Vincent Medical Manufacturing inspired O2FLO User manual
USER MANUAL
High Flow Heated
Respiratory Humidifier
Vincent Medical Manufacturing Co., Ltd
Flat/RM B2, 7/F., Hang Fung Industrial Building, Phase 2,
2G Hok Yuen Street, Hung Hom, Kowloon, Hong Kong
Tel: +852 2186 1010
Email: service@inspired-medical.com
Website: www.inspired-medical.com
Customer Service Contact Information
Customer Service Hotline
This manual and its corresponding intellectual property rights belong to Vincent
P/N.: xxxxxxxx Rev.A Release Date: 20xx-xx-xx
01 INTRODUCTION
02 WARNINGS AND CAUTIONS
11 SPECIFICATION
13 DEVICE OVERVIEW
19 SET-UP
25 OPERATION
TABLE OF
Page
CONTENTS
24 PRE-USE CHECKS
SETTINGS
RECORDING OF DATA
TROUBLESHOOTING
MAINTENANCE
EMC INFORMATION
34
42
45
46
48
51 DEFINITION OF SYMBOLS
50 WARRANTY
60L/min. The gas delivered is composed of an air-oxygen mixture and is capable of
rate from 2L/min to 60L/min.
ATTENTION:
for future reference.
INTRODUCTION
DESCRIPTION
INTENDED PURPOSE
under the supervision of trained medical personnel.
INTENDED POPULATION
The following adverse events are associated with this device:
ADVERSE REACTIONS / RESIDUAL RISKS
01
have not been approved by Vincent Medical may impair performance and
compromise safety.
WARNING
WARNING
CAUTION
NOTE / ATTENTION
Notesmanual. They provide
Symbol
WARNINGS AND CAUTIONS
02
accessories.
device. Use of damaged components or accessories may impair the performance
of the device and compromise safety.
other persons within the MR environment.
the maximum water level mark. Failure to do so may cause water to spill into the
chamber with a new one.
03
and compromise safety.
especially during ambulatory use, only use approved tubes that are listed in this
manual that are in conformance with ISO 5367 or ISO 80601-2-74.
and/or end user.
or operate the device.
04
Oxygen supply shall be standard dry and clean compressed oxygen for medical
and impair treatment.
list in this IFU for details on maximum period of use before change is necessary.
packaging is damaged before use.
05
Do not use the power cord or the power plug if it is damaged, and do not plug the
power cord into a loose electrical outlet/socket. Doing so may lead to electric shock.
power cord. Use of a damaged power cord may lead to electric shock or serious
may lead to electric shock.
before moving, servicing, or cleaning the device. Failure to do so may lead to
so may lead to device damage and electric shock.
of the environment when the device is used with an oxygen supply:
- Never smoke near the device.
a physician or trained medical professional.
with oxygen under pressure. These substances must be kept away from all
06
Smoking during oxygen therapy is dangerous and is likely to result in facial burns
device or any oxygen-carrying accessories.
cannula or mask on bed coverings or chair cushions, if the device is turned on,
and/or damage to the environment. If an oxygen leak is discovered, disconnect the
bed or couch/sofa, where the cooling vents may be blocked. Doing so may cause
thereby causing the device to overheat.
07
CAUTION
The device is intended to be used in a professional healthcare facility environment
should be separated.
provided by the manufacturer of this device could result in increased
detectors. Note that the presence of RFID devices may not be obvious. If such
To avoid damage when the device is not in use it must be kept clean and stored in
its original packaging.
replacement could result in damage to the device.
Keep the storage environment clean and free from dust and pests.
08
device is unplugged/ disconnected from the electrical outlet.
Do not use corrosive solvents to clean the surface of the device.
Avoid exposing the device to direct sunlight and/or high temperatures.
ATTENTION:
If the FiO2
22
2
the nasal cannula.
2alarm upper and lower limits will be reset
to the default values.
2alarm upper
and lower limits will resume the values set by the operator.
2level. Decreasing the
Flow Rate of the device will increase the FiO2level.
the FiO2
oxygen inlet port closed.
09
60L/min. Otherwise FiO2
Flow Rate, Dew Point Temperature and FiO2.
connected to ensure proper cooling. The device will alarm if any of these are disconnected.
Behaviour of the device when power is lost while running:
alarm signal will sound for more than 120 seconds.
- If the power cord is reconnected to mains power within 4 minutes, the device
- If the loss of power exceeds 4 minutes, the device will shut down. Therapy
to default values.
the main screen.
displayed on the LCD screen if the SD card is not installed.
10
SPECIFICATION
SAFETY CLASSIFICATIONS
SPECIFICATION
mixture with air or oxygen or nitrous oxide: Device is not suitable for use in the
Power Input
Rated Power
Dew Point Temperature Accuracy
Maximum Warm-up Time
100 – 240V~, 50/60Hz
300VA
10 – 60L/min
2 – 25L/min
< 10s
31 – 37°C
31 – 34°C
<±2°C
<±2°C
25 minutes
<±2L/min
<±4L/min
<±6L/min
2
11
RECOMMENDED ENVIRONMENTAL CONDITIONS
non-condensing, 86 - 106kPa.
BATTERY INFORMATION
ENVIRONMENTAL PROTECTION
At the end of service life, the device and its accessories should be disposed of and
CAUTION
could result in damage to the device.
Humidicaon Output
Maximum Temperature of Delivered Gas
Maximum Temperature of Accessible Surface
Maximum Limited Pressure
Sound Pressure Level Acousc Noise
Alarm Volume
Dimensions
Net Weight
Expected Service Life of the Unit
33mg/L @ 37°C
16mg/L @ 31 – 36°C
48°C
50°C
2
0dBA @ 1m
0dBA @ 1m
243mm x 220mm x 170mm
2.8±0.2kg
5 years
NOTE:
12
DEVICE OVERVIEW
IMAGE DESCRIPTIONQTY
1 pc
1 pc
25 pc
1 pc
1 pc
NOTE: Referred to as
OXYGEN TUBE in this
manual
Cable
NOTE: Referred to as
CONNECTION CABLE in
this manual
LIST OF DEVICE COMPONENTS
13
LIST OF APPROVED ACCESSORIES
MAXIMUM USE PERIOD
14 DAYS
14 DAYS
1 YEAR
14 DAYS
AUTOFEED HUMIDIFICATION CHAMBER
VHC60
ADULT INTEGRATED BREATHING CIRCUIT
PAEDIATRIC INTEGRATED BREATHING CIRCUIT
510-050
PRODUCT NAME AND IMAGE
CONNECTION CABLE
VUN-300
14
7 DAYS
30 DAYS
N/A
NASAL CANNULA
FILTER
OXYGEN TUBE
14 DAYS
NASAL CANNULA
NOTE:
Apart from the CONNECTION CABLE and the OXYGEN TUBE, all accessories are
single use.
15
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