Clarus 40L Mobile Cardiac Monitor Operator Manual
Contents Device Overview ........................................................................................................................................................4 Description .......................................................................................................................................................................... 4 Indications for Use ................................................................................................................................
Wireless Compliance ................................................................................................................................................ 33 EMC Precautions ...................................................................................................................................................... 35 Revision 1.10 Document No.
Device Overview Description Caution: US Federal law restricts this device to sale by or on the order of a physician. The Clarus 40L is a battery operated ambulatory electrocardiograph recorder for use in mobile cardiovascular telemetry. It is capable of storing up to 4 channels of patient ECG data acquired from surface electrodes adhered to the body for up to 30 days of continuous recording. The Clarus 40L employs a rechargeable lithium polymer battery to achieve such an extended recording duration.
Device Overview Indications for Use The Clarus 40L is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Device Overview Recorder Components Figure 1 1. Accessory Cable Connector/Charging port 2. Color Touchscreen 2 3 1 3. Power Button Front view of the Clarus 40L. Figure 2 4 4. Serial Number Back view of the Clarus 40L. Revision 1.10 Document No.
Device Overview Equipment Symbols Consult the Directions for Use Type BF device Electrically Isolated Manufacturer Info Rx Only IP22 Prescription Only Device has ingress rating of IP22 in accordance with IEC 60529 Recycling Symbol - Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE).
Device Overview Precautions Use only cables provided by TZ Medical with the Clarus 40L. Disconnect patient leads before defibrillation. To reduce the risks of strangulation or asphyxiation do not leave electrode cables accessible to infants or children. Carefully route the electrode cables to reduce the possibility of entanglement or strangulation during use. False positive and false negative pacer pulse detects may occur when using Pacemaker Pulse Detection.
Operation Initial Device Setup The Clarus 40L is delivered ready for use. Please consult with your software provider to determine if any additional configuration is required for your specific use case. Power on the Device To power on the Clarus 40L, hold down the circular power button, as shown in Fig. 1, for at least one second. After approximately three seconds, the Clarus 40L will vibrate and the screen will light up displaying the Starting Up screen provided in Fig. 3.
Operation User Interface The Clarus 40L employs a graphical user interface consisting of a color touchscreen for configuration and patient hookup procedures. The menus on the device can be navigated by gently touching and releasing the graphical buttons on the display. Figure 4 The welcome screen is displayed on startup.
Operation Network Status The network status is always displayed in the upper left-hand corner of the screen. The number of pending transmissions counts up to 99, and a blue antenna icon is shown when the device is connected to the network. The device will periodically turn off its modem to save power. In this case, no icon will be displayed next to the pending transmission count. It will also display a dash icon when searching for a network or a red antenna icon if it gets rejected by the network.
Operation Shutting Off There are two ways to turn off the Clarus 40L: 1) Start by pressing the power icon, provided in Fig. 5, on the Welcome screen. The device will be automatically redirected to a display as shown in Fig. 12. To confirm the shutdown press the power icon in the middle of the screen. Figure 12 Confirm the shutdown command by touching the power icon again.
Operation Adjusting the Settings Figure 13 After pressing the gear icon (settings button) provided in Fig. 7 on the Welcome screen, the device will automatically be directed to the first page of the settings menu with the display provided in Fig. 13. While on this screen, pressing the bottom-left arrow button will redirect the device back to the Welcome screen.
Operation Adjusting the Settings (continued) The check will light up as shown in Fig. 16 after a study length number has been input. After the correct study length has been input, press the check in order to save the new study length and return to the second page of the settings menu. Pressing the X button will result in returning to its previous study length setting, as well as returning to the second page of the settings menu.
Operation Starting a Study To start a study, press the plus icon provided in Fig. 6 on the Welcome screen. The device will be directed to a screen with a display similar to Fig. 19 or Fig. 20. On this screen, confirm the start of the study by pressing the plus icon in the center of the screen. To return back to the Welcome screen, press the bottom-left arrow button. The length of the study that was manually added within the settings will be displayed under the “Duration” text as shown in Fig. 19 and Fig.
Operation Starting a Study (continued) After the patient has pressed the check mark provided in Fig. 21 the user will then be able to enter their PIN Code which should be provided by their physician. In Fig. 22 it is noticed that the user cannot press the check mark until a number is input. Once a number has been put in, the check mark becomes visible as shown in Fig. 23.
Operation Electrode Application Employ the following procedure when applying electrodes to a patient and connecting them to the Clarus 40L: 1. Select electrode sites to match the configured electrode configuration shown in the following figures or as instructed by the physician. Select areas over bone, avoiding muscle areas and breast tissue. 2. Clean electrode sites with alcohol and use a razor to remove hair. 3. Abrade electrode sites with a scrub pad or gauze.
Operation Marking an Event Figure 29 Once a study has been started, the Clarus 40L will silently record ECG data with no intervention from the patient. The patient can wake the display provided in Fig. 29 by briefly pressing the power button. This display allows the user to view the time remaining for the study as well as instructions on how to mark an event. After pressing the plus button, the display shown in Fig. 30 will be displayed on the screen.
Operation Marking an Event (continued) Figure 32 Pressing the bottom-left arrow will bring the user back to the previous Symptom diary screen displayed in Fig. 31. Pressing the lower-right arrow will bring the user to the Activity Diary screen displayed in Fig. 33. Third page of marking an even. Figure 33 Use the up and down arrows to scroll through the activity list in order to place the correct activity into the white box.
Operation Marking an Event (continued) Once an event has been successfully marked, the display provided in Fig. 35 will be displayed on the screen and will vibrate for approximately three seconds. After those three seconds, the device will be redirected to the monitoring screen display provided in Fig. 29. Figure 35 Event confirmation page.
Operation Receiving Messages The Clarus 40L can receive messages, similar to the one displayed in Fig. 38, at any time if the device is connected to a network. The message can be confirmed by pressing the bottom-right arrow. Figure 38 The device has received a message. Revision 1.10 Document No.
Operation Ending a Study Figure 39 The Clarus 40L will end the study once the pre-configured recording duration is reached. At this point, it will notify the patient that the recording is complete by vibrating and displaying the screen shown in Fig. 39, notifying the patient that the device should be returned. The patient will be notified once the study is complete.
Operation Removing Patient Data In order to use the device for another study, or if there was some misunderstanding in setting up the device, the Clarus 40L can be easily reformatted: 1. Using the Clarus USB cable (H3R-0025), plug the device into a computer. 2. Follow the steps provided by your software provider for retrieving the patient’s data off of the device. 3. On your desktop, open the File Explorer tab so that you can view the plugged in device. 4.
Patient Instructions Patient Use Precautions The Clarus 40L contains sensitive electronic circuitry. Please observe the following precautions while using the Clarus 40L. Failure to do so may result in serious damage to the device. Avoid Exposure to Moisture The Clarus 40L should not be used while swimming, showering, bathing, or participating in any aquatic activities. In these situations, disconnect the cable from the device and place the device in a safe location.
Maintenance Charging The Clarus 40L employs a rechargeable lithium-ion battery to meet the demanding power requirements of cellular data transmissions. This battery cannot be recharged without interrupting the data recording. To charge the battery during a study, disconnect the patient recording cable and connect the Clarus 40L wall charger (H3R-0099).
Maintenance Storage When not being used for recording data, the Clarus 40L should be shut off as shown previously. To wake the Clarus 40L after it has been powered down, press the power button for at least 1 second. To maximize battery life, it is recommended that for long periods of storage that the device be stored at 50% battery charge in a cool environment. Cleaning Do not attempt to submerse, autoclave, or steam clean the Clarus 40L or the patient cable. Do not use solvents to clean the device.
Troubleshooting Error Messages The Clarus 40L has been designed to detect and recover from error conditions automatically. There are situations that may occur where the device simply cannot recover on its own. In such cases, the Clarus 40L will display an error message on the screen with an error code. An example of an error display is provided in Fig. 45. Figure 45 An example error message displayed on the Clarus 40L screen.
Specifications Functional ECG Channels Sample Rate User Interface Memory Total Recording Time Media Data Retention Up to 4 bipolar channels - or 2 bipolar channels and up to 2 unipolar channels 250, 500, 1000, 2000, or 4000 Hz Color touchscreen Up to 30 days, 7 days continuous (from full charge) 8GB internal Over 10 years Physical Dimensions Weight Electrical Input Impedance CMRR Signal Range Resolution Frequency Response Pacemaker Detection Environmental Ingress Protection Operating Temperature O
Specifications Projected service life The projected service life of the Clarus 40L and Clarus 9-device charging dock is 2 years on average based on the following assumptions: the typical 60-day shelf storage duration battery charge and discharge does not exceed 500 cycles for the service life of the device proper cleaning and maintenance per the operator manual The projected service life of the Clarus 40L cables and electrodes is 90 days based on the following assumptions: operator manual sug
Specifications Manufactured by TZ Medical, Inc. 17750 SW Upper Boones Ferry Rd STE #150 Portland, OR 97224 Revision 1.10 EU Authorized Representative: CEPartner4U Esdoornlaan 13 3951 DB Maarn The Netherlands Tel: +31 (0)6-516.536.26 Document No.
TZ Medical Warranty Limited Warranty This TZ Medical product is warranted to be free from manufacturing and material defects for a period of two (2) years from the date of shipment from TZ Medical to the original purchaser (“Warranty Period”). If a hardware defect arises and a valid claim is received within the Warranty Period, TZ Medical will either repair or replace the defective product free of charge for parts or labor.
Accessories The following accessories are available for use with the Clarus 40L. Part Number Description H3R-0017 H3R-0077 H3R-0025 H3R-0099 H3R-0079 H3R-0205 H3R-0027 H3R-0051 Clarus 3-Electrode Patient Cable Clarus 4-Electrode Patient Cable Clarus USB Data / Charging Cable Clarus Wall Charger Clarus 9-Device USB Charging Dock Clarus 9-Device Charging Dock Clarus 40L Plastic Holster Clarus Screen Protector Revision 1.10 Document No.
Wireless Compliance FCC ID: ZIMH40L FCC Compliance Statement This device complies with part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Wireless Compliance IC ID: 9647A-H40L License Exempt (Canada) Antenna Statement Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.
EMC Precautions The Clarus 40L needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information. List of all cables and maximum lengths of cables, transducers and accessories: Transducer / Accessories Maximum Cable Length Clarus 3-Electrode Patient Cable Clarus 4-Electrode Patient Cable Clarus USB Data 44.8 in (1138 mm) 44.8 in (1138 mm) 45.
EMC Precautions Guidance and Manufacturer’s Declaration - Emissions The Clarus 40L is intended for use in the electromagnetic environment specified below. The customer or user of the Clarus 40L should ensure that it is used in such an environment.
