Safety Elements Clause Samples

Safety Elements. Protective fencing extending an additional four feet in height to be added to the existing six foot high steel through plate girders on the span over the SEPTA Norristown Line; a ten foot high protective fence over the low use/low speed single Norfolk Southern track on the north side of the Schuylkill River; protective fence and railing at least four feet, eight inches in height to be attached to the existing post and rail barrier along the sides of the Bridge; a ten foot high protective fence along the entire length of the deck girder structure on the inside radius; metal fencing to be bonded and grounded to the Bridge structure; a ten foot high protective fence over I-76 for protection of the highway; a solid barrier along the sides of the Bridge span directly over the electrified SEPTA rails; anti-climb ▇▇▇▇▇▇▇ and access gates.

Safety Elements. ‌ 15.1 Adverse Events‌ Previous studies of emphysema patients who were followed longitudinally and treated using medical management [10,16,17], diagnostic or interventional bronchoscopy [448,49], or endobronchial valves [16,17] indicate that a moderate risk of adverse events may be anticipated during this study. Adverse events will be graded by defining their severity and relatedness to the study device. It is anticipated that the rates for adverse events will be higher for the study treatment arm than control arm during the treatment period (‘short’, or day of the study procedure to 45 days) but that the rates for these occurrences will be similar for both study arms during the post-treatment period (‘long’, or 46 days to 1 year). Adverse events that may be observed include: ❖ Cardiovascular events such as: o New onset cardiac arrhythmia o New diagnosis of congestive heart failure, which may be indicated by >1-point increase in NYHA functional classification score o Acute myocardial infarct requiring medical care o New diagnosis transient ischemia attack (TIA) or stroke o New diagnosis deep vein thrombosis o Pulmonary embolism, which may be indicated by direct clinical evidence or V/Q evidence of segmental or larger perfusion defects ❖ COPD and Emphysema events such as: o COPD exacerbation requiring treatment with antibiotics and/or oral steroids ▪ AECOPD requiring emergency room visit or hospitalization o Respiratory failure requiring re-intubation at any time during follow-up and/or invasive mechanical ventilation >24 hours after the bronchoscopy procedure o Pneumonia requiring treatment with antibiotics, indicated by consolidation on X- ray or CT scan and clinical characteristics of active infection (fever, leukocytosis, hypotension) ❖ Pulmonary / Thoracic events such as: o Hemoptysis requiring new evaluation or intervention o Pneumothorax indicated by clinical symptoms and/or X-ray ▪ Pneumothorax requiring intervention o Empyema requiring new evaluation or intervention o Non-cardiac chest pain driving the study participant to seek medical care o Pleural effusion noted radiologically o Lung mass / cancer noted radiologically o Fractured rib noted radiologically o Laryngospasm driving the study participant to seek medical care o Dysphonia driving the study participant to seek medical care o Hypoxemia requiring increased or new oxygen use o Adverse tracheobronchial observations such as bronchial granulation tissue, bronchial ulceration, bronchial trauma ❖...

Safety Elements