MBJ20 Instruction Manual V3.0 Sept 2012

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

About this manual Firstly, thank you very much for using our M&B product. To ensure correct use of MBJ20 transcutaneous jaundice detector (herein below mentioned as MBJ20 or jaundice detector), read the following points carefully and adhere to them. After reading this manual, keep it in a safe place where it can be referred to anytime a question arises. Model Number: MBJ20 Product Name: Transcutaneous Jaundice Detector Manufacturer: Beijing M&B Electronic Instruments Co., Ltd Address: Room 6319, Building 1, No. 27, Yongwang Road, Beijing Bioengineering and Medicine Industry Base, Huangcun Town, Daxing district, Beijing, People’s Republic of China Issued date: September 7, 2012, Version: V3.0

Intellectual property The intellectual property of MBJ20 and its manual belong to Beijing M&B Electronic Instruments Co., Ltd (herein below mentioned as M&B). Copying, reproduction or translation of all or any part of the contents of this manual without M&B’ s permission is strictly prohibited. All rights reserved by M&B.

Statement M&B has the final rights to interpretation for this manual. M&B is responsible for the product’s safety, reliability and performance if below conditions are satisfied:

 Assembly, extensions, modifications or repair are carried out by persons authorized by M&B.

 The electrical equipment conforms to CE standards.  MBJ20 is used in accordance with the instructions manual.

Maintenance Service Free service range: I

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0



Free services are offered in accordance with M&B warranty regulations.

Fee based service range: 

Beyond M&B warranty regulations.



During the warranty period, warranty shall not extend to the following conditions: 1) It is damaged from improper use. 2) Battery voltage is beyond the scope of product specification. 3) Natural disasters. 4) Replaced accessories, consumables without M&B authorisation. 5) Modification or repair by anyone except Beijing M&B authorized person or company.

Contact us Service telephone and product support: Please contact M&B if you have any questions regarding product support. +0086 010 61253803 (Working Time: Monday ~ Friday，8:30 ~ 17:30); Or contact the regional service partner or distributor.

Order consumables and repair parts Please purchase repair parts (circuit board etc) from the M&B service partner or distributor in your country.

Other questions Please contact us as below or visit our website：www.mbelec.com. Headquarters Company: M&B Electronic Instruments Co., Ltd. Address: No.27, Yongwang Road, Beijing Bioengineering and medicine industry base, Huangcun Town, Daxing district, Beijing. Information for The European Union representative: European Union Representative Name: Shanghai international (European) group company. European Union Representative Address: No. 80, Hamburg Love Buddha Road, Germany.

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MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

Content 1.

2.

BRIEF INDUCTION ... 1 1.1

INTENDED USER ... 1

1.2

FUNCTION AND INTENDED USE ... 1

1.3

COMPOSITION OF PACKAGE ... 1

1.4

SIZE AND NET WEIGHT ... 1

1.5

TRANSPORTATION AND STORAGE CONDITIONS ... 2

1.6

OPERATING CONDITIONS ... 2

1.7

VOLTAGE SUPPLY ... 2

SAFETY PRECAUTIONS ... 3 2.1

2.1.1

Terms and Symbols ... 3

2.1.2

Instrument Safety ... 4

2.2

3.

4.

SAFETY INFORMATION ... 3

CAUTIONS AND WARNINGS ... 4

2.2.1

Environment ... 4

2.2.2

Preparation ... 5

2.2.3

Power ... 5

2.2.4

Protection ... 5

2.2.5

Preventative Inspection and Maintenance ... 6

2.2.6

Other Notices ... 6

2.3

TRANSPORTATION AND STORAGE ... 7

2.4

INTERFERENCE INSTRUCTIONS ... 7

2.5

CLASSIFICATION ... 7

2.6

SAFE OPERATION AND PROCESSING CONDITIONS... 8

2.7

DEVICE SYMBOLS ... 8

2.8

STANDARDS AND REGULATIONS COMPLIANCE ... 10

CONTROL AND FUNCTION ... 11 3.1

FUNCTION ... 11

3.2

MAIN STRUCTURE ... 11

3.3

SPECIFICATIONS ... 12

PREPARATIONS BEFORE USE ... 14 4.1

BASIC KNOWLEDGE ... 14

4.1.1

Jaundice ... 14

4.1.2

When the Newborn Infant Is Undergoing Phototherapy... 14

4.1.3

Measurement Points ... 15

4.2

ATTENTION DURING OPERATION ... 15

4.3

OPERATION LOCATION ... 16

4.4

BATTERY CHECK ... 16

5.

OPERATIING INSTRUCTIONS ... 18

6.

USER RECOMMENDATIONS FOR USE DURING AND AFTER PHOTOTHERAPY ... 21

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0 6.1

6.1.1

Eye Patches ... 21

6.1.2

Adhesive Skin Patches... 21

6.2 7.

8.

AFTER PHOTOTHERAPY ... 22

SPECIAL OPERATION ... 24 7.1

DATA DELETION ... 24

7.2

UNIT CONVERSION ... 24

7.3

RECORD PLAYBACK ... 24

7.4

CALIBRATION ... 25

7.4.1

Settings of Calibration Coefficient ... 25

7.4.2

Calibration Method ... 26

MAINTENANCE ... 27 8.1

BIOCOMPATIBILITY ... 27

8.2

DAILY INSPECTION ... 27

8.3

STORAGE METHOD ... 27

8.4

MAINTENANCE PLAN ... 28

8.4.1

Inspecting Device ... 28

8.4.2

Regular Cleaning ... 28

8.4.3

Other Maintenance and Service ... 29

8.5

9.

DURING PHOTOTHERAPY ... 21

TECHNICAL SERVICE ... 30

8.5.1

Technical Maintenance ... 30

8.5.2

Technical Inspection ... 30

8.6

THE REPLACEMENT OF ACCESSORIES AND CONSUMABLE MATERIALS ... 30

8.7

DIAGNOSIS OF DEVICE MALFUNCTION ... 31

GUIDANCE AND MANUFACTURER’S DECLARATIONS ... 32

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

1. BRIEF INTRODUCTION 1.1

Intended User This manual is suitable for professional doctors and clinical personnel in

obstetrical, gynecological, neonatal and pediatric departments. The clinical personnel must have application knowledge of relevant medical procedures, practical experience and professional qualifications in neonatal care.

1.2

Function and Intended Use MBJ20 is used in the dynamic clinical examination of neonate jaundice, by

determining the concentration of bilirubin transcutaneously. It is used for the initial screening and monitoring of bilirubin values in jaundice treatment.

1.3

Composition of Package

Table 1- 1

No.

Name

Unit

Main Equipment

piece

1

Instruction Manual

piece

1

206025

Calibrator

piece

1

205040

Certificate quality

piece

1

205041

Warranty Card

piece

1

205140

Battery

piece s

2

1.4

of

Quantity Note MBJ20 Device

*optional

AA1.5V

Size and Net Weight 1.MBJ20 size: 176mm×54mm×35mm ( Length×Width×Height)

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2.MBJ20 Net Weight: 215g (including two alkaline batteries)

1.5

Transportation and Storage Conditions 1. Environment temperature of -20 deg C ~ ＋55 deg C; 2. Relative humidity of

≤93%;

3. Atmospheric pressure of 500hPa～1060hPa.

1.6

Operating Conditions 1．Environment temperature of ＋10 Deg C～＋40 Deg C; 2．Relative humidity of ≤80%; 3．Atmospheric pressure of 860hPa～1060hPa.

1.7

Voltage Supply The device requires DC 3.0V, AA1.5×2 alkaline batteries.

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2.

SAFETY PRECAUTIONS

2.1

Safety Information

2.1.1 Terms and Symbols 2.1.1.1

Terms

This manual is using the term of "risk", "warning" and "note", etc. from beginning to end, which aims to indicate the danger and specified severity degree or level. Please be familiar with its definition and importance. CAUTION: Denotes potential danger or unsafe treatment which may result in slight injury or damage to the device or other property. The note provides application hints or other useful information. Read the note carefully to ensure safe and correct use. WARNING: Denotes potential danger or unsafe treatment which may lead to death or serious physical injury. DANGER : Definition of danger is based on potential injury source to people. Danger denotes urgent risk which may lead to death or serious physical injury. 2.1.1.2

Explanation of Safety Symbols Denotes a note or warning content; Denotes a prohibited operation. The operation must never be

performed; Perform the operation accurately. The instruction must be strictly adhered to.

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MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

2.1.2 Instrument Safety This section presents the safety instructions according to the general specifications of the equipment, and in most cases, the statement applies to all aspects of the jaundice detector. The design of MBJ20 meets with the international safety requirements EN60601-1. WARNING:

Denotes that failure to adhere to the following points

may result in death or serious injury, and may also cause equipment damage or fire danger. CAUTION:

Please follow the instruction manual to ensure correct and safe operation. If you have any questions or find any errors, please contact M&B authorized service facility.

2.2

Cautions and Warnings As the manufacturer of medical devices, the company strives to ensure

the security, reliability and performance of the instrument. For correct use of this instrument, read the following points carefully and adhere to them. After reading this manual, keep it in a safe place where it can be referred to anytime a question arises.

Environment WARNING:

Jaundice Meter should not be used in situations that

include

environmental

vibration,

dust,

corrosive

or

flammable, explosive gas (anesthetic gas, gasoline), extreme temperatures and humidity, and there is enough space for easy operation. CAUTION:

Ambient temperature exceeding the range of technical specification will affect the jaundice meter accuracy,

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resulting in machine damage or reduced machine life.

2.2.1 Preparation Before starting measurements using this instrument, follow the procedure given below. CAUTION:

Operator must verify whether work procedures and

conditions are appropriate for the use of this instrument.

2.2.2 Power CAUTION:

If the device is not in use, the battery will discharge. Remove the batteries to store. Before use, check the battery adequacy.

2.2.3 Protection WARNING:

Prohibit operating MBJ20 during magnetic resonance

imaging (MRI) scan. (MBJ20 running may affect the MRI images and MRI may affect accuracy of MBJ20.) CAUTION:

Magnetic and electrical fields can interfere with the

normal operation of the instrument. Therefore, make sure that all external devices working in the vicinity of the jaundice meter comply with the relevant EMC requirements. X-ray equipment or MRI devices can emit a high level of electromagnetic rays, and they may be a source of interference. In addition, please ensure cell phones or other telecommunications equipment are kept away from the instrument.

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2.2.4 Preventative Inspection and Maintenance Warning： In order to avoid possible problems and to ensure normal operation, preventative maintenance is essential. Generally, preventative maintenance should be conducted at least annually. The maintenance should include an overall check of the device. If the following occurs, users must stop using the device until rectified by a qualified service person: ☉if the detector suffers excessive impact force, such as dropping. ☉if any solid or liquid touches the external case or permeates into the device. ☉if the instrument does not operate normally. ☉if external casing is ruptured or damaged. WARNING:

Inspection: ☉perform a routine inspection before use and at least every three months, including instrument case, probe and batteries. ☉perform a preventative maintenance inspection by an authorized service person every 12 months to ensure safety.

2.2.5 Other Notices CAUTION:

In order to avoid electric shock or detector failure, do not allow any liquid to permeate into the meter. If liquid has permeated into it, please contact your local service partner or distributor of M&B to inspect the detector.

CAUTION:

Do not use the detector near flammable anesthetic 6/33

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gases, steam or liquid. CAUTION:

Note that the device must be disposed of as described in the manual. If you have any questions about proper disposal of the device, please contact Beijing M&B Electronic Instruments Co. Ltd or your local representative.

CAUTION: For safe operation of the device, the user must follow this instruction manual. However, these instructions do not supersede established medical procedures concerning patient care. CAUTION:

Only people who have been trained properly should use this device.

2.3

Transportation and Storage

CAUTION:

Put the MBJ20 into the included storage case during transportation.

2.4

Interference Instruction

CAUTION:

The MBJ20 has functions that do not affect normal operation of other devices, and are these functions are not affected by other devices (except MRI equipment).

2.5

Classification

Table 2- 1

Type of protection against electric shock Degree of protection against electric shock Degree of protection against liquid penetration

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Internal power device Type B applied part IPO, ordinary equipment

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

CAUTION:

The classification of the electrical shock, fire disaster, machinery and other special risks are according to EN60601-1.

2.6

Safe Operation and Processing Conditions

Table 2- 2

The sterilization or disinfection method recommend by manufacturer Electromagnetic interference

Electric surgical interference damage

2.7

Not applicable

Avoid the using of wireless telephones or other strong interference equipment near the detector No damage

Device Symbols

CAUTION:

Some symbols may not appear on all devices.

Power: ON= turn on; OFF= turn off

Figure 2- 1 Nameplate of MBJ20 Jaundice Detector

Explanation of the product external logos and marks are as follows:

Serial number

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Date of manufacture

Manufacture information

Trademark

European delegate information: company and address

Caution

B type applied part

Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.

CE mark

External package symbols:

The maximum range of temperature in transport should be between -20C and 55C.

Rain prevention

The maximum number of layers stacked is 4.

The correct direction for stacking in transport is straight up 9/33

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Fragile, be careful when carrying.

2.8

Standards and Regulations Compliance MDD-Medical Device Directive (MDD) 93/42/EEC; EN 60601-1-2006: Medical Electrical Equipment-General Requirements for Safety; EN 60601-1-2-2001: Medical Electrical Equipment-Safety Requirements-EMC; EN 980-2008: Symbols for use in the labeling of medical devices; EN 1041-2008: Information supplied by the manufacturer of medical device.

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3.

CONTROL AND FUNCTION

3.1

Function MBJ20 Transcutaneous Jaundice Detector is a handheld device used in

the dynamic clinical examination of neonate jaundice. The transcutaneous bilirubin concentration which is correlative with serum bilirubin concentration can be measured instantly and non-invasively when the detector is placed on the neonatal skin. MBJ20 includes electronics, optics and information processing technology. It features accurate, safe and fast detection, light weight, long life, low energy consumption, and is easy to use and maintain.

3.2

Main Structure

Figure 3- 1 Explanation of front view and indicators Table 3- 1

No. 1

2

Name

Function Description Deletes the measured value displayed currently and prepares for the next measurement. Use this switch in Reset Button combination with the POWER switch and SET button to delete or playback previous measurements. Use this switch in combination with the Power switch Set Button and Reset button to delete or playback previous measurements. 11/33

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

Slide this switch to turn the power on/off. Use this switch in combination with the Set button and Reset button to delete or playback previous measurements. Display Display the measured value. Lights up to indicate that the instrument is ready for READY lamp measurement. Measuring Takes measurement when pressed against the Probe measuring point on the patient’s body. POWER Switch

3 4 5 6

Figure 3- 2 LCD screen

Table 3- 2 Explanation of LCD content

No.

Name

1

Test

2

Value display unit of measurement value

3

Function Description Means that the operator has pressed the RESET button Displays the measurement value µmol/L, mg/dL

4

Battery display

Battery displays empty when the battery power is low

5

Serial number of measurement

Indicating the sequence number of measurement

3.3

Specifications 1) Display: LCD, 3 figures 2) Power: AA 1.5V×2 alkaline battery 3) Indicator for ready: Green 12/33

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

4) Measurement range: 0.0mg/d L ~ 32.0 mg/d L 5) Measurement accuracy: Range is ±1.5 mg/d L (±25.5 µmol/L) 6) Charging preparation time: < 12 seconds 7) Record function: record 21 previous measurement values and review recorded data 8) Repeatability: < 10%

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4.

PREPARATIONS BEFORE USE

4.1

Basic Knowledge In order to prevent neonatal nuclear jaundice, it is very important to

diagnose pathological jaundice as early as possible. The concentration of transcutaneous bilirubin can be tested instantly and non-invasively by placing the probe on the neonatal forehead or sternum and pressing gently. It is suitable for neonatal jaundice screening. Though transcutaneous bilirubin is a very close correlation with the serum bilirubin concentration, there will be some difference between the measurement value and serum bilirubin concentration in the conditions noted below.

4.1.1 Precocious Jaundice If there is a possibility that the newborn infant is suffering from precocious jaundice (incompatible blood type, hemolytic jaundice), it is necessary to take frequent measurements or measure the total serum bilirubin concentration as well. (There is a possibility that bilirubin concentration in the subcutaneous tissue rises slower than the total serum bilirubin concentration)

4.1.2 When the Newborn Infant Is Undergoing Phototherapy During phototherapy, the bilirubin concentration in the subcutaneous tissue under the area exposed to light decreases before the total serum bilirubin concentration does, so it is necessary to limit the use of this instrument only when phototherapy equipment is used from the back of the patient, or by affixing a light-blocking patch to the measuring point on the forehead or chest. (In areas exposed to light, there are some cases in which only the bilirubin concentration in the subcutaneous tissue decreases before 14/33

MBJ20 Transcutaneous Jaundice Detector Instruction Manual V3.0

the total serum bilirubin concentration improves. In addition, if the total serum bilirubin concentration increases again after therapy, there is a possibility that the bilirubin concentration in the subcutaneous tissue will increase later.)

4.1.3 Measurement Points Measurements must be taken on the forehead or sternum, where a sufficient amount of blood is circulated. (There is a chance that the bilirubin concentration in the subcutaneous tissue is low for areas with small amounts of blood and areas in which the subcutaneous tissue is subject to keratinisation.)

4.2

Attention During Operation

1) This instrument must be used for newborn infants only. It is designed for estimating total serum bilirubin concentration that is necessary for the screening of jaundice in newborn infants. 2) When used in combination with phototherapy equipment, it may lead to misdiagnosis. 3) This instrument should be used under the following operating conditions: Temperature of 10°C to 40°C, relative humidity less than 85%, with no condensation. 4) This instrument is a precision instrument, so it should not be dropped, exposed to shocks and strong vibrations, nor should heavy objects be placed on it. Failure to observe these cautions may cause breakage. 5) Do not hang transfusion or infusion liquid near the device. 6) Do not use the instrument on a point where there is direct sunlight and excessive vibration. In addition, avoid excessive impact on the instrument. Failure to observe this may cause breakage. 7) This instrument emits intense light to take measurements. Measurements

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