Summary of Contents for Current G2
- Page 1 Instructions for Use Current Health Ltd Playfair House, Broughton Street Lane, Edinburgh, EH1 3LY,UK www.currenthealth.com 200002/1...
- Page 2 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. No part of this manual may be reproduced, copied, translated, or transmitted in any form or by any means without the prior written permission of Current Health.
- Page 3 The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation.
- Page 4 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...
- Page 5 Instructions for Use Meaning Meaning Symbol Symbol Classification Type Catalog Number BF Applied Part Consult Instructions Fuse for Use AC Current Input Fragile Flammable if Batteries Damaged Do not re-use Applies to IP Rating the strap Magnetic Prescription Only Resonance Unsafe...
- Page 6 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.
- Page 7 Instructions for Use WARNING: Ensure mobile device for receiving alarm signals has WiFi or data connection www.currenthealth.com 200002/1 Page 7 of 61...
- Page 8 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.
- Page 9 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.
- Page 10 When disposing of the wearable device or charging dock, please return to Current Health and observe all applicable laws and regulations. The return to Current Health will be arranged via the Current Health Support Center (see section 16). This medical device is subject to the EU Directive 2012/19/EU (WEEE). It is not registered for use in private households, and may not be disposed of at municipal collection points for waste electrical and electronic equipment.
- Page 11 The Homehub provided by Current Health for use in the home environment shall only be used by Current Health products and services. It cannot be used for, nor should it be used, for any other purpose, such as personal internet use.
- Page 12 Dealing with a lost or stolen Current Health wearable device In case a Current Health device is lost or stolen, please notify Current Health with the ID of the wearable device. General Guidelines for Security 1.
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Page 13: Table Of Contents
4 Charging Charging a Single Device while on-arm Charging a Single Device off-arm Fault detection in the Charging Dock 5 Admission and Discharge Admitting Patient to Current Health 5.1.1 A DMITTING A PATIENT 5.1.2 E NTERING DEMOGRAPHIC INFORMATION FOR A PATIENT DEPENDS ON CONFIGURATION 5.1.3 U... - Page 14 Instructions for Use Review all Technical Alarms 9 Trends 10 Pulse Rate 10.1 Principle of Operation 10.2 Averaging 10.3 Display Value, Outputs and Indicators 11 Respiration Rate 11.1 Principle of Operation 11.2 Averaging 11.3 Display Values, Output and Indicators 12 Pulse Oximetry (SpO2) 12.1 Principle of Operation 12.2...
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Page 15: Introduction
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... - Page 16 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.com 200002/1 Page 16 of 61...
- Page 17 Instructions for Use iHealth Neo Blood Pressure Monitor (Home) VivaLnk Fever Scout Axillary Temperatur e Sensor Spirobank Smart Spirometer Weighing Scales www.currenthealth.com 200002/1 Page 17 of 61...
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Page 18: System Software Components
Patient-Facing App Available on: The provided Current Health Patient Tablet for home use The Patient-Facing App provides an interface for the patient to use the integrated peripherals, communicate with their care team via video calling, and complete surveys www.currenthealth.com... -
Page 19: Wearable Device Setup & Management
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... -
Page 20: The Wearable Device
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. -
Page 21: Fitting The Device Into The Strap
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) ... -
Page 22: Sensor Data Transmission
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 2.4GhZ WiFi to the Current Health software platform. Vital signs are computed by the software platform, rather than on the wearable device. -
Page 23: Homehub
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. -
Page 24: Monitoring Wearable Device Battery Life
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. -
Page 25: Charging
WARNING: Consider and prevent liquid spillages onto the Charging Dock. If the Charging Dock is immersed in liquid, or has liquid spilled on it, disconnect it and return for service WARNING: Only Current Health approved peripherals should be connected to the Charging Dock www.currenthealth.com... -
Page 26: Charging A Single Device While On-Arm
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. - Page 27 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.
- Page 28 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.
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Page 29: Charging A Single Device Off-Arm
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. -
Page 30: Admission And Discharge
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. -
Page 31: Admitting A Patient
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... -
Page 32: Select The Patient ' S Location
5.1.6 Connecting a Home Pack to the patient 1. Tap Connect Home Pack 2. Pick up the Current Health tablet and turn it on 3. On the tablet screen, tap the “Scan QR Code” button 4. Use the tablet camera to scan the QR code shown on the mobile device 5. - Page 33 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.
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Page 34: Discharging Patient From Current Health
5.2 Discharging Patient from Current Health WARNING: Unpairing a patient will remove them from the mobile application and central dashboard. A patient can be discharged from Current Health by using the Devices App and following the below steps. 5.2.1 Discharging a patient 1. -
Page 35: Monitoring Live Vital Signs
(described in section 7). Patients with no active alarm conditions are grouped under low priority. Patients who are no longer being monitored e.g. wearable device has been removed but who have not been discharged from Current Health are grouped under the Unknown category. To monitor live vital signs, follow the below steps. -
Page 36: Physiological Alarms
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. -
Page 37: On-Duty/Off-Duty
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. Examples of user roles include “nurse”, “resident” and “attending”. Only your local operating institution can change your role. -
Page 38: Alarm Condition Delay & Alarm Signal Delay
2 seconds. This means that the delay between a triggering event occurring and the user is notified can be 35 seconds. The above timing assumes the wearable has connection to WiFi and the Current Health platform. 7.4 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. -
Page 39: Reviewing Alarms
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. -
Page 40: Adding Notes
7.7 Adding Notes You can add a textual note to the patient’s timeline. This note is then shared with all other members of your operating institution with access to Current Health, when they view that patient’s timeline. To add a note, simply select Add Note on the interface. -
Page 41: Technical Alarms
Instructions for Use 8 Technical Alarms 8.1 Types of Technical Alarm The below list of technical alarms is generated by Current Health. Type Priority Users who Receive Suggested Action Degradation of No further action Platform required. Current By local institution... -
Page 42: Receiving Alarm Signals
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. The user must stay within the hearing range of the audible alarm signal and adjust the volume according to the distance from acoustic alarm signal WARNING: Ensure mobile device for receiving alarm signals has audio switched on and is at an appropriate volume... -
Page 43: Reminder 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. -
Page 44: Trends
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. -
Page 45: Pulse Rate
Instructions for Use 10 Pulse Rate 10.1 Principle of Operation Current Health monitors pulse rate via pulse oximetry from the upper arm. Technical specifications are included in section 18.4.1. 10.2 Averaging Current Health utilizes averaging in order to smooth pulse rate data and prevent inappropriate and transient artifacts from affecting stability of results. -
Page 46: Respiration Rate
WARNING: The device does not monitor obstructive apnea. Patients at risk for respiratory crises should be observed closely WARNING: Current Health is not intended for use on patients with extremely low (less than 6rpm) and extremely high (greater than 60rpm) respiration rates 11.1 Principle of Operation... -
Page 47: Display Values, Output And Indicators
Instructions for Use 11.3 Display 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.com 200002/1 Page 47 of 61... -
Page 48: Pulse Oximetry (Spo2)
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. -
Page 49: Principle Of Operation
Extinction Spectra for HbO2 and Hb Current Health uses an optical sensor that shines both red and infra-red light at the skin of the upper arm to distinguish between oxygenated blood and deoxygenated blood. Signal data is obtained by the reflections of red and infra-red light back onto the sensor by the blood and other tissues. -
Page 50: Application Site & Frequency Of Change
24 hours. Failure to change application site may result in minor irritation to the skin. The Current Health wearable device should be attached to the upper arm to intact skin only. The upper arm should be inspected every twenty four hours to check skin quality and ensure the sensor is close to the skin. -
Page 51: Display Values, Outputs And Indicators
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. 12.4 Display Values, Outputs and Indicators SpO2 is presented as %. The time that SpO2 was last observed is presented next to each SpO2 observation. -
Page 52: Temperature
13.1 Principle 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. -
Page 53: 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. They are then grouped into 4 motion classifications: Level 1 to 2 –... -
Page 54: 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. -
Page 55: Support Center
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. -
Page 56: Cleaning And Disinfecting
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. -
Page 57: Technical Data
30cm (12 inches) to any part of the Current Health Wearable Device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 58: System Hardware Components
Instructions for Use 18.3 System Hardware Components 18.3.1 Wearable Device Physical Attributes Size (HxWxD) 4.8cm x 4.9cm x 1.8cm Weight Battery Specifications Rating Voltage 3.7 DC Nominal Capacity (for a new battery) 835mAh Operating Time 28 Hours Charge Time 30 Minutes Environmental Specifications Temperature Range Operating: 5°C (41°F) to 40C°C (104°F) -
Page 59: Monitoring Specifications
Instructions for Use Electrical Specifications Input Voltage AC 100 - 240 V, 50/60Hz Output Voltage DC 5V +/- 5% Maximum Output Current DC 3000mA Environmental Specifications Temperature Range Operating: 0°C (32°F) to 50°C (122°F) Storage: -40°C (-40°F) to 70°C (158°F) Relative Humidity <95%... -
Page 60: Respiratory Rate
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. 18.4.3 Respiratory Rate Sensing Method Chest Movements Measurement Range 6rpm –... -
Page 61: Temperature
Instructions for Use 18.4.4 Temperature Sensing Method Thermistor Measurement Range -20.0°C to 50.0°C (-4°F to 122°F) Resolution 0.1°C Response Time 130 milliseconds Accuracy 0.1°C (0.18°F) 18.5 Alarm Specifications Alarm Tone Sound Pressure High-Priority Alarms – 56dB to 76dB Medium-Priority Alarms – 54dB to 72dB Low-Priority Alarms –...