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Art. no.: 2.510701 rev.: c
Safety Notes 1
User Guide Responsibility of the User 1.1
BP-200 plus
1 Safety Notes
1.1 Responsibility of the User
1.2 Intended Use
1.3 Organisational Measures
V The BP-200 plus is provided for the exclusive use of qualified physicians or
trained personnel under their direct supervision.
V The numerical and graphical results as well as any interpretation suggested by
the device must be examined with respect to the patient's overall clinical condition
and the quality of the recorded data.
V The responsibilities of the personnel for the operation and maintenance of the
device must be specified.
V Ensure that personnel have read and understood these operating instructions. In
particular this section safety notes, must be read and understood.
V Damaged or missing components must be replaced immediately.
V The operator is responsible for compliance with all applicable accident prevention
regulations and safety regulations.
V The BP-200 plus is intended to be used as an adjunct to exercise stress testing
devices. It is intended to measure and display diastolic and systolic blood
pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2)
and pulse rate in adult or adolescent patients during stress tests. The BP-200
plus can be used for patients of both sexes and all races.
V Only operate the device in accordance with the specified technical data.
V Do not use this unit in areas where there is any danger of explosion or in the
presence of flammable gases such as anaesthetic agents.
V The blood pressure part of the unit is BF classified.
V The ECG and SpO
2
part of the unit is CF classified. It is defibrillation
protected only when the SCHILLER original patient cable is used. However, as a
safety precaution when possible, remove ECG electrodes before defibrillation.
V This product is not designed for direct cardiac application.
V The BP-200 plus is designed for use with adults and children over 30 kg and
should not be used with neonates.
V Before using the unit, ensure that an introduction regarding the unit functions and
the safety precautions has been provided by a medical product representative.
V Keep these operating instructions in an accessible place for reference when
required. Make sure that they are always complete and legible.
V Observe the operating instructions and maintenance instructions.
V These operating instructions do not override any statutory or local regulations, or
procedures for the prevention of accidents and environmental protection.
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