Philips IntelliVue MX40 - Page 10

4 Contents
Safety Standards ----------------------------------------------------------------- 10-2
Intended Use Statement -------------------------------------------------------- 10-4
Indications for Use --------------------------------------------------------------- 10-4
Intended Uses of MX40 --------------------------------------------------------- 10-4
Authorized EU Representative ------------------------------------------------ 10-5
Authorized Australia Sponsor ------------------------------------------------- 10-5
Patient Population ---------------------------------------------------------------- 10-5
Rx ------------------------------------------------------------------------------------- 10-5
Contraindications ----------------------------------------------------------------- 10-5
Essential Performance ---------------------------------------------------------- 10-6
Risk Management Considerations ------------------------------------------- 10-6
Electromagnetic Compatibility ----------------------------------------------------- 10-9
Reducing Electromagnetic Interference ---------------------------------- 10-10
Restrictions for Use ------------------------------------------------------------ 10-10
Electromagnetic Compatibility (EMC) Specifications ----------------- 10-11
Accessories Compliant with EMC Standards ------------------------- 10-11
Electromagnetic Emissions -------------------------------------------------- 10-11
Electromagnetic Immunity --------------------------------------------------- 10-12
Recommended Separation Distance -------------------------------------- 10-12
Electrosurgery Interference/Defibrillation/Electrostatic
Discharge --------------------------------------------------------------------- 10-14
Restart Time ------------------------------------------------------------------- 10-14
Battery Specifications -------------------------------------------------------------- 10-15
Lithium-ion Battery Charge Time ------------------------------------------- 10-18
Physical Specifications ------------------------------------------------------------ 10-19
MX40 1.4 GHz Smart-Hopping Radio ----------------------------------------- 10-20
MX40 2.4 GHz Smart-Hopping Radio ----------------------------------------- 10-21
MX40 Short-Range Radio -------------------------------------------------------- 10-22
MX40 2.4GHz WLAN Radio------------------------------------------------------ 10-23
FCC Radio Compliance------------------------------------------------------- 10-24
Industry Canada Radio Compliance--------------------------------------- 10-24
Environmental Specifications ---------------------------------------------------- 10-27
Measurement Specifications ----------------------------------------------------- 10-28
ECG -------------------------------------------------------------------------------- 10-28
ECG Performance Disclosure/Specifications --------------------------- 10-29
Distributed Alarm System Delay Specifications ------------------------ 10-30
Respiration ----------------------------------------------------------------------- 10-30
Respiration Alarm ------------------------------------------------------------ 10-30
FAST SpO
2
----------------------------------------------------------------------- 10-30
Masimo SET SpO
2
------------------------------------------------------------- 10-32
SpO
2
Accuracy Specifications ---------------------------------------------- 10-32