Current G2 Bedienungsanleitung
www.currenthealth.com
200002/1
G2
Instructions for Use
Current Health Ltd
Playfair House,
Broughton Street Lane,
Edinburgh, EH1 3LY,UK
Instructions for Use
www.currenthealth.com
200002/1
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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.
Instructions for Use
www.currenthealth.com
200002/1
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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.
Instructions for Use
www.currenthealth.com
200002/1
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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
Instructions for Use
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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
Instructions for Use
www.currenthealth.com
200002/1
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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
Instructions for Use
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WARNING: Ensure mobile device for receiving alarm signals has WiFi or data connection
Instructions for Use
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Page 8 of 61
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.
Instructions for Use
www.currenthealth.com
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Page 9 of 61
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.
Instructions for Use
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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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