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General Warnings and Cautions

SD32+

System

1.4. amplifier casing symbols

This symbol identifies ports or sockets equipped with a Type BF level of electrical
isolation in accordance with IEC60601-1.

This symbol prompts the user to refer to this manual for proper usage and safety
instructions.

This symbol identifies input connectors.

This symbol identifies output connectors.

This symbol identifies the manufacturing date

REF

This symbol identifies the part number of the device

SN

This symbol identifies the serial number of the device

2

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Содержание Sandman

Страница 1: ...embla Sandman Digital 32 Amplifier User Manual...

Страница 2: ...ut of the use of or inability to use this product Copyright Information in this document including URL and other Internet website references is subject to change without notice Complying with all appl...

Страница 3: ...sockets 16 3 4 LCD display 17 3 5 integrated pulse oximeter 18 3 6 Sandman elink adapter 19 3 7 power supply 20 3 7 1 external medical grade ac dc adapter 20 3 7 2 amplifier power modes 21 3 7 3 surg...

Страница 4: ...9 pulse oximeter performance 36 List of Figures Figure 1 the SD32 system 11 Figure 2 the headbox amplifier connection port 12 Figure 3 removable patient box headbox link port 12 Figure 4 headbox to am...

Страница 5: ...ant information to help the operator complete a procedure or task correctly 1 3 warnings 1 Do not disassemble the SD32 or Headbox 2 All connections on the Headbox are isolated from the ground of your...

Страница 6: ...n accordance with IEC60601 1 This symbol prompts the user to refer to this manual for proper usage and safety instructions This symbol identifies input connectors This symbol identifies output connect...

Страница 7: ...uations flicker emissions IEC 61000 3 3 Complies The device may be connected directly to a low voltage supply using an electrical ground Table 1 electromagnetic emission Immunity Test IEC 60601 1 2 Te...

Страница 8: ...han those provided in table 3 Table 2 electromagnetic immunity 1 5 1 recommended distance from Radio Frequency systems It is not recommended to use RF transmitting devices near the SD32 digital amplif...

Страница 9: ...2 5 GHz the distance can be estimated as follows D 2 3 P P the rated power of the transmitter in Watts W Note Always use the greater distance provided Note These values are general guidelines as elec...

Страница 10: ...eres with high oxygen concentration or in buildings where flammable substances or anesthetic agents are present Avoid contact with liquids The amplifier and its internal parts are not protected agains...

Страница 11: ...he amplifier to avoid the risk of burning the patient along electrode contact areas and damaging the amplifier Avoid contacting the patient and the electrodes with conductive metal items Do not allow...

Страница 12: ...then connect the patient to the device and begin collection At the same time you must disconnect the patient before you power the device down All connections on the Headbox are isolated from the AC po...

Страница 13: ...rked with the CE mark IMQ S p A Milan Italy issues the approval as the Notified Body notified by the European Commission The IMQ notified body identifier number is 0051 The equipment is marked with th...

Страница 14: ...eadbox to function without being physically mounted to the SD32 amplifier allowing for greater flexibility in lab setups The Sandman elink Adapter receives optical digital data from the SD32 amplifier...

Страница 15: ...input sockets that accept 1 5 mm electrode safety plugs including 32 AC monopolar input sockets 8 pairs of AC bipolar input sockets 3 neutral input sockets 13 isolated ground input sockets 2 temperatu...

Страница 16: ...s from the patient The cable should be kept clear of other devices or cables in order to achieve the best signal performance See Figure 3 removable patient box headbox link for an illustration of this...

Страница 17: ...red AC channel inputs There are three parallel neutral input sockets on the Headbox labeled NE This is also used as the reference when impedance testing is done Isolated Ground ISO GND Sockets These s...

Страница 18: ...ono polar AC DC Accepts channel signal input High 1 V 8 bits 8mV p p Low 2 V bit 128mV p p 1 DC1 10 V bit 640mV p p 2 DC2 20 V bit 1 28 V p p 3 DC23 100 V bit 6 4 V p p 4 Neutral NE N A N A References...

Страница 19: ...graphic LCD display and five menu control buttons as illustrated in Figure 6 SD32 amplifier s external connections front and Figure 7 SD32 amplifier s external connections back Figure 6 SD32 amplifie...

Страница 20: ...s use sensors that have been approved by Embla Systems Sensors must also be cleared for commercial use in your jurisdiction The oximeter does not possess alarm management capabilities and is not inten...

Страница 21: ...he left side of the screen points to the various options Press the Enter button to select an option The left W and right X buttons allow users to scroll through the displayed information For example d...

Страница 22: ...rated pulse oximeter The integrated pulse oximeter calculates oxygen saturation SpO2 and heart rate HR data collected using an approved sensor The Sandman Elite software receives this data and display...

Страница 23: ...nput Connector accepts the DC voltage output from the External Medical Grade AC DC Adapter 3 LAN RJ45 connector Local Area Network 10 100 Mbps Ethernet interface 4 Serial AUX I O A Circular 8 contact...

Страница 24: ...ransfers that are free of noise and electrical interference 3 7 power supply 3 7 1 external medical grade ac dc adapter Figure 10 shows the AC DC Adapter that is specified for use with the Sandman eli...

Страница 25: ...surge protection The AC DC Adapter used with the SD32 system contains an electronic fuse that may automatically turn off the amplifier if a power surge occurs If the Sandman elink Adapter does not po...

Страница 26: ...cept inputs from bed two DC devices The socket assignments on your expansion box were set up according to your lab s needs during installation Only the sockets that have been assigned to the current b...

Страница 27: ...stem installed on your computer that is compatible with the Sandman Elite software For more information about supported operating systems consult your Sandman Elite User Manual In most cases a qualifi...

Страница 28: ...lifier 3 Connect the other end of the Headbox to Amplifier Cable to the Removable Patient Box Link port on the Headbox 5 2 connecting the amplifier to the sandman elink adapter To connect the amplifie...

Страница 29: ...xpansion Box Cable into mouse or keyboard port on the computer 6 Plug the mouse or keyboard PS2 plug into socket D of the SD32 amplifier DC Expansion Box Cable Changes must also be made to the Sandman...

Страница 30: ...Amplifier System Assembly SD32 System Figure 14 typical SD32 system set up 26...

Страница 31: ...rformed at the beginning and at the end of every study Under the control of the Sandman Elite software the amplifier generates a standard 50 V square wave signal for calibration This calibration is im...

Страница 32: ...ains should be conducted periodically to ensure proper grounding is available in the operating environment of the SD32 system 7 3 amplifier calibration Semi annually Check the amplifier at various gai...

Страница 33: ...etely dry before attempting to apply power to it or before connecting it with other devices Caution Do not immerse the amplifier or its parts in liquids Do not oil any part of the amplifier Additional...

Страница 34: ...MDD IEC 60601 1 General safety standard for electromedical equipment IEC 60601 1 1 Collateral safety standard for electromedical systems IEC 60601 1 2 Collateral safety standard for device EMC test IE...

Страница 35: ...Part Number 4200022 Operating Channels 24 32 40 EEG Polygraphic Channel 40 DC Channel up to 8 Impedance Measurement By means of injected current 20Hz 0 01 A per electrode A D Conversion 2 s complement...

Страница 36: ...channels 1 to 24 High Low Gain Setting Resolution 1 8 V bit 2 V bit Full Scale Range 8 mV p p 128 mV p p Noise 0 1 Hz 70 Hz 1 5 V p p max 20 V p p max channels 25 to 32 High Low DC1 DC2 DC3 Gain Sett...

Страница 37: ...ously no sampling skew CMRR 100 dB 95 dB on polygraphic channels IMRR 120 dB Max DC Offset AC Mode 300 mV 8 5 headbox specifications Part Number 4200017 Case ABS Plastic Dimension 126 x 96 x 25 mm Ele...

Страница 38: ...ndards IEC 601 1 CEI 62 5 89 336 EEC EMC 73 23 EEC Low Voltage Mark CE TUV CSA UL Electrical protection level Class I Type B Case Material Plastic Dimensions 129 x 77 x 40 millimeter 8 6 2 SINPRO MPU5...

Страница 39: ...indicators Green LED 3 3 V power is on Yellow LED Ethernet Auto negotiation controller Yellow LED Ethernet Link 10 100 Mb controller o Yellow LED Ethernet LAN controller Device rated values CE0051 mar...

Страница 40: ...uals one standard deviation 1 SD which encompasses 68 of the population Accuracy specifications are based on controlled hypoxia studies with healthy non smoking adult volunteers over the specified sat...

Страница 41: ...ital display 17 impedance check 17 fiber optic cable 24 montage setup 17 flammable gases 6 safety 8 leakage current 8 liquids 6 G M ground 1 6 magnetic fields 6 H maintenance 28 cable and connectors 2...

Страница 42: ...removable patient box link port 12 24 S safety checks 28 LCD display 8 leakage current 8 operational environment 6 patient connection 8 Sandman elink Adapter 10 Sandman Elite software 10 17 18 27 seri...

Страница 43: ...4280034 REF 4280034...

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