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
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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
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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
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1
1.7 Specifications
- 39mm -
111mm
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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.
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