CMI Health SpiroLink User manual

User Manual
Model: B1
CMI Health Inc

Preamble
This instruction manual contains important
information that should be understood for safe
and correct use of this product. Therefore,
during the entire service life of this product, the
instruction manual should remain accessible for
easy reference.
This product should be operated by persons
who have received relevant training, relevant
knowledge and relevant experience. All persons
should read this instruction manual carefully
before using this product.This instruction
manual should be forwarded to subsequent
parties or users of this product.
This instruction manual contains copyright
information. All rights reserved. Without prior
written approval from CMI Health Inc. it is not
permitted to be copied, reproduced or
translated to any language. CMI Health Inc.
reserves the right to modify the information
contained in this document.
This product is safe and reliable, except for
hazards caused by special factors, such as,
caused by non-professional operations or used
for unintended purposes. Therefore, please
follow the stated instructions during use to
avoid accidents.
This product is subject to instruction or
authorization. Equipment maintenance shall be
operated by a technical attendant or skilled user
authorized by CMI Health Inc. If there are any
further questions about the operation not
mentioned, please contact CMI Health Inc.
Table of Contents
1. Product overview
2. Symbols
3. Safety precautions
4. Installation and operation
5. Maintenance
6. Troubleshooting
7. Warranty
8. Network security description
9. EMC statement
10. Manufacturer information
1
5
6
8
12
14
15
17
19
28

1. Product overview
1.1 Basic information
Product name: SpiroLink
Model: B1
Data Transmission: Bluetooth BLE
1.2 Intended use
This device is intended for monitoring PEF (Peak
Expiratory Flow) and FEV1 (Forced Expiratory
Volume in 1 second). The device is designed for
pediatric and adult patients. The device is
intended for monitoring respiratory conditions
such as asthma and COPD.
1.3 Product structure
The product is composed of the device,
mouthpiece and USB cable as shown below:
1-Front Housing 2-Rear Housing 3- Mouthpiece
4-USB Cable 5- Air Inlet 6-Power button
7-Display 8-Reset Keyhole 9-Speaker
10-USB port 11- Air Vent
1.4 Product performance
1.4.1 Measure parameters
PEF Peak Expiratory Flow
FEV1 Forced Expiratory Volume in 1 Second
*FVC *Forced Vital Capacity
1.4.2 Technical parameters
Measuring range PPEF:(0～14) L/s
FEV1:(0.5～8) L
*FVC:(0.5～8) L
Accuracy PEF: ±10% or ±18L/min
(whichever is greater)
FEV1: ±3% or ±0.05L
(whichever is greater)
*FVC: ±3% or ±0.05L
(whichever is greater)
Power supply 3.7V DC
21
1
2
3
4
6
5
7
8
9
11
10

1.6 Product content
1.5 Contraindications
1） Patients with severe asthma
2) Patients with severe COPD
3) Uncontrolled hypertension patients
4) Patients who had chest, abdominal or eye
surgery in the past 3 months
5) Patients who had heart disease (angina
pectoris, myocardial infarction, malignant
arrhythmia, etc.) in the past 3 months
6) Patients hospitalized for heart disease in the
last 1 month
7) Patients with massive hemoptysis in the last
1 month
8) Patients with stroke in the last 1month
9) Patients with aortic aneurysms
10) Patients with severe hyperthyroidism
Anti-shock Internal power supply
Safety category BF type
Water resistance IPX0
Operating mode Consecutive
EMC compatibility Group 1 Class B
* FVC is provided for wellness use only
11) Patients with seizures and in need of
medication
12) Patients with a history of retinal detachment
13) Patients with facial paralysis
Main unit 1
Quick Guide 1
USB data cable 1
Removable mouthpiece
User manual
2
1
1.7 Specifications
- 39mm -
111mm
43

2. Symbols
Graphic
Symbol Meaning
Please refer to the user manual
and follow the instructions
Keep Dry
Type BF applied part, can contact
patient isolate from other parts
Low-frequency electromagnetic
radiation
Caution! View accompanying
documents
“WEEE (Waste Electrical and
Electronic Equipment)”. The waste
products should be handled legally.
Waterproof rating is 0
3. Safety precautions
1）Please operate strictly according to this user
manual, otherwise, there might be inaccurate
measurement, or damage to device.
2）Do not use while charging，otherwise it will
lead to inaccurate measurement.
3）Regular maintenance to make sure there’s no
damage that affects safety and performance.
It is advised to check at least once a week, if
there’s obvious damage, please stop using
and contact customer service.
4）Do not repair this device by yourself, it should
only be done by qualified personnel
appointed by the manufacturer.
5）Do not use this device in an environment that
has anesthetics and other inflammables which
may cause explosion.
6）Do not use this device in strong
electromagnetic interference or direct wind
source, cold source and heat source
environment.
7）Do not immerse this device into liquid.
8）Do not spatter liquid onto this device which
may cause damage.
9）Do not place this device in a mechanical
vibration environment.
65

10）Do not drop this device from a high place.
11）Do not use sharp objects to press or scratch
the device shell.
12）Do not disassemble the device without
permission.
13）Do not place heavy objects on the device
which may cause performance or mechanical
damage.
14）Please use the device in specified working
environment, keep the working environment
clean and avoid corrosive or flammable
substance, too high or low temperature and
humidity.
15）Do not use high temperature high pressure
or gas disinfection to disinfect the device.
16）Do not spatter liquid directly on the device
when disinfect the device surface using
rubbing alcohol.
17）If the device continues to fail to display data
or there’s other abnormal conditions, press
power button to remeasure, or power off the
device and restart.
18）Please dispose of the device, its accessories
and package (such as mouthpiece, plastic
bag, foam and paper box) in accordance with
the local laws and regulations.
19）The measurement results serve as a clinical
reference which should be explained by
professional medical personnel.
20）When using the device, pay special attention
to the user manual where this symbol “!” is
marked.
4. Installation and operation
4.1 Device installation and preparation
Install the mouthpiece: Hold the device, make
the side of the mouthpiece with this triangular
symbol “△” face upward, insert the mouthpiece
into air inlet, then press slightly, the mouthpiece
will be firmly locked.
4.2 Testing procedure
Step 1: Hold the product upright in the hand,
press and hold the power button to start up, you
will see a device startup screen.
87

Power button
Step 2：Wait for the device to finish booting,
then short press power button, you will hear
“Please blow”.
Power button
Step 3： After hearing “Please blow”, Take a deep
breath, hold your breath while put the
mouthpiece into your mouth and close lips
around the mouthpiece. (the upper and lower
teeth should nibble the front of the mouthpiece,
and your lips should tightly cover the
mouthpiece), blow air out as fast and as far as
possible (the standard time is 6 seconds, while
blowing, you will hear “Come on, come on, 3, 2,
1, stop”.
Note:
Do not shake your head downward with your
body violently while blowing, since this may
affect test result.
Keep the standing posture during the test and
keep your body stable.
Adjust your breath before the test (inhale and
exhale for 3 rounds), keep your breath steady.
Step 4: After the test, there will be a prompt tone,
the results are shown in display screen (you can
test multiple times and take the maximum value).
CAUTION:
2）No matter what your reading is, if you have
signs and symptoms such as chest tightness,
shortness of breath, coughing or wheezing,
please seek medical assistance.
1） The measurement results serve as a
clinical reference which should be explained
by professional medical personnel.
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4.3 Shutting down
1）When device is powered on, long press power
button to power off. The device will display
shutdown interface (LOGO gradually zoom
out), while the device prompt “Device
shutting down”. After the above actions are
completed, the device is powered off.
2）The device will automatically power off after
6 minutes of inactivity.
4.4 Charging
There are two charging methods:
1）Use power adapter with a 5V-1A power
adapter to charge. Insert the standard USB to
the power adapter and the microUSB to the
device using included USB cable.
2）Insert the standard USB to a USB port on a
running computer and the microUSB to the
device.
5. Maintenance
5.1 Cleaning and disinfection
1）Use rubbing alcohol to wipe the shell of the
device, then use clean, soft cloth to dry it or
dry by natural air.
2）Remove and clean the mouthpiece regularly.
Rinse with clean water, or use clean, soft dry
cloth dipped in rubbing alcohol to wipe the
inner and outer wall of the mouthpiece and
dry by natural air. Alternatively dip the mouth
piece in rubbing alcohol for a while, wipe it
dry or dry by natural air.
3）Use cotton ball dipped in rubbing alcohol to
gently wipe the metal plate to keep it clean.
CAUTION:
2）It’s prohibited to immerse the device shell
into liquid.
4）Do not wash or disinfect the device with
strong alkali or strong acid.
3）Do not flush the main unit with high
pressure water.
1） Only use wet cloth to wipe (Wipe
disinfection).
1211

5.2 Maintenance
1）Please read the "Safety precautions" section
carefully and implement strictly.
2）When the display shows low charge, charge
the battery in time.
3）When the device is not in used for a long
period of time, it shall be recharged every 6
months.
4）We recommend performing quarterly check if
the device is used by Healthcare Professionals.
Please contact CMI customer service for device
calibration and repair.
5.3 Storage and transportation
requirements
1）Storage environment
Temperature: -4 F to 131 F
Relative humidity: 0%RH to 80%RH
Atmospheric pressure: 0.7 ATM to 105 ATM
Environment: non-corrosive gases and well-
ventilated clean rooms
2）Work environment
Temperature: 50 F to 104 F
Relative humidity: 0%RH to 80%RH
Atmospheric pressure: 0.7 ATM to 105 ATM
3）Transportation requirements
The product should be protected from heavy
pressure, direct sunlight and rain during
transportation. It should be in accordance
with the order contract.
CAUTION:
2）Avoid high temperature or direct sunlight.
1） Avoid falling or strong impact
6. Troubleshooting
Problem Cause analysis Solutions
Unable to
turn on
Unable
connect to
network
after turned
on
Low battery Please recharge
Please contact Customer
Service
Possible device
damage
Bluetooth on
phone not
turned on
Turn on the Bluetooth in
phone setting
Unable to
get the test
data Incorrect
exhalation
posture
Please refer to Chapter 4
for the correct blowing
posture
Device not in
test mode
Press the power button
to start test
1413

Sudden
disappearance
of display
Automatically
shut down
without any
operation for
6 minutes
Normal phenomenon
Please recharge
The device
usage time is
too short after
recharging
Battery
damaged
Low battery Please recharge
Low battery
Please contact
Customer Service
Data
transmission
failure
Bluetooth
disconnected
Turn on Bluetooth on
your smartphone
Please contact
Customer Service
Open the APP and
retry connection
7. Warranty
7.1 Duration and exceptions
One-year warranty from the purchasing date
upon presentation of proof of purchase.
Warranty does not include the following failure
conditions; unauthorized disassembly,
inappropriate transportation, lack of reasonable
maintenance, force majeure factors such as
natural disasters.
CMI Health assumes no responsibility for faulty
operation or problems caused by improper use
with other unapproved device, or accessory.
7.2 Maintenance and repair
Please contact CMI Health Customer Service at
888-985-1125 or [e-mail] for
detailed instructions.
Warranty will be void if maintenance is
conducted by the user, or unauthorized
personnel.
To process your maintenance request faster,
please provide the following information to our
Customer Service:
Product number
Detailed description of the problem
Caution:
Please use proper packaging (preferably the
original package) when shipping.
Our company has the right to return
contaminated product to the sender.
WARNING:
The service center has the right to reject
contaminated product for safety reasons.
Please pack the product in a way that does
not contaminate the package.
1615

Device
Administrator
7.3 Production date and expiration date
Product production date: see product label
Product expiration date: three years
8. Network Security
Description
The device can upload data to the mobile app
via Bluetooth.
8.1 Operating environment
requirements
B1
Device
SpiroLink
APP
Software
requirement
Android or
iOS phone
with Bluetooth
BLE
Hardware
requirement
Network
requirement
Bluetooth
ON; device
within 15
feet from
phone
8.2 Data and device interface
8.3 User Access
General
user
User Type
The user's
personal
account is
bound to the
device code,
and device
data can only
be obtained
after the
device is
bound.
User
authentication
method
Access
device
Measure
data
User
Authority
Password
strength
settings
Personal
account: The
account name
and password
match, and the
password length
is not less than
6 digits.
Device ID: Each
device has a
unique ID,
which serves
as a unique
identity.
Device ID is
encrypted.
CMI authorized
service
personell
Access
device
data and
perform
software
updates
Via account
and password
The password
must be in
English
uppercase and
lowercase, and
the length must
be at least 6
digits.
18
17
The spirometer (B1) complies with the BLE
protocol, enabling the embedded device to
communicate with other Bluetooth devices.

9. EMC statement
9.1 Parameter Description
Spirometer B1 Modulation type: GFSK
Radio Power: 12dbm
Operation Frequency: 2.4 GHz ISM band
9.2 Precautions statement
ATTENTION：
The SpiroLink complies with the relevant EMC
requirements of the YY0505-2012 standard;
users should install and use the
electromagnetic compatibility information
provided in the accompanying documents.
Portable and mobile RF communication
equipment may affect the performance of the
pulmonary function testing device. Avoid
strong electromagnetic interference while
using it, such mobile phones, microwave
ovens, etc.
Guidance and manufacturer's declaration are
detailed in the accessories.
USB cable length is about 2.6 feet
WARNNING：
The SpiroLink should not be operated near,
or stacked, with other equipment. If must be
stacked, it should be verified that it can
operate normally in the configuration in
which it is used.
Except for cables sold by the CMI Health Inc.
as spare parts for internal components, the
use of accessories and cables other than
those specified may result in increased EM
emissions or reduced immunity to
interference.
Even if other equipment meets the emission
requirements of the corresponding national
standard, the SpiroLink may still be
susceptible to interference by other
equipment.
20
19

9.3 Declaration of conformity
Manufacturer declaration - Electromagnetic Emissions
The SpiroLink is intended for use in the electromagnetic
environment specified below. The purchaser or user of
the spirometer should ensure that it is used in this
electromagnetic environment:
Compliance
Group 1
CAT B
Not applicable
Emission tests
RF emission GB
4824
RF emission GB
4824
Voltage
fluctuation /
flicker emission
GB17625.2
Harmonic
emission
GB17625.1
Electromagnetic
Environment Guide
The spirometer uses
radio frequency
energy only for its
internal functions. As
a result, its RF
emissions are low
and there is little
chance of interference
with nearby electronic
equipment
The spirometer is
suitable for use in all
facilities, including
domestic facilities
and public low-
voltage power grids
that are directly
connected to the
home
Not applicable
Manufacturer Declarations ‒ Electromagnetic Immunity
The spirometer is intended for use in the electromagnetic
environment specified below, and the purchaser or user
should ensure that it is used in this electromagnetic
environment:
IEC 60601
test level
± 6KV
contact
discharge
± 8KV air
discharge
± 2KV to
power line
± 1KV to
input /
output
± 1KV
differential
mode
± 2KV
common
mode
Immunity
test
Electrostatic
discharge
GB / T17626.2
Electrical fast
transient
Burst GB /
T17626.4
Coincidence
level
The floor should be
wood, concrete or
tile, and if the floor is
covered with
synthetic material,
the relative humidity
should be at least
30%
Electromagnetic
Environment Guide
Not
applicable
Not
applicable
Not applicable
Surge
GB /
T17626.5
Not applicable
22
21

<5% UT
for 0.5
cycles
(on UT,
>95% dip)
40% UT
for 5 cycles
(60% sag
on UT)
70% UT for
25 cycles
(30% sag
on UT)
<5% UT for
5s (on UT,
> 95% dip)
3A/m
Voltage sag,
short-term
interruption
and voltage
change on
the power
input line
GB / T17626.11
Not
applicable
3A/m 50/
60Hz
Not applicable
Frequency
magnetic field
(50 / 60Hz)
GB / T17626.8
Power frequency
magnetic fields
should have
power frequency
magnetic field
levels typical of
typical locations
in a typical
commercial or
hospital
environment.
Note: UT refers to the AC network voltage before the test
voltage is applied
Manufacturer's Declarations - Electromagnetic Immunity
The spirometer is intended for use in the electromagnetic
environment specified below. User should ensure that it
is operate in this electromagnetic environment:
IEC60601
Test level
Immunity
test
RF
conduction
GB/T
17626.6
RF
radiation
GB/T
17626.3
3V
(Effective
value)
150kHz ‒
80MHz
3V/m
80MHz ‒
2.5GHz
Coincidence
level
Electromagnetic
Environment Guide
Portable and mobile
RF communications
device should not be
used closer to any
part of the handheld
lung function tester
A1 than the
recommended
isolation distance,
including cables.
This distance should
be calculated by the
formula
corresponding to
the frequency of the
transmitter
Recommended
isolation distance:
3V/m
3V/m
24
23

NOTE 1: At 80MHz and 800MHz frequencies, the higher
frequency band formula is used.
NOTE 2 These guidelines may not be suitable for all
situations. Electromagnetic propagation is affected by
absorption and reflection from buildings, objects and
people
d = 1.2√P
d = 1.2√P 80MHz~800MHz
d = 2.3√P 800MHz~2.5GHzd
In formula:
P: the maximum output power
of the transmitter in watts (W)
according to the transmitter
manufacturer.
d: recommended isolation
distance in meters (m)The field
strength of the fixed
RF transmitter is determined by
surveying the electromagnetic
field c, and in each frequency
range d should be lower than
the compliance level.
Interference may occur near
equipment marked with the
following symbol. “!”
1. The field strength of fixed transmitters, such as base
stations for wireless (cellular / cordless) phones and
terrestrial mobile radios, amateur radios, AM and FM radio
broadcasts, and television broadcasts, cannot be accurately
predicted theoretically. To assess the electromagnetic
environment of fixed RF transmitters, surveys of
electromagnetic sites should be considered. If the measured
field strength of the hand-held pulmonary function tester A1
is higher than the applicable radio frequency compliance
level above, the hand-held pulmonary function tester A1
should be observed to verify its normal operation.
If abnormal performance is observed, supplementary
measures may be necessary, such as reorienting or
repositioning the handheld lung function tester A1.
2. In the entire frequency range from 150KHz to 80MHz, the
field strength should be lower than 3V/m.
26
25

Recommended distance between RF devices and
spirometers
Spirometry is expected to be operate in an electromagnetic
environment where RF radiation disturbances are
controlled. Depending on the rated maximum output
power of the communication device, user can prevent
electromagnetic interference by maintaining a minimum
distance between mobile RF communication device
(transmitters) and (equipment or system) as
recommended below.
Isolation distance corresponding to
frequencies (m)
150kHz~
80MHz
d = 1.2√P
Transmitter
rated
maximum
output
power (W)
100
For the rated maximum output power of the transmitters
not listed in the table above, the recommended isolation
distance d in meters (m) can be determined using the
formula in the corresponding to frequency, where P is
provided by the transmitter manufacturer Transmitter
maximum output power in watts (W).
12 12 23
10 3.8 3.8 7.3
1 1.2 1.2 2.3
0.1 0.38 0.38 0.73
0.01 0.12 0.12 0.23
80MHz~
800MHz
d = 1.2√P
800MHz~2.5GHz
d = 2.3√P
28
27
Note 1: At 80 MHz and 800 MHz, the higher frequency range
formula is used.
NOTE 2 These guidelines may not be suitable for all
situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and
people.
10. Manufacturer information
Manufacturer name: CMI Health Inc.
Manufacturer address:
5975 Shiloh Rd. Suite 114,
Alpharetta, GA 30005
Toll-Free Customer Service: 888-985-1125
Website: www.cmihealth.com
Email: [e-mail]