Patient Monitor Environmentally Conscious Design Requirements NO.

: CN92710000-458

Environmentally Conscious Design Requirements

Model：K15 K12 K10

Compiled:

Check:

Approved:

Shenzhen Creative Industry Co., Ltd.

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Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

Revision Record

Version Date Revision Record Editor

1.0 2019.8.20 Tan Junrong

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 Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

1 Introduce
1.1 Device name and model
Device Name: Patient Monitor
Device Model: K15, K12, K10
1.2 Intended Use
The K series are applicable for detecting ECG, respiratory, temperature, Spo2, pulse rate and
NIBP of adult and neonate patients in clinical institution and hospital.

2 Identification of environmental aspects during product lifecycle

2.1 Is there a procedure related to the establishment of management program for toxic and hazardous
substances?
Shenzhen Creative Industry Co., Ltd. (Creative) has established a management program for the
management of toxic and hazardous substances. The equipment is strictly controlled from the
whole process of design development, procurement, production, inspection, storage and finished
product shipment. Please see Annex 1 “CP-42 Toxic and hazardous Substances Management
Control Process”.

2.2 Whether the product has been tested for toxic and hazardous substances?
The K series (K15, K12, K10) are tested for toxic and hazardous substances and is compliant
with RoHS 2.0 (2011/65/EU). Please see Annex 2 “Patient Monitor RoHS Test Report”.

2.3 What’s the equipment consumable? Is there a battery?

The main consumable used in the K series is the lithium battery. The K series are an internal
power supply device with a battery. The harmful substances generated by the battery during the
production process have been properly handled. At the same time, the battery manufacturer has
passed ISO14001: 2004 Environmental Protection System Certification (Certificate No.:
PKC1023102). Please see Annex 3 “ISO14001 Certificate”. After the battery is exhausted, it
should be disposed of in accordance with the local laws and regulations.

2.4 Whether radioactive materials will be produced during the use of the equipment?
There is no radioactive substances during the production or use.

2.5 What are the main raw materials used in the equipment? What’s the main ingredient?
The raw materials and ingredients of the K series (K15, K12, K10) are shown in the table
below:

K series (K15, K12, K10)

Name Main Material RoHS Report Supplier
Battery SET2016-12508 深圳市润友科技有限公司
Front Casing ABS 0114020914a 002 惠州市鑫瑞宝源塑胶模具
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 Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

Rear Casing ABS 有限公司

Glass fiber
cloth base,
普达电路科技（深圳）有限
PCB epoxy resin, NO.CANML1800543902
公司
copper clad,
flame retardant
深圳市龙星辰电源有限公
Charger CANEC1510529301
司

2.6 Does the equipment have exhaust gas? If so, what are the main ingredients?
There are no substances such as exhaust gas during the production and use of the K series.

2.7 Whether the equipment will be involved in the pollution of surface water and groundwater during
the production and use process?
During the production of the K series, PCBs supplied by suppliers may be involved in surface
water discharge pollution during production. However, the PCB supplier has passed the
environmental protection review of the environmental protection department of the authorities.
Please refer to Annex 4 “Review and Approval of Environmental Impact Assessment of
Construction Project of Baoan District Environmental Protection Bureau of Shenzhen City”.
The production of other materials and complete machines does not involve pollution of surface
water and groundwater.The use of the K series doesn’t involve contamination of surface water
and groundwater.

2.8 What waste are produced during the production process, especially non-recyclable hazardous
substances?
Shenzhen Creative Industry Co., Ltd. is responsible for product design, incoming inspection,
finished product assembly, debugging and machine inspection. The suppliers are responsible for
the processing of materials and semi-finished products. The unqualified products found during
the incoming inspection are handled by the supplier. The unqualified finished products are
handled by Creative. Therefore, in the processing which is in charge by Creative, there is
generally no waste of materials. At the same time, Creative has relevant control procedures for
the disposal of waste generated during the production process. Please see Annex 5
“Supplementary Provisions for Disposal of Unqualified Materials”.

2.9 Whether the equipment has noise, vibration, odor, dust, electromagnetic interference etc.?
The K series are powered by an internal lithium battery and is free from noise, vibration, odor,
dust and other pollution. There may be electromagnetic interference. The K series have passed
the IEC60601-1-2: 2014 standard test, please see Annex 6 “IEC60601-1-2 test report
TRE18030064R1”.

2.10 What are the requirements of the production for the use environment and the transportation
environment?

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Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

The use and transportation requirements of the K series have been included in the User Manual
of K series:
Environment:
Ambient temperature: 5°C ~40°C
Relative humidity: 30%~85%
Atmospheric pressure: 70kPa~106kPa
Please see Annex 7 “User Manual”.

2.11 What are the risks or potential accident risks that production poses to the environment? What ‘s
the possible consequence of the incident?
The K series may cause environmental hazards (electromagnetic interference, mechanical
energy), biological hazards, chemical hazards, operational hazards, etc., but the product has
been analyzed for related risks, to analyze the probability of occurrence of the consequences of
the event. And the degree of risk and appropriate risk control and measures has been taken.
Please see Annex 8 "Risk Management Report (K series)".

2.12 Whether using the production will pollute the biological environment?
The K series will not pollute the biological environment during use. When the battery is
exhausted, discarding the battery at will may cause contamination of the biological
environment. When the lithium battery is scrapped, it should be disposed of in accordance with
local laws and regulations.

3 Environment Information
3.1 How to install product to minimize environment impact?
The K series have been assembled, debugged and inspected by the manufacturer before leaving
the factory. The user can use the K series directly without the need to install it.

3.2 How to use and maintain the me equipment to minimize the environmental impact during its
expected service life?
The K series can be operated according to the requirements in Chapter 2,3,4,5 of the manual.
The instructions have clearly defined the maintenance of K series in Chapter 7. Please check the
Annex 7 “User Manual”. Use and maintain the product in accordance with the instructions to
produce minimal environmental impact.

3.3 What energy consumption is generated during normal use? What gases, liquids, and other
environmentally hazardous substances will be emitted?
Energy consumption occurs during normal use of K series.
K series will not emit substances such gases and liquids that are harmful to the environment
during normal use.

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Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

3.4 Information on Hazardous Substances, Radioactive Sources and Induced Radioactive Materials
in Equipment
The K series ( K15, K12, K10) are tested for toxic and hazardous substances and are in
compliance with requirement of RoHS 2.0 (2011/65/EU) directives. Please see Annex 2 “Patient
Monitor RoHS Text Report”.

3.5 What are the key components for storing energy in the device? What unacceptable risks can be
caused? What measures are taken to control these risks?
The key component of the internal energy storage of the K series is the lithium battery.
May cause unacceptable risks as below:
1. The short circuit caused by the incorrect installation of the battery causes the K series to be
damaged. In severe cases, it may cause fire or explosion.
2. Due to the equipment storage environment does not meet the requirements, causing battery
power loss, resulting in the K series not working properly
Specific measures taken against these risks:
1.The battery compartment is designed according to the standard IEC60601-1, 15.4.3 item and
adopts anti-reverse interface design. Meanwhile, the K series have a battery protection circuit.
When the battery is installed incorrectly, the K series can’t be turned on normally. There is an
instruction to the installation method of the battery in Chapter 2 of the manual (The Installation
of the Battery).

2. There are repairs and maintenance in Chapter 8 of the manual.

Please see Annex 7 “User Manual” and Annex 8 "Risk Management Report (K series)".

3.6 After the end of the life cycle, what are the toxic and hazardous substances in the equipment
that need special treatment?
After the end of life cycle, the battery needs special treatment. The disposal of the battery shall
be disposed of in accordance with local laws and regulations.

3.7 What’s the safe way to disassemble and remove harmful substance (including radioactive sources
and induced radioactive materials) within the equipment after the end of the life cycle?
After the end of the life cycle, the battery in the equipment needs to be safely removed.
Instruction for removing the battery: Open the battery cover, remove the battery, and dispose of it
according to the local laws and regulations.

4 Summary of Environmental Issues

Shenzhen Creative Industry Co., Ltd. (Creative) has established a management program for the
management of toxic and hazardous substances. The equipment is strictly controlled from the
whole process of design development, procurement, production, inspection, storage and finished
product shipment. There are environmental requirements for product risk control, material
selection, and supplier qualification review.
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Patient Monitor Environmentally Conscious Design Requirements NO.: CN92710000-458

The K series are designed and manufactured by Creative under the concept of environmental
protection and health. It is in compliance with environmental protection requirements.

Reference：
Annex 1 “CP-42 Toxic and hazardous Substances Management Control Process”
Annex 2 “Patient Monitor RoHS Text Report”
Annex 3 “ISO14001 certificate”
Annex 4 “Review and Approval of Environmental Impact Assessment of
Construction Project of Baoan District Environmental Protection Bureau of Shenzhen City”
Annex 5 “Supplementary Provisions for Disposal of Unqualified Materials”
Annex 6 “IEC60601-1-2 test report TRE18030064R1”
Annex 7 “User Manual”
Annex 8 "Risk Management Report (K series)"