Philips IntelliVue ECG Serie Gebrauchsanweisung Seite 11

STERILIZATION
All lead sets and cable products described in this IFU are not intended to be sterilized.
PRODUCT DISPOSAL
Follow approved medical waste disposal methods as specified by your patient care facility or local
regulations.
INCIDENT REPORTING
Any serious incident that has occurred in relation to this device should be reported to Philips and the
competent authority of the European Economic Area (EEA) countries, including Switzerland and Turkey in
which the user and/or patient is established.
ENVIRONMENTAL SPECIFICATIONS
Temperature, humidity and atmospheric pressure ranges identified below must be maintained for all of the
lead set and cable products described in this IFU. Otherwise product damage could result.
Temperature
• Operating Temperature Range: -10°C to +55°C (14 to 131°F) at 20% R.H. to 95% R.H.
• Storage Temperature Range: -20°C to +70°C (- 4 to 158°F) at 15% R.H. to 90% R.H.
Humidity
• Minimum Operating: Humidity at +55°C (131°F); 15% R.H. 24hrs
• Maximum Operating: Humidity at +40°C (104°F); 95% R.H. 24hrs
Atmospheric Pressure
• Operating: 650 hPa – 1080 hPa
• Storage: 100 hPa – 1080 hPa
REORDERING INFORMATION
The products listed in the table below are CE marked and available in the European Union.
Part Number
AAMI Color-Coded ECG Lead Sets
M1671A (989803145091)
M1675A (989803145131)
M1673A (989803145111)
M1624A (989803144941)
M1532A (989803144841)
M1557A (989803144881)
M1968A (989803125841)
M1976A (989803125881)
M1979A (989803125901)
M1973A (989803125861)
M1602A (989803144911)
M1644A (989803144991)
M1647A (989803145011)
M1680A (989803145161)
M1682A (989803145181)
3 LEADSET, GRABBER, AAMI, ICU
3 LEADSET, GRABBER, AAMI, OR
3 LEADSET, SNAP, AAMI, ICU
UNSHIELDED 3 LD MINICLIP AAMI 0.7M
4 LEAD SET GRABBER AAMI, ICU
4 LEAD SET GRABBER AAMI, OR
5 LEADSET, GRABBER, AAMI, ICU
5 LEADSET, GRABBER,CHEST, AAMI, ICU
5 LEADSET, GRABBER, CHEST, AAMI, OR
5 LEADSET, GRABBER, AAMI, ORM
5 LEAD SNAP CHEST AAMI, ICU
5 LEADSET, SNAP, AAMI, ICU
UNSH. 5-LD MINICLIP AAMI 0.7/1.3M
6 LEAD SET GRABBER AAMI, ICU
6 LEAD SET SNAP, AAMI, ICU
3
Description