Instructions for use | Oxylog VE300 SW 1.n 11
Safety-related information
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with different underlying diseases
2.8.2 Symbols and product labels
Failure to observe symbols and product labels may result in personal injury and
property damage.
► Observe the symbols and product labels.
2.8.3 Monitoring the patient's condition
Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
► Monitor the patient's condition by suitable means and at appropriate intervals.
2.8.4 Duties of the operating organization
The tasks described in this document specify the requirements which have to be
met by each respective target group. If the respective target group is not
appropriately qualified, personal injury and property damage may result.
The operating organization of this product must ensure the following:
► The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
► The target group has been trained to perform the task.
► The target group has read the sections of these instructions for use relating to
the activity concerned and noted the safety instructions and precautionary
statements they contain.
2.8.5 Operation of the device by persons outside the defined target
groups
The device is not intended for use by non-specialists (persons not defined as target
group). Responsibility for use of the device that is inconsistent with its intended use,
particularly by non-specialists, lies with the operating organization. If the operating
organization nevertheless allows non-specialists to interact with the device,
appropriate instruction and supervision must be provided.
If non-specialists (e.g., visitors) are given access to the device, the following
precautions must be taken:
► Non-specialists must be informed that unauthorized interactions may lead to
injury.
2.8.6 Modifications to the product
Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
► Do not modify this product.