Professional Documents
Culture Documents
Manufacturer's Responsibility
Insighters will only be responsible for the impact on the safety, reliability and performance of this
product if all the following requirements are met.
All repairs, installation operations, extensions, changes and modifications of this product are
completed by Insighters authorized personnel.
The use or application of products or the use of parts or accessories is approved by Insighters.
The electrical installation in the relevant environment meets the applicable national and local
requirements.
Use the product according to the instructions.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE.
Warranty Period
Party A provides warranty period as described chart below for sold products and Party A offers free
of charge repair service within the warranty period except for the replacement of disposable parts.
The commencement of warranty period is determined by either the installation date on warranty
card or manufacturing date.
Product Name Warranty Period
Insight iS3-F Video Flexible Laryngoscope 1 Year
Insight iS3 Video Laryngoscope 3.5-inch Host 3 Years
This warranty shall not extend to any instrument which has been subjected to misuse, negligence
or accident; any instrument from which Insighters's original serial number tag or product
identification markings have been altered or removed, or any product of any other manufacturer.
It’ an obligation for Exclusive Distributor to assist Insighters Medical in case of product recall and
after-sales service.
Return Policy
1. If repairs become necessary, for other than damages incurred during initial shipment, the
customer must follow the repair procedure.
2. Warranty repairs will be made without charge. All other repairs are subject to Insighters’
applicable standard repair or exchange charges.
3. If requested, customer will be advised of the estimated cost of the repair work or a product
exchange before it is undertaken.
4. All repairs carry a 90 days warranty.
5. Exchange products carry the applicable Insighters product warranty.
6. If the damaged product is not returned within thirty (30) days of receipt of the replacement
product, customer will be invoiced for the full list price of the replacement.
7. Insighters reserves the right to refuse or return any product sent back without prior
authorization of Insighters Customer Support Department.
Other Terms
1. It is compulsory to provide customer information, troubleshooting description and address to
send back for after-sales repair. The freight cost should be shared by both parties under
warranty period.
2. No matter what causes device damage, please stop usage and contact Party A for repair.
3. Insighters Medical reserves the right of final interpretation.
Contact Information
Manufacturer: Shenzhen Insighters Medical Technology Co., Ltd
Address: The 13th floor of Hengtemei Building, Ganli Road No. 3, 518000 Shenzhen, Guangdong,
PEOPLE’S REPUBLIC OF CHINA
Tel: +86-755-28218609
Fax: +86-755-84509803
E-mail: intl-market@insighters.cn
www.insighters.cn
In this manual, the signal words WARNING, and CAUTION are used regarding safety and other
important instructions. The signal words and their meanings are defined as follows. Please
understand their meanings clearly before reading this manual.
.
1.2 Meaning of Safety Symbols
Symbol Description
WARNING
Only personnel authorized or trained by the manufacturer can carry out equipment
maintenance. No Team Authorization cannot install or remove equipment.
The user must receive adequate training and study before use. Official agencies and operators
shall meet the qualification requirements. Otherwise, only medical personnel approved by the
hospital safety administrator or department head can perform the laryngoscope. Only
personnel authorized or trained by the manufacturer can carry out equipment maintenance.
No team authorization cannot install or remove equipment.
Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near
this product, because there is danger of explosion.
The insight iS3 video laryngoscope host must be charged with the power adapter supplied by
Insighters, otherwise the device may be damaged.
The insight iS3 video laryngoscope are delivered non-sterile and require cleaning or
disinfection prior to initial use.
This product may only be cleaned, disinfected, or sterilized by using the approved methods
provided in this manual. Availability of cleaning, disinfection,and sterilization products varies in
different countries, and Insighters Medical is unable to test products in every market. For more
information, please contact Insighters after-sales team.
This product and related devices may contain batteries and other environmentally hazardous
materials.
Electric shock hazard. Do not attempt to open the system components. This may cause
serious injury to the operator or damage to the instrument and will void the warranty.
Before the installation and operation, the user should first check the appearance of the
medical device to ensure there are no unintended rough surfaces, sharp edges or protrusions
which may cause HARM.
CAUTION
Malfunctions due to radio waves:
(1) Use of radio-wave-emitting devices in the proximity of this kind of medical electronic system may
interfere with its operation. Do not bring or use devices which generate radio waves, such as
cellular telephones, transceivers, and radio controlled toys, in the room where the system is
installed.
(2) If a user brings a device which generates radio waves near the system, they must be instructed
to immediately turn OFF the device. This is necessary to ensure the proper operation of the system.
Video Laryngoscope is a kind of ordinarily sealed device. The user should keep its surface dry
and clean, and prevent any liquid into the internal.
The user should properly place Video Laryngoscope, preventing it from falling, violent
oscillation, or other damage caused by external mechanical force.
The following table is used to identify important symbols found in labels in laryngoscope.
Symbols Meaning
Date of Manufacture
Serial Number
Serial Number
2.6 EMC
Guidance and manufacturer’s declaration –electromagnetic emissions
The Video Flexible Laryngoscope is intended for use in the electromagnetic environment
specified below. The customer or the user of the SECP-II should assure that it is used in
such an environment.
Electromagnetic
Emissions test Compliance
environment - guidance
The Video Laryngoscope uses RF energy only
for its internal function. Therefore, its RF
RF emissions
Group 1 emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class A The Video Laryngoscope is suitable for use in
Harmonic emissions all establishments other than domestic and
Not applicable
IEC 61000-3-2 those directly connected to the public
Voltage fluctuations/ flicker low-voltage power supply network that supplies
Not applicable
emissions IEC 61000-3-3 buildings used for domestic purposes
Fig 3-4-1
3.5 Check Image
1. Turn on the power. LCD will display start-up image.
2. Connect host with handle, and then the white LED on distal end of handle will light up, host will
display image from camera.
4.3.1 Cleaning, Disinfection & Sterilization Methods for the iS3-F Series
Table 10
Chemical Concentration Disinfection Level
Enzymatic agent or detergent - Clean
4.3.2 Insighters Medical has validated the compatibility of iS3-F series with following AERs:
4.4.1 Storage
1. Make sure the host is turned off and the AC adapter is disconnected.
2. Avoid direct sunlight, high temperature, and acid erosion. Store it in a dry, clean place.
3. Avoid storing it in chemicals or at explosible gases.
4. The flexible tube part can’t be twisted when in storage, or it maybe get damaged.