G2 Instructions for Use Current Health Ltd Playfair House, Broughton Street Lane, Edinburgh, EH1 3LY,UK www.currenthealth.
Instructions for Use WARNING: To properly use this medical device, read and comply with these instructions for use WARNING: Current Health is intended for use by qualified medical personnel only CAUTION: USA Federal Law restricts this device to sale by or on order of a physician. All rights are reserved. Current Health Ltd. reserves the right to alter the products described in this manual at any time without notice.
Instructions for Use Intended Use The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms.
Instructions for Use Documentation Features Warnings and Cautions WARNING: A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury CAUTION: A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or in damage to the equipment or other property Cross-References Cross-references will specif
Instructions for Use Symbol Meaning Symbol Meaning Catalog Number Classification Type BF Applied Part Consult Instructions for Use Fuse AC Current Input Fragile Flammable if Damaged Batteries IP Rating Do not re-use Applies to the strap Prescription Only Magnetic Resonance Unsafe Non-ionizing electromagnetic radiation List of Abbreviations Abbreviation Meaning ECG Electrocardiogram EMC Electromagnetic Compatibility ICU Intensive Care Unit LED Light Emitting Diode RF Radiofrequenc
Instructions for Use Safety Considerations These Instructions for Use assume a working knowledge of vital signs monitoring. To support proper, safe, and accurate operation of equipment, read all operating instructions carefully before you use the monitor. Current Health should only be used by trained healthcare professionals.
Instructions for Use WARNING: Ensure mobile device for receiving alarm signals has WiFi or data connection www.currenthealth.
Instructions for Use Site of Operation Only use Current Health in areas that meet the environmental requirements outlined in the technical data section WARNING: Do not operate the equipment in areas such as: magnetic resonance imaging (MRI) environments, aircraft, ambulance, home or hyperbaric chambers. Do not operate the equipment in close proximity to equipment that emits microwave or other high-frequency emissions since they may interfere with the device’s operation.
Instructions for Use Maintenance Current Health equipment will be maintained by Current Health Service Staff only. WARNING: Risk of infection. Current Health technical staff can become infected with pathogenic germs. Disinfect and clean the equipment before returning the medical device for repair. WARNING: Current-carrying components are located under the cover. Do not remove the cover. Maintenance measures must be performed by the manufacturer only.
Instructions for Use Defibrillator Precautions WARNING: The wearable device and any other applied device parts should be removed before patient defibrillation Medical Device Disposal WARNING: Risk of infection. The device and its components must be disinfected and cleaned before disposal WARNING: The wearable device contains a lithium ion battery. Do not incinerate the device or place in a trash compactor. Do not puncture the battery.
Instructions for Use Current Health has authorized a firm to dispose of Current Health equipment in the proper manner. For more detailed information, please contact Current Health. The strap is single use and should be disposed of in clinical waste after patient use. Cybersecurity Current Health have taken significant steps to protect our system from cyberattacks, but the user has a crucial role in maintaining cybersecurity. The guidelines in this section must be followed.
Instructions for Use Include lowercase and uppercase alphabetic characters, numbers and symbols Generate passwords randomly where feasible Follow this general recommendation for a password renewal interval in case your institution does not have a more specific policy: Passwords should be renewed after 90 days. Users will be automatically logged out of the Patients App or Devices App if they are inactive for 15 minutes.
Instructions for Use Table of Contents 1 Introduction 1.1 System Hardware Components 1.2 System Software Components 15 15 18 2 Wearable Device Setup & Management 2.1 The Wearable Device 2.2 Fitting the device into the strap 2.3 Starting the Wearable Device 2.4 Sensor Data Transmission 2.5 Homehub 19 20 21 21 22 23 3 Monitoring Wearable Device Battery Life 24 4 Charging 4.1 Charging a Single Device while on-arm 4.2 Charging a Single Device off-arm 4.
Instructions for Use 8.5 Review all Technical Alarms 43 9 Trends 44 10 Pulse Rate 10.1 Principle of Operation 10.2 Averaging 10.3 Display Value, Outputs and Indicators 45 45 45 45 11 Respiration Rate 11.1 Principle of Operation 11.2 Averaging 11.3 Display Values, Output and Indicators 46 46 46 47 12 Pulse Oximetry (SpO2) 12.1 Principle of Operation 12.2 Application Site & Frequency of Change 12.3 Averaging 12.4 Display Values, Outputs and Indicators 48 49 50 50 51 13 Temperature 13.
Instructions for Use 1 Introduction Current Health allows wearable, multi-parameter physiologic monitoring in non-critical care environments within professional healthcare facilities, such as general medical-surgical units or skilled nursing facilities, and in the home. 1.1 System Hardware Components WARNING: Use only recommended accessories supplied by Current Health The system consists of: Wearable Device Sensor (Class II, Type BF Applied Part) Single Use Strap www.currenthealth.
Instructions for Use Charging Dock iHealth Ease Blood Pressure Monitor (Hospital) Omron Evolv Blood Pressure Monitor (Home) iHealth View Blood Pressure Monitor (Home) www.currenthealth.
Instructions for Use iHealth Neo Blood Pressure Monitor (Home) VivaLnk Fever Scout Axillary Temperatur e Sensor MIR Spirobank Smart Spirometer Weighing Scales www.currenthealth.
Instructions for Use Patient Tablet for Home 1.2 System Software Components The system has three software applications: Patients App Available on: Apple iPhones and iPads running iOS 11 or greater Android tablets and smartphones running Android 8 (Oreo) or 9 (Pie) Any web-connected device running Google Chrome version 68.0.3440 or later The Patients App provides access to real-time vital signs, vital sign trends and physiological alarms. It is explained in sections 5, 6 and 7.
Instructions for Use 2 Wearable Device Setup & Management WARNING: The wearable device and its attachments pose a choking hazard. The wearable is not a toy and should not be chewed on or placed in the mouth. WARNING: Use only the straps provided with the device to affix the device to the patient CAUTION: Do not apply the wearable device on open wounds, sores, or cuts CAUTION: If redness appears during use, remove the device www.currenthealth.
Instructions for Use It is expected that the Patient is able to set up the Wearable device, Homehub and Charging Dock themselves. They should also be able to charge the wearable device themselves, and will be provided with a Quick Start Guide to help them accomplish these tasks. 2.1 The Wearable Device The wearable device is worn on the upper arm of the patient using the supplied strap. The wearable device is re-usable, while the strap is single use.
Instructions for Use 2.2 Fitting the device into the strap An appropriate sized strap should be selected. The strap size can be determined visually by a tag on the strap. Straps are in three sizes: Up to 25cm – Small (S on Strap tabs) 25cm – 35.5cm – Medium (M on Strap tabs) 35.5cm – 56.5cm –Large (L on Strap tabs) The strap provided with the device has a plastic ring into which the device sits.
Instructions for Use 2.4 Sensor Data Transmission WARNING: Removing the wearable device from WiFi range will prevent transmission of signal data and thus no vital signs nor alarm signals will be generated for the patient CAUTION: If the device is removed from WiFi range, it will store signal data for a maximum of 17.5 hours. After 17.5 hours, no further signal data will be stored. The wearable device transmits physiologic signal data over standard IEEE 802.11 g/b/n 2.
Instructions for Use 2.5 Homehub WARNING: Unplugging the Homehub during active use will prevent transmission of signal and thus generation of vital signs and alarms CAUTION: We recommend placing the Homehub in a main area of the house, such as the lounge or bedroom. This ensures maximum signal coverage Where existing home WiFi is not available, our Homehub can be used. The Homehub provides an IEEE 802.11 WiFi network for our products and services.
Instructions for Use 3 Monitoring Wearable Device Battery Life CAUTION: The battery charge level displayed in the user interface is only accurate if the batteries are in normal working condition. The Devices App allows monitoring of device battery life for devices that are paired to a patient, and actively transmitting data. It also allows receipt of technical alarms, which is described in section 8. To check on the battery life of a device, follow the below steps. 1. Log into the Devices App 2.
Instructions for Use 4 Charging WARNING: Worn out or defective batteries can significantly reduce battery capacity or the operating time. WARNING: To avoid electrical shock, inspect all cables before use. Never use cables that appear cracked, worn or damaged in any way. WARNING: The Device Charging Dock must be powered by the supplied wall adapter WARNING: Consider and prevent liquid spillages onto the Charging Dock.
Instructions for Use CAUTION: Inspect the charging contacts and clean them of any debris before charging the wearable. The wearable device lithium ion battery is charged using the supplied on-arm charging dock. The wearable device has a battery life of around 28 hours. Daily charging is required for between 15 and 30 minutes. 4.1 Charging a Single Device while on-arm WARNING: The Charging Dock contains magnets.
Instructions for Use The Charging Dock is provided with the wearable device, and is responsible for charging the device through its Charging Head, powering the Current Health Patient Tablet (if used), and charging integrated peripherals (if used). Before charging a wearable device, inspect the Charging Dock and Mains Power adapter for damage. If damage is identified, the Charging Dock or Mains Power adapter should not be used. Please contact the Support Center, per section 16.
Instructions for Use Place the charging head onto the wearable device, matching the position of the charger electrodes with the metal pins on the surface of the wearable device. The Charging Head will click into place magnetically when in the correct position. If the Charging Head is not correctly located, the Charging Dock will continue to flash its orange LED.
Instructions for Use 4.2 Charging a Single Device off-arm When not in use, the device can be stored and charged on the Charging Dock, as shown below When charging in this mode, the LEDs on the front of the Charging Dock behave identically to when charging on-arm. The LEDs will flash from bottom to top while charging, turning solid green when fully charged. 4.
Instructions for Use 5 Admission and Discharge 5.1 Admitting Patient to Current Health WARNING: Healthcare professionals should inspect the physical condition of all kit before assigning it to a patient. WARNING: Visually check that the device has been placed securely against the skin. The strap should be snug and comfortable. You should be able to fit one finger under the strap.
Instructions for Use 5.1.1 Admitting a patient 1. Open the Current Health app and login 2. Tap the Admit button 3. Enter the patient’s identifier. Depending on your local operating institution’s configuration, you may also be permitted to use the mobile device’s camera to scan a machine-readable representation (usually a barcode or QR code) of the patient’s identifier. 4.
Instructions for Use a. Verify those that are marked as “(modified)” have been modified correctly 5. Tap Next to confirm alarm selection 5.1.4 Select the patient’s location A patient can only be assigned to one location. 1. Tap the relevant location label to select it 2. Tap Next to confirm the patient’s location 5.1.5 Connecting the first wearable device to the patient 1. Bring the active wearable device near the mobile device until it is discovered 2. Tap Done to complete the pairing process 5.1.
Instructions for Use a. Normally the wearable device is placed on the outer side of the upper left arm. It should be placed high enough above the elbow to minimize disturbance when the arm is bent. b. The placement may be rotated towards the rear of the arm if this is helpful, but do not place the device to the inside of the arm. If the left arm is absent, is bandaged, has broken skin, a tattoo, or shows localized edema, the device may be worn on the right arm c.
Instructions for Use 4. Hold the wearable device in place on the Patient’s arm with one hand 5. Hold the free end of the strap with the other hand, and pull it gently through the eyelet until the strap starts to stretch 6. Carefully release the stretch until the strap is neither tight nor slack - the neutral length. Repeat once or twice to establish a consistent result 7. From the neutral length, tighten the strap so that it is snug to the arm 5.
Instructions for Use 6 Monitoring Live Vital Signs The Patients App allows monitoring of live vital signs for a patient. A patient’s vital signs are available on both the Dashboard and Patient Live Vitals screens. The Dashboard provides one screen to review all vital signs for all patients. It groups patients into high, medium and low priority and will display them in priority order. This priority status is on the basis of alarm conditions that have been generated for the patient (described in section 7).
Instructions for Use 7 Physiological Alarms 7.1 Alarming Profiles WARNING: The operator should ensure that the alarming profile selected is appropriate for the patient. WARNING: For patients being monitored within the same care area, different alarming profiles can be configured per patient provided that the alarming profile set for the patient is appropriate. Physiological alarms can be configured to alert healthcare practitioners to particular deviations in the patient’s vital signs.
Instructions for Use Potential result of failure to respond to cause of Alarm Condition Death or Irreversible Injury Immediate Prompt Delayed High High Medium Reversible Injury High Medium Low Minor Injury or Discomfort Medium Low Low Onset of potential harm Where: Immediate = seconds to several minutes Prompt = several minutes to many minutes Delayed = many minutes to hours User roles are set by your local operating institution for your user account on Current Health.
Instructions for Use 2. If you wish to go On-Duty, tap the Profile icon in the bottom-right corner, choose the locations you wish to go on-duty for, then tap Go On Duty 3. Tap Confirm 4. If you wish to go Off-Duty, tap the Profile icon in the bottom-right corner, then tap Go Off Duty 7.3 Alarm Condition Delay & Alarm Signal Delay The Current Health wearable device transmits every 30 seconds. The vital sign calculation algorithms then utilize averaging, to smooth out inappropriate outliers.
Instructions for Use WARNING: When operating in a noisy environment, the volume of the alarm signals must be adjusted to suit. Always set the volume of the alarm signal sufficiently high. Alarm signals are received by the Patients App, running on iOS or Android. When an alarm signal is received it will cause a visual and audible indication. The visual signal will display the reason for the alarm as well the priority.
Instructions for Use Acknowledge You can acknowledge that you have reviewed the alarm. Your name is added to the patient’s timeline as having reviewed the alarm. Snooze You can acknowledge that you have reviewed the alarm and then pause any further reminder signal generation for a period of time. That period of time is selectable by a selection box. This then provides you time to review the cause of the alarm. If the patient subsequently triggers another alarm, this will still lead to alarm signals.
Instructions for Use 8 Technical Alarms 8.1 Types of Technical Alarm The below list of technical alarms is generated by Current Health. Type Degradation of Platform This occurs when the platform experiences an increase in latency or reduction in performance that may be noticeable to users Wearable Device Stops Transmitting* This occurs when a wearable device, which is monitoring a patient, stops transmitting data to the platform for greater than 5 minutes Priority By local institution configuration.
Instructions for Use 8.2 Receiving Alarm Signals WARNING: A rapid recognition of alarms and an appropriate response are only possible if the user is in hearing range of the audible alarm signals.
Instructions for Use You can acknowledge that you have reviewed the alarm and then silence any further reminder signal generation. This inactivates the alarm. The alarm will remain active until it is silenced. We recommend you only silence an alarm once you have dealt with the root cause of the technical alarm. Your name and the fact that the alarm has been inactivated will be added to the timeline. 8.
Instructions for Use 9 Trends Current Health allows the user to view trends for a patient’s vital signs across a number of different periods of time. The trends are provided as To access the Patient Trends screen, follow the below steps. 1. Select a Patient from the Dashboard 2. Select View Trends 3. You can change which vital sign you wish to view trends. 4. You can change the time period trends are displayed over 5.
Instructions for Use 10 Pulse Rate 10.1Principle of Operation Current Health monitors pulse rate via pulse oximetry from the upper arm. Technical specifications are included in section 18.4.1. 10.2Averaging Current Health utilizes averaging in order to smooth pulse rate data and prevent inappropriate and transient artifacts from affecting stability of results. The data update period is provided in the technical data in section 18.4.1.
Instructions for Use 11 Respiration Rate WARNING: The safety and effectiveness of the respiration measurement method in the detection of apnea has not been established. Do not rely solely on the device for detecting cessation of breathing WARNING: The device does not monitor obstructive apnea.
Instructions for Use 11.3Display Values, Output and Indicators Respiratory rate is presented as respirations per minute (RPM). The time that respiration rate was last observed is presented next to each respiration rate observation. www.currenthealth.
Instructions for Use 12 Pulse Oximetry (SpO2) WARNING: Movement, ambient light and low perfusion may affect SpO2 and pulse rate calculation and accuracy. Current Health is not intended for use in calculating accurate SpO2 during periods of high motion, high ambient light and low perfusion conditions. WARNING: SpO2 measurements are particularly sensitive to the pulsations in the artery and the arteriole.
Instructions for Use 12.1Principle of Operation Current Health calculates functional oxygen saturation (SpO2) using pulse oximetry from the upper arm. Technical specifications are available in 18.4.2. Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. O2 is carried in the blood in two forms, either dissolved in plasma or combined with hemoglobin. The majority of O2 is carried on hemoglobin.
Instructions for Use 12.2Application Site & Frequency of Change WARNING: The strap contains polyester, polyamide and nylon. Do not use if the patient has a known allergy to any of the materials. Some individuals may be sensitive to neoprene. If a rash develops, discontinue use. WARNING: Do not apply the device or strap over an open wound/broken skin WARNING: Inspect the application site of the wearable and the strap every twenty four hours to check the skin quality and correct optical alignment.
Instructions for Use The time that a oxygen saturation was calculated is displayed on the user interface next to each oxygen saturation, as shown below. 12.4Display Values, Outputs and Indicators SpO2 is presented as %. The time that SpO2 was last observed is presented next to each SpO2 observation. www.currenthealth.
Instructions for Use 13 Temperature WARNING: Do not use Current Health to monitor core temperature WARNING: Ambient, environmental temperature changes may impact the temperature of the patient and thus temperature monitoring. 13.1Principle of Operation Current Health monitors skin temperature in direct mode from a probe applied to the upper arm. This probe is an intrinsic part of the wearable device. Technical specifications are available in section 18.4.4. 13.
Instructions for Use 14 Motion Levels WARNING: Motion levels are provided for information purposes only. They should not be relied upon to inform patient care. Current Health monitors motion levels via a gyroscope and accelerometer. The patient’s level of motion is represented as one of ten motion levels, from Level 1 to Level 10.
Instructions for Use 15 Custom Scores WARNING: Custom scores are provided for information purposes only. They should not be relied upon to inform patient care. Where your local operating institution has enabled this, Current Health allows a Custom Score to be set for a particular patient. A Custom Score is a single aggregate integer number, which is calculated based on the level of one or more vital signs. Custom Scores are calculated via Custom Scoring Profiles.
Instructions for Use 16 Support Center The Current Health Support Center is available through the Patients App and Devices App and allows users to contact Current Health via instant message. To access the Support Center, select the Support button on the bottom menu. www.currenthealth.
Instructions for Use 17 Cleaning and Disinfecting WARNING: Do not autoclave or sterilize the wearable device or any part of the Current Health monitoring system The Wearable Device, Charging Dock system, Home Hub and power supply are re-usable and may be used for more than one patient. The strap is single use and should be disposed of in clinical waste or according to local guidelines and regulations.
Instructions for Use 18 Technical Data This section contains technical specifications for the physical and functional aspects of Current Health. These specifications apply to adult patients. 18.1Electrical Safety The Current Health Wearable Device and Charging Dock have been tested for electrical safety and meet IEC (ANSI/AAMI) 60601-1:2005 +AMD1:2012 and IEC (ANSI/AAMI) 60601-111:2015 for devices used in the home. 18.
Instructions for Use 18.3System Hardware Components 18.3.1 Wearable Device Physical Attributes Size (HxWxD) Weight Battery Specifications Rating Voltage Capacity (for a new battery) Operating Time Charge Time Environmental Specifications Temperature Range 4.8cm x 4.9cm x 1.8cm 32g 3.
Instructions for Use Electrical Specifications Input Voltage Output Voltage Maximum Output Current Environmental Specifications Temperature Range Relative Humidity Protection Against Ingress of Water AC 100 - 240 V, 50/60Hz DC 5V +/- 5% DC 3000mA Operating: 0°C (32°F) to 50°C (122°F) Storage: -40°C (-40°F) to 70°C (158°F) <95% IP40 18.4Monitoring Specifications 18.4.
Instructions for Use Note: Wavelength range can be especially useful to physicians, such as those performing photodynamic therapy. Note: A functional tester cannot be utilized to assess the accuracy of Current Health SpO2 monitoring. 18.4.
Instructions for Use 18.4.4 Temperature Sensing Method Measurement Range Resolution Response Time Accuracy Thermistor -20.0°C to 50.0°C (-4°F to 122°F) 0.1°C 130 milliseconds 0.1°C (0.18°F) 18.5Alarm Specifications Alarm Tone Sound Pressure High-Priority Alarms – 56dB to 76dB Medium-Priority Alarms – 54dB to 72dB Low-Priority Alarms – 41dB to 58dB 18.6FCC WARNING: This device complies with Part 15 of the FCC Rules.
