IQvitals PC. OPERATION MANUAL Version 8.6.1

Transcription

1 IQvitals PC OPERATION MANUAL Version 8.6.1

2 Notice The information in this manual is subject to change without notice. Midmark Diagnostics Group shall not be liable for technical or editorial omissions made herein, nor for incidental or consequential damages resulting from the furnishing, performance, or use of this guide. This document may contain proprietary information protected by copyright. No part of this document may be photocopied or reproduced in any form without prior written consent from Midmark Diagnostics Group. IQecg, IQholter, IQspiro, IQvitals, IQstress, IQpath and IQmanager are trademarks of Midmark Corporation. Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries. Intel and Intel Core are trademarks of Intel Corporation in the United States and other countries. Alaris and Turbo Temp are registered trademarks of CareFusion Corporation. UltraCheck is a registered trademark of Statcorp Medical, a division of OSI Optoelectronics Company. Fairbanks and TeleWeigh are trademarks of Fairbanks Scales, Inc. ENZOL, CIDEZYME, and CIDEX are registered trademarks of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company Part number for this Operation Manual: Rev. C CAUTION: Federal Law restricts this device to sale by or on order of a physician or properly licensed practitioner.

3 Related Documents: Midmark IQmanager Operation Manual (Part number: ) Midmark Setup Manual: Midmark Products over Thin Client using IQpath or COM port mapping (Part Number: ) All documents referenced above are located on the Midmark Operation Manuals CD (part number: ) included with every device. All product Operation Manuals can also be downloaded from midmark.com. For additional information, contact Midmark Technical Service at , option 2.

4 TABLE OF CONTENTS I. INTRODUCTION... 1 A.NECESSARY COMPUTER SKILLS... 1 II. PRODUCT OVERVIEW AND GENERAL INFORMATION... 1 A.INTENDED USE... 2 B.WARNINGS... 2 C.CAUTIONS... 3 D.SYSTEM SPECIFICATIONS... 5 E.MINIMUM COMPUTER REQUIREMENTS... 7 F.THIN CLIENT CONFIGURATION... 9 Thin Client Using IQpath Software Solution... 9 Thin Client Using COM Port Mapping III. SYMBOLS IV. DEVICE UNPACKING AND SETUP A.CONTENTS CHECKLIST B.INITIAL DEVICE SETUP Attach accessories Charge the battery Connect to computer Start the device C.SOFTWARE INSTALLATION Windows Taskbar Screen Saver Installing IQmanager and Bundled Software D.INTRODUCTION TO CONFIGURING IQMANAGER E.CONFIGURING IQMANAGER WITH IQVITALS PC F.IQVITALS PC SETTINGS G.CONFIGURING A DIGITAL SCALE WITH IQMANAGER H.CONFIGURING A HEALTH O METER DIGITAL SCALE WITH IQMANAGER V. BASIC FUNCTIONS A.AC POWER TRANSFORMER B.BATTERY C.ON/OFF BUTTON AND BATTERY CHARGE INDICATOR D.BLOOD PRESSURE BUTTON E.OPERATION OF IQVITALS PC WITH IQMANAGER Starting IQmanager Opening Screen... 34

5 VI. TESTING A NEW PATIENT A.HELP SCREEN B.IMPORTANT COMPUTER DATE INFORMATION C.VITAL SIGNS TAB D.REVIEW AND TRENDING OF VITAL SIGNS E.TESTING SCREEN DISPLAY F.DISPLAY OF DATA G.BLOOD PRESSURE OPERATION Blood Pressure Cuff Selection Proper Application and Positioning of Blood Pressure Cuff Initiating a Blood Pressure (BP) Measurement H.TEMPERATURE OPERATION Taking an Oral Temperature Taking an Axillary Temperature I.PULSE OXIMETRY OPERATION (SPO 2 ) J.PAIN SCORE K.MANUAL ENTRY OF RESPIRATION RATE L.MANUAL ENTRY OF HEIGHT M.MANUAL ENTRY OF WEIGHT N.USING A CONNECTED DIGITAL WEIGHT SCALE VII. ERROR CODES AND CORRECTIVE ACTIONS VIII. CLEANING OF IQVITALS PC IX. MAINTENANCE, STORAGE AND BATTERY REPLACEMENT A.MAINTENANCE STORAGE BATTERY REPLACEMENT X. CUSTOMER SUPPORT AND WARRANTY INFORMATION XI. DISPOSAL XII. ACCESSORIES AND SUPPLIES XIII. ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION XIV. CONTACT INFORMATION... 76

6 I. Introduction A. Necessary Computer Skills NOTE: This manual is intended for a user capable of using Microsoft Windows based applications with some understanding of PC operations and familiarity with the basic operations of Windows. This operation manual is a comprehensive guide, designed to educate the user on the operation and functions of the IQvitals PC device with IQmanager software. The information in this manual includes all options that are available with IQvitals PC, such as SpO 2 and a scale. The manual may contain information about functions that are not included with all devices. II. Product Overview and General Information The IQvitals PC automatically and non-invasively measures systolic and diastolic blood pressure, pulse rate, temperature (oral or axillary), and oxygen saturation (SpO 2 ) for adult and pediatric patients. All functions of the device are performed via the IQmanager software, except for the on/off function, controlled by a separate button on the front of the device. NOTE: IQvitals PC is not intended for use on neonatal patients. NOTE: For accuracy and safety in pediatric blood pressure measurements, the smallest cuff approved for use on infants and small children is the Infant (# ). It is important that the child s arm fits within the range markings on the cuff being used. IQvitals PC has a rechargeable, lithium ion battery and four mounting options: a mobile cart, countertop mount, wall mount, and IV pole mount. All vitals parameters can be simultaneously measured and are easily viewed in the IQmanager software. NOTE: The IQvitals PC is not intended for continuous monitoring of patients or for use during patient transport. Temperature is measured at oral and axillary sites. 1

7 A. Intended Use The IQvitals PC is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO 2 ), temperature, and weight. Patient information, such as name, age, height, pain score, etc., can be entered manually. B. Warnings WARNING: Do not use this device for any purpose other than its specified intended use. WARNING: IQvitals PC is not intended for continuous monitoring. Do not leave a patient unattended while taking measurements with this device. WARNING: IQvitals PC is not intended for use during patient transport. WARNING: To ensure patient safety, only use supplies and accessories that are supplied with the IQvitals PC and recommended by Midmark. Using unapproved accessories can affect patient and/or operator safety. WARNING: Regularly inspect the blood pressure cuff, SpO 2 cable, and other accessories for damage. Replace accessories as needed. WARNING: IQvitals PC is not intended to be hand-held during operation. WARNING: Do not connect more than one patient to the device at the same time. WARNING: Do not route the cables of the device in a way that may present a stumbling hazard. WARNING: IQvitals PC is not intended for use in the following cases: neonatal patients apnea monitoring in a magnetic resonance imaging (MRI) environment in an electro-static unit (ESU) environment applications requiring arrhythmia detection WARNING: FLAMMABLE ANESTHETICS: An explosion hazard exists if the monitor is used in the presence of flammable anesthetics. WARNING: BLOOD PRESSURE MEASUREMENT: Avoid frequent and prolonged blood pressure measurements, which can result in petechia, ischemia, purpura or 2

8 neuropathy. In addition, be sure that the blood pressure hose does not become kinked during a measurement. If left unattended, this could result in sustained pressure in the blood pressure cuff. WARNING: BATTERY HANDLING: The IQvitals PC contains a lithium ion battery. The following precautions should be taken regarding this battery: Do not immerse in water. Do not heat or throw in fire. Do not leave in conditions over 60 C or in a heated car. Do not attempt to crush or drop. Only use the battery with the IQvitals PC. Follow the instructions in the Disposal section of this manual when the IQvitals PC is taken out of service. C. Cautions Review the following information to avoid damage to the device and to ensure proper operation: CAUTION: Familiarize yourself thoroughly with the operational procedures of the device prior to use. CAUTION: Do not operate the IQvitals PC near high-frequency emissions (e.g. microwaves). CAUTION: IQvitals PC is intended for indoor use only. CAUTION: Substitution of components different from those supplied could result in measurement error. CAUTION: The device and its accessories are not intended to be sterilized by any method. Attempting to do so may permanently damage the equipment. CAUTION: Electronic devices can be damaged by exposure to liquids. Do not use or store the IQvitals PC near any type of liquids. CAUTION: In case of malfunction, call Midmark Technical Service department and be prepared to describe the problem. CAUTION: To ensure proper operation, perform routine inspection, and maintenance on the device. (See Section IX, Maintenance, Storage and Battery Replacement.) 3

9 CAUTION: Do not make any modifications to the device. Any modifications made will void the warranty. CAUTION: Refer servicing to qualified personnel. CAUTION: ARRHYTHMIA PATIENTS: The IQvitals PC device is designed to operate in the presence of cardiac arrhythmias, however, NIBP readings, and parameters derived from it, may be inaccurate for patients experiencing moderate to severe arrhythmia. CAUTION: BLOOD PRESSURE MEASUREMENT Do not allow the blood pressure cuff or hose to come into contact with fluids. If this occurs, consult the Cleaning section of this manual for drying instructions. Check the hose and cuff frequently for signs of damage or debris. An obstruction in the hose may interfere with inflation and deflation, resulting in inaccurate readings. To obtain accurate blood pressure readings, keep the limb and the cuff motionless. The blood pressure cuff should be at the same level as the patient's heart. If you cannot place the NIBP cuff at this level, add 1.4 mmhg to the measured pressure values for each 2 cm above the heart level, or subtract 1.4 mmhg for each 2 cm below heart level. Blood pressure measurements may not be accurate if the patient is convulsive or experiencing tremors. Check for kinks in the blood pressure hose if the device reports a measurement problem. CAUTION: PULSE OXIMETRY MEASUREMENT (SpO 2 ) Read instructions provided with the sensor to understand the best application technique and all relevant safety information. Do not apply the sensor on the same limb as the NIBP cuff. Refer to Section XII Accessories and Supplies for approved SpO 2 sensors. During blood pressure measurements, the perfusion is temporarily reduced, which can result in inaccurate pulse oximetry readings. Elevated levels of carboxyhemoglobin or methemoglobin can result in inaccurate pulse oximetry readings. Bright light can create problems with the pulse oximetry measurements, resulting in inaccurate readings. If the sensor is in a place where it may be exposed to bright light, you should cover it with some opaque material. Pulse oximetry readings may be inaccurate in the presence of excessive motion artifact or tremors. 4

10 D. System Specifications General Performance Category Product Name Product Type Product Weight IQvitals PC Specification PC based non-invasive, automated vital signs measurement device 3.2 Lbs. (1.45 kg) Product Dimensions 10.5 L X 4 W X 7 H (.27x.10x.18 m) Power Requirements Input: V ~/ 50 60Hz / 700mA Output: 15V / 2A Battery Requirements Type of Protection (Electrical) Degree of Protection (Water) Battery Type: Rechargeable, 10.8 V lithium ion Low Power Indicator Automatic Shutdown on low power Operating Time: Approximately 8 hours Leakage current: Meets AAMI/IEC/CSA requirements Battery charge time: 4 hours to fully charge, 3 hours for 95% charge Class II IPX1. Disinfecting Method Degree of Safety (Flammable Anesthetic Mixture) Per the instructions in the Cleaning section of this manual Not suitable for use in the presence of a Flammable Anesthetic Mixture EMS Standard Per IEC and FCC Part 15 (Emissions Class B) Device Connectivity USB (Client) and serial Accessory Connectivity USB1.1 (Master) Environmental Cooling Category Operating Temperature Storage Temperature Convection (no fan) Specifications 32 to 104 F (0 to 40 C) (For Patient Temperature Measurement: 16 to 33 C) -4 to 140 F (-20 to 60 C) Operating Humidity 15 to 90% non-condensing 5

11 Storage Humidity Operating Altitude Storage Altitude Non Invasive Blood Pressure Method Cuff Category Derived Parameters Measurement Range Measurement Accuracy Pulse Rate Range Pulse Rate Accuracy Initial Cuff Pressure Overpressure Cutoff Measurement Time Temperature 15 to 95% non-condensing 0 to 15,000 feet 0 to 40,000 feet Oscillometric Specifications Infant, Child, Small Adult, Adult, Adult Long, Large Adult, Large Adult Long, and Thigh Systolic, Diastolic and Mean Arterial Pressure Systolic: 30 to 250 mmhg MAP: 20 to 230 mmhg Diastolic: 10 to 210 mmhg Systolic: ±5 mmhg MAP: ±5 mmhg Diastolic: ±5 mmhg 30 to 240 BPM ±5% or ±2 BPM, whichever is greater User-selectable 290 ± 3 mmhg (normal means), 300 ± 30 mmhg (back-up) Approximately 30 seconds Probe Type Scale Category Measurement Type Measurement Range Measurement Accuracy Measurement Time Alaris Turbo Temp Fahrenheit (F) Celsius (C) Oral and Axillary Oral: 95 to 106 F Axillary: 95 to 106 F ±0.1 C (±0.2 F) (probe) Predictive Oral: 8-10 seconds Axillary: seconds Specifications 6

12 Pulse Oximetry (SpO 2 ) Method Category SpO 2 /PR Resolution Measurement Range Measurement Accuracy Report Interval Specifications Absorption Spectrophotometric (dual wavelength) (Functional oxygen saturation of arterial hemoglobin) SpO 2 : 1 O 2 % PR: 1 BPM (beat per minute) SpO 2 : 20 to 100% PR: 30 to 240 BPM SpO 2 : from 70 to 100%: ±2% (O 2 %), < 70%: unspecified PR: ±5% 1 second. Numeric values held < 30 seconds Fairbanks Scale Category Specifications Measurement Range Resolution Zeroing Power 0 to 500 lbs 0.5 lbs Automatic 12 VDC (from IQvitals device) E. Minimum Computer Requirements This section describes the minimum computer resources and hardware components needed when using new Midmark devices and software. As is the nature of technology to change often, these requirements will be evaluated and modified periodically. We suggest always referring to the most recent Minimum Computer Requirements document at or contact Midmark Technical Service at , option 2, for additional information. NOTE: If updating existing computer systems currently being used with older Midmark devices and software, please contact Midmark Technical Service before doing so. IQmanager is a Microsoft Windows based software package requiring approximately 90 megabytes (MB) of disk space when all options are installed. Additional disk space is required if storing the results of diagnostic tests performed, which is optional. This software operates on a personal computer using an Intel Core 2 Duo Processor or a faster processor, (Windows 8, or 7), and IQmanager software program with a minimum 2GB RAM. 7

13 CAUTION: IQmanager has been tested for proper function with the off-the-shelf (OTS) operating systems (OS) specified above; do not operate IQmanager with an OS other than those specified above. Future releases of currently approved OS should not be used until Midmark has conducted necessary performance tests with IQmanager. Before updating your OS, contact Midmark. IQvitals PC Minimum Computer Requirements Category Operating Systems Specification Windows 8, Professional and Enterprise, 32-bit and 64-bit Windows 7, Professional and Enterprise, 32-bit and 64-bit Hardware Requirements Windows compatible personal computer. CPU Intel Core 2 Duo Processor E4300 (2M Cache, 1.80 GHz, 800 MHz FSB) (x86) or 64-bit (x64) processor or faster Disk Memory Input/Output Ports 2 GB of free disks pace or greater Minimum 2GB of system memory One (1) USB port or one (1) serial port: Or One Universal Serial Bus (USB) port for the USB version of the IQ product One RS-232 Serial Port for the serial port version of IQ product The above computer port is required for new test acquisition. It is not required to review and/or edit a test. Additional USB ports may be required for keyboard, mouse, printer, etc. Pointing Device Keyboard Display Printer Windows compatible mouse Windows compatible keyboard 1024x768 or higher resolutions for the real-time acquisition screen. 16-bit color. Wide-screen (1680x1050) is highly recommended. Microsoft Windows compatible inkjet or laser printer. 8

14 Surge Protector One (1) hospital grade power surge protector for the computer system. The requirements above are the minimum specifications for operating the IQvitals PC through IQmanager. A faster CPU and/or more memory may be required to operate the IQvitals PC device through an EMR or install additional software. F. Thin Client Configuration If working within a thin client environment, IQmanager can be installed on the Terminal Server and operate the Midmark devices through a thin client terminal. Three types of thin client channels can be set up with this device: Citrix, Microsoft RDP and COM Port Mapping. IQmanager supports two thin client configurations: IQpath Software Solution and COM port mapping. IQpath works with either USB or serial port versions of IQvitals PC device in highlatency, limited bandwidth network configurations with Windows -based PC clients. For non- Windows thin-client devices on low-latency high-speed networks, use the serial port versions of the IQvitals PC and connect them to client devices via COM port mapping. Setting up any application in a network environment typically requires special access rights and knowledge of the network. Contact a system administrator to install and configure IQmanager. Thin Client Using IQpath Software Solution IQpath utilizes a dedicated flow control scheme to provide the following advantages over COM port mapping: Improved operation over high-latency, low-bandwidth, high-loss networks. o Microsoft Terminal Services: The performance improvement is approximately 10 to 1 in latency tolerance. o Citrix ICA: The performance improvement is approximately 40 to 1 in latency tolerance. No COM port mapping is required. The USB versions of the IQvitals PC device is compatible. Improved device auto-configuration and diagnostics. NOTE: IQpath has specific requirements for computer hardware, software, and network performance. System administrators should read Setup Manual: Midmark Products over Thin Client using IQpath or COM port mapping before installing, configuring, and using this software in a thin client environment. In a thin client environment, the client computers must be running Windows 8, or 7. To use IQpath, load IQmanager on the terminal server and install one of the following software components on each PC to be used for data acquisition: 9

15 IQpath Client for Microsoft Terminal Services if using Microsoft Terminal Services (Microsoft RDP) IQpath Client for Citrix ICA if using Citrix software These software products are provided separately and may be obtained by contacting Midmark at (800) , option 2. Once the software is installed on the client server network and client PCs, IQmanager must be configured for thin client operation as described in Section VI-F, of the IQmanager Operation Manual, Configuring for Client Server Networks. Thin Client Using COM Port Mapping COM port mapping is a configuration in which the IQvitals PC device connects to a serial port on a client computer and the server is configured to map the logical COM ports on the terminal server to the physical COM ports of the client. For a non-windows -based, thin-client terminal devices on a low-latency, high-speed network, use the serial port versions of the IQvitals PC device, and configure the thin client server for COM port mapping. NOTE: In order to use the COM port mapping solution in a thin client environment, the hardware, software, and network must meet stringent performance requirements. System administrators should read Setup Manual: Midmark Products over Thin Client using IQpath or COM port mapping before installing, configuring, and using this software in a thin client environment with COM port mapping. To use this configuration, install IQmanager on the terminal server and configure the server to map to the COM port on the client terminal. System administrators should configure the terminal server for COM port mapping as described in Setup Manual: Midmark Products over Thin Client using IQpath or COM port mapping. 10

16 III. Symbols The following symbols are associated with the IQvitals PC. Device Markings Follow instructions for use. Do not dispose of this product as unsorted municipal waste. For more disposal information, contact Midmark Diagnostics Group. MM/YYYY Manufacture date (month/year). Ingress protection against dripping water. Patient connections are type BF and protected against defibrillation. Device conforms to ANSI/AAMI ES :2005 Device is certified to CAN/CSA STD C22.2 No :08 Blood Pressure button: Stops blood pressure measurement in progress. Temperature Probe Connector. Power Input: Use only Midmark Power Supply (P/N ). Power Input: DC connector and connector polarity. USB B. Serial Network. Scale (for Health o meter scale connection). 11

17 IV. Device Unpacking and Setup Before unpacking IQvitals PC, inspect the external package for obvious signs of damage. If there are any signs of damage, file a claim immediately with the shipping company. Contact Midmark Technical Service immediately to report any product damage and to arrange for repair or replacement of damaged goods. A. Contents Checklist The IQvitals PC shipping box contains the items listed below. Open the package and account for each item. Inspect them for any signs of damage such as dents, cracks, tears, or scratches. If an item is missing or damaged, contact Midmark for a replacement. Depending on the device configuration purchased, not all items listed below will be in the box. Quantity Each Description 1 IQvitals PC Device 1 AC Power Cord 1 Adult Blood Pressure Cuff (26-35 cm) 1 Large Adult Blood Pressure Cuff (32-42 cm) 1 6.5' Blood Pressure Hose 1 Reusable, Adult SpO 2 Finger Sensor* 1 4' SpO 2 Extender Cable* 1 Oral/Axillary Temperature Probe 20 Temperature Probe Covers (one box) 1 Serial Cable 1 USB Cable 1 Operation Manual CD 1 Quick Reference Guide 1 Warranty Card *Applicable only to devices with the SpO 2 feature (device model number / kit product number ). 12

18 B. Initial Device Setup This section will guide you through the following initial device setup steps: Attach accessories Charge the battery Connect to computer Start the device Attach accessories Attach all accessories to the device before attaching the power cord and turning the power on. 1. Install the temperature probe to its connector, located on the back of the device (see Figure 3). Thread the temperature probe cord through the temperature cord guide (see Figure 3). Insert the temperature probe into its well (see Figure 1). Place the box of probe covers (included with the kit) in the probe cover holder of the device (see Figure 1). 2. Attach the blood pressure hose to the connector located on the left side of the device (see Figure 2). Attach the appropriate size blood pressure cuff to the fitting at the end of the blood pressure hose. 3. Connect the SpO 2 sensor to the left side of the device (see Figure 2). If desired, connect the included SpO 2 extender cable to the sensor. Next, attach the SpO 2 extender cable to the SpO 2 connector on the left side of the device (see Figure 2). *Applicable only to devices with the SpO 2 feature (refer to Section VI A, Contents Checklist. Charge the battery 1. Attach the power cord to the device (see Figure 3). The power input is located on the back of the device. Plug the power cord into the AC wall outlet. 2. It is suggested that the internal battery be fully charged before using the device: Allow approximately four hours to fully charge the battery. The Battery Charge Indicator will flash green when the unit is plugged into AC and the battery is being charged. The Battery Charge Indicator will be a solid green when the battery is fully charged. Connect to computer Connect the mini USB connector of the USB cable to the mini USB port on the back of the device and route the cable through the USB cable guide (see Figure 3) on the battery 13

19 door of the IQvitals PC device. The other end of the USB cable will be connected to an available USB port on the computer. Start the device 1. To start the IQvitals press the On/Off button located on the front of the device just below the touchscreen (see figure 4 below). The On/Off button will illuminate to indicate the device is on. The Battery Charge Indicator will flash green when the unit is plugged into AC and the battery is being charged. The Battery Charge Indicator light will be solid green when the battery is fully charged. Temperature Probe Well Probe Cover Holder Figure 1 14

20 SpO 2 Connector Blood Pressure Figure 2 USB Cable Guide Temperature Cord Guide Temperature Probe Connector Serial Connector Power Connector Input Figure 3 Scale Interface Mini USB 15

21 Blood Pressure Start/Stop Button Figure 4 On/Off Button Battery Charge Indicator 16

22 C. Software Installation The installation CD includes software for the installation and operation of IQmanager. Before installing IQmanager, it is important to complete the following tasks: Windows Taskbar IQmanager is designed to run as a full-screen program. For best results, set the taskbar to Auto-hide to provide maximum display area: Right-click on the taskbar, and select Properties. Make sure Auto-hide the taskbar is selected. Click OK. Screen Saver The screen saver or any energy-saving feature should be disabled when installing software. Close all windows. Right-click the desktop and select Properties. On the Screen Saver tab, click Power and turn off the screen saver. Installing IQmanager and Bundled Software To update a version of Brentwood/Midmark Diagnostic Workstation earlier than version 4.0 containing ECG or Holter records to transfer to IQmanager, the records must be archived to be restored after IQmanager is installed. Uninstalling version 4.0 or higher will not delete patient records or reports. WARNING: Uninstalling versions of the IQmark Diagnostic Workstation older than version 4.0 may automatically delete all patient records and reports. Contact Technical Service at (800) , option 2, before installing IQmanager. NOTE: Refer to Section VII-E, Save to File (Archive) of the IQmanager Software Operation Manual for information on how to archive patient records. Patient records should be archived to a temporary location other than the Brentwood folder. To restore patient archives, follow the instructions in Section VII-E, Read from File (Restore) in the IQmanager Software Operation Manual. NOTE: Close all programs before running the software installation. Once the installation program is initiated, it should not be interrupted until completed. The approximate installation time is five minutes. As with any software installation, log in as the administrator before proceeding. Contact the system administrator if you do not have this authority. 1. Insert the IQmanager software CD into the CD-ROM drive. 17

23 NOTE: If a previous version of IQmanager has not been uninstalled, the system will prompt you to do so. Follow the instructions on the screen to remove the previously installed version, and then reinstall the CD. 2. The CD should automatically start; the program will begin the InstallShield Wizard for IQmanager Click Install 3. Follow the instructions, and click Next. 4. At the license agreement, select Accept or Do Not Accept. Click Next to continue the installation 18

24 5. Select the hard drive on which to install the software, and click Next. If running the program on a single computer, it is recommended you select the C: drive. 6. The program automatically selects the Brentwood directory for the installation; this cannot be changed. Click Next. 19

25 7. Click Install to continue. The program will automatically install the software. This process may take 10 to 30 seconds, depending on your computer. 8. After installation is complete, the registration page is displayed. IMPORTANT: We encourage you to complete and return the registration form at this point of the set-up process. Once the product information is registered with Midmark it makes access to our Technical Service staff more efficient as we will know which devices you have and which software version you are currently using. Enter the practice s complete address and contact information; Provide serial numbers for all Midmark devices used with this software; Click Print; and Send completed form to Midmark. Fax number and mailing information will be included on the registration form. 20

26 9. Once the registration has been finished the following window will appear. Read the information and click OK to continue. 10. The following window will appear to indicate that the installation has completed successfully. Click Finish to proceed. 11. Return to the desktop and double click on the IQmanager icon to open the program. Midmark IQmanager 21

27 D. Introduction to Configuring IQmanager IQmanager can be customized by using the configuration settings. Access the Configuration Settings by one of the following ways: Double-click the shortcut installed on the desktop, or Click on the SETTINGS button in the upper right side of the IQmanager opening screen. If using the database on the network, the Configuration Settings also allows the user to set a default database. For complete details regarding configuring IQmanager Software refer to the IQmanager Operation Manual. If the practice name and details were entered during the registration/installation process, the information will appear in the Configuration Settings window under Institution Name and Institution Address. If the practice name and details were not entered during the registration/installation process, enter the information in the Configuration Settings window under Institution Name and Institution Address. This information will also be displayed on printed reports. Enter a name that describes the practice/location to enable other medical personnel to recognize the origin of the reports. 22

28 From the Configuration Settings dialog box, the following options can be selected: Metric or English units of measurement 12-hr or 24-hr formatted time AC power source frequency of 50 Hz or 60 Hz (The frequency setting is necessary for the ECG module, if it is connected to the computer. (Refer to the IQecg Operation Manual for more information.) Once the configuration settings are updated, click OK to save. The settings will take effect immediately if entered from the New Test screen; otherwise, they will be applied the next time IQmanager is started. Click Cancel to exit without making any changes, or click Default to restore the factory settings for all fields except Institution Name and Address. E. Configuring IQmanager with IQvitals PC The IQvitals PC Settings dialog box can be accessed in two ways: From the IQmanager Opening Screen From the main Patient Testing screen. To enter the Settings dialog box from the IQmanager Opening screen: 1. Click the Settings button. 23

29 2. Click the Serial Port button. 3. Click the box next to Enable Vital Signs Interface. 4. Next, click the Setup button under Enable Vital Signs Interface. 5. Update the settings, and click Save. (Refer to Section IV- F, IQvitals PC Settings for detailed explanation.) 24

30 To enter the Settings dialog box from the main Patient Testing screen: 1. Click the New Vital Signs button. 25

31 2. Click the Settings tab. 3. Update the settings, and click Save. (Refer to Section IV-F, IQvitals PC Settings for detailed explanation.) NOTE: When the device is properly connected a green USB - Connected message and a battery status bar will be visible on the screen. If the device is not properly connected, a red USB - Disconnected will appear on the screen and the battery status bar will not appear (see image in Step 3). 26

32 F. IQvitals PC Settings The IQvitals PC can be configured for customized operation. Ensure that the device is turned on and connected to a host computer. Navigate to the IQvitals Settings screen. 1. Click the Settings tab to make desired changes to the device settings. To change blood pressure inflation settings under BP Settings, click the up or down arrows to set the High, Medium, Medium-High, and Low settings to the desired range. Each pressure preset level has a range that can be entered. The following table lists the acceptable initial inflation values. BP Settings Default (mmhg) Range (mmhg) Low Medium Medium-High High Temperature Unit: Select Degree C or Degree F for the temperature measurement. Temperature Mode: Select Oral or Axillary to choose the thermometer mode. Weight Unit: Select Pounds or Kilograms to choose the measurement type for weight. Height Unit: Select Inches or Cm to choose the measurement type for height. 2. When all changes have been made in the Settings tab, click Save. 27

33 3. To return to the Patient Data Entry screen, click the Measurements tab. G. Configuring a Digital Scale with IQmanager IQmanager can import weight from specific digital instruments. 1. From the opening screen, click Settings. 28

34 2. In Configuration Settings dialog box, click the Serial Port button. 3. Select the Enable Scale check box. Click Setup. 4. From the Scale box, click the down arrow to choose the name and model number of the scale to be connected. If changes need to be made to the COM port or units of measure, change them from this screen. If the Midmark 625 Scale is selected, the IQvitals Control Panel will display the Midmark Table Scale icon in place of the normal Scale icon. 29

35 Click the Scale icon, and the following screen will appear. The Save button will be grayed out until a valid weight is captured from the IQscale. After the user clicks the Save button, the weight will be transferred to the weight control of the IQvitals Control Panel. Clicking the Close button will prompt a dialog box stating, Do you want to save the weight data? Click Yes or No, and the dialog box and Midmark IQscale Control Panel will close. 30

36 H. Configuring a Health o meter Digital Scale with IQmanager NOTE: If selecting the Health o meter scale option, the following window will appear. 1. Click Configure. The following window will appear. 2. Click AutoDetect, and follow the instructions on the screen. Once all steps have been completed click OK to save changes. 3. The system will close the window and return to the IQmanager Configurations Settings window. Click OK to return to the IQmanager Opening screen. 31

37 4. After the settings are saved, access the IQvitals PC from the Patient Data screen. 32

38 V. Basic Functions A. AC Power Transformer The IQvitals PC can be run on AC or battery power once the battery has been charged. B. Battery Check the battery level when the device is turned on. The device can be operated when the battery not fully charged. It takes approximately four hours to fully charge the battery. For optimal battery life, charge the battery before it reaches 20 percent battery power. A yellow warning will appear on the screen to let you know when the battery is at 40 percent power. When battery power is at 20 percent, the yellow warning will change to red. Charge the battery immediately. The battery icon will be displayed when you are connected to an IQvitals PC unit and the unit is powered by battery. The following screens show the icon images for the corresponding battery state. C. On/Off button and Battery Charge Indicator To start the device, press the On/Off button on the front of the device. The On/Off button will illuminate to indicate the device is on. The Battery Charge Indicator will flash green when the device is plugged into AC and the battery is being charged. The Battery Charge Indicator light will be solid green when the battery is fully charged. D. Blood Pressure Button To stop a blood pressure measurement at any time, press the BP button located on the front upper left of the device. This will discontinue cuff inflation and deflate the cuff. 33

39 E. Operation of IQvitals PC with IQmanager Starting IQmanager The software application for operating the IQvitals PC is called IQmanager and is located on the computer desktop as a shortcut icon. Double-click on this icon to start IQmanager. Opening Screen Midmark IQmanager When starting IQmanager, the following screen appears. 34

40 The following chart provides a brief description of all buttons on the IQmanager Opening screen and their functions. For further information, refer to the IQmanager Software Operation Manual. IQmanager Opening Screen Buttons Register a new patient and proceed with a new test. View a list of patients previously entered into the database. Select a patient from the list to enable access, edit, add and delete data from that patient s records, and view data from previous tests. Acquire an ECG before entering patient demographics or selecting a patient. Refer to the IQecg Operation Manual for more information. Acquire vitals before entering patient demographics or selecting a patient. Display which database is currently selected and enables users to configure the program to meet their needs. Calibrate the IQspiro. 35

41 IQmanager Opening Screen Buttons Assistance regarding the use, operation, and troubleshooting of IQmanager and other products. Exit the program and returns you to Windows. Connect to the Midmark website. These links only work if you are connected to the Internet. 36

42 VI. Testing a new patient To create a new patient file, click the New Patient icon on the Opening screen. This opens the Patient Data Entry screen for specific patient data entry. NOTE: If changes are made to any of the Vital Signs tabs after clicking New Patient from the Opening screen, a patient record must be created in order to exit the screen. NOTE: A patient name or ID must be entered to start a new test. It is highly recommended to enter all information available, including an ID. Each data field can be accessed by clicking it with the mouse or using the TAB key to move from field to field. Although some information is not essential for the operation of the IQvitals PC, it is important to complete each of these fields as accurately as possible. All four digits of the year must be entered for the Date of Birth. Height is located on the Vital Signs tab. 37

43 A. Help Screen The IQmanager has extensive online help that can be accessed by clicking the Help tab. 38

44 B. Important Computer Date Information The IQvitals PC uses the current date from the computer and the patient s birth date (entered by the user) to calculate the patient s age. Contact a system administrator if the computer s date is incorrect. The following table provides a brief description of the function for each field when acquiring data via the IQvitals PC device. Patient Data Entry Screen Fields for IQvitals PC Field Diagnostic Role Description Last Name First Name Middle Initial Required (except Middle Initial) Used for identification purposes. Letters and numbers may be used. ID Identification Used for identification purposes. Letters and numbers may be used. Race Informational Select one of several pre-labeled choices from the list. Date of Birth Enter using the mm/dd/yyyy format as set in the Informational (age) IQmanager Configuration Utility. Sex Informational Select the appropriate gender. Height Informational BMI is calculated from height and weight data entered. Use only numbers. Data may be entered in either English or Metric units, depending the setting in the IQmanager Configuration Utility. 39

45 C. Vital Signs Tab The Vital Signs tab displays the patient s most recent data. If no vital signs have been entered, the title of the control group title reads Vital Signs, and each field is editable. If vital signs have been previously entered, the control group title will read Vital Signs as of mm/dd/yy hh:mm:ss indicating the date and time of data entry, and those boxes will be read only. Enter the patient information needed in the empty data fields. NOTE: BMI (Body Mass Index) cannot be entered manually. This is calculated when the patient s height and weight are entered. BMI = W/H 2 (Metric). The World Health Organization measures BMI over 25 to be overweight and over 30 to be obese. There are a number of sources online that use different scales; research and use the point-of-reference preferred. If the boxes are not editable (gray), click New Vital Signs. The software will clear the current vital signs (except height and weight) and make the boxes available to enter the patient s current information. 40

46 D. Review and Trending of Vital Signs Each time the operator updates a vital signs measurement, the software stores the data as a new record in the database. To review the patient s vital signs records and trend a patient s vitals data: 1. Click Review Vital Signs to open the Vital Signs review screen. This screen displays the patient s vital signs history numerically and graphically in chronological order. 2. Previously entered vital signs numbers can be corrected or deleted. To edit a number, highlight the appropriate line and either double-click it or click Edit. The Edit Vital Signs dialog box appears. 41

47 3. To correct a previously entered number, highlight the number and type in the new number. 4. To delete a previously entered number, highlight the number and type in 0 (zero). The field will not display a zero after the Edit Vital Signs dialog box is closed. 5. To trend patient data, select the vitals data to trend from the Left Axis and Right Axis boxes. 42

48 IQvitals PC Operation Manual 6. Select different vital signs parameters to graph: Weight, Height, BP (Systolic), (Systolic) BP (Diastolic), BP (Sys/Dia) Pulse, Temperature, or SpO2. NOTE: BP (Sys/Dia) can only be selected to appear on one axis. 7. After selecting the data to display on both axes, click the Print icon toward the bottom of the screen and select Print to print a copy of the report. E. Testing Screen Display a. b. c. d. e. f. g. h. i. j. k. Settings Tab Blood pressure inflation settings Temperature mode selection Temperature measurement selection Time Display Save Battery charge level Help button Connect Cancel Table Scale (see Note below) a. b. c. d. k. j. i. e. h. g. 43 f.

49 NOTE: The Table Scale icon (item k. in diagram above) will appear when the IQvitals PC is configured to the IQscale. See Section IV-G Configuring a Digital Scale with IQmanager for complete instructions on configuring the IQscale with the IQvitals. F. Display of Data The following patient data will be displayed on the computer screen following an acquisition: a. Blood pressure b. SpO 2 c. MAP d. Pulse progress bar e. Temperature f. Pain score g. Respiration rate h. Height i. Weight j. Pulse rate b. c. d. a. j. e. i. f. h. g. 44

50 G. Blood Pressure Operation NOTE: Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, electronic or automated sphygmomanometers. Blood Pressure Cuff Selection Using the proper size blood pressure cuff is important for accurate blood pressure readings. Midmark recommends using Midmark or UltraCheck reusable cuffs with the IQvitals device. Cuffs that are too small may result in erroneously high blood pressure readings, and cuffs that are too large may result in erroneously low blood pressure readings. To verify the proper cuff size for a patient, wrap the cuff around the patient s extremity. The index line (white arrow) should fall within the white range markings on the cuff. If a patient falls between two cuff sizes, always use the larger cuff. 45

51 Refer to the following table to identify the size ranges of reusable blood pressure cuffs offered by Midmark. This table lists the cuff part number, name, and size range (based on the circumference of the patients arm*) in centimeters (cm) and inches (in). Midmark Part # Name Size Range (cm) Size Range (in) Infant Child Small Adult Adult Large Adult Adult Long Large Adult Long Thigh* *Part Thigh is based on the circumference of the patients thigh. NOTE: For accuracy and safety in pediatric blood pressure measurements, the smallest cuff approved for use on infants and small children is the Infant (# ). It is important that the child s arm fits within the range markings on the cuff being used. Proper Application and Positioning of Blood Pressure Cuff The preferred measurement site for adults and children is the upper arm. Other sites that can be used are the forearm, thigh, or ankle. Do not wrap a cuff over a patient s clothing; inaccuracies can occur. There may also be a marked difference between readings taken from the left arm and right arm. The cuff should be positioned level with the patient s heart. Measurements made with a cuff placed above heart level will produce lower blood pressure readings, and measurements made with a cuff placed below heart level will produce higher blood pressure readings. Place the cuff brachial artery marker over or close to the brachial artery. For best results, wrap the cuff snugly so that there is room for no more than two fingers under the cuff. Initiating a Blood Pressure (BP) Measurement 1. Make sure the IQvitals PC is in the Patient Data Entry screen. Enter the patient data in the top box before initiating a blood pressure test. Ideally, the initial inflation cuff pressure should be about 30 mmhg above the patient s systolic 46

52 pressure. A higher inflation pressure may cause the patient unnecessary discomfort. Choosing an inflation pressure that is too low may cause the device to re-inflate the cuff in order to obtain a systolic pressure. NOTE: Keep the patient s arm relaxed and motion free during the measurement. The patient should not talk or move during the BP measurement. 2. To stop a blood pressure measurement at any time, click the Stop button. When the measurement is stopped, the cuff will deflate and all buttons will be reenabled. 3. Click New Vital Signs. 4. With the properly sized and positioned cuff placed on the patient s arm, press the appropriate inflation rate button to start the IQvitals PC blood pressure module. The initial inflation cuff pressure should be about 30 mmhg above the patient s systolic pressure. 5. To change inflation rate settings, click one of the four BP inflation buttons. 6. While the BP measurement is running, an in-process wheel will appear, and a blue status bar will initially display NiBP Measuring..Wait. 7. When the BP measurement is complete, a blue status bar will display NiBP Measurement Complete, and the systolic and diastolic values will appear in the BP box on the screen. 47

53 8. A pulse rate will be displayed when a BP measurement is complete. The pulse rate value will appear below Pulse Rate on the screen. H. Temperature Operation The Alaris Turbo Temp Electronic Thermometer is an electronic thermometer that uses a heat-sensing device known as a thermistor to sense temperature. The thermistor is part of the electrical circuit and is located at the tip of the probe. In normal mode, a final temperature is displayed with an audible beep. To obtain this measurement, the probe tip measures the rate of change in temperature when the thermistor comes in contact with surrounding tissue. A final temperature is calculated based on this rate of change. Taking an Oral Temperature 1. Click the Temp button in the Patient Data Entry screen and make sure that the Oral button is highlighted; this indicates that the thermometer is in oral mode. If the Axil button is highlighted click the Oral button to return to Oral mode. 48

54 2. For oral temperatures, use the blue oral/axillary probe that is supplied with the IQvitals PC. Make sure that you are working in the Patient Data Entry screen. NOTE: If the probe needs to be replaced, use only Alaris brand probes. 3. Remove the probe from the probe well, grasping it in the top blue area between the thumb and index finger. Do not press down on the top area where the cord comes out of the top. An audible tone will sound when the probe has been removed from the storage well. 4. Insert the probe in a probe cover, and gently press down on the cover to ensure a secure fit. NOTE: Use only IVAC P850A probe covers with the Turbo Temp Thermometer. Size, shape, and thermal characteristics of the probe covers can affect the performance of the instrument. Inaccurate readings or retention problems may occur unless IVAC probe covers are used. To avoid cross contamination, use the probe cover only once. 5. Have the patient open his or her mouth, and place the probe with attached cover in the heat pocket (sublingual pocket) at the back of the mouth (see Figure 4.1). 49

55 Temperatures in the mouth can vary as much as 3 F from the relatively cool hard palate to the warm sublingual area. To take an accurate oral temperature reading, place the thermometer tip in either the right or left posterior pocket (heat pocket) at the base of the tongue. Figure Hold the probe during the entire measurement procedure. Keep the probe in contact with tissue at all times. Do not allow the patient to hold or reposition the probe during the measurement procedure. 7. During temperature measurement, a blue status bar initially displays Temp Measuring Wait. The oral measurement in normal mode takes approximately 8 10 seconds to complete. 8. An audible tone will sound when the measurement is complete. The blue status bar will display a Temp Complete message, and the patient s temperature will appear in the Temp box on the screen. 50

56 NOTE: Be sure to save the patient s temperature before taking another patient s temperature. NOTE: If there is a long delay from the time the probe is taken out of the well until a temperature is taken, the device may not take a temperature. Put the probe back in the storage well, and remove it again to reset the thermometer. NOTE: If the probe tip temperature is higher than 34.4 C (94 F) when taken out of the probe storage well, the thermometer will not be able to obtain a measurement and will report a TEMP-313 code. In this case, return the probe to its well and repeat the measurement. 9. To remove the probe cover, hold the probe as you would a syringe, and press the ejection button at the top of the probe (see Figure 4.2). Discard the used probe cover according to health care facility protocol. Figure Place the probe back in the storage well to reset the thermometer for the next patient. 51

57 Taking an Axillary Temperature 1. From the Patient Data Entry screen, click the Axil button to put the thermometer in axillary mode. If the Temp button displays Axil the thermometer is already in axillary mode. If the Temp button reads Oral, click the Axil button to return to Axil mode. The button will display Axil. 2. Remove the probe from the probe well, grasping it in the top blue area between the thumb and index finger. Do not press down on the top area where the cord comes out of the top. An audible tone will sound when the probe has been removed from the storage well. 3. Insert the probe in a probe cover and gently press down on the cover to ensure a secure fit. 4. Lift the patient s arm so that the entire axilla is visible, and place the probe in the axilla, making sure the tip of the probe is in contact with the skin and positioned close to the axillary artery. Once the probe is securely in place, the patient s arm should be tightly positioned alongside to the body. 5. To ensure continuous tissue contact and minimize patient discomfort, hold the probe in position until the audible tone sounds, indicating that the predictive measurement is complete. 6. Withdraw the probe, and eject the probe cover. Discard the used probe cover according to health care facility protocol. 7. Place the probe back in the storage well to reset the thermometer for the next patient. NOTE: With an audible tone and visual indication, the device will report a TEMP-313 code under the following conditions: Ambient temperature is less the 60.8 F or greater than 92.0 F Patient s predicted temperature is below 95.0 F or above 106 F Improper technique or inconsistent tissue contact Over one minute between probe removal from well and tissue contact 52

58 I. Pulse Oximetry Operation (SpO 2 ) Applicable only to devices with the SpO 2 feature (device model number / kit product number ). Each SpO 2 capable IQvitals PC Device is shipped with one reusable adult SpO 2 finger clip sensor. Carefully read the sensor directions for use before using. NOTE: Refer to Section XII Accessories and Supplies for approved SpO 2 sensors. 1. To perform the SpO 2 measurement, go to the IQmanager Patient Data screen. Click the New Vital Signs button. 2. Insert the patient s finger (preferably the left or right index finger) completely into the sensor. Place the sensor with the LED light positioned on the fingernail. NOTE: If patient movement is occurring or the finger size is inappropriate, select a different sensor that is appropriate for the patient. NOTE: The thumb should not be used with the finger clip sensor. NOTE: If the blood pressure measurement is occurring simultaneously, place the finger clip sensor on the limb opposite the one with the blood pressure cuff. NOTE: Avoid dark nail polish or direct sunlight on the probe, as these conditions may result in inaccurate readings. 53

59 3. When the SpO 2 test begins, the in-process wheel will appear. The blue status bar will display SpO 2 Measuring Wait while the measurement is in progress. 4. When the SpO 2 measurement is done, the blue status bar displays SpO 2 Complete. The SpO 2 value continues to update as long as the sensor is on the patient s finger. 5. When the sensor is removed or becomes detached from the patient, an audible tone is heard. If the sensor is not reconnected to the patient, the last measurement is displayed in the SpO 2 box on the screen. 6. When the measurement time has exceeded 10 minutes for one patient, a 312 error code appears that alerts the user that the SpO 2 has exceeded the 10- minute time limit. NOTE: The SpO 2 module is not intended for continuous monitoring of a patient. When the SpO 2 measurement is complete, click OK to save the data on the Patient Data testing screen. 54

60 J. Pain Score 1. Click in the Pain Score box. 2. Select the appropriate pain score by pressing the corresponding number. 3. Click Save to save the new pain score to the patient record and return to the Main Testing screen. 4. Click Cancel to disregard any changes and return to the Main Testing screen. NOTE: Pain Score will only be saved to the patient record if the Save button is clicked. If a pain score is selected but the Cancel button is clicked the changes will not be saved to the patient record. K. Manual Entry of Respiration Rate The respiration rate can be entered manually from the Patient Data testing screen. Click in the Respiration Rate box, and enter the data from RPM. If you enter data that is outside the range, an error message will appear asking you to enter a score within range. 55

61 L. Manual Entry of Height The height can be entered manually from the Patient Data testing screen. Click in the Height box, and enter the data from inches ( cm). If you enter data that is outside the range, an error message will appear asking you to enter a score within range. M. Manual Entry of Weight The weight can be entered manually from the Patient Data testing screen. Click in the Weight box, and enter the data from 1 1,000 lbs (1 500 kg). When the user enters data that is outside the range, an error message will appear asking the user to enter a score within range. 56

62 N. Using a Connected Digital Weight Scale Select digital scales can be connected to the IQvitals PC or to the user s computer to automatically read the patient s weight. The scale button is accessed from the IQvitals Control Panel. 1. Click the Scale button. 2. The Scale Control Panel will appear. NOTE: Do not proceed with the weight measurement until certain that the scale is displaying Have the patient stand on the scale or if using the Midmark with IQscale, have the patient sit on table. 4. Allow the weight measurement to stabilize. (Some Health o meter models will make an audible noise when the weight measurement is complete.) 5. The weight will display in the Weight field. 57

63 6. Click Save. 58

64 The system will return to the Patient Data screen in IQmanager, and the weight will be recorded. 59

65 VII. Error Codes and Corrective Actions The following table contains corrective actions for issues that may be encountered while operating IQvitals PC. If an issue persists after completing the recommended actions provided below, contact Midmark Technical Service at , option 2. Code Meaning Displayed Description Corrective action Non-Invasive Blood Pressure NIBP 305 Artifact The monitor was not able to measure blood pressure. Request that the patient remain still. Retry the measurement. NIBP 306 Hardware failure The monitor cannot measure blood pressure. Power cycle the monitor. (Power the unit off for a short time, and then power the unit on again.) If problem persists, contact Technical Service. NIBP 309 Overpressure The cuff pressure was too high. Request that the patient remain still. Retry the measurement. NIBP 310 Blocked line The BP hose is constricted. Straighten out the hose. Retry the measurement. NIBP 311 Open line The BP cuff is not inflating. Check to make sure the NIBP hose and cuff are attached to the monitor. If problem persists, contact Technical Service. NIBP 312 Measurement timeout The blood pressure measurement was taking too long to complete. Request that the patient remain still. Retry the measurement. NIBP 313 Cannot measure The monitor was not able to measure blood pressure. Request that the patient remain still. Retry the measurement. 60

66 Code Meaning Displayed Description Corrective action NIBP 314 Weak signal The monitor was not able to measure blood pressure. Check to see that the cuff is reasonably tight, or consider using a smaller cuff. Instruct patient to remain still. Retry the measurement. SpO 2 SpO Unplugged The SpO 2 cable is disconnected from the monitor. Connect the SpO 2 cable to the monitor and retry the measurement. SpO Artifact The monitor was not able to measure SpO 2. Request that the patient remain still. Retry the measurement. SpO Hardware failure The monitor cannot measure SpO 2. Power cycle the monitor. If problem persists, contact Technical Service. SpO Time Out The monitor was not able to obtain or finish an SpO 2 measurement in time. Check the SpO 2 sensor placement. Check to see if the patient has cold hands. If patient is moving request they remain still. Retry the measurement. SpO Weak signal The monitor was not able to measure SpO 2. Check the SpO 2 sensor placement, and check to see if the patient has cold hands. Retry the measurement. SpO Probe fault There is a problem with the SpO 2 sensor. Replace the SpO 2 sensor. If the problem persists, contact Technical Service. SpO Check sensor The SpO 2 sensor is misaligned or came off the patient. Check the SpO 2 sensor placement. Retry the measurement. TEMP 61

67 Code Meaning Displayed Description Corrective action TEMP 302 TEMP 304 TEMP 306 TEMP 313 TEMP 315 TEMP 330 Battery Unplugged Temp too high Hardware failure Cannot measure Probe fault Temp too low BAT 325 Battery low Monitor MON 332 Monitor fault The TEMP cable is disconnected from the monitor. The monitor was not able to measure TEMP. The monitor cannot measure TEMP. The monitor was not able to measure TEMP. There is a problem with the TEMP probe. The monitor was not able to measure TEMP. Battery low The monitor detected an internal problem. Connect the TEMP cable to the monitor. Retry the measurement. Check the TEMP probe placement. Keep the probe still. Retry the measurement. Power cycle the monitor. If problem persists contact Technical Service. Check the TEMP probe placement. Keep the probe still and retry the measurement. Replace the TEMP sensor. If the problem persists, contact Technical Service. Check the TEMP probe placement. Keep the probe still, and retry the measurement. Connect the monitor to the wall outlet to recharge the battery. Power cycle the monitor. If the problem persists, contact Technical Service. 62

68 Trouble Symptom Possible Causes Things to Try No power to outlet. Verify that the power outlet is working. Verify that the green power LED on the IQvitals PC front panel is illuminated. Verify that the green charging LED on the IQvitals PC front panel is The IQvitals PC is The IQvitals PC Power illuminated. plugged in, but it does Supply is not working. If possible, try using a different not start up. IQvitals PC Power Supply. The IQvitals PC is not working. The IQvitals PC speaker is not working. The IQvitals PC is not working and displays an error message. The IQvitals PC is powered off. Internal system error. Patient is moving. Device failure Speaker failure Operating system failure Set the power switch to the On position. Power cycle the IQvitals PC. If the condition persists, stop using the device. Contact Technical Service. Ask patient to remain still. Power cycle the IQvitals PC. If the condition persists, stop using the device. Contact Technical Service. Power cycle the IQvitals PC. If the condition persists, stop using the device. Contact Technical Service. Power cycle the IQvitals PC. If the condition persists, stop using the device. Contact Technical Service. 63

69 VIII. Cleaning of IQvitals PC A. Cleaning of the IQvitals PC and Accessories The following table provides instructions for how to clean the IQvitals PC and its accessories. The IQvitals PC should be cleaned monthly or as warranted. Before cleaning, refer to the cautions listed below. Part Recommended Cleaning Method Materials Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US) Distilled water Disinfectant solution (such as CIDEX OPA or a 10% solution of household bleach, with5.25% sodium hypochlorite, in distilled water) Soft cloths and/or soft-bristled brushes Protective gloves and eyewear IQvitals PC Temperature Probe Cable SpO 2 Cable NIBP Cuff NIBP Hose IQvitals PC Power Supply IQvitals PC Power Cord Procedure 1. Disconnect the unit from the wall outlet. 2. Put on gloves and protective eyewear. 3. Prepare the enzymatic detergent, or disinfectant solution, according to the manufacturer's instructions and in separate containers. 4. Apply detergent to product using a soft cloth. If material is dried on, allow to sit for one minute. 5. Wipe smooth surfaces with the cloth. 6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces. 7. Remove detergent from product using a cloth dampened in distilled water. 8. Repeat as necessary. 9. Apply disinfectant solution on affected area using a soft cloth. Allow product to sit for five minutes. 10. Wipe away excess solution, and clean product again with cloth dampened in distilled water. 11. Allow two hours for drying. 64

70 Part Recommended Cleaning Method Materials 70% isopropyl alcohol pad SpO 2 Sensor Procedure Remove sensor from patient, and disconnect sensor cable from the device. Wipe off with alcohol pad. Allow sensor to dry before placing it on a patient. Temperature Probe Covers Temperature probe covers are one-time use only. CAUTION: Always disconnect the IQvitals PC from AC power before cleaning. CAUTION: Electronic devices can be damaged by exposure to liquids. Do not use or store the IQvitals near any type of liquids. CAUTION: Do not use harsh chemicals for cleaning, especially disinfectants that contain phenol, as they can spot plastics. Do not steam-autoclave, gas-sterilize, or irradiate the unit; subject the unit to intense vacuum; or immerse the unit in water or cleaning solution. Keep cleaning liquids out of the unit and connectors. If any liquid gets inside the unit, allow it to dry in warm air for two hours, and then check to make sure all monitoring functions are working properly. CAUTION: Take particular care when cleaning the NIBP cuff, NIBP hose, and NIBP connector on the IQvitals PC to prevent fluid from entering the connectors. Fluid in the NIBP airway may affect blood pressure determination accuracy and damage the device. CAUTION: Accessories that fall on the floor should be inspected for contamination and proper functionality. In case of contamination, follow the cleaning procedure detailed above. CAUTION: The user accepts responsibility for deviations from the recommended method of cleaning and disinfection. 65

71 IX. Maintenance, Storage and Battery Replacement A. Maintenance The following table shows the recommended maintenance procedures for the IQvitals PC and its accessories. The IQvitals PC requires periodic calibration checks. However, it is a good idea to check that the device is in good working order, as described in the table. Calibration checks should be done every 12 months and can be performed by qualified service personnel. IQvitals PC Function Procedure Mechanical Integrity Check for cracks, abrasive edges, and other signs of damage. Verify that the green power LED is illuminated on the IQvitals PC Power Supply LED Power Supply when plugged into AC power. Verify that the green power LED is illuminated on the IQvitals PC Power LED when plugged into AC power. Verify that the green On/Off LED is illuminated on the back of the On/Off LED IQvitals PC when the unit is on. Power cycle the IQvitals PC to verify that the power-up speaker Speaker test tones are generated. Apply the pulse oximeter probe to your finger. Verify that the reported pulse rate matches your pulse rate as measured on your SpO 2 wrist and that the SpO 2 value seems reasonable (above 95% for a healthy non-smoker). Apply an appropriately sized blood pressure cuff to your arm. NIBP Measure your blood pressure and verify that the reported blood pressure is reasonably close to your typical blood pressure. Temperature None (self-checking) If one of the checks results in a functional failure, please contact Midmark Technical Service at , option 2. If the IQvitals PC needs to be returned for repair, Technical Service must provide a return authorization number. 66

72 5. Storage Storage Temperature Storage Humidity Storage Altitude -20 C to 60 C 15% to 95% non-condensing 0 to 40,000 feet CAUTION: The IQvitals PC may not conform to all of its performance specifications if stored outside these environmental specifications or used outside of the environmental specifications in Section II-D, Product Overview and General Information/System Specifications of this manual. 6. Battery Replacement CAUTION: Only use the lithium ion battery from Midmark. Using the incorrect battery will cause damage to the IQvitals PC and void the warranty. Battery Door Screws NOTE: A Phillips lips head screw driver will be needed to complete the following steps. 1. Turn the device over to view the back of the device. There are two screws in the battery door. The battery door is located on the right, back side of the device. Remove the two screws, and remove the battery door. 2. Hold a hand over the battery, and tip the device so that the battery falls out of the device and into the hand. 67

73 3. Replace the battery with a new one, being careful to place the new battery in the device the same way the old battery came out of the device. 4. Replace the battery door, and tighten the two screws. Do not over tighten the screws. 5. Connect the AC power transformer to the IQvitals PC, and allow the new battery to charge for approximately four hours. NOTE: The battery is a lithium ion battery and must be recycled or disposed of properly according to national or local regulations. 68

74 X. Customer Support and Warranty Information For help diagnosing problems by phone with this product, contact Midmark Technical Service at (800) , option 2, between 6:00 AM to 4:00 PM, Pacific Standard Time. Contact Midmark Technical Service via at Self-help knowledge base and live chat can be accessed at kb.midmark.com. Warranty Midmark warrants IQvitals PC to be free from manufacturing and material defects for two (2) years from the original date of purchase. Warranty periods for accessories shipped at the time of original purchase are: one (1) year for blood pressure cuffs and SpO2 sensor; 90 days for other accessories. Any misuse or abuse of a Midmark product or accessory voids all applicable warranties. Please refer to midmark.com for the full and current Warranty Terms and Conditions. Return Materials Authorization To return any product for repair, a Return Materials Authorization (RMA) number must be obtained from Midmark Technical Service. This RMA number should be referenced on the package(s) containing the items to be returned and in any correspondence regarding the return. Shipping Before shipping any unit to Midmark, be certain that an RMA number has been issued and that all guidelines regarding this authorization are followed. We highly recommend that you follow all guidelines for the shipment of medical products set forth by the shipping company you choose to use. If a question should arise regarding the appropriate method of shipment, please feel free to ask when calling for your RMA number. It is ultimately the responsibility of the customer when shipping a product to ensure that all packages and their contents get to Midmark safely. Midmark will not assume responsibility for damage due to improper packaging, shipment or product use. Such actions will void all applicable warranties Midmark Corporation 690 Knox Street, Suite 100 Torrance, California Ph: (310) USA: (800) , option 2 Fax:

75 XI. Disposal The disposal of accessories such as blood pressure cuffs, temperature probes, and SpO 2 sensors should be carried out according to the manufacturer s recommendations. The IQvitals PC should be properly disposed of as well. In particular, the IQvitals PC contains a lithium ion battery and electronic circuit boards that should not be incinerated or exposed to extreme heat. See Section II-B, Product Overview and General Information/Warnings at the start of this manual for further precautions. Do not put the lithium ion battery in a refuse container. Lithium batteries and electronic components should be recycled appropriately. Contact your local waste disposal agency for guidance on proper recycling or disposal. 70

76 XII. Accessories and Supplies The following table shows the accessories approved by Midmark for use with the IQvitals PC. WARNING: Use only approved accessories with the IQvitals PC. Substitution of a component different from that supplied could result in measurement error. Item Part Number AC Power Supply USB Cable 10' Serial Cable 10' Adult Reusable SpO 2 Sensor (Nellcor Compatible) Small Reusable SpO 2 Sensor (Nellcor Compatible) SpO 2 Extender Cable 4' (Nellcor Compatible) Power Supply Adapter Kit, Friwo NIBP Hose 6.5' Alaris Turbo Temp Oral/Axillary Temperature Probe Alaris Turbo Temp Probe Covers, Box of 10 (200 ea) Reusable Blood Pressure Cuff, Infant, 1 each (8-14 cm) Reusable Blood Pressure Cuff, Child, 1 each (13-20 cm) Reusable Blood Pressure Cuff, Small Adult, 1 each (18-26 cm) Reusable Blood Pressure Cuff, Adult, Midmark, 1 each (26-35 cm) Reusable Blood Pressure Cuff, Large Adult, Midmark, 1 each (32-42 cm) Reusable Blood Pressure Cuff, Adult Long, 1 each (26-38 cm) Reusable Blood Pressure Cuff, Large Adult Long, 1 each (35-44 cm) Reusable Blood Pressure Cuff, Thigh, 1 each (42-50 cm) IQvitals (PC) Lithium Ion Battery IQvitals (PC) Mobile Cart IQvitals (PC) Wall Mount IQvitals (PC) Countertop Mount IQvitals (PC) Equipment Pole Mount Scale Mount (for Fairbanks TeleWeigh Scale) Operation Manuals CD Quick Reference Guide IQvitals PC

77 XIII. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Portable and mobile radio frequency (RF) communications equipment can affect devices like the IQvitals PC. As such, the IQvitals PC should not be used adjacent to other equipment. If the IQvitals PC is used adjacent to such equipment, observe IQvitals the unit to make sure it is operating properly after installation. The use of accessories other than those recommended by Midmark may result in increased EMC emissions or decreased EMC immunity of the IQvitals PC. NOTE: This device meets the requirements of IEC Please refer to this standard regarding safety requirements for this device. Guidance and manufacturer s declaration: electromagnetic emissions The IQvitals PC is intended for use in the electromagnetic environment specified below. The user of the IQvitals PC should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment/guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Class A Complies The IQvitals PC uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The IQvitals PC is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings. 72

78 Guidance and manufacturer s declaration: electromagnetic immunity The IQvitals PC is intended for use in the electromagnetic environment specified below. The user of the IQvitals PC should assure that it is used in such an environment. Immunity test IEC test level Electrostatic discharge (ESD) IEC Electrical fast transient/burst ±6 kv contact ±8 kv air ±2 kv for power supply lines Compliance level ±6 kv contact ±8 kv air ±2 kv for power supply lines Electromagnetic environment/guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. IEC ±1 kv for input/output lines ±1 kv for input/output lines Surge IEC ±1 kv differential Mode 2 kv common mode ±1 kv differential Mode 2 kv common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles Mains power quality should be that of a typical commercial or hospital environment. If the user of the IQvitals PC requires continued operation during power mains interruptions, it is recommended that the IQvitals PC be powered from an uninterruptible power supply or a fully charged battery. Power frequency (50/60 Hz) magnetic field <5 % UT (>95 % dip in UT) for 5 s <5 % UT (>95 % dip in UT) for 5 s 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. IEC

79 Guidance and manufacturer s declaration: electromagnetic immunity The IQvitals PC is intended for use in the electromagnetic environment specified below. The user of the IQvitals PC should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment/guidance Portable and mobile RF communications equipment should be used no closer to any part of the IQvitals PC, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance is Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m d = 1.2 d = MHz to 800 MHz d = MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the IQvitals PC is used exceeds the applicable RF compliance level above, the IQvitals PC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the IQvitals PC. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 74

80 Recommended separation distances between portable and mobile RF communications equipment and the IQvitals PC The IQvitals PC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the IQvitals PC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IQvitals PC as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 khz to 80 MHz d = MHz to 800 MHz d = MHz to 2.5 GHz d = For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 75

81 XIV. Contact Information Midmark Corporation 690 Knox Street, Suite 100 Torrance, California Phone: (310) USA: (800) , option 2 Fax: [email protected] Website: midmark.com Knowledge base: kb.midmark.com Midmark Corporation