Current G2 User manual

www.currenthealth.com
200002/1
G2
Instructions for Use
Current Health Ltd
Playfair House,
Broughton Street Lane,
Edinburgh, EH1 3LY,UK

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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. 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. Information provided in this manual is intended to be
accurate and reliable. However, Current Health assumes no responsibility for use of this
manual, nor for any infringements upon the rights of third parties which may result from
such use. All brand and product names mentioned herein are trademarks or registered
trademarks of their respective holders.
This 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. Current Health Ltd has authorized a firm to dispose of
this device in the proper manner. For more detailed information, please contact Current
Health Ltd.
Copyright Notice
Current Health is a trademark of Current Health Ltd. This document is copyrighted by
Current Health Ltd.

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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. The Current Wearable Health Monitoring System is
intended for temperature monitoring where monitoring skin temperature at the upper arm
is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of
the following parameters in adults:
 Pulse rate
 Oxygen saturation
 Skin Temperature
 Movement
The Current Wearable Health Monitoring System is intended for intermittent or spot-check
monitoring, in adults, of:
 Respiration rate
 Non-invasive blood pressure
 Lung function & spirometry
 Weight
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. For these patients, they should be monitored using a device with
continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an
ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in
conditions of high motion or low perfusion.

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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 specify the section or sub-section. For example, sub-section 2.1 or
section 2.
List of Symbols
Symbol Meaning Symbol Meaning
Warning/Caution
The CE Mark and Notified
Body Registration Number
signify the device has met
all essential requirements
of European Medical
Device Directive
93/42/EEC
Manufacturer & Date
of Manufacture Serial Number
Batch Code
Separate Collection
for Electric and
Electronic
Equipment

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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 Radiofrequency
RPM Respirations per Minute
SpO2 Functional oxygen saturation
WEEE Waste Electrical and Electronic
Equipment

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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.
WARNING: To maintain patient safety, adhere to all WARNINGS and CAUTIONS listed in
these Instructions for Use and on equipment labels
WARNING: No modification of the equipment is allowed. Modification of this
equipment may cause interference with other devices, injury to patient and user
including electric shock, burns or death
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

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WARNING: Ensure mobile device for receiving alarm signals has WiFi or data connection

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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.
This equipment is neither approved nor certified for use in areas where oxygen
concentrations are greater than 25% or where combustible or explosive gas mixtures
are likely to occur.
CAUTION: To avoid short-circuiting or otherwise damaging the equipment, do not allow
fluids to come in contact with the equipment. If fluids are accidentally spilled on the
equipment, remove the affected unit from service as soon as possible and contact the
manufacturer.
CAUTION: Read all cleaning instructions carefully before cleaning the equipment. Refer to
the cleaning and disinfecting chapter of the instructions for use. Moisture may damage
the circuits, compromise critical performance and/or present a safety risk.

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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.
WARNING: Repair of the device may only be carried out by the manufacturer otherwise
the correct functioning of the device may be compromised.
WARNING: Risk of faulty components. Device failure is possible due to wear or material
fatigue of the components. To maintain proper operation of all components, this
equipment must undergo inspection at specified intervals.

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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.
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.

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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.
Current Health’s wearable device is connected to a network. No protected health
information is stored within the wearable device, nor transmitted by the wearable device.
Communications between the wearable device and the Current Health software platform
are encrypted to an industry-standard. Moreover, the wearable device connects to a
network over WPA2-PSK WiFi security.
Current Health’s Patients App or Devices App can be installed on an iOS device running iOS
version 13 or greater, or an Android device running Android version 8 (Oreo) or 9 (Pie). As
Apple review every application before it is allowed on the Apple App Store, the iPhone is
very resilient to cyberattacks. The Google Play store reviews applications for the Android
platform. No protected health information is stored within the mobile device’s local storage.
All communications between the Patients App and Devices App and the Current Health
software platform are encrypted to an industry-standard.
Current Health’s platform is also accessible via the Google Chrome web browser. All
communications between the Web Interface and the Current Health software platform are
encrypted to an industry-standard.
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.
About password policies, password expiration and auto-logout
A combination of username and password are used to control access to the Current Health
Patients App or Devices App.
It is the responsibility of the operating institution to apply the appropriate password policies
e.g. password complexity, renewal intervals.
Follow these general recommendations on password strength in case your institution does
not have a more specific policy:
 Use a minimum password length of 8 characters

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 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.
About periodical software updates and patches
On iOS and Android, the Current Health Patients App and Devices App should be updated as
soon as a new version becomes available. When a new version does become available, the
Apple App Store in the case of iOS or the Google Play Store in the case of Android, will
automatically update the app in-place.
When accessing the Current Health platform via the web interface, the user will always have
access to the most up to date version.
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. It is recommended that any mobile device with the Current Health Patients App or
Devices App installed also has a device passcode set
2. You should never disclose your Current Health username or password. No Current
Health staff will ever ask you for these details
3. You should never write your Current Health username or password down
4. You should never provide an unauthorized user access to the Current Health Patients
App or Devices App
5. You should never leave the Current Health Patients App or Devices App logged in
and unattended. Please log out when you have finished using the system
6. You should never disclose protected health information within a support message to
Current Health. This includes details like a patient’s name or date of birth.

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Table of Contents
1 Introduction 15
1.1 System Hardware Components 15
1.2 System Software Components 18
2 Wearable Device Setup & Management 19
2.1 The Wearable Device 20
2.2 Fitting the device into the strap 21
2.3 Starting the Wearable Device 21
2.4 Sensor Data Transmission 22
2.5 Homehub 23
3 Monitoring Wearable Device Battery Life 24
4 Charging 25
4.1 Charging a Single Device while on-arm 26
4.2 Charging a Single Device off-arm 29
4.3 Fault detection in the Charging Dock 29
5 Admission and Discharge 30
5.1 Admitting Patient to Current Health 30
5.1.1 ADMITTING A PATIENT 31
5.1.2 ENTERING DEMOGRAPHIC INFORMATION FOR A PATIENT (DEPENDS ON CONFIGURATION) 31
5.1.3 UPDATE ALARMS FOR A PATIENT 31
5.1.4 SELECT THE PATIENT’S LOCATION 32
5.1.5 CONNECTING THE FIRST WEARABLE DEVICE TO THE PATIENT 32
5.1.6 CONNECTING A HOME PACK TO THE PATIENT 32
5.1.7 FITTING THE WEARABLE TO THE PATIENT 32
5.2 Discharging Patient from Current Health 34
5.2.1 DISCHARGING A PATIENT 34
6 Monitoring Live Vital Signs 35
7 Physiological Alarms 36
7.1 Alarming Profiles 36
7.2 On-Duty/Off-Duty 37
7.3 Alarm Condition Delay & Alarm Signal Delay 38
7.4 Receiving Alarm Signals 38
7.5 Reviewing Alarms 39
7.6 Acknowledging, Notifying, Pausing & Silencing 39
7.7 Adding Notes 40
7.8 Reminder Signals 40
8 Technical Alarms 41
8.1 Types of Technical Alarm 41
8.2 Receiving Alarm Signals 42
8.3 Snoozing & Silencing 42
8.4 Reminder Alarm Signals 43

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8.5 Review all Technical Alarms 43
9 Trends 44
10 Pulse Rate 45
10.1 Principle of Operation 45
10.2 Averaging 45
10.3 Display Value, Outputs and Indicators 45
11 Respiration Rate 46
11.1 Principle of Operation 46
11.2 Averaging 46
11.3 Display Values, Output and Indicators 47
12 Pulse Oximetry (SpO2) 48
12.1 Principle of Operation 49
12.2 Application Site & Frequency of Change 50
12.3 Averaging 50
12.4 Display Values, Outputs and Indicators 51
13 Temperature 52
13.1 Principle of Operation 52
13.2 Display Value, Outputs and Indicators 52
14 Motion Levels 53
15 Custom Scores 54
16 Support Center 55
17 Cleaning and Disinfecting 56
18 Technical Data 57
18.1 Electrical Safety 57
18.2 Electromagnetic Compatibility (EMC) 57
18.3 System Hardware Components 58
18.3.1 WEARABLE DEVICE 58
18.3.2 CHARGING DOCK AND MAINS POWER ADAPTER 58
18.4 Monitoring Specifications 59
18.4.1 PULSE RATE 59
18.4.2 PULSE OXIMETRY (SPO2) 59
18.4.3 RESPIRATORY RATE 60
18.4.4 TEMPERATURE 61
18.5 Alarm Specifications 61
18.6 FCC 61

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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

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Charging
Dock
iHealth Ease
Blood
Pressure
Monitor
(Hospital)
Omron Evolv
Blood
Pressure
Monitor
(Home)
iHealth View
Blood
Pressure
Monitor
(Home)

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iHealth Neo
Blood
Pressure
Monitor
(Home)
VivaLnk
Fever Scout
Axillary
Temperatur
e Sensor
MIR
Spirobank
Smart
Spirometer
Weighing
Scales

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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.
Note that the Patients App is identical on both iOS and Android. As such, the processes
explained below are the same across both platforms.
Devices App
Available on:
 Apple iPhones and iPads running iOS 11 or greater
 Android tablets and smartphones running Android 8 (Oreo) or 9 (Pie)
The Devices App is responsible for patient admission, discharge and transfer. It also receives
technical alarms and allows monitoring of wearable device battery life.
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

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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

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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. Please review cleaning and
disinfection instructions in section 17.