Shenzhen Jumper Medical Equipment Co.,Ltd.

CE Technical Files
(JPD-800B)

Production name: Multi parameter patient monitors

Production Type: JPD-800B

Efficient Date: 2015-10-25
Document Pages: 33
Write Dept: R&D Dept.

Drafted by Du Shi Gui

Reviewed by Ai Hui Rong

Approved by Yi Hui

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CE Technical Files

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

1 Certificate JP-CE-PM-01 B 2

JP-CE-PM-02
2 Declaration of Conformity B 5

JP-CE-PM-03
3 labeling B 6

JP-CE-PM-04
4 Instruction Manual B 9

Part 2 :PLM B

5 Product introduction JP-CE-PM-05 B 10

JP-CE-PM-06
6 Essential requirements checklist B 12

JP-CE-PM-07
7 labeling C 18

JP-CE-PM-08
8 Instruction Manual B 22

JP-CE-PM-09
9 Pre-clinical investigation and compilation of clinical data B 23

JP-CE-PM-10
10 Risk management report B 25

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

11 B 29
Device CE Marking
JP-CE-PM-12
12 Declaration of conformity C 30

JP-CE-PM-13
13 List of applicable standards C 31

JP-CE-PM-14
14 Interface contract B 33

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Part 1
Certificate
Document No. : JPD-CE-PM-01
Version B

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第 4 页 共 34 页
第 5 页 共 34 页
Declaration of Conformity
Document No. : JPD-CE-PM-02
VersionB

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 Labeling
Document No. : JPD-CE-PM-03
Version B
Description
The control of language and labels conforms to MR/G01-21.5 ‘Control guidance of label
and language’ which conforms to EN980:2003 and EN1041:1998.

Control of the language in label

It is needed to use the different languages for the product sold to different countries. The
sales department answers for the different languages requirement of different countries where the
products will be sold. The languages using in the label, operation manual, patient information of
the products that sold to the European community countries must be conformed to the rule
according to the appendix.
Design of the label
The information in the label of the product includes:
Name of manufacture
Address of manufacture
Name of the product
Serial number of the product
Year of the product manufactured
CE mark
Name of the authorized EU-representative
Address of the authorized EU-representative

The two-page draft drawings of the label for STAR8000/STAR8000B/AV-9000B are in

following pages:

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Label on the outer carton: (Draft Copy)

第 8 页 共 34 页
Label on the monitor back 1) (Draft Copy)

Label on the monitor back 2) (Draft Copy)

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 Instruction Manual
Document No. : JPD-CE-PM-04
Version B

See attachment: usual manual(Comen)

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Part2
Product introduction
Document No. : JPD-CE-PM-05
Version B
Product Name: Multi parameter patient monitors

Feature
The functions of the STAR8000(JPD-800B)multi-parameter patient monitor:
* 12.1” Color TFT display
* Standard six parameters configuration: ECG, RESP, NIBP, SPO2, TEMP, PR.
* Voice/light alarming mode. The alarm limit of the each parameter can be setup. The monitor will alarm when
the monitoring parameter reach or surpass the alarm limit.
* Adjustable parameter data and waveforms color
* 7-lead display on the same screen
* ECG monitoring mode: monitor, operation, diagnosis
* ECG gain selection: x0.5, x1, x2, x4
* Sweep speed: 12.5mm/s, 25mm/s, 50mm/s
* NIBP mode: adult, pediatric and neonatal
* NIBP measurement mode: manual, automatic, continuous
* Reviewable ECG waveform
* 128 hours storing and reviewing of trends graphic
* Built-in battery, continuous power supply
* Optional build-in thermal recorder, special accessories for neonatal and pediatric patient
* The multi-parameter monitor is applicable to be equipped in hospital clinic district like internal medicine,
external medicine, ICU, operation room and so on. It can provide the patient’s vital signs information to
doctors.
Production Classification
Multi parameter patient monitor is classified as II b device according to MDD 93/42/EEC annex IX rule
10，so Annex II.3 is chosen for the conformity certification pathway.
Accessories list
material Name model Qty Supplier classification
S/N
Adult NIBP cuff U1880s 1 Unimed Medical Supplies lnc class I
Children NIBP cuff U1881s 1 Unimed Medical Supplies lnc
Neonate NIBP cuff U1882s 1 Unimed Medical Supplies lnc
Adult SpO2 probe TJ-S008T5 1 Shenzhen Taijia Electronics Co., Ltd. class IIb

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Children SpO2 TJ-S008T2 1 Shenzhen Taijia Electronics Co., Ltd.
probe
Neonate SpO2 TJ-S0213K1 1 Shenzhen Taijia Electronics Co., Ltd.
probe
TEMP body surface W0008C 1 Shenzhen Taijia Electronics Co., Ltd. class IIa.
probe
Five-in-one ECG EE002S3A 1 Shenzhen Med-Link Electronics Co., class I
leads cable Ltd.

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 Essential requirements checklist
Document No. : JPD-CE-PM-06
Version B
caption: The Multi parameter patient monitor is producted by Shenzhen Comen Medical Instrument Co., Ltd..As the OEM supplier of Jumper, Shenzhen
Comen Medical Instrument Co., Ltd. has got EC Certificate according to Annex II of the Directive 93/42/EEC. So the supplier has fullfilled the Annex II
requirements of MDD 93/42/EEC, and Jumper only changes the Label and IFU. The section 13 of essential requirements is shown as below:

Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?

13 Information supplied by the manufacturer

13.1 Each device must be accompanied by the information needed to use it safely and properly, taking Applicable EN60601-1
account of the training and knowledge of the potential users, and to identify the manufacturer. EN1041 Instruction Manual

This information compromises the details on the label and the data in the instructions for use.
EN12470-4
EN1060-1
As far as practicable and appropriate, the information needed to use the device safely must be set
EN1060-3
out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales
EN9919
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.

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 Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?

13.2 Where appropriate, this information should take the form of symbols. Any symbol or Applicable EN60601-1 Instruction Manual

identification color used must conform to the harmonized standards. In areas for which no IEC878
standards exist, the symbols and colors must be described in the documentation supplied with the EN1041
device. EN980
EN475
EN12470-4
EN1060-1
EN1060-3
EN9919

13.3 The label must bear the following particulars:

(a) the name or trade name and address of the manufacturer. For devices imported into Applicable EN 1041 Instruction Manual :

the Community, in view of their distribution in the Community, the label, or the outer EN 980 labeling (JP-CE-PM-07)
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;

(b) the details strictly necessary to identify the device and the contents of packaging Applicable EN 1041 Instruction Manual

especially for the users; EN 980 labeling (JP-CE-PM-07)

(c) where appropriate, the word ‘STERILE’; N/A

(d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial Applicable EN 980 labeling (JP-CE-PM-07)

number;

(e) where appropriate, an indication of the date by which the device should be used, in Applicable EN 1041 Instruction Manual

safety, expressed as the year and month; EN 980: labeling (JP-CE-FT-07)

(f) where appropriate, an indication that the device is for single use. A manufacturer’s N/A

indication of single use must be consistent across the Community;

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 Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?

(g) if the device is custom-made, the words ‘custom-made device’; N/A

(h) if the device is intended for clinical investigations, the words ‘exclusively for clinical Applicable EN980 Instruction Manual

investigations’;

(i) any special storage and/or handling conditions; Applicable EN 980 Instruction Manual

(j) any special operating instructions; Applicable EN 980 Instruction Manual

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

(l) year of manufacture for active devices other than those covered by (e). This Applicable EN 1041 Instruction Manual

indication may be included in the batch or serial number; EN 980 labeling (JP-CE-PM-07)

(m) where applicable, method of sterilization. Applicable EN 1041 Instruction Manual

EN 980 labeling (JP-CE-PM-07)

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

device contains a human blood derivative

13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state Applicable EN 1041 Instruction Manual

it on the label and in the instructions for use. EN 980

IEC60601-1

EN12470

EN9919

13.5 Wherever reasonable and practicable, the devices and detachable components must be identified, Applicable EN1041 Instruction Manual

where appropriate in terms of batches, to allow all appropriate action to detect any potential risk IEC60601-1 labeling (JP-CE-PM-07)
posed by the devices and detachable components.
EN1060-1

EN1060-3

EN9919

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 Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?

13.6 Where appropriate, the instructions for use must contain the following particulars:

(a) the details referred to in Section 13.3, with the exception of (d) and (e); Applicable EN 1041: Instruction Manual

EN 980: Labeling (JP-CE-BP-07)

(b) The performances referred to in Section 3 and any undesirable side-effects; Applicable EN60601-1 Instruction Manual

EN60601-1-2:

EN ISO 10993-5

EN ISO 10993-10

EN ISO 14971

(c) if the device must be installed with or connected to other medical devices or equipment Applicable EN 1041 Instruction Manual

in order to operate as required for its intended purpose, sufficient details of its EN 980:
characteristics to identify the correct devices or equipment to use in order to obtain a

safe combination;

(d) all the information needed to verify whether the device is properly installed and can Aplicable EN 1041 Instruction Manual

operate correctly and safely, plus details of the nature and frequency of the EN 980
maintenance and calibration needed to ensure that the devices operate properly and

safely at all times;

(e) where appropriate, information to avoid certain risks in connection with implantation N/A

of the device;

(f) information regarding the risks of reciprocal interference posed by the presence of the Applicable EN60601-1-2 Test Report

device during specific investigations or treatment;

(g) the necessary instructions in the event of damage to the sterile packaging and, where N/A

appropriate, details of appropriate methods of re-sterilization;

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 Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?
IEC 60601-1
(h) if the device is reusable, information on the appropriate processes to allow reuse, Applicable Instruction Manual
EN1041
including cleaning, disinfection, packaging and, where appropriate, the method of

sterilization of the device to be resterilized, and any restriction on the number of

IEC60878
reuses.
IEC60601-2-30

ISO9919

IEC 60601-2-49

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;

(i) details of any further treatment or handling needed before the device can be used (e.g. Applicable Instruction Manual

sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, details of the nature, N/A

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:

(k) precautions to be taken in the event of changes in the performance of the device; Applicable EN 1041 Instruction Manual :

EN 980

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 Applicable
Essential Requirement Standards Identity of Specific Documents
to Device?

(l) precautions to be taken as regards exposure, in reasonably foreseeable environmental Applicable EN 1041 Instruction Manual :

conditions, to magnetic fields, external electrical influences, electrostatic discharge, EN 980

pressure or variations in pressure, acceleration, thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or products which the device in Applicable

question is designed to administer, including any limitations in the choice of

substances to be delivered;

(n) precautions to be taken against any special, unusual risks related to the disposal of the Applicable EN 1041: Instruction Manual

device; EN 980 labeling JP-CE-BP-07

(o) medicinal substances, or human blood derivatives incorporated into the device as an N/A

integral part in accordance with Section 7.4;

(p) degree of accuracy claimed for devices with a measuring function. Applicable EN 1041 Instruction Manual

(q) date of issue or the latest revision of the instructions for use. Applicable EN 1041 Instruction Manual

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 Labeling
Document No. : JPD-CE-PM-07
Version C

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,China

Telephone: +86-755-26696279

FAX: +86-755-26852025

Postcode: 518102

Website: http: //www.jumper-medical.com

E-mail: [email protected]

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

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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”

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

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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

correctness.

3.3.The labeling for bulk, medium and small package must meet the requirements of EN980: 2009 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:

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第 22 页 共 34 页
 Instruction Manual
Document No. : JPD-CE-PM-08
Version B
See attachment: usual manual (Jumper )

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 Pre-clinical investigation and compilation of clinical data
Document No. JP-CE-PM-09
Version B

The earliest foundations for acquiring physiological data date to the end of the Renaissance period.2 In 1625,
Santorio, who lived in Venice at the time, published his methods for measuring body temperature with the spirit
thermometer and for timing the pulse (heart) rate with a pendulum. The principles for both devices had been established
by Galileo, a close friend. Galileo worked out the uniform periodicity of the pendulum by timing the period of the
swinging chandelier in the Cathedral of Pisa, using his own pulse rate as a timer. The results of this early
biomedical-engineering collaboration, however, were ignored. The first scientific report of the pulse rate did not appear
until Sir John Floyer published “Pulse-Watch” in 1707. The first published course of fever for a patient was plotted by
Ludwig Taube in 1852. With subsequent improvements in the clock and the thermometer, the temperature, pulse rate,
and respiratory rate became the standard vital signs. In 1896, Scipione Riva-Rocci introduced the sphygmomanometer
(blood-pressure cuff), which permitted the fourth vital sign, arterial blood pressure, to be measured. A Russian physician,
Nikolai Korotkoff, applied Riva-Rocci's cuff with a stethoscope developed by the French physician Rene Laennec to
allow the auscultatory measurement 3 of both systolic and diastolic arterial pressure. Harvey Cushing, a preeminent U.S.
neurosurgeon of the early 1900s, predicted the need for and later insisted on routine arterial blood pressure monitoring in
the operating room. Cushing also raised two questions familiar even at the turn of the century: (1) Are we collecting too
much data? (2) Are the instruments used in clinical medicine too accurate? Would not approximated values be just as
good? Cushing answered his own questions by stating that vital-sign measurement should be made routinely and that
accuracy was important [Cushing, 1903].
Since the 1920s, the four vital signs—temperature, respiratory rate, heart rate, and arterial blood pressures—have
been recorded in all patient charts. In 1903, Willem Einthoven devised the string galvanometer for measuring the ECG,
for which he was awarded the 1924 Nobel Prize in physiology. The ECG has become an important adjunct to the
clinician's inventory of tests for both acutely and chronically ill patients. Continuous measurement of physiological
variables has become a routine part of the monitoring of critically ill patients. At the same time that advances in
monitoring were made, major changes in the therapy of life-threatening disorders were also occurring. Prompt
quantitative evaluation of measured physiological and biochemical variables became essential in the decision-making
process as physicians applied new therapeutic interventions. For example, it is now possible—and in many cases
essential—to use ventilators when a patient cannot breathe independently, cardiopulmonary bypass equipment when a
patient undergoes open-heart surgery, hemodialysis when a patient's kidneys fail, and intravenous (IV) nutritional and
electrolyte (for example, potassium and sodium) support when a patient is unable to eat or drink.
Patient monitor is a kind of increasing demand and clinic necessary instrument. In past it mainly applies in monitor
serious patient. ECG monitor is used in ICU、CCU ward. Now it has changed to common sick house, base medical unit
and society area has new demand to it. Development of monitor is rapid since 1990s. Clinic application scope of monitor
technology has been expanded. Science and manufacture level rises and transfers to intelligent, network in view of
introduce of computer technology and OEM manufacture mode.
At present, common monitors are composed of multi-parameter biological (blood pressure、 blood oxygen, ECG,
heart rhythm, impedance breath, body temperature), 24 hours dynamic monitor(ECG, EEG), operation monitor, mother
and son monitor, fetus monitor, sleeping monitor. Apply ways are bedside monitor, central monitor, remote monitor,
dynamic monitor and family monitor and so on.
Multi-parameter patient monitor is an important device, which can be used for patient with serious ill and operation

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process and monitored the patient’s physiological parameters in the hospital. Through 24-hourmonitoring and analysis on
various physiological parameters, and alarming when patients’ physiological mechanism parameter exceeds a limit, it
alerts medical staff to conduct rescue. It provides important bases for medical staff to do diagnosis and rescue, especially
for the course of surgical incision for cancer, nurse after operation and radiation treatment. With the rapid development
of monitor technology, monitor is now used in various departments of the hospitals, such as operating room, mental
disorder room, coronary heart disease room, trauma care room, radiotherapy machine care room.
Multi-parameter patient monitor monitors patients’ vital signs such as ECG, RESP, NIBP, SpO2 and TEMP. It
converts the various physiological changes sensed by the sensors into data and calculates, analyzes and edits the data
with the data analysis software, and then, displays the data on the screen or records or prints the data according to
requirements. When the monitored data exceed the preset limits, alarm system will be activated and send signal to alert
medical staff’s attention.
This confidential document is the property of Jumper Medical Equipment Co., Ltd. No published and unpublished
information contained here in may be disclosed without prior written approval from Jumper Medical Equipment Co.,
Ltd.
The Multi-parameter patient monitor is produced by Shenzhen Comen Medical Instrument Co., Ltd. that is the
OEM supplier of Jumper. Shenzhen Comen Medical Instrument Co., Ltd. is not only a domestic capital enterprise, but
also an advanced company with full of experiences on healthcare instrument's research and development for many years.
Our production line is now occupied 3,500 square meters. & we own total number of staff and workers by 320 people;
registration with funds 1400 ten thousand Yuan at this moment.
We have change nothing about the electrical blood pressure meter, so clinical data of this product is acceptable;

We are a professional medical devices manufacturer and development company. After over ten years' development,
we have built up and enjoyed the fame for our various products in the world. They keep popular with our clients, no
matter in hospitals or clinics. Multi-parameter patient monitor is safety and well performance. No cases of medical
negligence related to our Multi-parameter patient monitor were reported till now.
We declare that the functions and clinical performance of our Multi-parameter patient monitor r are same as our
OEM supplier.

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 Risk management report for multi parameter patient monitor
Document No. : JPD-CE-PM-10
Version B
1.Preface
We are private label manufacturer for the multi parameter patient monitor. It is produced by our OEM
manufacturer,and it has been certified according to the MDD93/42/EEC Annex II.3 and fullfill the relevant requirements
and standards.As private label manufacturer,we have only changed the labels and trade marks on the device.We will not
change the intended use and the product itself.So we only need analysis and control the risk of labels, storage and
transport.

2. Criteria for Risks Acceptability

2.1 Criteria for severity level evaluation

No. Class Severity Illustration

It is likely to cause little harm or no
1 Negligible Have nausea temporarily
harm.
2 Marginal It is likely to cause slight harms. Mechanical hazards caused by sharp edges;
1. Get an electric shock because of contact
It is likely to cause grievous bodily with mains supply;
3 Critical
harm or death. 2. Equipment cannot be operated due to
malfunctions.
It is likely to cause grievous bodily
4 Catastrophic Fire caused by invalid recharge.
harm or death to many persons.

2.2 Criteria for probability level evaluation

No. Class Probability Illustration

1 Incredible ＜10 -6
Fire caused by invalid charger in hospital..
2 Unlikely 10-4-10-6 Equipment cannot be operated due to malfunctions.
3 Rare 10-2-10-4 A certain cable breaks.
4 Occasional 10-1-10-2 A certain probe is inserted incorrectly..
5 Probable 1-10-1 The accessory falls to the ground.
6 Frequent ＞1 Alarm when HR is beyond limit.

2.3 Criteria for Risk Evaluation

Risk level = Severity × probability of occurrence

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 Severity
Probability
1 Negligible 2 Marginal 3 Critical 4 Catastrophic
6 Frequent * NACC NACC NACC
5 Probable * * NACC NACC
4 Occasional * * * NACC
3 Rare ACC * * *
2 Unlikely ACC ACC * *
1 Incredible ACC ACC ACC ACC
NACC = non-acceptable ACC =broadly acceptable

*= as low as reasonably practicable (ALARP)

3. Labels, storage and transport risk review

3.1 Risk analysis group is made of by:
Name Position Responsible scope
Liang Pei Ji Management Project manager: responsible for the implementation of risk analysis
representative To estimate the potential misuse of operators from view of application
Du Shi Gui R&D manager

Yi hui Medical consultant To estimate severity of harm form medical side

To identify potential production shortcomings from view of technology
Bai Song Yin QC manager To identify the potential shortcoming from view of production
Chen De Ping Production manager
Du Shi Gui Engineering manager To identify the ratio of hardware failure from view of technology
Liang Pei Ji Marketing manager
Du Shi Gui Evaluating the probability of software failure from technical view
He Lei Software engineer

3.2 Potential hazard

Storage or operation outside prescribed environmental conditions: Fetal/Maternal Monitor has specific storage and

operation environmental conditions.

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3.3.Table of Risk management
Description Cause Risk evaluation
Verdict
Severity Probability Hazard Solution New
Before/after Before/after Before/after Hazard Verification

H3.4 C3.4 3/3 4/2 ALARP Check the packaging design to meet N/A
Packaging Y
accidental Storage or /ACC requirements for shock and drop.
test
mechanical transportation
breakage conditions deviate
from intended
environment.
H4.1 C4.1 4/4 4/1 NACC/AC Marking on the device shall meet N/A
Sample Y
Improper lack of marks or C requirements of EN 60601-1
submitted
Markings improper marks All information on the Original Label
for test
is/ has to be transferred identically
to the PLM Label
H4.2 C4.2 4/4 4/1 NACC/AC State in the Instruction manual that N/A Instruction
Y
Inadequate Accessories used C only those accessories specified or manual
specification for do not meet recommended by the manufacturer
accessories requirements. can be used.
H4.3 C4.3.1 4/4 4/2 NACC/AC Examining steps of each measuring N/A Instruction
Y
Inadequate No examination is C function shall be explained in manual
pre-check before performed before Instruction manual.
use use.
H4.4 C4.4 3/3 4/2 ALARP/AC The target reader of Instruction N/A Instruction
Y
Over-complicated Instruction manual C manual of which contents are sorted manual
operation is too complex. out according to functions for easy
instructions consultation is medical professionals
and other professionals.

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4. The overall residual risk can be reviewed
Review group overall review all residual risk,consider under the influence of all the residual risks, the
result of review will be thought: the overall residual risk of this products is acceptable
4.1 Whether there have contradictory demands in risk of individual risks control
Conclusion: no found contradictory situation in existing risk control
4.2 Review of warnings (include whether it have too many warning)
Conclusion: Warned point clearly, conform to criterion
4.3 Review of use manual (include whether there have contradiction, and whether it is hardly in complying
with
Conclusion: the use manual comply with products special safety standard requirement of, relative
description of products safety side is clearly, the user is easy to understand it.
4.4 Expert conclusion
Conclusion: After risk management review group analyze above point, and communicate with clinic
application expert, it will be thought:
The overall residual risk of those products is acceptable;

5. Risk management review conclusion

After risk management review group reviewed multi parameter patient monitor, it will be thought:
The risk management plan had been appropriately implemented
The overall residual risk is acceptable;
Due to above-mentioned measures were taken, the probability of occurrence of hazards during use of multi
parameter patient monitor during use is relatively small. Each hazard of harm has been reduced to
acceptable level. Moreover, the occurrence of all kinds of hazards is reduced to acceptable level. The
benefits outweigh risks. Due to above-mentioned measures were taken, the probability of occurrence of
hazards during use of multi-parameter patient monitor during use is relatively small. Each hazard of harm
has been reduced to acceptable level. Moreover, the occurrence of all kinds of hazards is reduced to
acceptable level. The benefits outweigh risks.

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 EC Authorized Representative Agreement for Medical Device CE
Marking
Document No. : JPD-CE-PM-11
Version B

See attachment ： EC Authorised Representative Agreement for Medical Device CE

Marking

第 30 页 共 34 页
 Declaration of conformity
Document No. : JPD-CE-PM-12
Version C
Manufacturer:
Name： Shenzhen Jumper Medical Equipment Co., Ltd
Address：D Building, No. 71, Xintian Road, Fuyong Street, Baoan,Shenzhen, Guangdong,China
European Representative:
Name: MedPath GmbH
Address: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
Product:
Name: Multi parameter patient monitors
Model: JPD-800B
Classification:
Multi parameter patient monitor is classified as II b device according to MDD 93/42/EEC annex IX
Conformity assessment Route:
Annex II 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 V 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-PM CE Technical Documentation B/oct 25,2015

Standards applied: see List of applicable standards - JP-CE-PM-13

Notified Body: MEDCERT GmbH

Pilatuspool 2, 20355 Hamburg
(EC) Certificate(s): 0482
Products covered:
Place, Date of Issue: shenzhen,Oct25,2015

Signature: ____________________

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 List of applicable standards
Document No. :JPD-CE-PM-13
Version C
NO. Standard Description
1 graphical symbols for electrical equipment in medical
IEC/TR60878:2015
practice
2 ISO1000:1992+A1:1998 the international system of units (si) and its application
3 Medical devices-Application of risk management to Medical
ISO14971:2019
devices
4 Biological evaluation of medical devices -Part1:Evaluation
ISO10993-1:2009
and Testing
5 Medical devices — Symbols to be used with medical
EN ISO 15223:2016 device labels, labelling and information to be supplied Part
1: General requirements
6 Information supplied by the manufacturer of medical
EN1041:2008
devices
7 Medical Electrical Equipment- Part 1: General Requirements
IEC60601-1:2005
for Basic Safety and Essential Performance
8 Medical electrical equipment - Part 1-1: General
EN60601-1-11:2015 requirements for safety - Collateral standard: Safety
requirements for medical electrical systems
9 Medical Electrical Equipment-Part 1-2: General
IEC60601-1-2:2015 Requirements for safety-Collateral Standard:
Electromagnetic Compatibility-Requirements and tests
10 Medical electrical equipment-Part 1-4:General requirements
EN60601-1-4:1996/A1:19
for safety-Collateral tandard:Programmable electrical
99
medical systems
11 Medical electrical equipment–Part 1-6:General requirements
EN60601-1-6:2007+AC:2
for basic safety and essential performance–Collateral
010
Standard: Usability
12 Medical electrical equipment-Part 1-8:General requirements
for safety-Collateral Standard: General requirements, tests
EN60601-1-8:2007
and guidance for alarm systems in medical electrical
equipment and medical electrical systems
13 Medical electrical equipment - Part 2-27: Particular
EN60601-2-27:2014 requirements for the safety, including essential performance,
of electrocardiographic monitoring equipment
14 Medical electrical equipment-part2-30:particular
requirements for the safety, including essential performance,
EN60601-2-30:2019
of automatic cycling non-invasive blood pressure
monitoring equipment
15 Medical electrical equipment-Part 2-49:Particular
EN60601-2-49:2019 requirements for the safety of multifunction patient
monitoring equipment
16 Non-invasive sphygmomanometers Part 1:General
EN1060-1:1995+A2:2009
requirements
17 Non-invasive sphygmomanometers part3:supplementary
EN1060-3:1997+A2:2009 requirements for electro-mechanical blood pressure
measuring systems
18
EN1060-4:2004 Non-invasive sphygmomanometers-Part 4:Test procedures

第 32 页 共 34 页
 to determine the overall system accuracy of automated
non-invasive sphygmomanometers
19 Medical electrical equipment - Part 2-61: Particular
ISO 80601-2-61:2019 requirements for basic safety and essential performance of
pulse oximeter equipment
20 Non-invasive sphygmomanometers-Part 4:Test procedures
EN12470-4:2000+A1:200
to determine the overall system accuracy of automated
9
non-invasive
21 Clinical investigation of medical devices for human
EN14155-1:2011
subjects-Part 1:General requirements
22 Clinical investigation of medical devices for human subjects
EN14155-2:2011
- Part 2: Clinical investigation plan
23 EN62304:2015 Medical device software - Software life-cycle processes
24 Medical devices - Application of usability engineering to
EN 62366-1:2015
medical devices

第 33 页 共 34 页
 Interface contract
Document No. : JPD-CE-PM-14
Version B

See attachment: Interface contract

第 34 页 共 34 页