EU erfordert das Inverkehrbringen – hierunter wird die entgeltliche oder unentgeltliche Abgabe von Medizinprodukten an andere verstanden (§ 3 Nr. 11 MPG) – ein CE‐Zeichen, das der Hersteller nach erfolgreichem Abschluss eines Konformitatsbewertungverfahrens anbringen muss. Damit erklart er die Konformitat seines Produktes mit den einschlagigen Gesetzen und Vorschriften, eine explizite Zulassung durch eine Behorde findet nach europaischen Recht nicht statt. Medizinprodukte werden klassifiziert, um entsprechend der Risiken spezielle Anforderungen festlegen zu konnen. Diese Klassifizierung erfolgt nach Anhang IX der Richtlinie 93/42/EWG [3]. Gemas seiner Zweckbestimmung wird ein Medizinprodukt nach 18 Klassifizierungsregeln mit steigendem Risiko einer der vier Risikoklassen I, IIa, IIb oder III zugeordnet. Von dieser Zuordnung hangen auch die Wege ab, die fur das Konformitatsbewertungsverfahren gewahlt werden konnen. Medizinprodukte werden bei der Klassifizierung (vereinfacht) nach folgenden Kriterien bewertet

For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system.

Wir berichten von einem Fruhgeborenen [Gestationsalter 24 5/7 Schwangerschaftswochen (SSW)], das am 11. Lebenstag eine schwere Sepsis mit Escherichia-coli-Pneumonie entwickelte. 9 Wochen nach Diagnosestellung wurden Verkalkungen des Lungenparenchyms rechts festgestellt. Nach intermittierender antibiotischer Therapie fur insgesamt 98 Tage, 47 Tagen invasiver Beatmung und 65 Tagen CPAP-Atemunterstutzung (CPAP: „continuous positive airway pressure“) wurde die Patientin mit zusatzlichem Sauerstoffbedarf entlassen.

Mono- and multi-segmental testing methods are required to identify segmental motion patterns and evaluate the biomechanical behaviour of the spine. This study aimed to evaluate a new testing system for multisegmental specimens using a robot combined with an optical motion analysis system. After validation of the robotic system for accuracy, two groups of calf specimens (six monosegmental vs. six multisegmental) were mounted and the functional unit L3-4 was observed. Using rigid body markers, range of motion (ROM), elastic zone (EZ) and neutral zone (NZ), as well as stiffness properties of each functional spine unit (FSU) was acquired by an optical motion capture system. Finite helical axes (FHA) were calculated to analyse segmental movements. Both groups were tested in flexion and extension. A pure torque of 7.5 Nm was applied. Statistical analyses were performed using the Mann-Whitney U-test. Repeatability of robot positioning was -0.001±0.018 mm and -0.025±0.023° for translations and rotations, respectively. The accuracy of the optical system for the proposed set-up was 0.001±0.034 mm for translations and 0.075±0.12° for rotations. No significant differences in mean values and standard deviations of ROM for L3-4 compared to literature data were found. A robot-based facility for testing multisegmental spine units combined with a motion analysis system was proposed and the reliability and reproducibility of all system components were evaluated and validated. The proposed set-up delivered ROM results for mono- and multi-segmental testing that agreed with those reported in the literature. Representing the FHA via piercing points determined from ROM was the first attempt showing a relationship between ROM and FHA, which could facilitate the interpretation of spine motion patterns in the future.

Controversies exist about the management of esophageal perforation in order to eliminate the septic focus. The aim of this study was to assess the etiology, management, and outcome of esophageal perforation over a 12-year period, in order to characterize optimal treatment options in this severe disease. Between May 1996 and May 2008, 44 patients (30 men, 14 women; median age 67 years) with esophageal perforation were treated in our department. Etiology, diagnostic procedures, time interval between clinical presentation and treatment, therapeutic management, and outcome were analyzed retro- or prospectively for each patient. Iatrogenic injury was the most frequent cause of esophageal perforation (n= 28), followed by spontaneous (n= 9) and traumatic (n= 4) esophageal rupture (in three patients, the reasons were not determinable). Eight patients (18%) underwent conservative treatment with cessation of oral intake, antibiotics, and parenteral nutrition. Twelve (27%) patients received an endoscopic stent implantation. Surgical therapy was performed in 24 (55%) patients with suturing of the lesion in nine patients, esophagectomy with delayed reconstruction in 14 patients, and resection of the distal esophagus and gastrectomy in one patient. In case of iatrogenic perforation, conservative or interventional therapy was performed each in 50% of the patients; 89% of the patients with a Boerhaave syndrome underwent surgery. The hospital mortality rate was 6.8% (3 of 44 patients): one patient with an iatrogenic perforation after conservative treatment, and two patients after surgery (one with Boerhaave syndrome, one with iatrogenic rupture). No death occurred in the 25 patients with a diagnostic interval less than 24 hours, whereas the mortality rate in the group (n= 16 patients) with a diagnostic interval of more than 24 hours was 19% (P= 0.053). In three patients, the diagnostic interval was not determinable retrospectively. An individualized therapy depending on etiology, diagnostic delay, and septic status leads to a low mortality of esophageal perforation.

Of 99 patients with acute pancreatitis 31 had to be operated upon. Surgical intervention was indicated if, in the presence of pancreatic necrosis demonstrated by computed tomography, clinical evidence of sepsis developed. The operation was performed on average ten days after the onset of symptoms. Evidence of bacterial contamination of the pancreatic necrosis was obtained in 26 patients. The operation consisted of left pancreatic resection with formation of a left compartment. Four of the 31 operated patients died (12.9%).

In a retrospective analysis the risks were assessed of transthoracic oesophagectomy with mediastinectomy and regional lymphadenectomy followed 48-72 hours later by an abdomino-cervical operation with supra-pancreatic lymphadenectomy, retrosternal gastric interposition and cervical oesophageal stump anastomosis. Results in this group of 37 patients were compared with those in a group of 42 patients who had undergone a transmediastinal oesophagectomy (without thoracotomy) and immediate reconstruction. The 30-day death rate was 8.1% in the former (group I) and 7.1% in the latter (group II), total hospital death rate 10.8% and 11.9%, respectively. The complication rate was similar in the two groups, as was the recorded operative stress. The results indicate that the risk of an oncologically indicated oesophagectomy with regional lymphadenectomy is no greater than that of a palliative transmediastinal oesophagectomy.

From July 1st 1982 to December 31st 1986, 359 patients with a histologically confirmed gastric carcinoma were operated on. At the beginning of therapy, 44.3% were in the pathological anatomical stages I and II, 55.7% in stages III and IV (UICC 1987). 307 patients could be resected (resection rate 85.5%). The proportion of R0 resections (no residual tumor) was 61.9%, R1 resections (microscopically demonstrable tumor residues) 23.1% and R2 resections (macroscopical tumor residues) 15%. Overall, a curative resection could be carried out in 61.9% of the cases and a palliative resection in 38.1% of the cases. In 21.5%, a subtotal gastric resection, in 48.2% a total gastrectomy and in 30.3% an extended total gastrectomy was necessary in addition. The lethality was 3.0% for subtotal resection, 5.4% for the simple total gastrectomy and 9.6% for the extended total gastrectomy. The prognosis corresponds to the tumor stage at the beginning of therapy (three year actuarial survival: stage I 76%, stage II and III 26%, stage IV 7%).

Accidentally swallowed dentures can lead to severe complications in the gastrointestinal tract. Therefore, early detection and effective therapeutic management are important. We report on two cases of accidentally swallowed dentures with exceptional clinical courses. In the first case, the patient initially did not notice the swallowed denture for several days. After diagnosis of the impacted foreign body, endoscopy revealed that an interventional removal was not feasible, and thus surgical removal was performed. In the second case, endoscopic retrieval of the ingested denture was also impossible, however, unsuccessful endoscopic extraction induced a large esophageal perforation, leading to an urgent esophagectomy. After a complicated course on the intensive care unit, a reconstruction with a colon interposition was carried out. The two cases highlight the importance of early detection and effective management in cases of swallowed dentures. A controlled surgical removal should be considered early as a safe procedure compared to endoscopic extraction.

Typical findings of disseminated intravascular coagulation were found in patients following kidney allotransplantation where quantitative determinations revealed fibrin degradation products in the urine. Split-product E, which was quantitatively determined in urine samples, contributes to this fibrinuria. Elevated levels of fibrinogen split products in serum as well as in urine are detectable several days prior to clinical signs of rejections and serve as an early indicator of impending rejection in patients with renal allografts.

The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the systematic exchange of much safety-relevant information. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk management in health-care facilities without risk policy is dangerously incomplete.

For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system.

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.

Being a wireless communication system, the UHF-RFID may cause electromagnetic malfunctions on sensitive medical devices, the reason why most hospitals refuse its integration. That makes a Risk Management procedure inevitable to identify the potentially hazardous incidents in critical medical care equipments, estimate and evaluate the risks, control them and monitor effectiveness of the controls. In this paper, an international Risk Management standard procedure (ISO-14971) was applied to 24 medical devices. Various measurements were conducted to examine the interference properties of different optional UHF-RFID modulation schemes, electromagnetic fields strengths and transmission powers. Measurements methods are consistent with the IEC60601-1-2 and ANSI-C63.18-EMI-Test Standards. Moreover they recognize the reasons for malfunctions and suggest solutions to overcome them.

The rolling and shear textures of aluminium (f.c.c.) and Fe-16% Cr (b.c.c.) have been compared. First a 90° rotation relationship about the transverse direction was found experimentally between the stable orientations of the rolling textures and the shear textures. This was explained with the symmetry of the glide systems and the orientation relationship between both coordinate systems. Second for both kinds of deformation namely rolling and shear a 90° rotation relationship about the transverse direction was also found between the stable b.c.c. and f.c.c. orientations. This was explained with the Taylor theory and the Sachs model making use of the orientation relationship between f.c.c. and b.c.c. glide systems.

From 1982 to 1992 103 patients with ovarian cancer stage FIGO III have been treated. In 38% of the patients there was no residual tumour postoperatively, in 40.8% the residual tumour was smaller than 2 cm. In 51.5% bowel resections were necessary, a stoma was unavoidable in just one case. A lymphadenectomy (pelvic, paraaortic or combined) was done in 46.6% of the patients. Postoperatively, 54.4% of the patients received a platinum-based chemotherapy, in the other patients other kinds of chemotherapy were applied. A radiation of the whole abdomen was done only in 3.9%. A median survival time for more than 60 months could be achieved in tumour-free patients due to the increased radical operations in combination with the platinum based chemotherapy. The lymphadenectomy seems to prolong the survival time of the patients. The positive nodal status is definitely unfavourable for the prognosis. By this therapeutic approach, an increased survival time with a good life quality can be achieved.

A testing system was developed with the aim of evaluating in vitro kinematics of multisegmental spine specimens. This includes a robot (KUKA-KR125) and an optical tracking system (NDI, Optotrak-Certus) measuring the three-dimensional kinematics of each vertebral body simultaneously. The robot has the option of saving kinematic and force/torque (F/T) data for repeating a prerecorded motion path. It can apply unconstrained physiologic movement. In a first evaluation study the robots’ F/T control unit was conducted using a linear rod with a second F/T load cell in-line. Kinematic accuracy of the tracked optical data and the calculation software was determined. The study was complemented by testing six four-segmental lumbar calf specimens (L2-6). Three cycles of pure unconstrained moments (7.25±0.05Nm) were applied to each specimen in flexion-extension. Robot data and optical system records were synchronized using a self-developed software algorithm. For each spinal segment load-displacement data were analyzed for range of motion (ROM), neutral zone (NZ) and elastic zone (EZ). In addition the finite helical axes (FHA) for spinal segment motions were calculated. For each level ROM was compared to literature values from monosegmental studies matching with 102±17.6% for L2-3 to 101±15.7% for L5-6 of used reference. Segmental stiffness ranged from 0.3±0.14 to 0.7±0.14Nm/° for NZ and from 2.7±0.55 to 4.9±1.79Nm/° for EZ. Position and orientation of the inter-segmental FHA varied significantly for each segment and specimen. In general, the precision of the robot system seems to be adequate and the results are consistent with intact monosegmental data from literature. Therefore the testing system can be used to investigate adjacent level effects including coupled motion in a multisegmental specimen in future experiments.

Radio frequency identification (RFID) applications have become popular in many areas. RFID uses wireless technology to transmit information stored within a RFID-tag to a RFID-reader. Passive RFID-tags are powered through the received signal from the reader. Therefore the reader has to transmit its request with a certain power to bridge the gap between reader and tag. In contrast to bar-code technology this technique allows communication without requiring a line of sight.

Accidentally swallowed dentures can lead to severe complications in the gastrointestinal tract. Therefore, early detection and effective therapeutic management are important. We report on two cases of accidentally swallowed dentures with exceptional clinical courses. In the first case, the patient initially did not notice the swallowed denture for several days. After diagnosis of the impacted foreign body, endoscopy revealed that an interventional removal was not feasible, and thus surgical removal was performed. In the second case, endoscopic retrieval of the ingested denture was also impossible, however, unsuccessful endoscopic extraction induced a large esophageal perforation, leading to an urgent esophagectomy. After a complicated course on the intensive care unit, a reconstruction with a colon interposition was carried out. The two cases highlight the importance of early detection and effective management in cases of swallowed dentures. A controlled surgical removal should be considered early as a safe procedure compared to endoscopic extraction.

A 33 year old woman from Lebanon presented with recurrent hemoptysis, subfebrile temperature, dyspnoe in stress, fatigue, weight loss, and pruritus. Serological tests and results from chest X-ray and computer tomography revealed cystic echinococcosis with pulmonary involvement. After refusal of surgical therapy a medical treatment with albendazole was implemented. Two months after the start of the therapy only a small fibrotic residuum in the lung was seen. A spontaneous healing success seems unlikely because of the duration of the pulmonary cyst and the progressive symptoms before treatment.

Introduction: Repair of the endothelium after vascular injury is crucial for preserving endothelial integrity and preventing the development of vascular disease. The underlying mechanisms of endothelial cell repair are largely unknown. Here, we sought to investigate whether endothelial microparticles (EMP), released from apoptotic endothelial cells (ECs), influence EC repair. Methods and results: EMP were generated from human coronary endothelial cells (HCAEC) and characterized by confocal microscopy and flow cytometry. Systemic treatment of mice with EMP after electrical denudation of the endothelium accelerated reendothelialization in vivo (29.81±2.31 vs. 50.71±9.84, p

The special risk constellation of renal transplant patients suffering from rupture of the Achilles tendon promoted the development of a therapeutic concept with early functional treatment. The significant differences to the methods usually employed so far are: local anaesthesia, additional interlacing of the tendon suture, and early functional after-treatment. In a total of ten patients, 15 spontaneous ruptures of the Achilles tendon were treated according to this therapeutic principle. Follow-up after an average of 26 months yielded in all cases a good to very good functional result. This treatment method avoids risk factors that can lead to secondary complications and is thus very suitable for treating spontaneous ruptures of the Achilles tendon in the renal transplant patient.

From 1982 to 1992 103 patients with ovarian cancer stage FIGO III have been treated. In 38% of the patients there was no residual tumour postoperatively, in 40.8% the residual tumour was smaller than 2 cm. In 51.5% bowel resections were necessary, a stoma was unavoidable in just one case. A lymphadenectomy (pelvic, paraaortic or combined) was done in 46.6% of the patients. Postoperatively, 54.4% of the patients received a platinum-based chemotherapy, in the other patients other kinds of chemotherapy were applied. A radiation of the whole abdomen was done only in 3.9%. A median survival time for more than 60 months could be achieved in tumour-free patients due to the increased radical operations in combination with the platinum based chemotherapy. The lymphadenectomy seems to prolong the survival time of the patients. The positive nodal status is definitely unfavourable for the prognosis. By this therapeutic approach, an increased survival time with a good life quality can be achieved.

There is plenty of evidence that survival time associated with advanced ovarian cancer is predominantly related to the amount of residual tumor after primary operation. However, there are only few and inconclusive reports concerning the effect of second debulking procedures on survival time after relapse.To evaluate the effect of radical second operation, 30 patients with clinically diagnosed relapses had second operations after a median recurrence-free interval of 16 months. Considerable efforts were made to resect all tumor tissue. Complete resection was achieved in 14 of 39 (47%) patients, and residual tumors smaller than 2 cm remained in 12 (40%) patients. In 19 (63%) patients, intestinal resections were necessary. Operation time, blood units needed, hospital stay, and complication rates were comparable to those associated with primary debulking procedures.Survival time after second operation was closely correlated with the residual tumor remaining after second surgical procedure and also with the length of the recurrence-free interval. Patients with complete resections had significantly longer survival times than those with residual tumors of less than 2 cm (median, 29 months versus 9 months; P = 0.004). Patients with a recurrence-free interval of more than 12 months had a longer survival time than those with a shorter disease-free time (median, 29 months versus 8 months; P = 0.002). Postoperative treatment also was shown to influence survival time, whereas grade of the tumor (P = 0.74), age of the patient (P = 0.87), and initial FIGO stage (P = 0.58) had no influence on survival time after second operation. Multivariate analysis (Cox regression) revealed that residual tumor after second surgical procedure (relative risk, 4.7) was the most important independent variable predicting survival time after second surgical procedure. Recurrence-free interval (relative risk, 2.7) and postoperative (second-line) treatment (relative risk, 3.0) were equally potent variables. Residual tumor after primary operation, was almost significant (P = 0.06) in the univariate analysis, but was canceled in the multivariate setting by the recurrence-free interval. Again, FIGO stage, grade of the tumor, and patient age had no predictive value.The authors conclude that radical surgical procedure can prolong survival times in patients with recurrent ovarian cancer. Patients who had a complete resection of cancer tissue in the primary operation or those who experienced a disease-free interval of more than 12 months after primary operation are most likely to benefit from second operation in recurrent ovarian cancer. Radical surgical procedure should be offered to these patients to enhance efficacy of second-line chemotherapy, which is of limited value in bulky recurrent disease.

Auch nach erfolgreicher Nierentransplantation entwickelt sich bei einem Teil der Patienten aus dem vorbestehenden sekundaren Hyperparathyreoidismus (tHPT) ein tertiarer HPT. Es besteht eine Korrelation zur Dialysedauer vor Transplantation. Bei 15 von insgesamt 229 von 4/85 bis 5/91 transplantierten Patienten wurde bei symptomatischem HPT (Hypercalzamie, Hypophosphatamie, Knochenschmerzen, suboptimale Transplantatfunktion) eine subtotale Parathyreoidektomie (n =11), tot. Parathyreoidektomie mit Autotransplantation (n = 2), isolierte Adenomextirpation (n =1), und eine Verkleinerung eines Autotransplantats (n = 1) durchgefuhrt. In 7 Fallen kam es zu passagerer Hypocalzamie, in einem Fall zu persistenter Hypocalziamie. Schadigungen des N. recurrens traten nicht auf. In allen Fallen kam es zu einer Normalisierung der pathologischen Parathormon-, Calzium-u. Phosphatwerte. Transplantatfunktion und Beschwerden zeigten mehrheitlich Besserung.

In our clinic we observed uni- or bilateral ruptures of the Achilles tendon as a complication in 5% of all renal transplant patients. The majority of ruptures took place within the first two months following transplantation in a phase of increasing physical activity. Besides steroid treatment, elevated uric acid and hyperparathyroidism, advanced age at the time of transplantation as well as long duration of chronic hemodialysis must be considered as risk factors.

This study reports on the first clinical use of HTK preservation solution devised by Bretschneider in renal transplantation. Using this HTK solution, nine living related donor kidneys subjected to cold ischemia for up to 4 h were consecutively transplanted between 1987 and 1989. The postoperative function of the donor and recipient kidneys is analyzed. The endogenous creatinine clearance and the plasma creatinine level are used as function parameters. Within 24-48 h after transplantation a postischemic normal graft function occurred. With triple drug therapy the transplanted kidneys showed an increase in renal function identical with that in the donor's single remaining kidney. Within 7 postoperative days no perfusion damage and no HTK or CyA nephrotoxicity was observed.

Die Verletzung eines gesunden, nicht durch eine Grunderkrankung mitbetroffenen Nachbarorgans ist gegenuber der Verletzung infolge eines mehr oder weniger ungewollten Praparationsschnittes am erkrankten Nachbarorgan selten. Wird diese erkannt und kunstgerecht versorgt, so ist ihre Prognose gut. Eine intraoperative Verletzung sollte der Patientin gegenuber nicht verschwiegen werden.

Improvements in diagnostic measures and intensive care treatment have added to the knowledge of acute pancreatitis and have changed the role of surgery in this field [1]. Nevertheless, there are still some questions to be settled, including: Which patients benefit from surgical treatment? What procedure seems most adequate? When is the optimal time for surgical intervention? With the analysis of our own clinical data we hope to contribute some answers to these questions.

The therapeutical concept of programmed relaparotomy, as applied at our institution in the treatment of diffuse peritonitis, procedurally does not permit leaving the abdomen unclosed. Instead, following removal or elimination of the infectious source (focus sanitation) and meticulous debridement of the abdominal cavity with lavage, the abdominal wall is primarily closed without drainage. This procedure is repeated at fixed 48-h intervals until the peritonitis subsides. A final “control relaparotomy” is then performed as a form of insurance that the infection has in fact cleared. When early sanitation of the source of infection proves surgically impossible, however, extraperitonization of the septic focus through placement of a laparostomy must be attempted.

Immunologische Untersuchungen zur Fibrinurie wurden an 80 Urinchargen von 10 allogen nierentransplantierten Patienten mit verschiedenen Techniken durchgefuhrt. Das Fibrinogenspaltoprodukt E wurde dabei semiquantitativ durch zweidimensionale Immunoelektrophorese bestimmt. Wahrend das Spaltprodukt E nicht mehr als etwa 10% des Gesamtgehalts aller Fibrinderivate im Harn ausmacht, konnte ein Anstieg bis zu 35% wahrend schwerer akuter Abstosungsreaktionen beobachtet werden. Auch wahrend der ersten 2 – 3 Wochen nach der Transplantation, in denen die Fibrinurie kein Indiz einer drohenden Abstosungskrise darstellt, kann durch die vermehrte Spaltprodukt E-Ausscheidung auch wahrend dieses Zeitraumes ein diagnostischer Hinweis fur eine drohende Abstosungsreaktion erhalten werden.