Safety information
This section contains the safety information for the Panthera-Puncher 9.
Conventions
The following conventions are used in all system documentation:
Warning:
A warning indicates a hazardous situation or operation that, if not avoided, could result in serious personal
injury or death to the operator or the patient. Follow all stated precautions.
Caution:
A caution indicates an operation that could cause damage to the instrument or loss of data, or personal
injury to the operator or the patient if correct procedures are not followed.
Note:
A note emphasizes significant information in a procedure or description, and alerts users to key points of interest
not related to personal injury.
In cases where a specific hazard or warning has been identified – such as an electrical or burn hazard – that symbol is
added to the cautions and warnings.
Notice regarding serious incidents
For a patient/user/third party in the European Union and in countries with an identical regulatory regime (IVDR; EU
2017/746/EU); if, during the use of this device or as a result of its use, a serious incident has occurred, please report
it to the manufacturer and to your national authority. The contact information for the manufacturer of this device to
report a serious incident is:
Wallac Oy
Mustionkatu 6, FI-20750 Turku, Finland
Phone: +358 2 2678 111
Warnings and precautions
Please counsult the
Warnings and precautions
section in the
Panthera-Puncher
®
9 User Manual
.
Warning:
Make sure the instrument is switched off before opening the side panels! Both side panels are fastened
with a screw to ensure maximum safety.
Warning:
The electromagnetic environment should be evaluated prior to operation of the device. Do not use this
device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as
these can interfere with the proper operation.
Caution:
This equipment is designed for use in a professional healthcare facility environment. It is likely to
perform incorrectly if used in a home healthcare environment. If it is suspected that performance is affected by
electromagnetic interference, correct operation may be restored by increasing the distance between the equipment
and the source of the interference.
Safety requirements
The instrument is designed to meet the following safety standards.
• CAN/CSA-C22.2 61010-1
• UL 61010-1
• EN 61326:1
• EN IEC 61326-2-6
• EN 61010-1
• EN IEC 61010-2-101
Panthera-Puncher
™
9 Instrument Manual
Safety information
3
