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natus Dantec Keypoint Focus, Hardware Instructions For Use

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Dantec Keypoint Focus 

5 

Table of Contents

 

Intended Use ........................................................................................................................................ 7

 

Safety Information ............................................................................................................................... 7

 

Contraindications ................................................................................................................................. 7

 

Danger ............................................................................................................................................... 7

 

Warnings ........................................................................................................................................... 8

 

Cautions ............................................................................................................................................. 9

 

Side Effects ............................................................................................................................................. 9

 

Safety Requirements ............................................................................................................................ 10

 

Excerpt from the IEC 60601-1 Standard ............................................................................................... 12

 

System Overview ............................................................................................................................... 13

 

Keypoint Focus Main Unit .................................................................................................................... 13

 

System Setups ...................................................................................................................................... 14

 

KEYPOINT Notebook PC ................................................................................................................... 14

 

KEYPOINT Standard ......................................................................................................................... 14

 

Cable Connections ................................................................................................................................ 15

 

Main Unit ............................................................................................................................................. 15

 

Connection 

―

 Side Panel ................................................................................................................ 15

 

Rear Panel ....................................................................................................................................... 16

 

Technical Specifications........................................................................................................................ 17

 

Controls .............................................................................................................................................. 18

 

Control Panel ........................................................................................................................................ 18

 

Control Functions ............................................................................................................................ 19

 

Footswitch (optional) ........................................................................................................................... 22

 

Amplifiers ........................................................................................................................................... 23

 

Amplifier Module 

―

 3 Channels ........................................................................................................... 23

 

Amplifier Modules ― 3, 4, 6, 8 Channels

 ............................................................................................. 25

 

EP Amplifier Module ― 6 Channels

 ...................................................................................................... 28

 

Current Stimulators ............................................................................................................................ 30

 

Safety Information ............................................................................................................................... 30

 

Stimulator ........................................................................................................................................ 30

 

Stimulation Electrodes .................................................................................................................... 30

 

Advanced Stimulation Handgrip (optional) .......................................................................................... 31

 

Multi-Constant Current Stimulator Module ......................................................................................... 33

 

Additional information related to stimulation ..................................................................................... 34

 

Source Voltage ................................................................................................................................ 34

 

Stimulation Electrodes .................................................................................................................... 34

 

Maximum Current Density .............................................................................................................. 35

 

Power Up Test .................................................................................................................................... 36

 

 Warnings ............................................................................................................................................. 36

 

Summary of Contents for Dantec Keypoint Focus

Page 1: ...Dantec Keypoint Focus Hardware Instructions for Use 9033M3703EN Rev C...

Page 2: ...Hardware Instructions for Use 2 Blank page...

Page 3: ...Medical Incorporated in the U S and in other countries Note that the documentation accompanying the Keypoint devices include a Software Instructions for Use manual a Hardware Instructions for Use man...

Page 4: ...Hardware Instructions for Use 4 Blank page...

Page 5: ...de Panel 15 Rear Panel 16 Technical Specifications 17 Controls 18 Control Panel 18 Control Functions 19 Footswitch optional 22 Amplifiers 23 Amplifier Module 3 Channels 23 Amplifier Modules 3 4 6 8 Ch...

Page 6: ...nts 37 Safety 37 Performance 37 Maintenance 38 Cleaning Instructions 38 Safety Checks 38 Waste Management 39 Classification 39 General Regulatory Symbols 40 Electromagnetic compatibility 41 List of sy...

Page 7: ...re refer to the Software Instructions for Use Make sure to read and understand the information before proceeding to use this equipment Contraindications It is a medical decision whether the risk of us...

Page 8: ...to any other ground connections as the electrode inputs are galvanically isolated Simultaneous connection of a patient to HF surgical equipment may result in burns at the site of the electrical stimul...

Page 9: ...rode always reset the stimulator Pay attention to the intensity indicator during the use of the program See the section Stimulator Overload in the software user guide and the section Stimulators in th...

Page 10: ...ow in this section The device has been designed for indoor use at temperatures between 10 C and 35 C 50 F to 95 F The mains plug must only be inserted in a mains socket outlet provided with a protecti...

Page 11: ...atus authorized service personnel except for such works described in this manual as being performed by the operator Make sure that only fuses with the required rated current and of the specified type...

Page 12: ...60601 1 but with the relevant safety standard for such equipment the additional equipment 1 must either be placed outside the patient environment the patient environment is any area in which intentio...

Page 13: ...Dantec Keypoint Focus 13 System Overview Keypoint Focus Main Unit 1 Main Unit 2 Notebook PC 3 Rear Panel 4 Side Panel 5 Control Panel...

Page 14: ...Hardware Instructions for Use 14 System Setups KEYPOINT Notebook PC KEYPOINT Standard...

Page 15: ...from Natus to avoid hum line interference especially near the patient or the amplifier NOTE Make sure the device connected to the wall power outlet is positioned in such a way to allow easy disconnect...

Page 16: ...tput Socket isolated For connection of stimulation electrodes with DIN plugs Support for the active handgrip LINK HS Link Output Connector Amplifier Connection AEP AEP Headset Connector VEP VEP Goggle...

Page 17: ...tic Stimulation tendon hammer or synchronization of external trigger or external stimulation acquisition VEP VEP Monitor Connector Power Outlet only for Notebook PC when not used with the Isolating Tr...

Page 18: ...eys 5 Cursor Mode Indicator 6 Volume Cursor Control Knob 7 Volume Indicator 8 Loudspeaker Mute Indicator 9 Loudspeaker Mute Key 10 Software Navigation Keys 11 Numeric Keypad 12 Standby Indicator 13 Po...

Page 19: ...or Coded The Software Function keys allow you to control the different software functions on the application The 12 Software Function keys colors and functions correspond to those of the Software Func...

Page 20: ...e stimulation press either the same Repetitive Stimulation key or the Single Stimulation key Stimulation Intensity Duration Repetition Rate Stimulation Intensity Control Knob The Stimulation Intensity...

Page 21: ...creases the stimulation repetition rate Loudspeaker Volume Cursor Mode Trace Marker Trigger Loudspeaker Mute Key Indicator Press the Loudspeaker Mute key to switch between the On and Off function The...

Page 22: ...w keys select the active cursor In EMG Application The Up and Down arrow keys move the trigger cursor in small steps The Left and Right arrow keys move the trigger cursor to the left and to the right...

Page 23: ...s as it may damage the amplifier or affect its performance Active Electrode Black The Active electrode corresponds to the black input connector Reference Electrode Red The Reference electrode correspo...

Page 24: ...former Unit or to any other ground connections as the electrode inputs are galvanically isolated Patient Ground Connector Connect the patient s ground electrode to the green connector Rear Panel LINK...

Page 25: ...8 channels only Press the Impedance Test key to start the impedance measurement The green light LED indicates that the impedance test is in progress Loudspeaker Mute Key Indicator Press the Loudspeake...

Page 26: ...light LED indicates that the reference input connectors above the reference line are interconnected This feature is active when selected in the software application setup Patient Ground Connector Ind...

Page 27: ...he operator and or patient must not directly or indirectly touch the metal shield on the LINK cable attached to the rear of the amplifier LINK HS Link Output Connector Extra Module Connection HS Linkp...

Page 28: ...On Amplifier Input isolated All amplifier input connectors are electronically isolated Electrostatic Sensitive Amplifier Input Connectors WARNING Do not touch the Amplifier Input connectors as it may...

Page 29: ...ED Status and Results description under Amplifier Input Connectors Common Array above Patient Ground Connector Indicator Connect the patient s ground electrode to the green connector The green light L...

Page 30: ...mity e g 1m to short wave or microwave therapy equipment may produce instability in the electrical stimulator output WARNING Dangerous physiological effects The current stimulator may give off dangero...

Page 31: ...ton on the handle 3 Repetitive Stimulation Button Press and hold down the button on the handle for at least 1 second Stop To stop the repetitive stimulation press the Repetitive Stimulation button aga...

Page 32: ...n as The footswitch pedal C Button C on the Keypoint NET application Shortly press the button on the handle 5 Button A Next Test Active in Motor Sensory F wave and H Reflex Press and hold down the but...

Page 33: ...ease Indicator Flashes for the stimulation pulse CC Stimulator Output Socket isolated For connection of stimulation electrodes with DIN plugs Support for the active handgrip Touch proof Output Connect...

Page 34: ...al Ring Electrode 9013L069 Velcro Digital Ring Electrode 9013L036 Hand held Stimulation Electrode 9031E017 Advanced Stimulation Handgrip When using the surface cutaneous electrodes the following appli...

Page 35: ...ty may be calculated as follows ______ J f Tp I A where f designates the frequency of stimulation Tp pulse width I pulse current and A the area of the electrode In certain cases however e g nerve dama...

Page 36: ...or Exit the Keypoint NET program and verify the cable connection Do not use the current stimulator when this message is shown the stimulator might be defective No Hardware detected Communication betwe...

Page 37: ...irements and tests and The whole system must fulfill the requirements in the safety standard IEC 60601 1 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safet...

Page 38: ...e at push buttons and other openings in the enclosure CAUTION Do not use cleaning detergents or cleaning agents based on alcohol solvent silicon based abrasive and or flammable substances Safety Check...

Page 39: ...the basic insulation Method s of sterilization or disinfecting recommended by the manufacturer Please see section on Maintenance Degree of protection against electric shock Type BF applied part provi...

Page 40: ...ociated with this device Attention Consult Instructions for Use The device is of Type BF i e the applied part is electrically isolated Waste Electrical and Electronic Equipment Compliance Information...

Page 41: ...acts which are distinguishable but must recover after test with no mode or parameter changes It is not considered an unacceptable risk or affect on the ESSENTIAL PERFORMANCE if the DIAGNOSTIC EQUIPMEN...

Page 42: ...and maximum cable length of 3 m 9006A253 Power interface cable printer Cable length 0 5 m 9006A254 Power interface cable display Cable length 1 5 m 9006A250 Power interface cable PC Cable length 1 2...

Page 43: ...m 9031E027 Tubal ear inserts Cable length 5 m 9031E025 Headset Cable length 5 m 9031E026 Screened headset Cable length 5 m 9031E028 Bone conductor Cable length 5 m 9031B030 Footswitch 3 key Cable leng...

Page 44: ...Hardware Instructions for Use 44 Please consult www natus com for your local Sales Service office Natus Manufacturing Limited IDA Business Park Gort Co Galway Ireland RX only Reg No 9033M3703EN Rev C...

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