CREATIVE MEDICAL K12 5lead ECG Cable User Manual
- September 23, 2024
- CREATIVE MEDICAL
Table of Contents
K12 5lead ECG Cable
Specifications
- Manufacturer: Shenzhen Creative Industry Co., Ltd.
- Model Number: PN 3502-2000017
- Storage Temperature: Not specified
- Storage Atmospheric Pressure: Not specified
- Storage Humidity: Not specified
- Use: Multi-patient use
- Compliance: ECG TRUNK CABLES and PATIENT LEADWIRES (ANSI/AAMI
EC53)
Product Usage Instructions
How to Use
-
Refer to Figure 1 in the manual to correctly place electrodes
on the patient. -
Plug the trunk cable into the ECG connector of the device.
-
Connect the lead wires to the electrodes on the patient before
monitoring.
Instructions for Safe Operation
-
Choose the appropriate ECG trunk cable and lead wire based on
the connector type of the patient monitor. -
Regularly check the ECG trunk cable and lead wire for any
damage or material degeneration before patient monitoring.
Warnings
-
Avoid tangling or suffocating the patient with the cable.
-
Do not use the ECG trunk cable for MRI to prevent burning
risks. -
Minimize patient movement during measurements.
-
Avoid using non-defibrillation trunk cables for
defibrillation. -
Keep the ECG trunk cable and lead wire away from HF
electrosurgical equipment during operation. -
ESU-proof ECG cables have additional circuits for patient
protection and reducing electrical interference.
FAQ
Q: Can I reuse the ECG trunk cable on multiple patients?
A: Yes, the cable is intended for multi-patient use. Ensure
proper cleaning and maintenance between uses.
Q: How often should I check the ECG trunk cable for
damage?
A: It is recommended to check the cable for any signs of damage
or material degeneration before each patient monitoring
session.
Q: What should I do if I notice improper electrode placement
affecting measurements?
A: Re-adjust the electrodes following the correct positions as
shown in the user manual to ensure accurate measurements.
ECG Cable User Manual
Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, BaiWangXin High-Tech
Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen,
PEOPLE’S REPUBLIC OF CHINA Tel: +86-755-2643 3514 Fax: +86-755-2643 0930
Website: www.creative-sz.com E-mail: info@creative-sz.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrae 80, 20537 Hamburg, Germany
1 About the Products
Product Name: ECG Cable Model: See product label Serial Number/Manufacturing
Date: See product label Service life: 3 years Scope of Application: The
reusable ECG trunk cable and lead wire are used to connect human body (via ECG
electrodes) and ECG devices to acquire and transfer ECG signals. The ECG trunk
cable and lead wire should be used with the monitoring device (including
accessories) speicified by us. The user has the liability to read the user
manual of the device (including accessories) or contact and consult us before
use in order to confirm the compatibility of the accessories with the device
(including accessories). The products must be used by trained clinical
professionals. Structure: These products consist of the plug, trunk cable and
lead wires.
3 Symbols
Medical device General warning sign Batch code
Type CF applied part, Defibrillation-Proof
Storage temperature
Storage atmospheric pressure
Manufacturer
Country of manufacture (CN stands for Made in China) and Date of manufacture
Model number No latex Use-by date Type CF applied part, Not Defibrillation-
Proof
Storage humidity
Do not throw away CE mark
Authorised representative in the European Community
Revision Date: December 07, 2023
Manual Version: V1.1
PN: 3502-2000017
Declaration
The intellectual property rights of these products and this user manual belong
to Shenzhen Creative Industry Co., Ltd (hereinafter referred to as
“Creative”). No individual is allowed to copy, revise and translate this user
manual wihtout the prior written approval of Creative.
This cable meeets the requirements of the standard, ECG TRUNK CABLES and
PATIENT LEADWIRES (ANSI/AAMI EC53). This cable is intended for MULTI-PATIENT
USE.
This user manual details the purpose, function and operation of these
products. Before use, please read it carefully and understand all information
contained in it to ensure your correct use of these products, the safety of
patients and the operator.
Provided that all the following conditions are conformed to, Creative will be
resposible for the safety, reliablity and performance of these products if the
products are:
Used as per this user manual and; Damaged due to non-human factors, human
factors
mean careless drop, deliberate damage, etc.
2 How to Use
Before use, ensure that you have understood all notices listed here. 1. Refer
to Figure 1 to place the electrodes to all correct
positions on the patient. 2. Plug the trunk cable into the device’s ECG
connector. 3. Connect the corresponding lead wires to the
electrodes stuck onto the patient before patient monitoring. Note: Improper
placement of the electrodes may affect the accuracy of measurements.
3-lead (AHA) 3-lead (IEC) 5-lead (AHA) 5-lead (IEC)
Instructions for Safe Operation
Choose an appropriate ECG trunk cable and lead wire according to the connector
type of the patient monitor.
Check the ECG trunk cable and lead wire, in case of damage or material
degeneration, never apply them for patient monitoring.
Warnings
The cable shall be properly arranged to avoid tangling or suffocating the
patient.
Never use the ECG trunk cable for MRI to reduce the burning risk.
Minimize patient movement during patient measurement.
Do not use the non-defibrillatiuon trunk cables to perform defibrillaiton on a
patient.
When HF electrosurgical equipment is used, the ECG trunk cable and lead wire
should be away from the surgical operation site and other devices.
ECG cables with ESU-proof capability have additional circuits, which can
protect the patient in operation from being burnt and can lower the electrical
interference.
Never use this product to measure respiration. When connecting the electrode
or trunk cable, ensure
that all ECG electrodes are connected onto the patient and that the connector
does not contact other conductive parts and grounded surface.
12-lead (AHA)
12-lead (IEC)
Figure 1 Electrode placement
IEC Standard
AHA Standard
Identifier Color Code Identifier Color Code
R
Red
RA
White
L
Yellow
LA
Black
N or RF Black
RL
Green
F
Green
LL
Red
C1
White/Red V1
Brown/Red
C2
White/Yellow V2
Brown/Yellow
C3
White/Green V3
Brown/Green
C4
White/Brown V4
Brown/Blue
C5
White/Black V5
Brown/Orange
C6
White/Violet V6
Brown/Violet
Table 1 Identifiers and Colors
Refer to User Manual (Background: blue; Symbol: white)
Follow WEEE regulations for disposal
4 Cleaning and Disinfection
Cleaning: 1. 2% glutaraldehyde solution; 2. 10% sodium hypochlorite solution;
3. Wipe the cable suface with a clean cloth dampened in
the above cleansers and clear water, to dry the suface. Disinfection: The
following disinfectants are recommended: 70% ethanol, 70% isopropanol and 2%
glutaraldehyde solution.
1. Before disinfection, clean the cable; 2. Wipe and clean the cable module
with a cotton ball or
soft cloth dampened with disinfectant solution; 3. Remove the disinfectant
residual solution on the cable
with soft cloth dampened with clean water; 4. Air-dry the cable in a cool, dry
place. Cautions: Do not immerse the cable module into water or
disinfectant. Never allow any liquid to enter the cabvle connector. Only
disinfect the cable according to the hospital
regulations where necessary as frequent disinfections may result in cable
damage. Always use the cleanser and disinfector specified in this instructions
for use.
5 Working and Storage Environment Requirements
Working Environment: Temperature: 5- 40 Relative Humidity: 80% Atmospheric
Pressure: 70kPa-106kPa Storage Environment: Temperature: -20-55 Relative
Humidity: 93% Atmospheric Pressure: 70kPa-106kPa
6 Replacement and Disposing
Replacement: In case of broken or discontinuity, a new ECG cable shall be used
to replace the damaged one. Disposing: Follow the local or hospital laws and
regulations to properly dispose of this product.
7 Packing List
ECG cable User manual
1 set 1 copy