Shenzhen Jumper Medical Equipment Co. Ltd.

CE Technical Files
(JPD-300P/JPD-300E/JPD-600P)

Document No. : JPD-CE-FT

Production name: Fetal/Maternal Monitors

Production Type: JPD-300P/JPD-300E/JPD-600P

Efficient Date: 2020-11-30
Document Pages:
Write Dept: R&D Dept.

Drafted by Vicky Wang

Reviewed by Liu Bing

Approved by Yi Hui

1
CE Technical Files

Part 1 :OEM
S/N No. Version Page
NAME

1 Certificate JP-CE-FT-01 E 2

JP-CE-FT-02
2 Declaration of Conformity D 6

JP-CE-FT-03
3 labeling D 8

JP-CE-FT-04
4 Instruction Manual D 11

Part 2 :PLM

5 Product introduction JP-CE-FT-05 E 12

JP-CE-FT-06
6 Essential requirements checklist E 14

JP-CE-FT-07
7 labeling E 34

JP-CE-FT-08
8 Instruction Manual E 38

Declaration of Equivalent For clinical investigation JP-CE-FT-09

9 E 39

Declaration of Equivalent For risk analysis JP-CE-FT-10

10 E 40

EC Authorized Representative Agreement for Medical JP-CE-FT-11

11 E 41
Device CE Marking
JP-CE-FT-12
12 Declaration of conformity E 42

JP-CE-FT-13
13 List of applicable standards E 43

JP-CE-FT-14
14 Interface contract D 44

1
Part 1

Certificate
Document No. : JPD-CE-FT-01

Version E

2
3
4
5
Declaration of Conformity
Document No. : JPD-CE-FT-02
Version D

6
7
 labeling
Document No. : JPD-CE-FT-03
Version D
1. Design of labeling

Labeling must contain below information:

1) Device name, specification, quantity:
2) CE marking, composed of two semi-circle with diameter no less than 5mm,notified identification number 0482
affixed below
3) Lot number, production date, expiration date:
4) Manufacturer:
Shenzhen Luckcome Technology Inc., Ltd
5) Address：
3A1, Tower A , Zhengxing Building , Industry Road 3 , Shekou Shenzhen,Guangdong,P.R.China
Tel.: +86-755-26834376
Fax: +86-755-26853526
Contactor: Mr. Huang Ping
1) European representative: LVMED LTD
2) Address of European representative:33 block, “Kukush” str., 1345 Sofia, Bulgarla
Tel:+359 2 920 36 35
E-mail: lvmed@mbox.contact.bg
2. Symbols on labeling:
2.1 All medical devices sold out to European market are labeled as per requirements of MDD93/42EEC.
2.2 labeling:

2.2.1 Notice
The background color is yellow, and the signal itself and frame are black. It’s big enough to be noticed. Below the
symbol please write out precautions, instructions for use.（special operating instruction）

2.2.2 Fragile, be careful

The background color is white, and the signal itself and frame are black. It’s big enough to be noticed.

2.2.3 keep dry

The background color is white, and the signal itself and frame are black.

40 C

2.2.4 10C
Symbol for temperature limitation
The background color is white, and the signal itself and frame are black. Mark the temperature at the upper limit and
lower limit
8
 5
2.2.5 Symbol for direction for piling up and layer
To indicate layers piled up alongside

2.2.6 SN symbol for “serial number”

The background color is white, and the signal itself and frame are black. The serial number shall be written after the
symbol.

2.2.7 0482 CE marking

Device certified must bear CE marking.
The diameter of the CE marking is no less than 5mm. And the identification number of notified body comes after. It
should be visible, legible, clear and indelible.

3. CE marking and language

3.1 All medical devices sold to European community market shall bear CE marking, which means：
a. The device conforms to essential requirements of MDD
b. The device can be legally placed on the market within EU territory
c. The device has been the subject of corresponding conformity assessment procedure.
There are two types of CE marking affixed on the medical device, that is CE marking with and without Notified body
identification number. CE marking without identification number is only used for Class I devices need not sterilized and
no measuring function.
3.2 The language of labeling must conform to the language requirements of EU member states and also ensure its
correctness.
3.3.The labeling for bulk, medium and small package must meet the requirements of EN980: 2008 and contain
contents of Article 8.2. Place for additional requirements from customer is available.

4. Special requirements:
4.1 Besides fulfilling special customer requirements, other contents shall design according to the above-mentioned
format.
4.2 The custom-made product shall not bear CE marking, meanwhile indicate “custom made” in the labeling.
4.3 The device intended for clinical investigation shall not bear CE marking, meanwhile indicate “only for clinical
investigation” in the labeling.
5、label sample

9
10
 Instruction Manual
Document No. : JPD-CE-FT-04
Version D

See attachment: L8 usual manual

11
Part 2

Product introduction
Document No. : JPD-CE-FT-05
Version E

1. Brief introduction to ultrasound Fetal/Maternal Monitor

A. Ultrasound Fetal/Maternal Monitor is medical device which can detect the heart rate of fetus through ultrasound

Doppler principle and electronic technology.

B. JPD-series Fetal/Maternal Monitor first send continuous Doppler ultrasonic waves, which is regarded as

information carrier, into target to be measured by emission transducer, and then revert back the reflect waves which is

dispersed by organs by receiving transducer to this detectors. Detectors recover the sounds of heart rate. If detectors with

display unit, the heart rate can be showed in LCD .

C. JPD-series Fetal/Maternal Monitor are mainly composed of two parts: Receiving/emission probes and host

machine. Receiving/emission transducers include oscillating, emission and magnifying circuits. While the host machine

include demodulation, A/D exchanger and digital computation.

a)JPD-series Fetal/Maternal Monitor have built-in rechargeable battery unit which can repeatedly charged.

Features
Model
FHR TOCO MARKER TEMP. SpO2 NIBP

JPD-series JPD-300P × × × ﹣ ﹣ ﹣

JPD-600P × × × × × ×

JPD-300E × × × ﹣ ﹣ ﹣
“×”available；“﹣”not available。

D. Technical tests show that error coefficient of this medical device is within the accepted value: When working
under room temperature, low temperature and high temperature, the fetus sound signals detected ranging from 50-210
times/min, acceptable error coefficient is ±2 times.

2. Intended use of ultrasound Fetal/Maternal Monitor

Fetal/Maternal Monitor: To monitor the heart rate of fetus, TOCO, fetal movement and maternal Spo2 and NIBP

before laboring. It is mainly used to detect fetus heart sound in medical institutions or clinics.

3. Product classification and assessment route

A. We classify the product according to its intended use as well as the requirements of MDD93/42/EEC, Anne IX.

MDD 93/42/EEC, Annex IX, rule 10: Active devices intended for diagnosis are in class IIa if they are intended to

supply energy (eg. nuclear magnetic resonance, ultrasound diagnostic equipment)

12
 B. Conformity of product to requirements of MDD 93/42/EEC is assessed according to Annex Ⅱ.3

4. Precautions during clinical use, limitation

A. Precautions:

a) Operator shall get basic training before operating the equipment. During the usage of Fetal/Maternal

Monitor, they shall be supervised by doctors or nurses.

b) The operating environment of Fetal/Maternal Monitor shall be in the temperature of 5℃-40℃. Before its first use,

charge the battery for 12 hours.

c) In later use, please use out the battery before recharge.

d) It is forbidden to use the device under direct irradiation of sunlight or radiation from other heat sources. No cell

phone can be used during its operation.

d) It is forbidden to clean the Fetal/Maternal Monitor by organic solvents such as alcohol. Also prevent direct

disposure to ultraviolet radiation.

B. Limitation

The rechargeable battery of Fetal/Maternal Monitor can be repeatedly charged for over 500 times if used

correctly. The shelf life of battery will be shortened otherwise.

13
 Essential requirements checklist
Document No. : JPD-CE-FT-05
Version E

Applicable
No. 93/42EEC Essential requirements checklist Standards Conformity Location
N/A
I GENERAL REQUIREMENTS
EN/ISO 14971
The devices must be designed and manufactured in
EN 60601-1
such a way that, when used under the conditions and
IEC 60601-1-2
for the purposes intended, they will not compromise
IEC 60601-2-37
the clinical condition or the safety of the patients, or
EN/ISO 80601-2-61
the safety and health of users or, where applicable,
other persons, provided that any risks which may be
associated with their intended use constitute
acceptable risks when weighed against the benefits
to the patient and are compatible with a high level of
protection of health and safety. Risk management Report
Development
1 Applicable Clinical data compilation
This shall include: department
 reducing as far as possible, the risk of use error
due to the ergonomic features of the device and
the environment in which the device is intended
to be used (design for patient safety), and
 consideration of the technical knowledge,
experience, education and training and where
applicable the medical and physical conditions
of intended users (design for lay, professional,
disabled or other users).

14
 The solutions adopted by the manufacturer for the EN 1041
design and construction of the devices must conform EN/ISO 14971
to safety principles, taking account of the generally EN 60601-1
acknowledged state of the art. IEC 60601-1-2
IEC 60601-2-37
In selecting the most appropriate solutions, the
EN/ISO 10993-1 Risk management Report
manufacturer must apply the following principles in
the following order: See Test Report Development
2 Applicable
- eliminate or reduce risks as fat as possible See EMC Test Report department
(inherently safe design and construction),
- where appropriate take adequate protection
measures including alarms if necessary, in relation to
risks that cannot be eliminated,
- inform users of the residual risks due to any
shortcomings of the protection measures adopted.
EN/ISO 14971
the devices must achieve the performances intended Development
EN 60601-1
by the manufacturer and be designed, manufactured Risk management report department
IEC 60601-1-2
3 and packaged in such a way that they are suitable for Applicable See Test Report Quality
IEC 60601-2-37
one or more of the functions referred to in Article 1 Instructions for use management
EN/ISO 80601-2-61
(2) (a), as specified by manufacturer. department.
EN 1041
The characteristics and performances referred to in EN/ISO 14971
sections 1, 2 and 3 must not be adversely affected to IEC 60601-1
IEC 60601-1-2 Development
such a degree that the clinical conditions and safety
IEC 60601-2-37 Risk management report department
of the patients and, where applicable, of other
4 Applicable EN/ISO 80601-2-61 Clinical data compilation Quality
persons are compromised during the lifetime of the
management
device as indicated by the manufacturer, when the
department
device is subjected the to stresses which can occur
during normal conditions of use.

15
 The devices must be designed, manufactured and EN/ISO 14971
packed in such a way that their characteristics and IEC 60601-1 Comprehensive product
performances during their intended use will not be IEC 60601-1-2 description Development
5 Applicable IEC 60601-2-37
adversely affected during transport and storage Risk management report department
taking account of the instructions and information EN/ISO 80601-2-61
provided by the manufacturer.

Any undesirable side-effect must constitute an EN/ISO 14971 Risk management report
IEC 60601-1 Development
6 acceptable risk when weighed against the Applicable IEC 60601-2-37 Clinical data compilation
department
performances intended. EN/ISO 80601-2-61 Instructions for use

Demonstration of conformity with the essential

6a requirements must include a clinical evaluation in
accordance with Annex X.
II REQUIREMENTS REGRADING DESIGN AND CONSTRUCTION

7 Chemical, Physical and Biological properties

The devices must be designed and manufactured in
such a way as to guarantee the characteristics and
performances referred to in Section I on the ‘General
requirements’. Particular attention must be paid to:
Development
- then choice of material used, particularly as regards
EN/ISO 10993-1 department
toxicity and, where appropriate, flammability, Documentation supplied by the
7.1 Applicable IEC 60601-1 Quality
- the compatibility between the material used and IEC 60601-2-37 manufacturer
management
biological tissues, cells and body fluids, taking
department
account of the intended purpose of the device.
-where appropriate, the results of biophysical or
modeling research whose validity has been
demonstrated beforehand.

16
 The devices must be designed, manufactured and
packed in such a way as to minimize the risk posed
by contaminants and residues to the persons
7.2 involved in the transport, storage and use of the N/A
devices and to the patients, taking account of the
intended purpose of the product. Particular attention
must be paid to the tissues exposed and to the
duration and frequency of exposure.
The devices must be designed and manufactured in
such a way that they can be used safely with the
materials, substances and gases with which they
enter into contact during their normal use or during
routine procedures; if the devices are intended to
7.3 administer medicinal products they must be N/A
designed and manufactured in such a way as to e
compatible with the medicinal products concerned
according to the provisions and restrictions
governing these products and the their performance
is maintained in accordance with the intended use.

Where a device incorporates, as an integral

part, a substance which, if used separately, may be
considered to be a medicinal product as defined in
Article 1 of Directive 2001/83/EC and which is
liable to act upon the body with action ancillary to
7.4 N/A
that of the device, the safety, quality and usefulness
of the substance must be verified by analogy with
the methods specified in Annex I to Directive
2001/83/EC.

17
For the substances referred to in the first paragraph,
the notified body shall, having verified the
usefulness of the substance as part of the medical
device and taking account of the intended purpose of
the device, seek a scientific opinion from one of the
competent authorities designated by the Member
States or the European Medicines Agency (EMEA)
acting particularly through its committee in
accordance with Regulation (EC) No 726/2004 on
the quality and safety of the substance including the
clinical benefit/risk profile of the incorporation of
the substance into the device. When issuing its
opinion, the competent authority or the EMEA shall
take into account the manufacturing process and the
data related to the usefulness of incorporation of the
substance into the device as determined by the
notified body.
Where a device incorporates, as an integral
part, a human blood derivative, the notified body
shall, having verified the usefulness of the substance
as part of the medical device and taking into account
the intended purpose of the device, seek a scientific
opinion from the EMEA, acting particularly through
its committee, on the quality and safety of the
substance including the clinical benefit/risk profile
of the incorporation of the human blood derivative
into the device. When issuing its opinion, the EMEA
shall take into account the manufacturing process
and the data related to the usefulness of
incorporation of the substance into the device as

18
 Where changes are made to the ancillary
substance incorporated in a device, in particular
related to its manufacturing process, the notified
body shall be informed of the changes and shall
consult the relevant medicines competent authority
(i.e. the one involved in the initial consultation), in
order to confirm that the quality and safety of the
ancillary substance are maintained. The competent
authority shall take into account the data related to
the usefulness of incorporation of the substance into
the device as determined by the notified body, in
order to ensure that changes have no negative impact
on the established benefit/risk profile of the addition
of the substance in the medical device.
When the relevant medicines competent
authority (i.e. the one involved in the initial
consultation) has obtained information on the
ancillary substance, which could have an impact on
the established benefit/risk profile of the addition of
the substance in the medical device, it shall provide
the notified body with advice, whether this
information has an impact on the established
benefit/risk profile of the addition of the substance
in the medical device or not. The notified body shall
take the updated scientific opinion into account in
reconsidering its assessment of the conformity
assessment procedure.

19
 The devices must be designed and
manufactured in such a way as to reduce to a
minimum the risks posed by substances leaking from
the device. Special attention shall be given to
substances which are carcinogenic, mutagenic or
toxic to reproduction, in accordance with Annex I to
Council Directive 67/548/EEC of 27 June 1967 on
the approximation of laws, regulations and
administrative provisions relating to the
classification, packaging and labeling of dangerous
substances.
If parts of a device (or a device itself) intended
to administer and/or remove medicines, body liquids Development
or other substances to or from the body, or devices department
Risk management report
7.5 intended for transport and storage of such body Applicable IEC 60601-1 Quality
fluids or substances, contain phthalates which are management
classified as carcinogenic, mutagenic or toxic to department
reproduction, of category 1 or 2, in accordance to
Directive 67/548/EEC, these devices must be labeled
on the device itself and/or on the packaging as a
device containing phthalates.
If the intended use of such devices includes
treatment of children or treatment of pregnant or
nursing women, the manufacturer must provide a
specific justification for the use of these substances
with regard to compliance with the essential
requirements, in particular of this paragraph, within
the technical documentation and, within the
instructions for use, information on residual risks for
these patient groups and, if applicable, on

20
 Devices must be designed and manufactured in such
a way as to reduce, as much as possible, risk posed
by the unintentional ingress of substances into the See Test Report Development
7.6 Applicable IEC 60601-1
device taking into account the device and the nature department
of the environment in which it is intended to be
used.
8 Infection and microbial contamination
The devices and manufacturing processes must be
designed in such a way as to eliminate or reduce as Development
far as possible the risk of infection to the patient, department
IEC 60601-1 Documentation supplied by the
8.1 user and third parties. The design must allow easy Applicable EN/ISO 10993 Quality
manufacturer
handling and, where necessary, minimize management
contamination of the device by the patient or vice department
verse during use.
Tissues of animal origin must originate from animals
that have been subjected to veterinary controls and
surveillance adapted to the intended use of the
tissues.
Notified bodies shall retain information on the
geographical origin of the animals.
8.2 Processing, preservation, testing and handling of N/A
tissues, cells and substances of animal origin must
be carried out so as to provide optimal security. In
particular safety with regard to viruses and other
transferable agents must be addressed by
implementation of validated methods of elimination
or viral inactivation in the course of the

21
 Devices delivered in a sterile state must be designed,
manufactured and packed in a non-reusable pack
and/or according to appropriate procedures to ensure
8.3 that they are sterile when placed on the market and N/A
remain sterile, under the storage and transport
condition laid down, until the protective packaging
is damaged or opened.

Devices delivered in s sterile state must have been

8.4 manufactured and sterilized by an appropriate, N/A
validated method.
Devices intended to be sterilized must be
8.5 manufactured in appropriately controlled (e.g. N/A
environmental) conditions.
Packaging system for non-sterilized devices must
keep the product without deterioration at the level of
cleanliness stipulated and, if the devices are to be
8.6 sterilized prior to use, minimize the risk of microbial N/A
contamination; the packaging system must be
suitable taking account of the method of sterilization
indicated by the manufacturer.

The packaging and/or label of the device must

8.7 distinguish between identical or similar produces N/A
sold in both sterile and non-sterile condition.

9 Construction and environmental properties

22
 If the device is intended for use in combination with
other devices or equipment, the whole combination, Development
IEC 60601-1
including, the connection system must be safe and IEC 60601-2-37 See Test Report department
9.1 must not impair the specified performance of the Applicable EN/ISO 80601-2-61 Quality
EN 1041 Instructions for use management
devices, Any restrictions on use must be indicated on
the label or in the instruction for use. department

Devices must be designed and manufactured in such

IEC 60601-1
a way as to remove or minimize as far as is possible: IEC 60601-1-2
- the risk of injury, in connection with their physical IEC 60601-2-37
EN/ISO 80601-2-61
features, including he volume/pressure ratio,
dimensional and where appropriate ergonomic
features, EN/ISO 14971
- risk connected with reasonably foreseeable IEC 60601-1
See Test report Development
environmental conditions, such as magnetic fields, IEC 60601-1-2
Risk management report department
external electrical influences, electrostatic discharge, IEC 60601-2-37
9.2 Applicable See EMC Test report Quality
pressure, temperature or variations in pressure and EN/ISO 80601-2-61
See Test report management
acceleration,
Risk management report department
- the risks of reciprocal interference with other EN/ISO 14971 Instructions for use
devices normally used in the investigations or for the IEC 60601-1
treatment given,
- risks arising where maintenance or calibration are
not possible (as with implants), from ageing of
materials used or loss of accuracy of any measuring
or control mechanism.
Devices must be designed and manufactured in such
a way as to minimize the risks of fire or explosion Development
during normal use and in single fault condition. department
Risk management report
9.3 Applicable IEC 60601-1 Quality
Particular attention must be paid to devices whose
intended use includes exposure to flammable management
substances or to substances which could cause department
combustion.
23
 10 Devices with a measuring function

Devices with a measuring function must be designed

Development
and manufactured in such a way as to provide Risk management report
department
sufficient accuracy and stability within appropriate IEC 60601-2-37 Instructions for use
10.1 Applicable EN/ISO 80601-2-61 Quality
limits of accuracy and taking account of the intended See Test Report
management
purpose of the device. The limits of accuracy must
department
be indicated by the manufacturer.
Development
The measurement, monitoring and display scale IEC 60601-2-37 department
EN/ISO 80601-2-61 See Test Report
10.2 must be designed in line with ergonomic principles, Applicable EN/ISO 10993-1 Quality
Instructions for use
taking account of the intended purpose of the device. management
department
The measurements made by devices with a
measuring function must be expressed in legal units
10.3 N/A
conforming to the provisions of Council Directive
80/181/EEC .
11 Protection against radiation

11.1 General
Device shall be designed and manufactured in such a
way that exposure of patients, users and other Development
persons to radiation shall be reduced as far as department
IEC 60601-1 See EMC Test Report
11.1.1 possible compatible with the intended purpose, Applicable IEC 60601-1-2 Quality
whilst not restricting the application of appropriate management
of specified levels for therapeutic and diagnostic department
purposes.
11.2 Intended radiation

24
 Where devices are designed o emit hazardous levels
of radiation necessary for a specific medical purpose
the benefit of which is considered to outweigh the
11.2.1 risks inherent in the emission, it must be possible for N/A
the user to control the emissions. Such devices shall
be designed and manufactured to ensure
reproducibility and tolerance of relevant variable
parameters.
Where devices are intended to emit potentially
hazardous, visible and/or invisible radiation, they See EMC Test Report Development
11.2.2 Applicable IEC 60601-1-2
must be fitted, where practicable, with visual department
displays and/or audible warnings of such emissions.

11.3 Unintended radiation

Devices shall be designed and manufactured in such

a way that exposure of patients, users and other See EMC Test Report Development
11.3.1 Applicable IEC 60601-1-2
persons to the emission of unintended, stray or department
scattered radiation is reduced as far as possible.

11.4 Instructions
The operating instruction for devices emitting
radiation must give detailed information as to the
nature of the emitted radiation, means of protecting
11.4.1 N/A
the patient and the user and on ways of avoiding
misuse and of eliminating the risk inherent in
installation.
11.5 Ionizing radiation

25
 Devices intended to emit ionizing radiation must be
designed and manufactured in such a way as to
11.5.1 ensure that, where practicable, the quantity, N/A
geometry and quality of radiation emitted can be
varied and controlled taking into account the
intended use.
Devices emitting ionizing radiation intended for
diagnostic radiology shall be designed and
manufactured in such a way as to achieve
11.5.2 N/A
appropriate image and/or output quality for the
intended medical purpose whilst minimizing
radiation exposure of the patient and user.
Devices emitting ionizing radiation, intended for
therapeutic radiology shall be designed and
11.5.3 manufactured in such a way as to enable monitoring N/A
and control of the delivered dose, the beam type and
energy and where appropriate the quality of
radiation.
12 Requirements for medical devices connected to or equipped with an energy source

Devices incorporating electronic programmable

systems must be designed to ensure the repeatability
reliability and performance of these systems
12.1 according to the intended use. In the event of a N/A
single fault condition (in the system) appropriate
means should be adopted to eliminate or reduce as
far as possible consequent risks.

26
 For devices which incorporate software or which are
medical software in themselves, the software must
12.1a be validated according to the state of the art taking N/A
into account the principles of development lifecycle,
risk management, validation and verification.

Development
Devices where the safety of the patients depends on Risk management report department
IEC 60601-1
12.2 an internal power supply must be equipped with a Applicable See Test Report Quality
IEC 60601-2-37
mean of determining the state of the power supply. management
department
Development
Devices where the safety of the patients depends on Risk management report department
12.3 an external power supply must include an alarm Applicable IEC 60601-1 See Test Report Quality
system to signal any power failure. management
department

Devices intended to monitor one or more clinical Development

parameters of a patient must be equipped with Instructions for use department
12.4 appropriate alarm systems to alert the user of Applicable EN/ISO 80601-2-61 Risk management report Quality
situations which could lead to death or severe management
deterioration of the patient’s state of health. department

Devices must be designed and manufactured in such

a way as to minimize the risks of creating See EMC Test Report Development
12.5 Applicable IEC 60601-1-2
electromagnetic fields which could impair the department
operation of other devices or equipment in the usual
12.6 Protection against electrical risks

27
 Devices must be designed and manufactured in such
a
way as to avoid, as far as possible, the risk of Applicabl IEC 60601-1-2 See Test Report Development
12.6.1 IEC 60601-1
accidental electric shocks during normal use and in e department
single fault condition provided the devices are
installed correctly.
12.7 Protection against mechanical and thermal risks

Development
Devices must be designed and manufactured in such
See Test Report department
a way as to protect the patient and user against
12.7.1 Applicable IEC 60601-1 Risk management report Quality
mechanical risks connected with, for example,
management
resistance, stability and moving parts.
department

Devices must be designed and manufactured in such

a way as to reduce to the lowest possible level the
risks arising from vibration generated by the
12.7.2 devices, taking account of technical progress and of N/A
the means available for limiting vibrations,
particularly at source, unless the vibrations are part
of the specified performance.
Devices must be designed and manufactured in such
Development
a way as to reduce to the lowest possible level he
department
risks arising from the noise emitted, taking account See Test Report
12.7.3 Applicable IEC 60601-1 Quality
of technical progress and of the means available to
management
reduce noise, particularly at source, unless the noise
department
emitted is part of the specified performance.
Terminals and connectors to the electricity, gas or
hydraulic and pneumatic energy supplies which the
12.7.4 N/A
user has to handle must be designed and constructed
in such a way as to minimize all possible risks.

28
 Accessible parts of the devices (excluding the parts Development
or areas intended to supply heat or reach given department
See Test Report
12.7.5 temperature) and their surrounding must not attain Applicable IEC 60601-1 Quality
potentially dangerous temperatures under normal management
use. department
12.8 Protection against the risks posed to the patient by energy supplies or substances

Devices for supplying the patients with energy or Development

substances must be designed and constructed in such department
See Test Report
12.8.1 a way that the flow-rate can be set and maintained Applicable IEC 60601-1 Quality
accurately enough to guarantee the safety of the management
patient and of the user. department

Devices must be fitted with the means of preventing

and /or indicating any inadequacies in the flow-rate
which could pose a danger.
12.8.2 Devices must incorporate suitable means to prevent, N/A
as far as possible, the accidental release of
dangerous levels of energy from an energy and/or
substance source.

12.9 The function of the controls and indicators must be clearly specified on the devices

Where a device bears instructions required for its

operation or indicates operating or adjustment
EN 1041 See Test Report Development
12.9.1 parameters y means of a visual system, such Applicable
Instructions for use department
information must be understandable to the user and,
as appropriate, the patient.

13 Information supplied by the manufacturer

29
13.1 Each device must be accompanied by the information needed to Applicable IEC 60601-1
use it safely and properly, taking account of the training and EN 1041 Labeling(JP-CE-FT-07)
knowledge of the potential users, and to identify the EN/ISO 14971 Instruction Manual
manufacturer. IEC 60601-1
This information compromises the details on the label and the IEC 60601-1-2
data in the instructions for use. IEC 60601-2-37
As far as practicable and appropriate, the information needed to EN/ISO 80601-2-61
use the device safely must be set out on the device itself and/or
on the packaging for each unit or, where appropriate, on the sales
packaging. If individual packaging of each unit is not
practicable, the information must be set out in the leaflet
supplied with one or more devices.
Instructions for use must be included in the packaging for every
device. By way of exemption, no such instructions for use are
needed for devices in Class 1 or 11a if they can be used safely
without any such instructions.
13.2 Where appropriate, this information should take the form of Applicable EN 1041:2008 Instruction Manual
symbols. Any symbol or identification color used must
conform to the harmonized standards. In areas for which no IEC60601-1
standards exist, the symbols and colors must be described in the
documentation supplied with the device.
13.3 The label must bear the following particulars:

the name or trade name and address of the manufacturer. For Applicable EN 1041:2008 Instruction Manual :
devices imported into the Community, in view of their labeling (JP-CE-FT-07)
distribution in the Community, the label, or the outer packaging,
or instructions for use, shall contain in addition the name and
address of the authorized representative where the manufacturer
does not have a registered place of business in the Community;
the details strictly necessary to identify the device and the Applicable EN 1041 Instruction Manual
contents of packaging especially for the users; labeling (JP-CE-FT-07)

30
 where appropriate, the word ‘STERILE’; N/A

where appropriate, the batch code, preceded by the word ‘LOT’, Applicable labeling (JP-CE-FT-07)
or the serial number;
where appropriate, an indication of the date by which the device Applicable EN 1041 Instruction Manual
should be used, in safety, expressed as the year and month; labeling (JP-CE-FT-07)
where appropriate, an indication that the device is for single use. N/A
A manufacturer’s indication of single use must be consistent
across the Community;
if the device is custom-made, the words ‘custom-made device’; N/A

if the device is intended for clinical investigations, the words N/A

‘exclusively for clinical investigations’;
any special storage and/or handling conditions; Applicable EN 1041 Instruction Manual

any special operating instructions; Applicable EN 1041 Instruction Manual

any warnings and/or precautions to take; Applicable EN 1041 Instruction Manual

year of manufacture for active devices other than those covered Applicable EN 1041 Instruction Manual
by (e). This indication may be included in the batch or serial labeling (JP-CE-FT-07)
number;
where applicable, method of sterilization. N/A

in the case of a device within the meaning of Article 1(4a), an N/A

indication that the device contains a human blood derivative
13.4 If the intended purpose of the device is not obvious to the user, Applicable EN 1041 Instruction Manual
the manufacturer must clearly state it on the label and in the IEC60601-1
instructions for use.
13.5 Wherever reasonable and practicable, the devices and detachable Applicable EN1041 Instruction Manual
components must be identified, where appropriate in terms of IEC60601-1 labeling (JP-CE-FT-07)
batches, to allow all appropriate action to detect any potential
risk posed by the devices and detachable components.

31
13.6 Where appropriate, the instructions for use must contain the
following particulars:
the details referred to in Section 13.3, with the exception of (d) Applicable EN 1041: Instruction Manual
and (e); Labeling (JP-CE-FT-07)
The performances referred to in Section 3 and any undesirable Applicable EN60601-1 Instruction Manual
side-effects; EN60601-1-2:
EN ISO 10993-5
EN ISO 10993-10
EN ISO 14971:2012
if the device must be installed with or connected to other medical Applicable EN 1041 Instruction Manual
devices or equipment in order to operate as required for its
intended purpose, sufficient details of its characteristics to
identify the correct devices or equipment to use in order to
obtain a safe combination;
all the information needed to verify whether the device is Applicable EN 1041 Instruction Manual
properly installed and can operate correctly and safely, plus
details of the nature and frequency of the maintenance and
calibration needed to ensure that the devices operate properly
and safely at all times;
where appropriate, information to avoid certain risks in N/A
connection with implantation of the device;
information regarding the risks of reciprocal interference posed Applicable EN60601-1-2:2007 Test Report WT99300065
by the presence of the device during specific investigations or
treatment;
the necessary instructions in the event of damage to the sterile N/A
packaging and, where appropriate, details of appropriate
methods of re-sterilization;

32
if the device is reusable, information on the appropriate Applicable EN 1041 Instruction Manual
processes to allow reuse, including cleaning, disinfection,
packaging and, where appropriate, the method of sterilization of
the device to be resterilized, and any restriction on the number of
reuses.
Where devices are supplied with the intention that they be
sterilized before use, the instructions for cleaning and
sterilization must be such that, if correctly followed, the device
will still comply with the requirements in Section 1;
If the device bears an indication that the device is for single use,
information on known characteristics and technical factors
known to the manufacturer that could pose a risk if the device
were to be re-used. If in accordance with Section 13.1 no
instructions for use are needed, the information must be made
available to the user upon request;
details of any further treatment or handling needed before the Applicable Instruction Manual
device can be used (e.g. sterilization, final assembly, etc.);
in the case of devices emitting radiation for medical purposes, N/A
details of the nature, type, intensity and distribution of this
radiation.
The instructions for use must also include details allowing
medical staff to brief the patient on any contra-indications and
any precautions to be taken. These details should cover in
particular:

33
 Labeling
Document No. : JPD-CE-FT-07
Version E

1. Design of labeling
Labeling must contain below information:
1) Device name, specification, quantity:
2) CE marking, composed of two semi-circle with diameter no less than 5mm,notified identification number 0482
affixed below
3) Lot number, production date, expiration date:
4) Manufacturer:
Shenzhen Jumper Medical Equipment Co. Ltd.
5) Address：D Building, No. 71, Xintian Road, Fuyong Street, Baoan，Shenzhen, Guangdong
Telephone: +86-755-26696279
FAX: +86-755-26852025
Postcode: 518102
Website: http: //www.jumper-medical.com
E-mail: project@jumper-medical.com
Authorized European Representative: MedPath GmbH
Address of European Representative: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
2. Symbols on labeling:
2.1 All medical devices sold out to European market are labeled as per requirements of MDD93/42EEC.
2.2 labeling:

2.2.1 Notice
The background color is yellow, and the signal itself and frame are black. It’s big enough to be noticed. Below the
symbol please write out precautions, instructions for use.（special operating instruction）

2.2.2 Fragile, be careful

The background color is white, and the signal itself and frame are black. It’s big enough to be noticed.

2.2.3 keep dry

The background color is white, and the signal itself and frame are black.
40 C

2.2.4 10C
Symbol for temperature limitation
The background color is white, and the signal itself and frame are black. Mark the temperature at the upper limit and
lower limit

5
2.2.5 Symbol for direction for piling up and layer
To indicate layers piled up alongside

2.2.6 SN symbol for “serial number”

34
The background color is white, and the signal itself and frame are black. The serial number shall be written after the
symbol.

2.2.7 0482 CE marking

Device certified must bear CE marking.
The diameter of the CE marking is no less than 5mm. And the identification number of notified body comes after. It
should be visible, legible, clear and indelible.

2.2.8
Consult instructions for use of the Product and/or its accessories.

2.2.9
Warning Information

2.2.10
Authorized Representative in the European Community

2.2.11
Date of manufacture

2.2.12
Manufacturer

2.2.13
Specifies serial number of the Product

2.2.14
Production batch

2.2.15
It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after
its useful life.
3. CE marking and language
3.1 All medical devices sold to European community market shall bear CE marking, which means：
a. The device conforms to essential requirements of MDD
b. The device can be legally placed on the market within EU territory
c. The device has been the subject of corresponding conformity assessment procedure.
There are two types of CE marking affixed on the medical device, that is CE marking with and without Notified body
identification number. CE marking without identification number is only used for Class I devices need not sterilized and
no measuring function.
3.2 The language of labeling must conform to the language requirements of EU member states and also ensure its

35
correctness.
3.3.The labeling for bulk, medium and small package must meet the requirements of EN ISO 15223:2016 and
contain contents of Article 8.2. Place for additional requirements from customer is available.
4. Special requirements:
4.1 Besides fulfilling special customer requirements, other contents shall design according to the above-mentioned
format.
4.2 The custom-made product shall not bear CE marking, meanwhile indicate “custom made” in the labeling.
4.3 The device intended for clinical investigation shall not bear CE marking, meanwhile indicate “only for clinical
investigation” in the labeling.
5. Label management
5.1 Technical Department will design the label according to the said requirements, with related design host machine
drawing as part of technical documents.
5.2 Quality Control Department is responsible to inspect corresponding product label and language relative to this
procedure regulation and design host machine drawing, and then to manage and control the label to guarantee the normal
application.
6. Label sample:

36
37
 Instruction Manual
Document No. : JPD-CE-FT-08
Version E

See attachment: Instruction Manual

38
 Declaration of Equivalent For clinical evaluation
Document No. : JPD-CE-FT-09
Version E

Manufacturer:
Name： Shenzhen Jumper Medical Equipment Co., Ltd
Address： D Building, No. 71, Xintian Road, Fuyong Street, Baoan，Shenzhen, Guangdong

European Representative:
Authorized European Representative: MedPath GmbH
Address of European Representative: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany

Product:
Name: Fetal/Maternal Monitors
Model: JPD-300P, JPD-600P, JPD-300E

OEM Manufacturer:
Name： Shenzhen Luckcome Technology Inc., Ltd
Address：3A1, Tower A , Zhengxing Building , Industry Road 3 , Shekou Shenzhen, Guangdong,P.R.China

Corresponding device:
Name: Fetal/Maternal Monitors
Model: L8, L8A

We, the manufacturer, herewith declare that the stated medical device JPD-300P and JPD-300E are equivalent to the
device L8, and the device JPD-600P is equivalent to the device L8A, on clinical investigation. We just change the labels
and trade marks on the device. The electrical safety and performance won’t change. So, the clinical investigation of the
equipment is equivalent to corresponding devices.

Signature: ____________________

39
 Declaration of Equivalent For risk analysis
Document No. : JPD-CE-FT-10
Version E
Manufacturer:
Name： Shenzhen Jumper Medical Equipment Co., Ltd
Address： D Building, No. 71, Xintian Road, Fuyong Street, Baoan，Shenzhen, Guangdong

European Representative:
Authorized European Representative: MedPath GmbH
Address of European Representative: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany

Product:
Name: Fetal/Maternal Monitors
Model: JPD-300P, JPD-600P, JPD-300E

OEM Manufacturer:
Name： Shenzhen Luckcome Technology Inc., Ltd
Address：3A1, Tower A , Zhengxing Building , Industry Road 3 , Shekou Shenzhen, Guangdong,P.R.China

Corresponding device:
Name: Fetal/Maternal Monitors
Model: L8, L8A

We, the manufacturer, herewith declare that the stated medical device JPD-300P and JPD-300E are equivalent to the
device L8, and the device JPD-600P is equivalent to the device L8A, on risk analysis. We just change the labels and trade
marks on the device. The electrical safety and performance won’t change. So, the risk analysis of the equipment is
equivalent to corresponding devices.

Signature: ____________________

40
EC Authorized Representative Agreement for Medical Device CE Marking
Document No. : JPD-CE-FT-11
Version E

See attachment ：EC Authorised Representative Agreement for Medical Device CE Marking

41
 Declaration of conformity
Document No. : JPD-CE-FT-12
Version E
Manufacturer:
Name： Shenzhen Jumper Medical Equipment Co., Ltd
Address：D Building, No. 71, Xintian Road, Fuyong Street, Baoan，Shenzhen, Guangdong
European Representative:
Authorized European Representative: MedPath GmbH
Address of European Representative: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
Product:
Name: Fetal/Maternal Monitors
Model: JPD-300P, JPD-600P, JPD-300E
Classification:
Fetal/maternal Monitor is classified as II a device according to MDD 93/42/EEC annex IX rule 10
Conformity assessment Route:
Annex II.3 is chosen for the conformity certification pathway.

We, the manufacturer, herewith declare that the stated medical devices meet the transposition into national law, the
provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices including, at 21 march 2010, the
amendments by Council Directive 2007/47/EEC.
The validity period of this declaration of conformity is limited by the issuing of a revised declaration of conformity after
change of the product and/or by the expiration date of the related Annex II certificate issued by the notified body.

The object of the declaration described above is in conformity with the requirements of the following documents:
Documents No. Title Edition/Date of issue

JP-CE-FT CE Technical Documentation D/NOV,30,2016

Standards applied: See the List of applicable standards - JP-CE-FT-13

Notified Body: MEDCERT GmbH
Pilatuspool 2, 20355 Hamburg
(EC) Certificate(s): 0482
Products covered:
Place, Date of Issue: Shenzhen,Nov 30,2016

Signature:
____________________

42

No. Standard
1 EN 60601-1:2006+A12:2014
2 EN 60601-1-2:2015
3 EN 60601-2-37:2015
4 EN/ISO 14971:2019
5 EN/ISO 80601-2-61:2019
6 ISO 80601-2-56:2017+A1:20
18
7 EN ISO 15223-1:2016
8 MEDDEV 2.7.1
9 ISO14155-1: 2011
10 EN 1041:2008+A1:2013
11 IEC 80601-2-30：2018
12 EN/ISO10993-1: 2009
13 EN/ISO10993-5: 2009
14 EN/ISO10993-10: 2010
15 EN/ISO 13485: 2016
16 MDD 93/42/EEC
List of applicable standards
Document No. :JPD-CE-FT-13
Version E
Description
Medical electrical equipment- Part1: General requirements for safety
Medical electrical equipment--Part1-2: General requirements for
safety--Collateral standard: Electromagnetic compatibility- requirements and
tests
Medical electrical equipment - Part 2-37: Particular requirements for the safety
of ultrasonic medical diagnostic and monitoring equipment.
Medical devices--Application of risk management to medical devices
Medical electrical equipment - Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use
medical electrical equipment part 2-56: particular requirements for basic safety
and essential performance of clinical thermometers for body temperature
measurement
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
Clinical evaluation:a guide for manufacturers and notified bodies
Clinical investigation of medical devices for human subjects
Information supplied by the manufacturer with medical devices
Medical electrical equipment -- Part 2-30: Particular requirements for the basic
safety and essential performance of automated non-invasive
sphygmomanometers
Biological evaluation of medical device--Guidance on selection of tests
Biological evaluation of medical devices--Part 5:Test for in vitro cytotoxicity
Biological evaluation of medical devices--Part 10:Tests for irritation and
delayed-type hypersensitivity
Medical devices--Quality management systems--Requirements for regulatory
purposes
Council Directive 93/42/EEC concerning medical devices
43
 Interface contract
Document No. : JPD-CE-FT-14
Version D

See attachment: Interface contract

44