User's Manual

6 Contents

Software Hazard Prevention -------------------------------------------------- 15-2

AC Power Source ---------------------------------------------------------------- 15-2

Industrie Canada Compliance (Canada) ----------------------------------- 15-2

Safety Standards ----------------------------------------------------------------- 15-2

Intended Use Statement ------------------------------------------------------- 15-3

Indications for Use --------------------------------------------------------------- 15-3

Intended Uses of MX40 -------------------------------------------------------- 15-3

Authorized EU Representative ----------------------------------------------- 15-4

Patient Population --------------------------------------------------------------- 15-4

Rx ------------------------------------------------------------------------------------ 15-4

Essential Performance --------------------------------------------------------- 15-4

Risk Management Considerations ------------------------------------------ 15-5

Electromagnetic Compatibility ----------------------------------------------------- 15-8

Reducing Electromagnetic Interference ------------------------------------ 15-9

Restrictions for Use-------------------------------------------------------------- 15-9

Electromagnetic Compatibility (EMC) Specifications ------------------- 15-9

Accessories Compliant with EMC Standards -------------------------- 15-9

Electromagnetic Emissions --------------------------------------------------- 15-10

Electromagnetic Immunity ---------------------------------------------------- 15-10

Recommended Separation Distance -------------------------------------- 15-11

Electrosurgery Interference/Defibrillation/Electrostatic Discharge15-13

Restart Time ------------------------------------------------------------------- 15-13

Battery Specifications -------------------------------------------------------------- 15-14

Lithium-ion Battery Charge Time ------------------------------------------------ 15-17

Physical Specifications ------------------------------------------------------------- 15-18

MX40 1.4 GHz Smart-Hopping Radio ------------------------------------------ 15-19

MX40 2.4 GHz Smart-Hopping Radio ------------------------------------------ 15-20

MX40 Short-Range Radio --------------------------------------------------------- 15-22

MX40 2.4GHz WLAN Radio ------------------------------------------------------ 15-23

FCC and Industry Canada Radio Compliance -------------------------- 15-24

Environmental Specifications ----------------------------------------------------- 15-25

Measurement Specifications ----------------------------------------------------- 15-26

ECG -------------------------------------------------------------------------------- 15-26

ECG Performance Disclosure/Specifications ---------------------------- 15-27

Respiration ------------------------------------------------------------------------ 15-29

Respiration Alarm------------------------------------------------------------- 15-29

FAST SpO

----------------------------------------------------------------------- 15-30

SpO

Sensor Accuracy -------------------------------------------------------- 15-31

A. Accessories A-1

MX40 Accessories --------------------------------------------------------------------- A-2

Pouches ------------------------------------------------------------------------------ A-2

Miscellaneous ----------------------------------------------------------------------- A-2

ECG Accessories ----------------------------------------------------------------------- A-3