User's Manual

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Indications for Use

The Nonin Model X-100 SenSmart modular, universal oximeter system is indicated for use in

simultaneously measuring, displaying, monitoring, and recording up to 6 channels of functional

oxygen saturation of arterial hemoglobin (SpO

) and pulse rate or cerebral or somatic

hemoglobin oxygen saturation (rSO

) of blood underneath the sensor. Patient population

includes adult, pediatric, infant, and neonate through the use of SenSmart-compatible

sensors.

The system is intended for use in hospitals, long-term care, medical facilities, sleep

laboratories, subacute environments, and Emergency Medical Services (EMS), including

patient transport. The X-100 SenSmart system may be used for spot-checking and continuous

monitoring with patient alarms. The SenSmart pulse oximetry (SpO

) functionality is suitable

for use in both motion and non-motion conditions, including patients who are well or poorly

perfused.

Contraindications

Do not use this device in an MR environment.

Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gases.

This system is not intended to be used simultaneously on multiple patients.

Warnings

This device is intended only as an adjunct device in patient assessment. It should not be used as the sole basis

for diagnosis or therapy decisions. It must be used in conjunction with other methods of assessing clinical signs

and symptoms.

Use only Nonin-branded SenSmart oximeter signal processors, sensors, and accessories. These sensors are

manufactured to meet the accuracy specifications for this device. Using other manufacturers’ sensors can result

in improper oximeter performance.

Always inspect the device before use. Do not use a damaged device or sensor. Before using any sensor, carefully

read the sensor Instructions for Use, which contains sensor application information for each sensor.

Protect from exposure to water or any other liquid, with or without AC power.

Use the device only with Nonin-specified power supplies.

As with all medical equipment, carefully route patient cables and connections to reduce the possibility of

entanglement, strangulation, or tripping.

Use the X-100M monitor only within its designated range (approximately 100 meters (300 feet) spherical radius

from monitor to remote location). Moving outside this range may cause missing or lost data at the remote

monitoring location.

Memory is cleared if error code E06 appears on the display screen.

This device turns off after approximately 30 minutes when in low battery condition.

If this device is used adjacent to or stacked with other equipment, the device should be observed carefully to

verify normal operation.

DRAFT 10 DEC 2012

Summary of content (26 pages)

PAGE 1
Indications for Use DRAFT 10 DEC 2012 Indications for Use The Nonin Model X-100 SenSmart modular, universal oximeter system is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to 6 channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient population includes adult, pediatric, infant, and neonate through the use of SenSmart-compatible sensors.
PAGE 2
DRAFT 10 DEC 2012 Indications for Use Warnings (Continued) The battery pack must be installed at all times while the device is operating—even when operating on AC power. Do NOT use the device without batteries. The use of signal processors, sensors, accessories, and cables other than those listed in the Parts and Accessories List may result in increased electromagnetic emission and/or decreased immunity of this device.
PAGE 3
DRAFT 10 DEC 2012 Indications for Use ! Cautions (Continued) This device is designed to determine regional hemoglobin oxygen saturation of blood underneath the sensor and the percentage of arterial oxygen saturation of functional hemoglobin.
PAGE 4
DRAFT 10 DEC 2012 Indications for Use Declaration of Conformity with FCC and Canadian Ministry of Health Rules for Electromagnetic Compatibility • Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares under its sole responsibility that the Model X-100M, to which this declaration relates, comply with part 15 of the FCC Rules.
PAGE 5
DRAFT 10 DEC 2012 Guide to Symbols Guide to Symbols This chapter describes the symbols that are found on the Model X-100 system components and packaging. Detailed information about functional symbols can be found in "Displays, Indicators, and Controls" on page 7. Table 1. Symbols Symbol ! EC REP Description CAUTION! Authorized Representative in the European Community. Consult instructions for use. Follow instructions for use.
PAGE 6
DRAFT 10 DEC 2012 Guide to Symbols Table 1. Symbols (Continued) Symbol Description Defibrillation-Proof Type BF Applied Part (patient isolation from electrical shock). (X-100SP) Do not discard. Do not pull on cable. Retract connector and remove. Lot Number Non-sterile NON STERILE +70°C Storage/shipping temperature range of -30 °C to 70 °C (-22 °F to 158 °F). -30°C Handle with care. Keep dry.
PAGE 7
Displays, Indicators, and Controls DRAFT 10 DEC 2012 Displays, Indicators, and Controls This chapter describes the displays, indicators, and controls for the Model X-100M. 1 7 2 3 4 5 8 6 9 11 10 12 Figure 1. X-100M Front View Table 2: X-100M Features No. 1 Symbol Description Alarm Silence Button Press Alarm Silence to silence alarms for 2 minutes. Audible alarms may be reactivated before the 2 minute silence period is over by pressing Alarm Silence again.
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DRAFT 10 DEC 2012 Displays, Indicators, and Controls Table 2: X-100M Features No. 3 Symbol Description Menu Button Pressing this button opens the Settings menu and allows access to the Presets, Case, and System menus: • Settings – allows users to assign a sensor site name to a channel, select sensor type (rSO2 or SpO2), set limits and graphs, and review presets. See "Settings Menu Screen" on page 30 for more information.
PAGE 9
Displays, Indicators, and Controls DRAFT 10 DEC 2012 Table 2: X-100M Features No. Symbol 7 Description Navigation Buttons These buttons are used to navigate between fields and scroll the timescale. (Up) and (Down): In menus, used to navigate between items. On the monitoring screen, used to change the rSO2 trendline timescale. (Right): In menus, used to navigate between items. On the monitoring screen, used to scroll forward in time in the current case. (Left): In menus, used to navigate between items.
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DRAFT 10 DEC 2012 Displays, Indicators, and Controls 1 2 3 4 6 5 8 7 9 14 10 15 16 13 11 12 Figure 2. Monitoring Screen (Four-Channel View) Table 3. X-100M Monitoring Screen Symbols and Indicators No. 1 2 Symbol Description ex. A B Event Marks Located at the top of the monitoring screen, event marks (A, B, C, D, etc.) display when the Event Mark button is pressed. ex.
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Displays, Indicators, and Controls DRAFT 10 DEC 2012 Table 3. X-100M Monitoring Screen Symbols and Indicators (Continued) No. Symbol Description 6 %rSO2 Regional Hemoglobin Oxygen Saturation %rSO2 displays from 0 to 100% when a monitored channel is setup to measure %rSO2 or a regional sensor is attached to a signal processor. The device continually displays an rSO2 trendline for each monitored channel.
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DRAFT 10 DEC 2012 Displays, Indicators, and Controls Table 3. X-100M Monitoring Screen Symbols and Indicators (Continued) No. Symbol Description 11 Sensor Fault This yellow indicator flashes when a sensor is disconnected, has failed, or is not compatible with the monitor. 12 Poor Signal This yellow indicator flashes when there has been a sustained period of poor patient signals from the sensor. Check the sensor site and reposition or replace the sensor if necessary.
PAGE 13
DRAFT 10 DEC 2012 System Components and Setup System Components and Setup NOTES: • Before using the SenSmart system, please review all contraindications, warnings, and cautions. • Before using the Model X-100M for the first time, the battery should be charged for 4 hours. Carefully remove the monitor and accessories from the shipping carton. Save the packaging materials in case the monitor or accessories must be returned.
PAGE 14
DRAFT 10 DEC 2012 System Components and Setup Figure 3. System Components and Setting Up the Monitor X-100M (Monitor) The X-100M SenSmart monitor allows the user to view up to six channels of rSO2 and SpO2 data. Each channel is color coded to match a signal processor. See table 2 for monitor features and descriptions. For cleaning instructions, refer to "Care and Maintenance" on page 67.
PAGE 15
System Components and Setup DRAFT 10 DEC 2012 X-100H (Hub) The X-100H hub connects to the connector port on the front of the monitor. The hub provides connections for up to six X-100SP signal processors via the hub ports. Each hub port has a protective port cover. ! CAUTION: Do not attempt to connect more than one hub in the system. ! CAUTION: Do not attempt to use an extension cable between the monitor and the hub. For cleaning instructions, refer to "Care and Maintenance" on page 67. Figure 4.
PAGE 16
DRAFT 10 DEC 2012 System Components and Setup X-100HH (Hub Holster) The hub fits inside the X-100HH hub holster. The hub holster features a clamp that allows the hub to be attached to hospital bed rails and equipment poles. Using the Hub Holster 1. Align the hub and hub cable to the hub holster. 2. Push firmly to insert the hub into the hub holster. Figure 5. X-100HH – Hub Holster Table 5.
PAGE 17
System Components and Setup DRAFT 10 DEC 2012 Connect/Disconnect a Signal Processor to/from Hub or Monitor 1. To connect: a. Align the arrow on the signal processor cable connector with the arrow on one of the hub ports or the monitor connector port. b. Push the signal processor cable connector into the port. c. The signal processor cable connector will click when it locks into the hub or monitor. 2. To disconnect: a. Grasp the ring on the X-100SP signal processor cable connector. b.
PAGE 18
DRAFT 10 DEC 2012 System Components and Setup X-100EC (Extension Cable) Extension cables are available in 1- or 2-meter lengths. An extension cable may be used: • Between the hub and a signal processor. • Between the monitor and a signal processor. ! CAUTION: Do not attempt to use an extension cable between the monitor and the hub. ! CAUTION: Do not attempt to connect multiple extension cables between the monitor and the hub or between the hub and a signal processor.
PAGE 19
DRAFT 10 DEC 2012 System Operation System Operation ! CAUTION: Between patients, turn the X-100M monitor off (Standby mode) or start a new case (Case Menu). Failure to do so could result in inaccurate baseline values for the new patient. When the device is turned ON or a new case is started, the monitor clears the baseline values, resets the limits to the default values, and begins a new patient record in data memory.
PAGE 20
DRAFT 10 DEC 2012 System Operation Sensor Application Refer to the sensor Instructions for Use (IFU) for proper sensor application sites and sensor application cautions and warnings. WARNING: This device is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
PAGE 21
System Operation DRAFT 10 DEC 2012 Operating Screens and Menus The X-100M monitoring screen can be configured to display up to six channels of rSO2 and SpO2 data, along with rSO2 trendlines and SpO2 plethysmograms. See “Monitoring Screen” on page 25 for more information. The operating menus display when the Menu button is pressed. The Settings Menu screen opens and additional menu tabs for Presets, Case, and System display across the top of the screen.
PAGE 22
DRAFT 10 DEC 2012 System Operation Bluetooth Technology Bluetooth allows wireless connections between electronic communications and computing devices. The technology is based on a radio link that offers fast and reliable data transmissions. Bluetooth uses a license-free, globally available frequency range in the ISM band—intended to ensure communication compatibility worldwide.
PAGE 23
DRAFT 10 DEC 2012 System Operation Dymo® Printer The optional Dymo LabelWriter® SE450 printer connects to the monitor via the RS-232 port. When the printer is connected and the RS-232 port is set to Printer, an event summary label prints each time the Event Mark button is pressed. The label (figure 9) provides the following information: • Event date and time (if date and time are set correctly on the monitor). • Event mark letter displays along with space to write a patient summary for the event.
PAGE 24
DRAFT 10 DEC 2012 System Operation g. Press up/down to select “Printer.” h. Press Select to save the setting. i. Press Menu to close the pop-up and return to the System Menu screen. j. Press Menu to return to the monitoring screen. 2. Connect the printer cable to the RS-232 port. 3. When monitoring a patient, an event summary label prints each time Event Mark is pressed.
PAGE 25
Monitoring Screen DRAFT 10 DEC 2012 Monitoring Screen This section contains: • Description of the monitoring screen features • Monitoring screen procedures (see “Monitoring Screen – Procedures” on page 29) Monitoring Screen – Description Channels Real-time numeric data displays by channel on the right side for up to four channels. When six channels are monitoring, the channels display on the right side and along the bottom of the screen.
PAGE 26
DRAFT 10 DEC 2012 Monitoring Screen Figure 10. Monitoring Screen with 4 rSO2 and 2 SpO2 Channels Connected (Example) Event Marks Event marks are located at the top of the monitoring screen above the timescale (figure 11). When pressed, the Event Mark button places a mark on the displayed trendline, in the memory, and in the real-time serial data output. Events are marked with increasing alphabetic letters. When Z is reached, the letters start over at A. Figure 11.