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Hardware Instructions for Use

General Regulatory Symbols

The devices comply with the EC directive 93/42/EEC with amendments up to

2007/47/EEC for Medical devices.

Instructions for Use.

Follow instructions for use.

Warnings associated with this device. / Attention! Read instructions for

use.

Cautions associated 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.

Reference Number

Serial Number

SWL

Safe Working Load

Date of Manufacture

Manufacturer

Rx only

For US audiences only. US laws restrict this device to sale by or on the order

of the physician.

NOTE

For symbols related to the computer, monitor and printer, please refer to their

accompanying documentation.

Содержание Dantec Keypoint Focus

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

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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