Catheter-positioning guiding system

（U8, U8A）

File Name CE Technical File

Project Code 0066 File No. 0066-96
Version 1.2 Total pages 74
Author/Date Gong Yizhuang/2021.3.9 Auditor/Date Wang Sai/2021.3.9
Auditor/Date Auditor/Date Duan Gang/2021.3.9
Auditor/Date Approver/Date Zou Haitao/2021.3.9
Index files
File No. File Name Version

Correction Record
Version Descriptions Reviser Date
Yan
1.0 Establish the document 2020.07.01
Hongbo
Update the intended use, the classification of the monitor, Gong
1.1 2021.1.15
add shelf life of disposable accessory Yizhuang
Update the intended use by specifying the application area of Gong
1.2 2021.3.9
ultrasound function Yizhuang

1
 Catalog
Chapter 1 Revision History....................................................................................................................................1
Chapter 2 Production Description..........................................................................................................................3
2.1 Photograph...............................................................................................................................................3
2.2 Introduction of Catheter-positioning guiding system..............................................................................3
2.3 Intended use.............................................................................................................................................3
2.4 Construction of the monitor.....................................................................................................................4
2.5 Accessories...............................................................................................................................................4
2.5.1 Accessories list......................................................................................................................................4
2.5.2 Reusable Accessory Service Life..........................................................................................................4
2.6 Critical components.................................................................................................................................4
2.7Certificate of subcontractor and external testing facilities.......................................................................7
2.7.1 The list of critical subcontractor...........................................................................................................7
2.7.2 The list of external testing facilities......................................................................................................8
2.8 Rationale of classification........................................................................................................................8
Chapter 3 Product-related standardization...........................................................................................................10
Chapter 4 EC Declaration of conformity.............................................................................................................12
Chapter 5 Product Specification..........................................................................................................................13
5.1. Product mode...............................................................................................................................13
5.2. Monitor Type................................................................................................................................14
5.3. Environmental Specifications......................................................................................................14
5.4. Power Supply...............................................................................................................................14
5.5. General Specifications.................................................................................................................15
5.6. Ultrasonic Specification...............................................................................................................15
5.7. ECG Specifications......................................................................................................................16
Chapter 6 Manufacture process............................................................................................................................17
Chapter 7 Product Label marking and packaging................................................................................................18
7.1 Label.......................................................................................................................................................18
7.2 The explanation of symbols...................................................................................................................19
7.3 labels.......................................................................................................................................................20
7.4 Marking..................................................................................................................................................20
7.5 Packaging and transportation test..........................................................................................................22
Chapter 8 Biocompatibility Assessment..............................................................................................................23
Chapter 9 Drawings..............................................................................................................................................24
Chapter 10 The List of DMR..............................................................................................................................25
Chapter 12 Post Market Surveillance..................................................................................................................26
Chapter 13 Annexes.............................................................................................................................................27

1
 Chapter 1 Revision History

These CE Technical Documents should be revised whenever changes in regulatory requirements

dictate. Revision to these documents comes into effect only on the following conditions: revised
and checked by R & D department, issued by Quality Assurance Dept.
Once the issue changes, the invalid and obsolete page(s) should be promptly removed from all
points of issue or use and return the feedback to Quality Assurance Dept.

Version Description of Changes Revised by Checked by Date

Duan
1.0 Establish the document Yan Hongbo Gang/managemen 2020.07.01
t representative
Update the intended use, the
Duan
classification of the monitor,
1.1 Gong Yizhuang Gang/managemen 2021.1.15
add shelf life of disposable
t representative
accessory
Update the intended use by Duan
1.2 specifying the application area Gong Yizhuang Gang/managemen 2021.3.9
of ultrasound function t representative

2
Chapter 2 Production Description

2.1 Photograph

The photographs of U8 and U8A are showed as following：

Fig. 2.1.1 U8/U8A

2.2 Introduction of Catheter-positioning guiding system

The product can be used in ultrasound-guided vascular puncturing and ECG-guided Peripherally
Inserted Central Catheter (PICC) tip positioning. The product can also be used for common
ultrasound diagnosis. The accessories of this product consist of ultrasound probe and ECG
cable; When performing PICC, the ultrasound probe is used to identify the blood vessel and
direct the puncturing while the ECG cable is to gather the ECG signal. After the catheter arrives
at the superior vena cava, the feature of ECG waveform is used for determing the catheter's right
position. And the ultrasound probe can also be used in the common ultrasound diagnosis.

2.3 Intended use

The product is suitable for clinical ultrasound vascular puncture and central venous indwelling
catheter positioning, and the ultrasound part is also suitable for human diagnostic ultrasound
specifically on abdomen, peripheral vessels, thyroid or other small organs.
The intended patient population are adult, pediatrics and neonate.
This device is intended for trained professionals and personnel who are expected to have

3
working knowledge of medical procedures, practices and terminology as required for the
ultrasonic examination and puncture surgery.

Contraindication
1. The use of this system is prohibited for patients with atrial fibrillation, ventricular arrhythmia
or patients with pacemaker.
2. This system is not suitable for the examination of gas-containing organs such as lung tissue

2.4 Construction of the monitor

This monitor is mainly composed of a main unit (including battery, bracket, display, and
housing) and functional accessories (ECG cables,

2.5 Accessories

2.5.1 Accessories list

Model Description Manufacturer / Supplier

 Disposable electrode wit Shenzhen Comen Medical
98ME01AC019
h extension wire Instruments Co., Ltd
98ME01AC017 PICC 4-lead AHA
Shenzhen Launch Electrical
PICC 4-lead AHA for
98ME01EC018 Co. Ltd
predicate/neonate
Linear array ultrasound Shenzhen Comen Medical
L25
probe Instruments Co., Ltd
Convex array ultrasound Shenzhen Comen Medical
C60
probe Instruments Co., Ltd

2.5.2 Reusable Accessory Service Life

Name Service Life

ECG cable Two years
Ultrasound Probe One year

2.5.3 Shelf life of accessory

The shelf life of disposable electrode with extension wire is one year.

2.6 Critical components

4
 1.1.
1.1.1.1
Kind of Component Type Specification Standard(s) App
Manufacturer
requ

Dongguan Nan Ke XTH-005 AC 250 V; 16 A DIN VDE 0620-

Investment Co., 2-1 (VDE 0620-
LTD 2-1):2016-01
Plug (EU) DIN VDE 0620- VDE 40026370
2-1/A1 (VDE
0620-2-1/A1):2
017-09
Dongguan Nan Ke H05VV-F AC 250 V; 10 A
Power supply cord EN 50525-2-
Investment Co., 3G0.75mm2. VDE 40043002
(EU) 11:2011
LTD

Dongguan Nan Ke XTH-021 AC 250 V; 10 A IEC 60320-

Investment Co., 1:2015
Connector (EU) VDE 40025516
LTD IEC 60320-
3:2014
Input: 100-240 Vac; 50-
60 Hz; 1,5-0,75 A
Output: 19 V d.c.; IEC 60601-
4.74A; 1:2005+A1:201
DELTA 2 MOPP between mains 2 UL CB Cert.:
ELECTRONICS, MDS- input and secondary ANSI/AAMI ES DK-30103-A2-
Adaptor
INC 090AAS19 B output, 60601-1 UL
1 MOPP between mains CAN/CSA- UL E356265
part and protective earth: C22.2 No.
60601-1:14
Max. ambient 40°C; up
to 3000m

Shenzhen Comen 022-000186-00 SGS Test

Medical Instrument Report No.
Lithium battery pack 14.8Vd.c.; 6600mAh IEC 61133-2
Co., Ltd. GZES19040114
6801

Coin Battery on main

Panasonics CR2032 3V d.c.; 200 mAh UL 1642 UL MH12210
control board
IEC 60601-
DC fan near ventilation SUNON HA30101V3- Tested with
1000C-A99 12Vd.c.; 0.56W 1:2005+
opening equipment
A1:2012

5
 Shenzhen Comen C60
IEC 60601-
Ultrasonic transducer Medical 3.3MHz Tested with
1:2005+
assembly (3.5MHz) Instruments Co., 128 equipment
A1:2012
Ltd

Shenzhen Comen L25

IEC 60601-
Ultrasonic transducer Medical 8.5MHz Tested with
1:2005+
assembly (8.0MHz) Instruments Co., 128 equipment
A1:2012
Ltd
UL 796;
PCB of ultrasonic Q&D Circuits Co.,
HF-4 V-0;130℃ UL 94; UL E251494
power board LTd
UL 746A
SHENZHEN UL 796;
PCB of main control
HUAFENG HF-4 V-0;130℃ UL 94; /
circuit board
EEEDM CO LTD UL 746A
DONGGUAN 1571 22 AWG; 105℃ UL 758 UL E214500
Internal wire of
WENCHANG CSA C22.2 No.
secondary circuit
ELECTRONIC CO 210-15
LTD
LG CHEM LTD UL 94;
UL 746A,B,C,D Tested with
Plastic enclosure HF11 0.125mm；V-0;80℃
IEC 60601-1: equipment
2005 + A1:2012
Kyocera corporation TCG121XGLPB IEC 60601-
Tested with
LCD screen PNN-AN42-S 12 VDC;0.9A;12.1 inch 1:2005+
equipment
A1:2012
IEC 60601-
DC fan on ultrasonic SUNON MC30060V2- Tested with
000C-A99 5Vd.c.; 0.36W 1:2005+
power board equipment
A1:2012
ECG parameter board
ANSI/UL 1577
VISHAY
VO615A- Isolation voltage:5000 DIN EN 60747- ULE52744
Optocoupler (U26) SEMICONDUCTO
9X017T Vac; 110°C; 5-5 (VDE 0884- VDE 40034610
R GMBH
5)

Isolation Voltage 5000 V

per UL1577; 250Vr.m.s UL 1577
Non-optical isolator ANALOG ADUM2201AR UL: E214100
reinforced insulation per DIN V VDE V
(U28) DEVICES INC IZ VDE 40011599
IEC 60601-1 0884-10: 2006
105 °C;
MURATA 100M; 1/2W; Dielectric IEC 60601-
High voltage resistor MHR0314SA10 Tested with
MANUFACTURIN strength test voltage: 1,5 1:2005+
(R159) 7F70 equipment
G CO., LTD kV A1:2012

6
 SHENZHEN
DC breakdown voltage:
Surge arrester (gas BENCENT
B3D090L 90 V; Impulse discharge ANSI/UL 497B UL: E232249
tube) of ECG ELECTRONIC CO
current: 5kA@8/20μs
LTD

JINMEIJIA MKB15-039 Pri. Winding:

ELECTRONIC N1&N2 (Pin1-4):
(SHENZHEN) CO., 2UEW, Ф0.18mm x2P,
LTD. 18 turns.
Sec. Winding:
N3 (Pin 5-6):
IEC 60601-
2UEW, Ф0.35 mm, Tested with
Transformer on PCB 1:2005+
12Turns. equipment
A1:2012
N4 (Pin 7-8):
2UEW, Ф0.25 mm ,
12Turns.
Class B
Three layers insulation
tapes between pri-sec
CHANG CHUN T375HF UL94
PLASTICS CO UL 1694
V-0; 150℃; Minimum
Bobbin LTD UL746A/B/C/D/ UL: E59481
thickness: 0.45mm
R/H
IEC 60695-2-20

JINGJIANG PZ, CT
YAHUA
Insulation tape PRESSURE 130℃ UL 510 UL E165111
SENSITIVE
GLUE CO LTD

SHENZHEN 2UEW-B
CHENGWEI
Magnetic wire 130℃ ANSI/UL 1446 UL E227475
INDUSTRY CO
LTD

GUANGDONG 2 UEW-B/QA-1
JINYAN
- Magnetic wire ELECTROTECHNI 130℃ ANSI/UL 1446 UL E238500
CSJOINT STOCK
CO LTD

HANG CHEUNG
- Varnish COATINGS 8562/A 155℃ ANSI/UL 1446 UL E200154
(HUIYANG) LTD

7
 JINGJIANG WF-2901,
YAHUA WF-2902
- Margin tape PRESSURE 130℃,Width 2 mm UL 510 UL: E165111
SENSITIVE GLUE
CO LTD

2.7Certificate of subcontractor and external testing facilities

2.7.1 The list of critical subcontractor

Critical subcontractor Activity Certificate in Annex 11

Shenzhen Hanshine SMT ISO 13485:2016: 44325
technology Co., Ltd (Refer to File 11-1)
Shenzhen Well.d Medical Design and manufacture of ISO 13485:2016: 272992-2018-
Electronics Co., Ltd Ultrasound probe AQ-RGC-NA-PS (File 11-2)
CE Certificate: 9931-2017-CE-
RGC-NA-PS (File 11-3)
Shenzhen Launch Manufacture of ISO 13485:2016: Q5 065652 0006
Electrical Co., Ltd Disposable electrode with  (File 11-4)
extension wire
Guang Zhou MedClear Sterilization for ISO 13485:2016 and ISO
Medical Device Service Disposable electrode with  11135:2014: Q8 102697 0001 (File
Co., Ltd extension wire 11-5)

2.7.2 The list of external testing facilities

Nanme Address Certificate

SGS-CSTC Standards No.198, Kezhu Road, Refer to Annex 12-1
Technical Services Co., Science City, Economic
Ltd Guangzhong Branch & Technological
Testing Center Development Area,
Guangzhou, Guangdong,
China
Shenzhen Testing Center No.28, High-tech Middle Refer to the website
of Medical Devices Road, Nanshan District, https://las.cnas.org.cn/LAS_FQ/
Shenzhen publish/queryOrgInfo1.
action?
id=cb9be1e314c943009e9ba19d1a603a2d
&orgEnOrCh=Ch&authInterceptCode=36wx

8
2.8 Rationale of classification

2.8.1 The classification of the monitor

U8/U8A is intended for central venous indewelling catheter positioning combined with clincal
ultrasound vascular puncture and human diagnostic ultrasound examination. The former
function belongs to IIb according to Rule 11 of MDD 93/42/EEC, as it's to administer
substances from the body in a potentially hazardous manner taking account of the part of the
body concerned and the mode of application. As for the latter, it bellongs to IIa according to
Rule 10 of MDD 93/42/EEC, as it's intended to allow monitoring of vital physiological
processes.
In a conclusion, U8/U8A belongs to IIb according to Rule 11 of MDD/93/42/EEC.
2.8.2 Conformity routes
The conformity assessment route we choose is Annex II of MDD 93/42/EEC.
2.8.3The lifetime of the monitor
The monitor’s service life is 10 years. And the evidences of life of the monitor and the related
accessories and other components are shown in the report service life test report (File 1-27 in
Annex I of this CE technical file) .

9
Chapter 3 Product-related standardization

Item Standard Description Report No.

Restriction of the use of certain
1. Directive 2011/65/EU /
hazardous substances（RoHS）
Medical Devices Directive:
COUNCIL DIRECTIVE 2007/47/EC
2. MDD 2007/47/EC /
of 5 September 2007 concerning
medical devices
Medical devices Quality
3. ISO 13485: 2016 Management Systems Requirements /
for Regulatory Purposes
Medical electrical equipment -- Part
IEC 60601-
4. 1: General requirements for basic GZES191002614001
1:2005+A1:2012
safety and essential performance
Medical electrical equipment -Part 1-
2: General requirements for basic
5. IEC 60601-1-2:2014 safety and essential performance- GZES191002614101
Collateral standard: Electromagnetic
compatibility-Requirements and tests
Medical devices – Symbols to be
used with medical device labels,
6. EN ISO 15223-1:2016 labelling and information to be 0066-59-12
supplied – part 1: general
requirements
Information supplied by the
7. EN 1041:2008 0066-59-13
manufacturer of medical devices
Medical electrical equipment - Part 2-
37: Particular requirements for the
IEC 60601-2-
8. basic safety and essential GZES191002614003
37:2007+A1:2015
performance of ultrasonic medical
diagnostic and monitoring equipment
Biological evaluation of medical
devices - Part 1: Evaluation and
9. ISO 10993-1:2018
testing within a risk management 0066-96
process
10. ISO 10993-5:2009 Biological evaluation of medical

10
Item Standard Description Report No.
devices - Part 5: Tests for in vitro
cytotoxicity
Biological evaluation of medical
11. ISO 10993-10:2010 devices - Part 10: Tests for irritation
and delayed-type hypersensitivity
Medical device software - Software
12. IEC 62304:2015 0066-98
life-cycle processes
Medical devices – Application of
13. IEC 62366:2007 usability engineering to medical GZES191002614002
devices
Medical electrical equipment – Part
1-6: General requirements for basic
14. IEC 60601-1-6:2013 GZES191002614002
safety and essential performance –
Collateral standard: Usability
Medical devices - Application of risk
15. EN ISO 14971:2012 0066-17
management to medical devices

11
 Chapter 4 EC Declaration of conformity
Refer to Annex 3 Declaration of conformity

12
 Chapter 5 Product Specification

5.1. Product mode

U8 U8A
Function Parameters

ECG function √ √

Ultras 2D imaging √ √

ound Color Doppler and

√ √
diagno power Doppler Mode
stic
Pulse wave doppler
functi √ √
(PWD)
on

Movie playback √ √

Measurement and calculation √ —

Power adapter
One DC 19V power interface
interface

Interfa Network Interface One standard RJ45 interface

ce One USB2.0 standard interface

USB interface
One USB3.0 standard interface

HDMI interface One

Dimension 346.1±5×111.5±5×285.8±5（mm）

Weight ≤5 Kg

Size of display 12.1 inch

Display resolution 1024×768

Rating (power/frequency) 100-240V～，50/60Hz

Internal battery
DC14.8V 6600mAh, Rechargeable lithium battery
specification

Note 1. “√”means the device of the corresponding type has the function
parameter in the table.
2. “—” means the device of the corresponding type has no function

13
 parameter in the table.

The only difference between U8 and U8A is the function of measurement and calculation. U8 has the
function of measurement and calculation. U8A doesn't have the function of measurement and calculation.
The function of measurement and calculation is measurement and calculation on the ultrasound images,
including catheter percentage measurement, distance measurement, area measurement, perimeter
measurement and spectrum doppler measurement.

5.2. Monitor Type

Name
Classified by the type of electric
shock protection
Classified by the degree of electric
shock protection
Classified by the degree of
protection of liquid intake
Working mode
Classified by permanently installed
equipment or non-permanently
installed equipment.
Safety standards
Type
Class-I equipment powered
equipment with CF-type and BF-type applied parts, the equipment
with internal power supply. ECG is CF-type (with defibrillation-
proof) applied parts, and ultrasound is BF type (without
defibrillation-proof) applied parts.
Host isIPX0, and ultrasonic probe is anti-immersion equipment
IPX7
Continuous
Non-permanent installation equipment
IEC60601-1 and IEC60601-2-37

5.3. Environmental Specifications

Name Environmental requirements

Environment temperature
0℃～45℃
range
Operating
RH range 15% ~ 80%, non-condensing
environment
Atmospheric pressure
80.0kPa～106.0kPa
range
Severe impact, vibration and rain and snow splash must be prevented during
transportation. The packaged instrument shall be stored in a non-condensing room
Transportation
with ambient temperature of-20℃ ~+60℃, RH of 5%~93%, non-corrosive gas,
atmospheric pressure range of 70.0 kPa ~ 106.0 kPa and good ventilation.
The packaged instrument shall be stored in a non-condensing room with ambient
Storage temperature of-20℃ ~+60℃, relative humidity of 5%~93%, non-corrosive gas,
atmospheric pressure range of 70.0 kPa ~ 106.0 kPa and good ventilation.

5.4. Power Supply

Name Power supply environment

14
Alternating
current input 100-240V～; allowance ±10%
voltage
AC input
50Hz/60Hz
frequency
DC input voltage DC19V
Power supply The power supply can be carried out by built-in battery, or external AC power supply.
Rated input
current of 1.5-0.75A
equipment
Continuous operating time shall be more than 8 hours when connecting the power
supply of the network.
Continuous
Battery: 14.8V /6600mAh, fully charge the battery, image brightness level is
operatinghours
adjusted to 60%, sound is turned on to 5, and then continuous operating time using the
battery shall be ≥80 minutes
Startup state: it takes about 8 hours for the battery to charge from 0% to 100% of the
capacity.
Charging time
Shutdown state: it takes about 4 hours for the battery to charge from 0% to 100% of
the capacity.

5.5. General Specifications

Name Specification
Appearance size 346.1±5×111.5±5×285.6±5

Weight ≤5Kg (excluding accessories, including batteries)

Specification of Dimension: 12.1"
display screen Resolution: 1024×768

5.6. Ultrasonic Specification

Name Specification (C60(Convex array), L25(linear array))

Sound working Nominal frequency: convex array: 3.5MHz linear array: 8 MHz
frequency The deviation between the sound working frequency and the nominal frequency
shall be within 15%
Depth of detection Convex array ≥160mm; linear array ≥60mm
Lateral resolution Convex array ≤3mm (depth ≤80mm)
≤4 mm (80 mm < depth ≤130mm)
Linear array ≤1mm (depth ≤40mm)
Axial resolution Axial resolution: convex array ≤2mm (depth ≤ 80 mm)
≤ 3 mm (80 mm < depth ≤130mm)
linear array ≤1mm (depth ≤50mm)
Blind area Convex array ≤ 5mm; linear array ≤2mm
Slice thickness Convex array≤10mm; linear array ≤5mm
Lateral geometric Convex array ≤ 15%; linear array ≤10%

15
position accuracy
Longitudinal Convex array ≤ 10%; linear array ≤5%
geometric position
accuracy
Measurement ≤±20%
deviation of
circumference and
area
Performance of color the probing depthat Doppler operating frequency: convex array ≥ 90 mm (2.7
Dopplerblood flow MHz); inear array ≥ 40 mm (5.8 MHz)
imaging mode
Spectral Doppler the probing depth at Doppler operating frequency: convex array ≥ 80 mm (2.7
mode performance MHz); linear array ≥ 40 (5.8 MHz)
Error of blood flow ≤20%
velocity reading

5.7. ECG Specifications

Name: Specification
Lead mode Four leads (RA, LL, RL, h)
Lead mode Out body II lead, In vivo II lead
Waveform 2

At least support 10 mm/mV(×1), 20 mm/mV(×2) and 40 mm/mV(×4) with

Sensitivity (gain) and
errors less than 5%. When ±750mV DC polarization voltage is applied, the
error
sensitivity variation range is 5%.

Two gears, 25mm/s and 50mm/s, are available with an error of no more
Scanning speed
than 10%
Frequency
Operation mode: 1 Hz～20 Hz (-3.0dB～+0.4dB)；
characteristic
Scope of input signal ±4 mV
Trigger threshold of
heart rate detection Heart rate detection triggers a threshold level of 200 μ V.
level
System noise (p-v RTI) ≤25µV
Adult 15～300bpm
HR measurement range Neonatal/pediatric 15～350bpm
and accuracy Measurement
±1% or ±1 bpm, whichever is greater.
accuracy
HR resolution 1 bpm
Defibrillation recovery
≤8s
time

HR Calculation

16
Tall T-wave rejection
1.2mV
capability
As required in Section 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the HR is
calculated as follows. If all of the last 3 RR intervals are longer than
HR calculation 1200ms, the average of the last 4 RR intervals is the HR. In other cases, the
average of the last 12 RR intervals (with the longest interval and shortest
interval excluded) is the HR.
As required in Section 201.7.9.2.9.101 b) 4) of IEC 60601-2-27, the HR is
displayed as follows after the 20s stable segment:
Cardiotachometer
A1(bigeminy): 80±1bpm
accuracy and response
A2(slowly varying bigeminy): 60±1bpm
to arrhythmia
A3(quickly varying bigeminy): 120±1bpm
A4 (two-way contraction): 90±2bpm
As required in Section 201.7.9.2.9.101 b) 5) of IEC 60601-2-27: the
Response time for HR
response time for a HR change, whether from 80bpm to 120bpm or from
changes
80bpm to 40bpm, is less than 10s.

17
 Chapter 6 Manufacture process
Refer to File 4-1 Flow chart in Annex 4.

18
 Chapter 7 Product Label marking and packaging
7.1 Label
1. Description
The control of languages and labels conforms to COMEN\QP40 ‘Control procedure of label and language’

which complies with EN ISO 15223-1：2016, EN 1041:2008,

2. Language control
According to the MDEG - 2008-12 - II-6.3. Mandatory Languages Requirements for Medical Devices,

which is provided as document No.2-9 in Annex 2, different countries have different language requirement

towards different elements, which include label and display, safety instruction, and instruction for use. The

following table has shown that for U8/U8A, such elements have been clearly identified.

User manual Displays and user Label Language requirement according to

(the symbols in the user manual interface document 2-9MDEG_-_2008-12_-_II-
are according to the standards 6.3._Mandatory_Languages_Requirement
IEC60601-1 and EN ISO 15223- s_for_Medical_Devices_update_Sept.08(Se
1:2016,don't need translation) e document 2-9 in Annex 2.)

User manual in English, refer to Refer to Refer to English

2-11 displays and labels and
user interface carton label
screenshots in from 2-2 to
user manual in 2-5.
English 2-11

Considering the device has not been on the market, English version should satisfy the
registration requirement. To ensure the future marketing still satisfy the requirement,
procedure document "Compiling and translating specification of instruction manual, label,
maintenance manual and interface entry", which is provided as document 2-10 in Annex 2, is
implemented. According to this procedure, each different language version should be
confirmed by the corresponding language native speaker, which should be recorded with
Language Translation Confirmation Records. For U8/U8A English user manual, the
confirmation record has been provided as document No. 2-11 in Annex 2.

19
7.2 The explanation of symbols
Table 7.1 Product Symbols
Note! See accompanying Ingress protection rating of
IPX7
documentation probe (exclude connector)

Type BF applied part does not

Ingress protection rating of
have defibrillation-proof IPX0
host and adaptor
function.

Type CF applied part with

Manufacturer
defibrillation-proof function.

On/off key Network connection symbol

Battery operating indicator

USB interface
light

Alternating current indicator

WEEE classified collection
light

Complies with medical

Serial number mark equipment directive

93/42/EEC

Warning: Only use the ECG

cable provided by Comen.

Other types of ECGcable may

DVI interface
decrease the defibrillation

energy delivered to the

patient.

Follow instructions for use Manufacturing date

20
Note: Keys on the monitor and their functions are described in “2.2.1 Front View ”.

 Symbols on Package

This way up Stacking layer limit

Fragile Keep away from rain

Interference may occur near the Transport and Storage

equipment marking with this environment temperature

symbol of -20℃～+60℃

Transport and
Transport and Storage
Storageatmospheric
environment humidity 5%~93%
pressure of 70kPa~106kPa

7.3 labels
Labels of equipment and accessories are in Annex 2 User manual and labels.

7.4 Marking
1 Instrument

21
 Fig. 7-1 front view
1 Ultrasonic probe holder

Power indicator light On: switch on AC power

(white) Off: not switch on AC power

On: the battery is charging.

2
Battery indicator light Flashing: use battery for power supply

(white) Off: The battery is fully charged, battery is not

installed, or batteryfailure occurs.

3 Display screen

4 Product model

5 Handle

22
Figure 7-2 Left view

Figure 7-3 Right view

23
 Figure 7-4 Rear view

1. USB port (plug and play): support mouse, keyboard and U disk.
2. HDMI port: it can be connected to an external HD display to show monitored information currently

displayed on the monitor. It enables medical workers to view information on a large screen

conveniently, or allows presentation by the teaching staff.

3. Network port: networking with other systems such as servers through network cables.
4. Power adapter interface
5. Storage box(The maximum bearing capacity does not exceed 3 kg): it is used for placing power

adapter, cable, etc.

7.5 Packaging and transportation test

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 Chapter 8 Biocompatibility Assessment
Please refer to Annex 7 Biocompatibility Assessment.

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Chapter 9 Drawings

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 Chapter 10 The List of DMR

Refer to File 4-2 DMR in Annex 4.

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 Chapter 12 Post Market Surveillance
Refer to Annex 9 PMS

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 Chapter 13 Annexes

The folders information is described below.

Annex 1: Test report
Annex 2: User manual and labels
Annex 3: Declaration of conformity
Annex 4: Manufacture file
Annex 5: Essential Requirement Checklist
Annex 6: European Authorized Representation Agreement
Annex 7: Biocompatibility accessment
Annex 8: Clinical evaluation report
Annex 9: PMS
Annex 10: Risk management report
Annex 11: Critical Subcontractor
Annex 12:CNAS Accreditation

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