Draeger JM-105 User guide

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Instructions for Use

JM-105

WARNING To properly use this medical device, read and comply with these instructions for use.

Jaundice Meter Software 1.20

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Instructions for Use JM-105

Typographical conventions

1 Consecutive numbers indicate steps of action,

with the numbering restarting with "1" for each new sequence of actions.

 Bullet points indicate individual actions or differ-

ent options for action.

– Dashes indicate the listing of data, options, or

objects.

(A) Letters in parentheses refer to elements in the

related illustration.

A Letters in illustrations denote elements referred

to in the text.

> The greater-than symbol indicates the naviga-

tion path in a dialog window.

Bold, italicized text indicates labels on the device and texts that are displayed on the screen.

Trademarks

Trademarks owned by third-party manufacturers

Illustrations

Illustrations of products and screen content in this document may differ from the actual products depending on configuration and design.

Use of terms

Dräger uses the term "accessories" not only for accessories in the sense of IEC 60601-1, but also for consumables, removable parts, and attached parts.

Trademark Trademark owner

Actichlor Ecolab USA

Oxycide Ecolab USA

Adobe Reader

Klorsept 17 Medentech

Peridox RTU Bio Med Protect

Windows Microsoft Corporation

Windows Vista

Pentium Intel Corporation

Dismozon pur

Instructions for Use JM-105 i

Adobe Corporation

BODE Chemie

Safety information definitions

WARNING A WARNING statement provides important

information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.

NOTE

A NOTE provides additional information intended to avoid inconvenience during operation.

ii Instructions for Use JM-105

Contents

Typographical conventions. . . . . . . . . . . . . . . . i

Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Safety information definitions . . . . . . . . . . . . . . ii

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

For your safety and that of your patients. . . 1

General safety information . . . . . . . . . . . . . . . . 2

Target groups . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Product-specific precautions . . . . . . . . . . . . . . 7

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Indications/contraindications . . . . . . . . . . . . . . 12

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Device views. . . . . . . . . . . . . . . . . . . . . . . . . . . 16

External devices . . . . . . . . . . . . . . . . . . . . . . . . 19

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Operating concept . . . . . . . . . . . . . . . . . . . . . 25

Screen layout for device. . . . . . . . . . . . . . . . . . 26

Screen layout for data transmission software. . 28

Trends and Data. . . . . . . . . . . . . . . . . . . . . . . 63

Viewing measurements stored in the data

log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Deleting individual measurements in the

data log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Deleting all measurements in the data log . . . 65

Transmitting data to electronic charts . . . . . . . 66

Viewing the transmission log from the JM-

S1w software. . . . . . . . . . . . . . . . . . . . . . . . . . 68

Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 69

Changing settings on the JM-105 . . . . . . . . . . 70

System and default settings for the JM-105 . . 70

Problem solving . . . . . . . . . . . . . . . . . . . . . . 75

Fault – Cause – Remedy. . . . . . . . . . . . . . . . . 76

Reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . 81

Safety information . . . . . . . . . . . . . . . . . . . . . . 82

Information on reprocessing . . . . . . . . . . . . . . 82

Classifications for reprocessing. . . . . . . . . . . . 83

Before reprocessing . . . . . . . . . . . . . . . . . . . . 84

Validated reprocessing procedures . . . . . . . . . 85

Other agents and reprocessing procedures . . 87

After reprocessing . . . . . . . . . . . . . . . . . . . . . . 88

Assembly and preparation . . . . . . . . . . . . . . 33

Charging the battery. . . . . . . . . . . . . . . . . . . . . 34

Unpacking the data transmission software . . . . 36

Getting started . . . . . . . . . . . . . . . . . . . . . . . . 37

Switch on and pre-set the device for the

first time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Pre-use checkout . . . . . . . . . . . . . . . . . . . . . . . 40

Data transmission software . . . . . . . . . . . . . . . 42

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Ensuring correct measurement . . . . . . . . . . . . 52

Choosing settings for measurement. . . . . . . . . 53

Measuring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Storing the device. . . . . . . . . . . . . . . . . . . . . . . 60

Switching off the device . . . . . . . . . . . . . . . . . . 61

Measuring quick guide . . . . . . . . . . . . . . . . . . . 62

Instructions for Use JM-105 iii

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Definition of service terminology . . . . . . . . . . . 90

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Performing service . . . . . . . . . . . . . . . . . . . . . 92

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Disposal of the product . . . . . . . . . . . . . . . . . . 94

Technical data . . . . . . . . . . . . . . . . . . . . . . . . 95

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 96

Ambient conditions . . . . . . . . . . . . . . . . . . . . . 98

EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 99

Principles of operation . . . . . . . . . . . . . . . . . 101

Contents

Measuring principle . . . . . . . . . . . . . . . . . . . . . 102

List of accessories . . . . . . . . . . . . . . . . . . . . . 105

Appendix A Clinical performance

summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Investigating The Agreement Between Transcutaneous Bilirubin Measurements Using the JM-105 and Total Serum Bilirubin Measurements By Site, Before, During and After Phototherapy in an ethnically diverse

population of infants ≥ 24 weeks gestation. . . . 108

Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

References . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Instructions for Use JM-105

For your safety and that of your patients

General safety information . . . . . . . . . . . . . . 2

Strictly follow these instructions for use . . . . . . 2

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Connected devices. . . . . . . . . . . . . . . . . . . . . . 3

Not for use in areas of explosion hazard . . . . . 3

Safe connection with other electrical

equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Connection to other devices. . . . . . . . . . . . . . . 3

Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 4

Electromagnetic compatibility (EMC) . . . . . . . . 4

Storing the instructions for use. . . . . . . . . . . . . 5

Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Tar get gro ups . . . . . . . . . . . . . . . . . . . . . . . . . 6

Duties of the operating organization. . . . . . . . . 6

Description of target groups . . . . . . . . . . . . . . . 6

For your safety and that of your patients

Product-specific precautions . . . . . . . . . . . . 7

Electrical precautions . . . . . . . . . . . . . . . . . . . . 7

General precautions . . . . . . . . . . . . . . . . . . . . . 8

Storage and transportation precautions . . . . . . 9

Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 9

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Instructions for Use JM-105 1

For your safety and that of your patients

General safety information

The following WARNING and CAUTION statements apply to general operation of the medical device.

WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical device.

Strictly follow these instructions for use

WARNING Risk of incorrect operation and of incorrect

use

Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under Intended use on page 12 and in conjunction with appropriate patient monitoring (see page 4).

Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance

WARNI NG Risk of medical device failure and of patient

injury

The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by specialized service personnel.

If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Service".

Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

Service

WARNI NG Risk if service is not performed regularly

If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage.

Perform the service in accordance with the chapter "Service".

Instructions for Use JM-105

For your safety and that of your patients

Connected devices

WARNING Risk of electric shock and of device malfunc-

tion

Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.

Not for use in areas of explosion hazard

WARNING Risk of fire

The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.

Safe connection with other electrical equipment

CAUTION

Risk of patient injury

Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer.

Connection to other devices

If a device combination is not approved by Dräger, proper operation of the devices can be compromised.

The operator must ensure that the device combination meets the applicable standards.

Strictly observe instructions for use and assembly instructions of all connected devices.

Patient safety

The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device.

Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

The instructions for use do not contain any information on the following points:

– Risks that are obvious to users

– Consequences of obvious improper use of the

medical device

– Potentially negative effects on patients with dif-

ferent underlying diseases

Medical device modification or misuse can be dangerous.

Instructions for Use JM-105 3

For your safety and that of your patients

Patient monitoring

WARNING Risk of patient injury

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

WARNING Risk of patient injury

The device is not intended as a stand-alone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device with other clinical signs and laboratory measurements.

The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition.

Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs.

The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration" (page 99).

This device can be affected by other electrical devices.

WARNI NG Risk due to electrostatic discharge

Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations: – When touching the pins of connectors that

carry the ESD warning symbol.

– When establishing connections with these

connectors.

To prevent malfunctions, observe the following measures and train the relevant personnel: – Observe the ESD protective measures.

Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while making the connection, or using electrically insulating and antistatic gloves.

– Observe the requirements for the electro-

magnetic environment. Observe the following section: "EMC declaration" (page 99).

WARNI NG Risk due to electromagnetic disturbance

Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this device may be compromised by electromagnetic disturbances. As a result, the patient could be put at risk.

Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled.

Maintain an adequate distance between this device and other medical electrical equipment.

Instructions for Use JM-105

Storing the instructions for use

CAUTION

Risk of incorrect use

Instructions for use must be kept accessible to the user.

Training

Training for users is available via the Dräger organization responsible (see www.draeger.com).

Service

WARNING Risk if service is not performed regularly

If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage.

Perform the service in accordance with the chapter "Service".

For your safety and that of your patients

Instructions for Use JM-105 5

For your safety and that of your patients

Target groups

Duties of the operating organization

The tasks described in this document specify the requirements that have to be met by each respective target group.

The operating organization of this product must ensure the following:

– The target group has the required qualifications

(e.g., has undergone specialist training or acquired specialist knowledge through experience).

– The target group has been trained to perform

the task.

– The target group has read and understood the

chapters required to perform the task.

Description of target groups

The target groups may only perform the following tasks if they meet the corresponding requirements.

User

Service personnel

Task Requirement

Installation Specialist knowledge in

Basic service work (inspection, maintenance according to the "Maintenance" chapter)

Dräger recommends arranging a service contract with DrägerService.

electrical engineering and mechanics

Experience in the servicing of medical devices

Task Requirement

Use of the product in accordance with the intended use

Reprocessing personnel

Task Requirement

Reprocessing Specialist knowledge in the

Specialist medical knowledge in neonatology

Specialist medical knowledge in the use of the product

reprocessing of medical devices

Instructions for Use JM-105

Product-specific precautions

For your safety and that of your patients

Electrical precautions

WARNING Risk of fire, electric shock, or equipment dam-

age

Using a docking station or AC adapter other than the one provided with the device could damage the device.

Use only the docking station JM-A33 and the AC adapter JM-A32 with the device.

WARNING Risk of fire, electric shock, or equipment dam-

age

Connecting to a power source without a protective earth ground could damage the device.

Connect the device only to a power source with a protective earth ground.

WARNING Risk of fire, electric shock, or equipment dam-

age

Pulling the power cable by the cable could damage the cable and cause fire or electric shock.

Hold the AC power cable by the plug-end when disconnecting from a power source or the AC adapter.

WARNING Risk of fire

Dust or water could collect at the plug of the power cable.

Disconnect the power cable when the device is not being used or charged for any length of time.

WARNING Risk of electric shock

Touching the AC power cable with wet hands could cause electric shock.

Do not connect or disconnect the AC power cable with wet hands.

WARNING Risk of electric shock or device malfunction

Penetrating metal objects may damage the device or docking station, causing malfuntion of the device, which may endanger the patient.

Do not allow metal objects to penetrate into the device or docking station.

WARNING Risk of fire

Operating the device and its accessories when they are damaged could cause a fire.

Do not operate the device or its accessories if any of them are damaged, or if there is smoke or an odd odor.

WARNING Risk of patient injury

Strong ambient light, electromagnetic interference, and mobile telephone use can interfere with accurate measurement of data.

Do not use the device in strong ambient light, or near electronic devices or mobile telephones.

Instructions for Use JM-105 7

For your safety and that of your patients

General precautions

WARNING Risk due to modifications

Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage.

Do not modify this product.

WARNING Risk of injury

Operating the device while the probe is directed at the eyes can cause eye damage.

Do not press the measuring probe when it is directed at the eyes.

WARNING Risk of patient injury

Pathologic or other skin conditions that may affect light scattering or absorption could result in incorrect TcB measurements.

Do not conduct measurements in patients with early jaundice and pathologic jaundice.

Do not conduct measurements when skin conditions may violate the assumption made concerning light scattering and light absorption.

Use device only on healthy skin of the patient. Do not conduct measurements on birthmarks and hairy areas. Avoid areas of thickness that in the opinion of the physician would preclude or interfere with the use of the TcB meter.

WARNI NG Risk of delayed therapy

Using the device without checking the accuracy of the measurements could cause incorrect measurements.

To check the measurement reliability of the system, compare the transcutaneous bilirubin value (TcB) determined by the device and the total serum bilirubin (TSB) determined on the basis of blood samples. Follow your hospital guideline to determine the frequency of checks (e.g. after repair or calibration of JM105 or TSB lab equipment, or following a change to clinical processes.

CAUTION

Risk of equipment damage

The device or docking station could overturn or fall.

Do not place the device on an unstable or sloped surface.

CAUTION

Risk of equipment damage

Do not drop the device or place heavy objects on top of the device.

CAUTION

Risk of equipment damage

The device is not waterproof or liquid proof.

Do not expose the device to rain, water, blood, or other liquids.

CAUTION

Risk of equipment damage

Excessive vibration or impact could damage the device.

Handle the device gently, and avoid excessive impact or vibration.

Instructions for Use JM-105

For your safety and that of your patients

NOTE

Ensure that the device is placed near the AC power source. Also ensure the AC power cable can be easily connected and disconnected.

Storage and transportation precautions

CAUTION

Risk of equipment damage

Do not store the device in areas where direct sunlight, pressure, temperature, humidity, ventilation, dust, strong magnetic fields, or saline or sulphurous atmospheres affect the device.

Do not store the device where it is exposed to water.

Do not store the device in areas where chemicals are stored or where gas is emitted.

CAUTION

Risk of equipment damage

The device or docking station could overturn or fall.

Do not store the device on an unstable or sloped surface, or a surface subject to vibration or physical shock.

Restrictions for use

CAUTION

Device for use in health care facilities only and exclusively by persons with specific training and experience in its use.

Accessories

WARNING Risk due to incompatible accessories

The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence.

Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product.

CAUTION

Risk of equipment damage

Avoid vibration and physical shock during transportation.

NOTE

Thoroughly clean the device and accessories before storing.

Instructions for Use JM-105 9

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10 Instructions for Use JM-105

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Indications/contraindications . . . . . . . . . . . . 12

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Contraindications/limitations. . . . . . . . . . . . . . . 12

Application

Instructions for Use JM-105 11

Application

Intended use

The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.

The device is intended for use in hospitals or doctors offices under a physician’s supervision, or at their direction. It helps clinicians to monitor newborn infants. The device is a screening device for the detection of neonatal hyperbilirubinemia in the early stages. The measurement data provided by the device should be used in conjunction with other clinical symptoms and laboratory measurements for diagnosis and therapy decisions.

Indications/contraindications

Indications

The Jaundice Meter is indicated for use in neonatal patients born 24 weeks gestation who have not undergone exchange transfusion. The device is indicated for use before, during, and after phototherapy treatment.

Newborn infants whose Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physicians for appropriate patient management. Specific neonatal patient bilirubin levels should be confirmed by other methods, such as serum bilirubin, before treatment determinations.

The Jaundice Meter is not intended for home use.

The JM-105 is a prescription medical device.

The JM-105 may only be used at the sternum measurement site for Physician's office applications.

Contraindications/limitations

The Jaundice Meter is not intended as a diagnostic device. It is a screening device for the detection of neonatal hyperbilirubinemia in the early stage that shall be used in conjunction with other clinical symptoms and laboratory measurements for diagnosis and therapy decisions.

Do not use this device on infants with pathologic jaundice. If there is a possibility that the infant is suffering from pathologic jaundice, as a result of an incompatible blood type or hemolytic jaundice, then total serum bilirubin should be measured.

Do not use this device on patients with hydrops fetalis major, congenital malformations, diseases or skin conditions or thickness that in the opinion of the physician would preclude or interfere with the use of the TcB meter (e.g. skin infections, purpura, etc.)

Instructions for Use JM-105

Limitations (During phototherapy)

Before beginning measurements, ensure that all phototherapy lights are shut off.

Limitations (Doctors Office Use)

Use only on infants up to 14 days of age.

Please be aware, performance in doctors offices may vary from performance in hospitals.

Measuring Point

Typically clinicians measure the TCB on either the sternum, or the forehead or both. Some studies reported the sternum to be more accurate than the forehead in term and near term infants [17, 18]. Some studies show the forehead had a stronger correlation with TSB that the sternum. In other studies looking at the agreement between TCB and TSB measurements, the site of TCB measurement has not been indicated [19, 20].

Therefore, measuring site (forehead or sternum) shall be at the clinician’s discretion in a hospital setting (avoid birthmarks and hairy areas). However, only sternum measurements are recommended at the doctor’s office, as there is a possibility that the difference may be more pronounced for infants that have been exposed to sunlight.

Application

Instructions for Use JM-105 13

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14 Instructions for Use JM-105

Overview

Device views . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Jaundice meter JM-105 - Front . . . . . . . . . . . . 16

Jaundice meter JM-105 - Rear. . . . . . . . . . . . . 16

Docking station JM-A33 - Front . . . . . . . . . . . . 17

Docking station JM-A33 - Rear. . . . . . . . . . . . . 17

AC adapter JM-A32 . . . . . . . . . . . . . . . . . . . . . 18

External devices . . . . . . . . . . . . . . . . . . . . . . . 19

Valid device combinations . . . . . . . . . . . . . . . . 19

Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Device software . . . . . . . . . . . . . . . . . . . . . . . . 19

Data transmission software . . . . . . . . . . . . . . . 19

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 20

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Symbols on device . . . . . . . . . . . . . . . . . . . . . . 21

Symbols on touch screen . . . . . . . . . . . . . . . . . 22

Symbols on the PC. . . . . . . . . . . . . . . . . . . . . . 23

Overview

Instructions for Use JM-105 15

Overview

002

003

Device views

Jaundice meter JM-105 - Front Jaundice meter JM-105 - Rear

Power button

Measuring probe

Display/Touch panel

READY lamp

Screen LOCK button

Charging contact

Communication port

Battery cover

Barcode reader

Instructions for Use JM-105

Docking station JM-A33 - Front Docking station JM-A33 - Rear

004

005

USB connector

DC jack

Overview

Checker cover

Standard checker values

Reading checker

Communication window

Charger jack

Instructions for Use JM-105 17

Overview

006

AC adapter JM-A32

AC power cable plug

AC power cable

AC adapter

DC plug

Instructions for Use JM-105

External devices

Overview

Valid device combinations

The JM-105 can only be combined with the JM-A33 docking station and the JM-A32 AC adapter to measure bilirubin. It can also be connected to a computer to transmit data from the device to an electronic health records system.

Software

Device software

The JM-105 is a non-invasive transcutaneous bilirubinometer. It uses the digital data generated by converting the amount of light reflected from human tissue. The device displays the results on the LCD display. The software is installed in the device ROM. The device becomes operable when the batteries supply power and then the release signal is released.

Interfaces

The USB port provides a connection for transmitting data to electronic health records systems. It also provides an alternate method to charge the device.

Data transmission software

The data transmission software, SW JM-S1w, enables the JM-105 to transmit measurement data to a PC and send it to an electronic health record system (EHR). It also enables saving the data to a CSV file.

Instructions for Use JM-105 19

Overview

Abbreviations

Abbreviation Meaning

AC Alternating current

AP Applied part

CD Compact Disc

CSA Canadian Standards Association

DC Direct current

DVD Digital Video Disc

EHR Electronic Health Record

EMC Electromagnetic compatibility

ESD Electrostatic discharge

GMDN Global Medical Device Nomencla-

ture

IEC International Electrotechnical Com-

mission

LCD Liquid crystal display

PC Personal computer

RH Relative humidity

ROM Read only memory

UMDNS Universal Medical Device Nomen-

clature System

USB Universal Serial Bus

Instructions for Use JM-105

Symbols

Overview

The following symbols appear on labels on the JM105 jaundice meter, on the screen, and in these instructions for use. These standards apply as noted in the table.

Symbols on device

Warning

Caution

Degree of protection against electric shock: Type BF

Refer to instructions for use

USB port

Standby or On/Off

Input

Circuit output terminal

AC power

DC Power

Do not discard with regular waste

Date of manufacture

Instructions for Use JM-105 21

Overview

…

DEL



BACK

EDIT

CLEAR

NEXT BABY

Symbols on touch screen

Rechargeable battery

Priority flag - to show baby has high bilirubin level and may need further evaluation.

Lock

Phototherapy flag - to show baby has been treated with phototherapy

Key

Go BACK to previous screen

EDIT the selected item

CLEAR the entry

Proceed to the NEXT BABY

Nurse ID

Baby ID

DEL

Scan

Sent to chart

Delete

L Value (long)

S Value (short)

Delta Value (difference between long value and short value)

Instructions for Use JM-105

CANCEL the entry or stop the task

CANCEL

Confirm the entry

Busy

Symbols on the PC

JM-S1w

Overview

JM-S1w error

Instructions for Use JM-105 23

This page intentionally left blank.

24 Instructions for Use JM-105

Operating concept

Screen layout for device . . . . . . . . . . . . . . . . 26

Main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

MENU screen . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Measured data screen . . . . . . . . . . . . . . . . . . . 27

Averaging screen . . . . . . . . . . . . . . . . . . . . . . . 27

Screen layout for data transmission

software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

JM-S1w menu. . . . . . . . . . . . . . . . . . . . . . . . . . 28

Common screen . . . . . . . . . . . . . . . . . . . . . . . . 28

Network screen. . . . . . . . . . . . . . . . . . . . . . . . . 29

HL-7 screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Edit custom message screen . . . . . . . . . . . . . . 30

Transmission log screen. . . . . . . . . . . . . . . . . . 31

Barcode reader screen . . . . . . . . . . . . . . . . . . . 32

Operating concept

Instructions for Use JM-105 25

Operating concept

007

2012/08/0110:00

MEASURE

CHECKER

HISTORY

CLR ALL

008

MEASURE

CHECKER

HISTORY

CLR ALL

Screen layout for device

Main screen

The main screen contains these fields.

A Date

B Time

C Available selections

– MEASURE

– CHECKER

–HISTORY

–CLR ALL

D OK

E Arrows F MENU

MENU screen

2012/08/0110:00

BACK OK

The MENU screen contains these buttons.

A Date

B Time

C Available selections

– MEASURE

– CHECKER

–HISTORY

–CLR ALL

–CONFIG

D OK

E Arrows

Instructions for Use JM-105

Operating concept

046

A B

C D

E F

043

CLEAR

2012/08/0110:00

NEXT BABY

NURSE001

BABY0001

004/100

AVE.3

12. 4

12. 3

12.3

mg/dL

K J

H G

Measured data screen

2012/08/0110:00

＊＊＊＊

0001

BABY0002

01/12 11:23AM 01/12 11:23AM

01/12 11:23AM

The Measured data screen contains these fields.

A NURSE ID (nurse ID) B BABY ID (baby ID)

C Date of measurement

D Time of measurement

E/ F Dots - Indicates no flags

are set. Push button to begin setting Priority or Phototherapy flags.

E Priority flag - Push button to show baby

has high bilirubin level and may need further evaluation.

F Phototherapy flag - Push button to set

flag to show baby has been treated with phototherapy.

G Sent to electronic chart

…

002/004



DEL

2. 2

2. 4

2. 3

mg/dL

Instructions for Use JM-105 27

Averaging screen

The Averaging screen contains these fields.

A Display lock

B Battery indicator

C Measurement result

D Touch to proceed to next baby

E Number of measurements for averag-

ing

F Data log capacity

G Number of measurements stored in

data log

H/ I Dots - Indicates no flags

are set. Push button to begin setting Priority or Phototherapy flags.

H Priority flag - Push button to show baby

has high bilirubin level and may need further evaluation.

I Phototherapy flag - Push button to set

flag to show baby has been treated with phototherapy.

J BABY ID (baby ID) (9 trailing charac-

ters if ID is 10 or more characters long.)

K NURSE ID (nurse ID) (9 trailing charac-

ters if ID is 10 or more characters long.)

Operating concept

067

Preferences

Exit

069

A B C

Screen layout for data transmission software

JM-S1w menu

The JM-S1w menu screen contains these selections.

A Preferences - Opens the JM-S1w dia-

log where preferences are set.

B EXIT

Common screen

C Save data on PC - Enables/disables

saving data to CSV (comma-separated value) text files on the computer.

D CSV Folder - Shows the selected folder

in which to save the CSV file.

E Open - Opens a window for selecting

the CSV folder.

F COM port (Docking Station) - Shows

a list of available COM ports.

G Allow changes. - Check if you want to

change preferences on any of the preferences screens.

H OK - Saves the selections and closes

the dialog.

I CANCEL - Cancels the transaction.

The Common screen contains these fields.

A Send HL7 Message - Enables/disables

communication with an electronic health records system.

B Retry Interval - Sets the time to wait

before resending data after an error occurs.

Available selections:

No retry

1 Min. 10 Min. 30 Min.

Instructions for Use JM-105

Operating concept

070

071

C D

Network screen

The Network screen contains these fields.

A Server address - Enter the IPv4

address or alphanumeric host name of the electronic health records server.

Restrictions:

Proxy cannot be used. A PC on the LAN should be set as the destination.

B Server port - Enter the communication

destination port on the server. The default is the HL-7 default port (2575).

C Allow changes. - Check if you want to

change preferences on any of the preferences screens.

D OK - Saves the selections and closes

the dialog.

E CANCEL - Cancels the transaction.

Instructions for Use JM-105 29

HL-7 screen

The HL-7 screen contains these fields.

A HL7 version - Select Ver. 2.3.1 or Ver.

2.5.1.

B Message structure - JM-105 can take

up to 3 measurements per baby ID. Select how JM-S1w handles such grouped measurements.

C Send 1 message per measurement -

JM-S1w creates 1 message for each measurement taken. If 3 measurements were taken for a baby ID, then 3 messages are created.

D Send 1 message per baby (up to 3

measurements) - JM-S1w creates 1

message for each baby ID. If 3 measurements were taken for a baby ID, then 1 message is created containing all 3 measurements. A maximum of 3 measurements per baby is allowed.

E Send 1 message with highest mea-

surement per baby - JM-S1w creates

1 message containing only the highest measurement taken for each baby ID (maximum of 3 measurements per baby ID). If the highest value occurs for more than 1 measurement, the message contains the first highest measurement recorded.

F Swap ORC - OBR field - When

checked, switches the sending order of the ORC and OBR fields.

Operating concept

072

G Swap AR - AE - When checked,

switches AR and AE in sent and received messages.

H Add ’0B’ before message - When

checked, adds OB to the beginning of sent messages.

I Use custom message - Enables the

use of a custom message. When checked, the "Edit custom message" button is enabled.

When this button is checked, the settings for "HL7 version" and " Swap ORC - OBR field" is ignored.

J Edit custom message - When

enabled, clicking this button opens the "Edit custom message" dialog.

K Transmission log - Opens the trans-

mission log dialog. NOTE: This field only applicable for JMS1w version 1.40 or higher.

L Sending facility - User can edit this

field as needed. NOTE: This field only applicable for JMS1w version 1.40 or higher.

M Allow changes. - Check the radio but-

ton if you want to change preferences on any of the preferences screens.

N OK - Saves the selections and closes

the dialog.

O CANCEL - Cancels the transaction.

Edit custom message screen

The Edit custom message dialog appears when the Edit custom message button on the HL7 screen is clicked. The Edit custom message screen contains these fields.

A Pick list - lists fields available for cus-

tomizing.

B Insert - Inserts the selected field at the

end of the current message or wherever the cursor is placed.

C OK - Saves the custom message for-

mat and closes the dialog.

D CANCEL - Cancels the transaction.

Instructions for Use JM-105

Transmission log screen

JM-S1w

Failed transmission data

Successfull transmission data

Allow changes. Delete All

Transmission log

Transmission Date/Time Date/Time 1

Value 1

Value 2

2017/02/28/12:34:56

:::::: :::

:::

2017/02/28/12:34:56

2017/02/28/12:00:00

Date/Time 2

2017/02/28/12:00:10

2017/03/01/12:00:15

JOHN DOE

NURSE ID

JOHN DOE

NURSE_01

BABY ID Instrument ID

NURSE_01

3501001

3051000

12.1

12.3

12.2

12.4

Value 3 Error

Date/Time 2

2017/02/28/12:00:20

2017/03/01/12:01:00

12.1

12.2

Transmission Date/Time

Value 1

Value 2

2017/02/28/12:34:56

:::: :::

2017/02/28/12:34:56

2017/02/28/12:00:00

Date/Time 2

2017/02/28/12:00:10

2017/03/01/12:00:15

JOHN DOE

NURSE ID

JOHN DOE

NURSE_01

BABY ID Instrument ID

NURSE_01

3501001

3051000

12.1

12.3

12.2

12.4

Value 3

Date/Time 2

2017/02/28/12:00:20

2017/03/01/12:01:00

12.1

12.2

Retry Delete

Operating concept

076a

The Transmission log dialog appears when the Transmission log button on the HL7 screen is clicked. The Transmission log screen contains these fields.

L Error - Shows the type of error. When

you click on the error, a pop-up message appears with details of the error.

M Retry - Attempts the transmission

again.

A Failed transmission data - Lists all

transmissions that failed or had errors.

B Transmission Date/Time - Shows the

date and time of the transmission.

C Nurse ID - (Editable) D Baby ID - (Editable) E Instrument ID (instrument ID) - F Date/Time1 - Shows the date and time

of the first averaged measurement.

G Value1 - Shows the value of the first

averaged measurement.

H Date/Time2 - Shows the date and time

of the second averaged measurement.

I Value2 - Shows the value of the second

averaged measurement.

J Date/Time3 - Shows the date and time

of the third averaged measurement.

K Value3 - Shows the value of the third

Instructions for Use JM-105 31

averaged measurement.

NOTE: This field may be hidden if contents of other fields are long.

N Delete - Deletes the failed transmis-

sion.

NOTE: This field may be hidden if contents of other fields are long.

O Successful transmission data - Lists

all successful transmissions.

P Allow changes. - Check if you want to

edit fields or delete/retry transmissions.

Q Delete All - Deletes all transmissions. R Close - Closes the dialog.

Operating concept

Barcode reader screen

The Barcode reader screen contains these fields.

NOTE

The Barcode reader screen is only applicable to JM-S1w version 1.30 or higher and requires device firmware 1.10 or higher.

A Code 39 check digit Disable - dis-

ables the check digit.

B Code 39 check digit Enable - enables

the check digit.

C Code 39 full ASCII conversion Dis-

able - disables the ASCII conversion.

D Code 39 full ASCII conversion

Enable - enables the ASCII conversion.

E Write - applies the selection of enable

or disable.

F Read current setting - shows current

barcode settings.

G Allow changes. - Check if you want to

change preferences on any of the preferences screens.

H OK - Closes the dialog. I CANCEL - Closes the dialog.

074

Instructions for Use JM-105

Assembly and preparation

Charging the battery . . . . . . . . . . . . . . . . . . . 34

Alternate charging method using AC

adapter (optional) . . . . . . . . . . . . . . . . . . . . . . . 35

Unpacking the data transmission

software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Assembly and preparation

Instructions for Use JM-105 33

Assembly and preparation

012

011

Charging the battery

Before using the instrument, charge and inspect the instrument.

When using the instrument for the first time, ensure that it is fully charged. To always maintain a full charge, place the instrument on the charger unit when it is not being used for measurements. When the battery charge is low, the Battery display blinks.

NOTE

The power of the battery diminishes when the device is left uncharged for a long time. Ensure that the battery is charged before use.

1 Before charging the JM-105 using a USB con-

nector, ensure the USB port meets these minimum specifications:

– USB connection must be USB 2.0 or later

– USB connection must supply 5V, 500mA or

more of power to the JM-105

– USB connection must have passed electri-

cal safety certifications for CE and UL

2 Plug the USB cable into the USB connector of

the docking station.

3 Plug the USB cable into a USB port on a com-

puter.

4 Place the device into the docking station.

Ensure that the display faces forward.

E ADY

NOTE

When the device is placed in the docking station, the power switches on and the READY lamp turns orange. When charging is completed, the READY lamp switches off.

The device charges in 2 hours. Two hundred fifty measurements can be performed with a fully charged new battery.

NOTE

Do not connect the JM-105 to bus-powered or selfpowered USB hubs that are connected to a PC USB port. They do not provide sufficient power to charge the JM-105. The JM-105 may not charge fully or may not charge at all.

Instructions for Use JM-105

Alternate charging method using AC

009

010

060

011

EADY

adapter (optional)

The AC adapter can be used to charge the device instead of the USB cable.

1 Plug the power cable into the AC adapter.

WARNING Risk of fire, electric shock, or equipment dam-

age.

Using a docking station or AC adapter other than the one provided with the device could damage the device.

Use only the docking station JM-A33 and the AC adapter JM-A32 with the device.

2 Plug the AC adapter into the DC jack of the

docking station.

Assembly and preparation

WARNING Risk due to incorrect mains voltage or missing

protective ground

If the device is connected to a power socket with incorrect mains voltage or a power socket without a protective ground, an electric shock may occur.

Connect the device only to power sockets with correct mains voltage and a protective ground.

3 Plug the power cable into an appropriate AC

source.

4 Place the device into the docking station.

Ensure that the display faces forward.

NOTE

When the device is placed in the docking station, the power switches on and the READY lamp turns orange. When charging is completed, the READY lamp switches off.

Instructions for Use JM-105 35

Assembly and preparation

NOTE

When the docking station is plugged into both the AC adapter and the USB port, the device takes power from the AC adapter.

Unpacking the data transmission software

WARNING Risk of fire, electric shock, or equipment dam-

age.

Connecting to a power source without a protective earth ground could damage the device.

Connect the device only to a power source with a protective earth ground.

The JM-105 device is accompanied by data transmission software. Software SW JM-S1w enables the PC to receive measurement data from a JM105 and send it to an electronic health record system (EHR). It also enables saving the data to a file.

Please note that this manual assumes that the user is familiar with basic Windows operations.

Package contents

 Installation CD-ROM of data transmission soft-

ware for jaundice meter, SW JM-S1w

 USB Cable

Instructions for Use JM-105

Getting started

Switch on and pre-set the device for the

first time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Configuring Code 39 barcode format . . . . . . . . 39

Checking Out of range message format. . . . . . 39

Pre-use checkout . . . . . . . . . . . . . . . . . . . . . . 40

Data transmission software. . . . . . . . . . . . . . 42

Notes on Use . . . . . . . . . . . . . . . . . . . . . . . . . . 42

System requirements . . . . . . . . . . . . . . . . . . . . 43

Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Installation of Microsoft Visual C++ 2015

Redistributable Package. . . . . . . . . . . . . . . . . . 44

Installation of Microsoft .NET Framework

4.6.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Installation of JM-S1w . . . . . . . . . . . . . . . . . . . 46

Getting started

Instructions for Use JM-105 37

Getting started

013

A DY

014

ENGLISH

日本語

中文

言語

2012/08/0110:00

015

016

Switch on and pre-set the device for the first time

When switching on the device for the first time, you can select display language and date format, and set the date and time.

1 Press the POWER button and hold for 1 s. The

language screen appears.

2 Select display language by touching the desired

language or by using the UP/DOWN arrows. Selected language is highlighted.

5 Select date format.

2012/08/0110:00

M/D/Y D/M/Y

Y/M/D

言語

BACK

6 Touch OK to save selection.

7 Set date/time screen appears.

8 Set date and time by touching the item you want

to change.

9 Touch EDIT button (A).

3 Touch OK to save selection.

4 Date format screen appears.

EDIT

10 To change value, touch UP/DOWN arrows.

Instructions for Use JM-105

Getting started

11 Touch OK to save selection.

12 Touch OK again when you complete changes.

OPENING and the software version appear on the display.

Configuring Code 39 barcode format

1 If using Code 39 barcode format, set prefer-

ences in the data transmission software (refer to Setting preferences - Barcode on page 50.)

NOTE

Requires device firmware version 1.10 or higher.

Checking Out of range message format

1 To check the current format, Touch MENU but-

ton, if needed.

2 Touch the CONFIG button or press UP/DOWN

arrows.

3 Touch the UNITS button. The device shows the

current setting as either HI:>20 or HI:>340.

Instructions for Use JM-105 39

Getting started

018

BACK OK

2012/08/0110:00

MEASURE

CHECKER

HISTORY

CLR ALL

019

020

Pre-use checkout

WARNING Risk of delayed therapy

Using the device without checking the accuracy of the measurements could cause incorrect measurements.

NOTE

Do not touch the checker surface. If the checker surface is dirty, wipe with a soft cloth dampened with alcohol. To dry it, wipe with a soft cloth.

1 Switch on device.

2 Select CHECKER.

4 Open checker cover.

5 Place the measuring probe perpendicular to the

checker and push gently until a flash occurs.

NOTE

Do not take measurements with the device slanted on the checker.

3 Touch OK to save selection.

6 Review check results.

– L value (measured value of long optical

path)

– S value (measured value of short optical

path)

– Delta value (difference between L

and S values)

NOTE

If values are repeatedly out of range, contact DrägerService.

Instructions for Use JM-105

Getting started

017

021

– All values should fall within the ranges

shown on the checker cover.

– If any value is out of range, clean the

checker and probe. Repeat the measurement.

2012/08/0110:00

L 2.4

S 2.2

0.2

㸊

NOTE

Product labels shall be inspected for legibility before use.

7 Close checker cover.

NOTE

If a device check has not been performed during the current day, the MEASURE READING CHECKER message appears for 3 s. when you switch on the device.

To clear the message, check the device.

NOTE

If 12 months or more have passed since the last device calibration, the TIME FOR PERIODIC CALIB. message appears for 3 s. when you switch on the device.

To clear the message, calibrate the device.

Instructions for Use JM-105 41

Getting started

066

Data transmission by software JM-S1w

JM-105

Docking station

CSV text file

Electronic health records system (HL7 protocol)

Data transmission software

After the user sets the JM-105 MEMORY to LINK ON and the device is set into the docking station, it

sends data to the docking station. Through the USB port, the docking station then sends data to the data transmission software SW JM-S1w. The software sends data to an electronic health records system using the HL-7 Application Protocol for Electronic Data Exchange in Healthcare Environments using TCP/IP. Or it sends a CSV file to a folder on the PC as identified during set-up.

Block diagram of the system

Notes on Use

 No operating system is included with this soft-

ware.

 Operating system must be installed on the PC

before this software can be installed.

 When inserting the CD-ROM into the CD-ROM

drive, note the correct orientation of the disc and insert it gently.

 Keep the CD-ROM clean and free from

scratches. If the recorded surface becomes dirty or the label surface is scratched, a read error may result.

 Avoid exposing the CD-ROM to rapid tempera-

ture changes and condensation.

 Avoid leaving the CD-ROM in locations where it

is exposed to high temperatures from direct sunlight or heaters.

 Do not drop the CD-ROM or subject it to strong

impact.

 Keep the CD-ROM away from water, alcohol,

paint thinners, and other such substances.

 Remove the CD-ROM from the DVD-ROM drive

while the computer is turned on.

 Use only Data Transmission SW 1.50 or higher.

Instructions for Use JM-105

Getting started

System requirements

Operating Systems Windows 7 Professional SP1 32-bit

Windows 7 Professional SP1 64-bit

Windows 8.1 Professional 32-bit

Windows 8.1 Professional 64-bit

Windows 10 Professional 64-bit (Creators update)

Screen resolution 1024 X 768 or higher

CPU Pentium III 1.6 GHz or higher

Memory 1 GB or more

Hard disk At least 3.5 GB of available disk space (Of this disk

space, at least 300 MB must be on the system drive.)

Other CD-ROM drive (for installation)

USB port For connecting docking station

Languages (CE1) English, French, German, Italian, Spanish

Languages (CE2) English, Dutch, Portuguese, Russian, Swedish

Languages (CE3) English, Croatian, Polish, Serbian, Turkish

Languages (CE4) English, Czech, Hungarian, Norwegian, Slovakian

Languages (CE5) English, Danish, Finnish, Greek, Romanian

Instructions for Use JM-105 43

Getting started

Preparations

Software license compliance

The license agreement terms of the data transmission software for Jaundice Meter, SW JM-S1w are provided in the Software License Agreement dialog box displayed on-screen during installation. This software can be installed only if you agree to all the terms of the agreement.

Introduction

Three setup files are needed to set up the JM-S1w (version 1.50) software. These three files must be installed in the following order:

1 setup1.exe: Microsoft Visual C++ 2015 Redis-

tributable Package Installer

2 setup2.exe: Microsoft .NET Framework 4.6.2

Installer

3 setup3.exe: JM-S1w Installer

NOTE

Use only Data Transmission SW 1.50 or higher.

NOTE

If CSV file storage was used with the old software, it might be necessary to manually adjust the location to an appropriate directory. The default location is: C:\users\public\documents\jm-s1w\CSV.

Installation of Microsoft Visual C++ 2015 Redistributable Package

NOTE

When the Microsoft Visual C++ 2015 Redistributable package has already been installed on your PC, you should move to the next step (Installation of Microsoft .NET Framework 4.6.2).

NOTE

In case the login user who executes JM-S1w installer does not have administrative right of windows, the "User Account Control" dialog will appear.

1 Run the setup1.exe.

NOTE

If a previous software version of JM-S1w is installed, do not uninstall it. Installing JM-S1w (version 1.50) will automatically uninstall the previous version of software and inherit the previous settings.

NOTE

For JM-S1w (version 1.30) or older, settings were allocated to each Windows login user. JM-S1w (version 1.50) has only one set of settings for all users.

000

2 Check the I agree to the license terms and

conditions check box (A).

3 Click the Install button (B).

4 Click the Yes button (C).

Instructions for Use JM-105

Getting started

5 Click the Close button (D).

Installation of Microsoft .NET Framework

4.6.2

NOTE

When the later version of .NET Framework has already been installed on your PC, you should move to the next step (Installation of JM-S1w).

001002

3 Check the I have read and accept the license

terms. check box (B).

4 Click the Install button (C).

5 If the dialog below appears, click the Yes button

(D).

003004005

1 Run the setup2.exe.

2 Click the Yes button (A).

Instructions for Use JM-105 45

Getting started

6 Click the Finish button (E).

7 Click the Restart Now button (F) to restart the

PC.

1 Run the setup3.exe.

2 Click the Yes button (A).

008009010

3 Open the drop-down list (B).

006007

4 Select the language that you want to install (C).

5 Click the OK button (D).

Installation of JM-S1w

NOTE

Use only Data Transmission SW 1.50 or higher.

Instructions for Use JM-105

Getting started

6 Click the Next button (E).

7 Select the I accept the terms in the license

agreement button (F).

8 Click the Next button (G).

10 Click the Next button (I).

011012

11 Click the Install button (J).

013014015

12 Click the Install button (K) to install the USB

driver.

9 To install the software in another location, click

the Change... button (H).

Instructions for Use JM-105 47

Getting started

13 Click the Finish button (L).

Installing the USB driver for the docking station

Before using the software, it is necessary to connect the docking station to the computer.

When the docking station is connected to a computer for the first time, installation of the USB driver is required.

1 Ensure MEMORY is set to LINK ON.

2 Plug the USB cable, TA-15, into the docking sta-

tion and the USB port of the computer.

3 The Found New Hardware Wizard starts on the

PC, prompting for installation of the driver for the Jaundice Meter. Accept the software license agreement.

4 Check that Install the software automatically

(Recommended) is selected, and click Next >.

5 If a warning message stating that the software

has not passed the Windows logo test appears, click Continue or OK. Then continue the installation of the USB driver.

6 When the dialog with the message that driver

installation has been completed, click Close to close the dialog.

Checking the COM port

To check the COM port that has been assigned to the docking station, follow the procedure.

1 Open Control Panel.

2 Double-click System.

3 Select the Hardware tab, and click Device

Manager.

4 Click the + next to Ports (COM & LPT). The list

of connected devices appears.

5 Jaundice meter appears in the list, followed by

the assigned COM port in parentheses.

If Jaundice meter is not shown in the list under

016

Ports (COM & LPT), then the driver has not been installed correctly. If Jaundice meter is shown somewhere else on the list, select it and uninstall the driver. Then unplug the docking station from the computer and plug it back into the computer and reinstall the driver.

Verifying software load

1 Restart PC.

2 Once JM-S1w has been installed on a PC, JM-

S1w starts when Windows starts. The JM-S1w

runs in the background. A symbol appears in the task tray when JM-S1w is in progress.

NOTE

While JM-S1w in progress, the computer is prevented from automatically entering Sleep mode. If the computer is set to Sleep mode manually, communication errors may occur when Sleep mode is canceled.

3 If JM-S1w does not start automatically, it can be

started by clicking Start > All Programs >

Draeger

> JM-S1w.

Instructions for Use JM-105

Getting started

067

Preferences EXIT

ABCD

Exiting JM-S1w software

1 Right-click on the task tray symbol for JM-

S1w.

2 Select Exit. JM-S1w shuts down.

When Windows is restarted, JM-S1w also restarts.

Notes on CD-ROM Storage

 After using the CD-ROM, return it to its case

and store in a safe place.

 Do not leave the CD-ROM in locations that are

exposed to high temperatures from direct sunlight or heaters.

 Do not store the CD-ROM in areas of high

humidity.

Setting preferences

1 Access the JM-S1w menu by clicking or right-

clicking on the JM-S1w symbol on the task tray.

This action opens the JM-S1w menu.

NOTE

All users can change preferences. However, preferences apply to all users. Users cannot set individual preferences.

1 Select Preferences.

Setting preferences - Common

1 A dialog box opens that shows tabs for each of

4 setting categories: Common (A), Network (B), HL7 (C), and Barcode (D). The Common tab is in front.

Instructions for Use JM-105 49

069

2 Check the box (E) to allow changes to settings.

3 Determine if you want to save to CSV text file or

to EHR.

4 If CSV text file is preferred, change Common

settings, by checking the Save data on PC box (F).

5 Click on the OPEN button (G) to select CSV file

storage location.

Getting started

6 Click OK (H) to save settings.

Setting preferences - Network

1 If EHR is preferred, select the Network tab.

2 Change Network settings to input the server

address (A) and the server port (B).

Setting preferences - HL7

1 Select the HL7 tab.

Setting preferences - Barcode

NOTE

This function is only available using JM-S1w version 1.30 or higher and device firmware 1.10 or higher.

1 If Code 39 barcode is preferred, select the Bar-

code tab.

070071

2 Check the appropriate radio button to disable

(A) or enable (B) the Code 39 check digit.

3 Check the appropriate radio button to disable

4 Press the Write button (F) to apply the setting.

5 Click OK (

G) to save.

074

2 To allow changes to settings, check the radio

button (A) to allow changes to settings.

3 Change HL7 settings: HL7 version (B) and

Message structure options (C) and (D).

4 Click the Edit custom message button (E), if

desired.

5 Edit messages as desired.

6 Edit the Sending facility field (F), if desired.

7 Click OK to save.

NOTE

To see the current settings, click on the Read current setting button (E).

Instructions for Use JM-105

Operation

Ensuring correct measurement . . . . . . . . . . 52

Measuring point . . . . . . . . . . . . . . . . . . . . . . . . 53

Choosing settings for measurement . . . . . . 53

Setting the number of average

measurements . . . . . . . . . . . . . . . . . . . . . . . . . 53

Selecting whether to store measurements . . . . 54

Measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Removing from docking station . . . . . . . . . . . . 56

Measuring bilirubin (not storing

measurements in data log). . . . . . . . . . . . . . . . 57

Measuring bilirubin (storing measurements

in data log) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Storing the device . . . . . . . . . . . . . . . . . . . . . 60

Switching off the device . . . . . . . . . . . . . . . . 61

Operation

Measuring quick guide. . . . . . . . . . . . . . . . . . 62

Instructions for Use JM-105 51

Operation

022

023

SINGLE

2TIMES

3TIMES

4TIMES

Ensuring correct measurement

WARNING Risk of injury.

This device emits intense light.

Never allow device to emit light into the eyes. Always take measurements from either the sternum or the forehead.

WARNING Risk of patient injury

Pathologic or other skin conditions that may affect light scattering or absorption could result in incorrect TcB measurements.

Do not conduct measurements in patients with early jaundice and pathologic jaundice.

Do not conduct measurements when skin conditions may violate the assumption made concerning light scattering and light absorption.

1 Before beginning measurements, ensure that

all phototherapy lights are shut off.

2 Place measuring probe perpendicular to mea-

suring point.

3 Push down gently. Do not lean the measuring

probe.

4 Configure the device to the desired number of

measurements (refer to Choosing settings for measurement on page 53). Dräger recommends that the device is set to average 2 times to 5 times. This setting minimizes measurement errors due to leaning measuring probe.

2012/08/0110:00

NOTE

Clean measuring probe before use.

NOTE

Incorrect position of measuring probe can result in erroneous measurements. Ensure that measuring probe is perpendicular to measuring point.

NOTE

Ensure that patient is calm before taking measurements. Movement can interfere with correct probe placement.

NOTE

There is a minor risk of administering phototherapy when not clinically indicated.

Instructions for Use JM-105

Operation

024

READ

025

READY

Measuring point

WARNING Risk of patient injury

Pathologic or other skin conditions that may affect light scattering or absorption could result in incorrect TcB measurements.

Do not conduct measurements in patients with early jaundice and pathologic jaundice.

Do not conduct measurements when skin conditions may violate the assumption made concerning light scattering and light absorption.

Measurements must be taken only on the sternum (at hospital sites or physicians offices) or forehead (at hospital sites only) where enough blood is circulated.

Choosing settings for measurement

This device performs single measurements and average measurements. Single measurements take the results from each measurement as the measured value. Average measurements take the average results from 2 to 5 individual measurements as the measured value.

The device also allows the user to select whether to store the measurements. Set-up of the device depends on the measuring point and conditions.

Instructions for Use JM-105 53

Setting the number of average measurements

1 Touch MENU button, if needed.

2 Using UP/DOWN arrows, scroll through the list

until CONFIG appears.

Operation

026

BACK OK

2012/08/0110:00

CONFIG

CLR ALL

HISTORY

CHECKER

027

2012/08/0110:00

UNITS

AVERAGE

MEMORY

NURSE ID

028

SINGLE

2TIMES

3TIMES

4TIMES

029

CONFIG

CLR ALL

HISTORY

CHECKER

3 Select CONFIG.

4 SETTING screen appears.

5 Select AVERAGE.

 2TIMES to 5TIMES: Shows the average of

the results from 2 measurements to 5 measurements. AVE indicates that multiple measurements were selected.

2012/08/0110:00

8 Touch OK to save selection.

Selecting whether to store measurements

1 Touch the MENU button, if needed.

2 Select CONFIG.

6 Touch OK to save selection.

7 Select the number of measurements.

 SINGLE: Shows the result form one mea-

surement.

3 Touch OK to save selection.

4 SETTING screen appears.

2012/08/0110:00

BACK OK

Instructions for Use JM-105

Operation

030

UNITS

AVERAGE

MEMORY

NURSE ID

031

2012/08/0110:00

OFF

MEM ONLY

LINK ON

5 Select MEMORY. Previous selection is high-

lighted (OFF, MEM ONLY, or LINK ON).

2012/08/0110:00

6 Select desired option

 OFF: No measured data is stored in data

log.

 MEM ONLY: Measured data is stored in

data log.

 LINK ON: Measured data is stored in data

log and sent to PC.

Instructions for Use JM-105 55

Operation

032

MEASURE

CHECKER

HISTORY

CLR ALL

Measuring

WARNING Risk due to incorrect reading

Screening measurements must be compared to measurements from collected blood samples. – Compare TcB value (Transcutaneous Bili-

rubin) measured by the device and TSB value (Total Serum Bilirubin) measured from collected blood samples.

NOTE

For quality control purposes, periodically compare the JM-105 to serum bilirubin results. This checks that the instrument maintains consistent performance over time and that the operators are using the instrument properly.

Removing from docking station

1 Before beginning measurements, ensure that

all phototherapy lights are shut off.

2 Remove device from docking station.

3 Clean measuring probe.

4 Switch on device.

6 Select MEASURE.

2012/08/0110:00

NOTE

After a few s. the READY lamp turns green. This action indicates that the device is ready.

NOTE

If not operated for 1 min or longer, touch screen goes blank. If needed, touch the display to activate it.

5 Touch MENU button, if needed.

Instructions for Use JM-105

Operation

033

034

CLEAR

2012/08/0110:00

mg/dL

12.1

12.



12.2

AVE.3

Measuring bilirubin (not storing measurements in data log)

WARNING Risk of patient injury

Pathologic or other skin conditions that may affect light scattering or absorption could result in incorrect TcB measurements.

Do not conduct measurements in patients with early jaundice and pathologic jaundice.

Do not conduct measurements when skin conditions may violate the assumption made concerning light scattering and light absorption.

1 Before beginning measurements, ensure that

all phototherapy lights are shut off.

2 Ensure that MEMORY is set to OFF (refer to

Selecting whether to store measurements on page 54).

3 Ensure that the READY lamp is on.

4 Place measuring probe perpendicular to mea-

suring point (on forehead or sternum).

REA

 If AVERAGE is selected, display shows

remaining number of measurements needed for averaging.

6 If averaging, wait for green READY lamp and

repeat measurement for the number of times selected (2TIMES or 5TIMES). Display shows the average calculated from the multiple measurements.

7 Read measurements.

 Display shows up to 3 measured values.

 If >20 or >340 blinks in a measured value

field, the measured value is outside the measurement range (>20.0 mg/dL/>340 mol/L).

 To take another measurement, touch

CLEAR button (A) and repeat step 2 through step 6.

NOTE

Touching CLEAR once deletes the last measured

5 Push gently until it flashes.

 If AVERAGE is not selected, display shows

value. Touching and holding CLEAR deletes all displayed measured values.

the measured data.

Instructions for Use JM-105 57

Operation

036

BABYID

2012/08/0110:27

MENUKEY

SCAN

ABC

123

038

039

Measuring bilirubin (storing measurements in data log)

 Ensure that MEMORY is set to MEM ONLY

or LINK ON (refer to Selecting whether to store measurements on page 54).

 Maximum 15 characters

Entering NURSE ID (nurse ID) and BABY ID (baby ID) using barcode reader

1 Touch SCAN button. Barcode reader emits

light.

2 Scan NURSE ID (nurse ID) (optional), and

touch OK.

3 Scan BABY ID (baby ID), and touch OK.

4 Ensure that the READY lamp is on. Go to Per-

forming measurements on page 59.

3 When in numeric mode, touch the number

desired.

NURSEID 1234567890

2 31 5 64 8 97

ABC

123

 When in alphabet mode, touch the appropri-

ate button for the desired letter. To move to the next letter, touch the right arrow button .

NURSEID

1234567890AB CD

DEL

ABC DEF

JKL MNOGHI

Entering NURSE ID (nurse ID) and BABY ID (baby ID) using touch screen

1 To select letter/number input mode, touch KEY

button.

NOTE

Touching the BARCODE button switches you back to barcode input mode.

2 To switch between alphabet mode and numeric

mode, touch ABC/123 button.

TUV WXYZPQRS

ABC

123

 Example of alphabet mode:

To enter BR, touch ABC button twice. Touch the right arrow button. Touch the PQRS button 3 times.

4 Touch OK to save the ID entered. Device

returns to measurement screen.

5 Ensure that the READY lamp is on.

Instructions for Use JM-105

DEL

Operation

040

041

CLEAR

2012/08/0110:00

NEXT BABY

NURSE001

BABY0001

004/100

AVE.3

12. 4

12. 3

12.3

mg/dL

CLEAR

2012/08/0110:00

mg/dL

>20

CLEAR

2012/08/0110:00

umol

>340

Performing measurements

WARNING Risk of patient injury

Pathologic or other skin conditions that may affect light scattering or absorption could result in incorrect TcB measurements.

Do not conduct measurements in patients with early jaundice and pathologic jaundice.

Do not conduct measurements when skin conditions may violate the assumption made concerning light scattering and light absorption.

1 Before beginning measurements, ensure that

all phototherapy lights are shut off.

2 Place measuring probe perpendicular to mea-

suring point (on forehead or sternum).

REA

4 If averaging, wait for green READY lamp and

repeat measurement for the number of times selected (2TIMES or 5TIMES). Display shows the average calculated from the multiple measurements.

5 Read measured data.

 Display shows up to 3 measured values.

 If >20 or >340 blinks in a measured value

field, the measured value is outside the measurement range (>20.0 mg/dL/>340 mol/L).

3 Push gently until it flashes.

 If AVERAGE is not selected, display shows

the measured data.

 If AVERAGE is selected, display shows

Instructions for Use JM-105 59

remaining number of measurements needed for averaging.

042a

Operation

NURSE001

BABY0001

004/100

AVE.3

12. 4

052

053

6 To attach flags, perform the following:

 To attach a priority flag, touch

the dots button (the priority

flag appears which indicates high bilirubin level in the patient).

 To attach a phototherapy flag, touch the

button again (the

phototherapy flag appears which indicates that patient has been treated with phototherapy).

 To attach both flags, touch the button again

(both flags appear ).

 To remove flags, touch the button again

(both flag disappear and the dots

return .

WARNI NG Risk of delayed phototherapy

Set flags must be considered when intepreting test measurements. Otherwise there is an increased risk of incorrect therapy.

– Follow hospital procedures on the assess-

ment of phototherapy needed or of any further evaluation needed.

7 To proceed to the next patient, touch NEXT

BABY button (A), enter NURSE ID (optional) and BABY ID, and repeat steps 6 through 9.

NOTE

When the number of measurements stored in the data log reaches 100, measuring is disabled.

Storing the device

1 Clean the measuring probe with a wipe soaked

in alcohol.

 While the device is in the docking station,

power remains on. After 1 min, the screen

2 Place the device in the docking station.

EADY

3 Leave the device in the docking station when

not in use.

goes blank. The power remains on.

Instructions for Use JM-105

 If the device is left out of the docking station

for 1 min, the screen goes blank. After 9 mins, the power switches off.

Switching off the device

To switch off power when the device is not in the docking station, press the power button and hold it down for 1 s.

Operation

Instructions for Use JM-105 61

Operation

Switch on power.

Perform initial settings (if switching on device for the first time).

Change settings if needed.

Check device.

Take measurement.

If internal memory is deactivated:

-Take measurement.

Check data.

If internal memory is activated:

-Enter nurse ID.

-Enter baby ID.

-Take measurement.

Place device into docking station.

Transfer data to electronic medical chart system (MEMORY must be set to LINK ON).

Refer to Switch on and pre-set the device for the first time on page 38.

Refer to "Choosing settings for measurement" on page 53.

Ensure phototherapy is shut off.

Refer to Pre-use checkout on page 40.

Refer to "Measuring" on page 56.

Refer to "Measured data screen" on page 27.

Refer to "Transmitting data to electronic charts" on page 66.

Measuring quick guide

Instructions for Use JM-105

Trends and Data

Viewing measurements stored in the

data log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Deleting individual measurements in the

data log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Deleting all measurements in the data log. . 65

Transmitting data to electronic charts . . . . . 66

Data transmission errors . . . . . . . . . . . . . . . . . 67

Transmission log . . . . . . . . . . . . . . . . . . . . . . . 67

Viewing the transmission log from the

JM-S1w software . . . . . . . . . . . . . . . . . . . . . . 68

Trends and Data

Instructions for Use JM-105 63

Trends and Data

044

BACK OK

2012/08/0110:00

HISTORY

CLR ALL

CHECKER

MEASURE

045

1:

...

Y0001

2:

...

Y0002

3:

...

Y0003

4:

...

Y0004

2012/08/0110:00

046

Viewing measurements stored in the data log

1 Touch MENU button, if needed.

2 Touch HISTORY.

3 Touch OK to save selection. Display shows list

of baby IDs (5 trailing characters if ID is 6 or more characters long), measurement numbers, and flags.

4 Select desired baby ID.

5 Touch OK to save selection. Display shows

detailed measured data.

2012/08/0110:00

＊＊＊＊

0001

BABY0002

01/12 11:23AM 01/12 11:23AM

01/12 11:23AM

…

002/004



DEL

2. 2

2. 4

2. 3

mg/dL

WARNI NG Risk due to incorrect reading

Screening measurements must be compared to measurements from collected blood samples. – Compare TcB value (Transcutaneous Bili-

rubin) measured by the device and TSB value (Total Serum Bilirubin) measured from collected blood samples.

Instructions for Use JM-105

Deleting individual measurements in the data log

035

047

2012/08/0110:00

＊＊＊＊

0001

BABY0002

01/12 11:23AM 01/12 11:23AM

01/12 11:23AM

2. 2

2. 4

2. 3

mg/dL

DEL



002/004

…

048

CLR ALL

HISTORY

CHECKER

MEASURE

Trends and Data

1 Touch MENU button, if needed.

4 Select the desired measurement.

2 Touch HISTORY.

3 Select the desired baby ID.

2012/08/0110:00

...

1:

Y0001

2:

3: 4:

...

Y0002

...

Y0003

...

Y0004

5 Touch DELETE (A).

6 Touch OK to save selection.

Deleting all measurements in the data log

1 Touch MENU button, if needed.

2 Touch CLR ALL.

2012/08/0110:00

3 Touch CLEAR on the confirm screen.

4 Touch OK to save selection. All measurements

in the data log are deleted.

BACK OK

Instructions for Use JM-105 65

Trends and Data

049

050

CONFIRM

SENDING

Transmitting data to electronic charts

If Send HL7 Message is enabled in the Common tab of the JM-S1w dialog, measurements from JM105 are automatically sent to the electronic health records system. If Save data on PC in the Common tab is enabled, then measurements from the JM-105 are sent to a CSV log file on the PC. Refer to Setting preferences - Common on page 49 to confirm settings.

1 On the jaundice meter, navigate to the settings

menu: MENU>CONFIG.

2 Select MEMORY from the menu items.

3 Select LINK ON from the menu items.

4 Connect the docking station to the PC.

5 Open the SW JM-S1w on the PC.

NOTE

Ensure the Common screen shows (docking station) (A) above the list of COM ports and that there is at least 1 COM port in the list.

6 Confirm COM port (B) on Common screen.

7 Place the device in the docking station that is

connected to the PC.

E ADY

8 Display shows the CONFIRM screen.

2012/08/0110:00

NOTE

Ensure the COM port is selected before placing the JM-105 into the docking station.

CANCELOK

069

Instructions for Use JM-105

Trends and Data

051

9 Touch OK to transmit data. Display shows

SENDING screen.

2012/08/0110:00

SENDING

…

001/004

CANCEL

Display shows the number of data transferred and the number of data in memory to be transferred. It also shows the progress of the transfer of all data in memory.

NOTE

Touching CANCEL during data transmission stops data transmission. The data already transmitted is considered transmitted.

Data transmission errors

If data transmission could not be completed, for example, if the wrong COM port was selected or no COM port was selected, data transfer times out on the JM-105. JM-105 display shows SEND FAILED and a balloon with the error message appears above the JM-S1w tray symbol on the PC.

When an error message appears on the JM-105, press OK to continue. When the balloon with the error message appears on the PC, close it.

If data transmission to the electronic health records system fails, JM-S1w saves the data in a file. It later attempts to resend the data after the period specified by the Retry Interval setting. If No retry is set, no attempt to resend is performed. Resend attempts are performed at the specified interval until success is achieved or until Send HL7 Mes- sage is disabled.

Transmission log

If Send HL7 Message is enabled in the Common tab of the JM-S1w dialog, the results of sending measurements to the HL-7 system are saved in the transmission log.

Refer to Viewing the transmission log from the JMS1w software on page 68.

Instructions for Use JM-105 67

Trends and Data

JM-S1w

Failed transmission data

Successfull transmission data

Allow changes. Delete All

Transmission log

Transmission Date/Time Date/Time 1

Value 1

Value 2

2017/02/28/12:34:56

:::::: :::::::

2017/02/28/12:34:56

2017/02/28/12:00:00

Date/Time 2

2017/02/28/12:00:10

2017/03/01/12:00:15

JOHN DOE

NURSE ID

JOHN DOE

NURSE_01

BABY ID Instrument ID

NURSE_01

3501001

3051000

12.1

12.3

12.2

12.4

Value 3 Error

Date/Time 2

2017/02/28/12:00:20

2017/03/01/12:01:00

12.1

12.2

Transmission Date/Time

Value 1

Value 2

2017/02/28/12:34:56

:::: ::::::

2017/02/28/12:34:56

2017/02/28/12:00:00

Date/Time 2

2017/02/28/12:00:10

2017/03/01/12:00:15

JOHN DOE

NURSE ID

JOHN DOE

NURSE_01

BABY ID I nstrument ID

NURSE_01

3501001

3051000

12.1

12.3

12.2

12.4

Value 3

Date/Time 2

2017/02/28/12:00:20

2017/03/01/12:01:00

12.1

12.2

Retry Delete

Viewing the transmission log from the JM-S1w software

1 Select the HL-7 tab (A).

2 Edit the Sending facility (B), if desired.

3 Select the Transmission log button (C).

4 The Transmission log dialog opens.

5 Use the scroll bars (D) to navigate through the

data (left and right/ up and down).

6 Check the Allow changes. radio button (E) to

allow editing of the transmission log.

7 To view error details, click on the AE/AR/CN/UN

link (F).

8 To resend a failed transmission, click on the

Retry button (G).

10 Sort data as desired by date or by name by

clicking the arrow (I) in the column header (ascending or descending order). Data can be sorted by fields: Transmission Date/Time, Nurse ID, Baby ID, Date/Time1.

NOTE

The default sort order shows the newest transmission on top.

071076a

11 Edit data as desired in fields: Nurse ID, Baby

ID.

NOTE

The transmission log can hold 500 entries. When the log reaches 500 entries, new entries push out the oldest entries in the log.

12 To clear all data from the transmission log, click

on the Delete All button (J).

13 A confirmation message appears, Are you

sure you want to delete all items?.

14 Select yes or no.

15 To close the window, click on the Close button

(K).

080

081

NOTE

The Retry and the Delete buttons may be hidden to the right if data in other fields is long. Use the scroll bars to find these buttons.

9 To delete a failed transmission, click on the

Delete button (H).

Instructions for Use JM-105

Configuration

Changing settings on the JM-105 . . . . . . . . . 70

System and default settings for the JM-

105 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Configuration

Instructions for Use JM-105 69

Configuration

054

BACK OK

2012/08/0110:00

CONFIG

CLR ALL

HISTORY

CHECKER

055

UNITS

AVERAGE

MEMORY

NURSE ID

Changing settings on the JM-105

1 Switch on device.

2 Touch MENU button, if needed.

3 To select CONFIG, touch CONFIG button or

press UP/DOWN arrows.

4 Touch OK to save selection.

5 Settings screen appears.

6 Touch item you want to change.

7 To change value, touch UP/DOWN buttons.

8 Touch OK to save selection.

2012/08/0110:00

9 Touch OK again when you have finished chang-

ing settings.

System and default settings for the JM-105

Setting Description Options Description

UNITS Select unit for measuring and view-

ing data log.

AVERAGE Select number of measurements for

averaging.

mg/dL Default

mol/L

SINGLE Default

2TIMES 3TIMES 4TIMES 5TIMES

Instructions for Use JM-105

Configuration

Setting Description Options Description

MEMORY Select whether to store data in

device or transfer to PC.

OFF Default

No data stored in data log.

MEM ONLY Data stored in data log. LINK ON Data stored in data log.

Data transmitted to PC (USB cable and communication software required).

NURSE ID Select whether to enter nurse ID. NONE No nurse ID entered.

BARCODE

Default

Enter nurse ID using barcode reader.

TOUCH Enter nurse ID using touch

screen.

BABY ID Select how to enter baby ID. BARCODE

Default

Enter baby ID using barcode reader.

TOUCH Enter baby ID using touch

screen.

BUZZER Select whether to activate beeper. OFF No beep sound.

ON Default

Beep sound.

ALERT ON Beep sounds for alerts only.

SET TIME Set date and time. Must be set or selected

when device is switched on for the first time.

DATE FMT

Select date format. M/D/Y

D/M/Y Y/M/D

TIME FMT Select format of time stamp for mea-

12-HOUR

sured data in data log.

(Time in upper right of touch screen is always 24-hour format.)

24-HOUR Default

Instructions for Use JM-105 71

Configuration

Setting Description Options Description

LANGUAGE2)

Select display language. ENGLISH Default

for CE1

DEUTSCH ESPAÑOL FRANÇAIS ITALIANO

LANGUAGE

Select display language. ENGLISH Default

for CE2

NEDERL. SVENSKA РУС. PORTUG.

LANGUAGE

Select display language. ENGLISH Default

for CE3

POLSKI TÜRKÇE HRVATSKI SRPSK

LANGUAGE

Select display language. ENGLISH Default

for CE4

ČEŠTINA MAGYAR NORSK SLOVENSK

LANGUAGE

Select display language. ENGLISH Default

for CE5

SUOMI DANSK



ROMÂNĂ

CONTRAST Select contrast of touch screen. 1 Darkest

3 Default

5 Lightest

Instructions for Use JM-105

Setting Description Options Description

TOUCHSCR Adjust touch screen. Touch the cen-

ter of X.

COM T.O. Select the time after which data

1-MIN Default

transmission is canceled.

5-MIN S/W VER. Shows software version. INITIAL Initialize device.

(Allows you to select display language, date format and to set date and time.)

Data transmission software Code 39

check digit

Select whether or not the barcode

contains a check digit.

Disable

Enable Default Code 39 full

ASCII conver-

sion

Select whether or not to enable full ASCII.

This page intentionally left blank.

Disable

Enable Default Sending facil-

ity3) for HL-7

Displays the facility sending the data during data transmission. This

Nursery Default

field is editable by the user.

1) Only applies to devices with firmware 1.10 or higher and barcode feature using JM-S1w version 1.30 or higher.

2) Must be set or selected when device is switched on for the first time.

3) Requires JM-S1w version 1.40 or higher.

Instructions for Use JM-105 73

This page intentionally left blank.

74 Instructions for Use JM-105

Problem solving

Fault – Cause – Remedy . . . . . . . . . . . . . . . . 76

Error messages . . . . . . . . . . . . . . . . . . . . . . . . 76

Battery indications . . . . . . . . . . . . . . . . . . . . . . 77

Other problems. . . . . . . . . . . . . . . . . . . . . . . . . 78

JM-S1w errors . . . . . . . . . . . . . . . . . . . . . . . . . 79

Problem solving

Instructions for Use JM-105 75

Problem solving

Fault – Cause – Remedy

The table shows possible causes for a fault and corresponding remedies. Causes and remedies must be worked through in the order listed until the fault has been resolved.

Error messages

Fault Cause Remedy

ERROR01 Measured value is abnormal. For

averages, the difference between measurements is excessively large.

ERROR03 RAM error. Abnormalities or cor-

rupted data in RAM.

ERROR03 ERROR04 ERROR06

ERROR04 Memory error. Abnormalities or

ERROR05 Insufficient charge, circuit error. Charge the device.

ERROR06 Calibration data error. Calibration

ERROR07 Communication error between PC

JIG MODE Ver. 1.x Battery exhausted. Charge device for 32 hours.

Averaging failure Switch OFF power.

Hardware failure Switch OFF power.

corrupted data in EEPROM.

data in the EEPROM is corrupted.

and electronic clinical record system.

Repeat the measurement.

Switch off the device and remove it from service.

Wait 10 s. Switch ON power.

If the failure continues, switch off the device and remove it from service.

Wait 10 s. Switch ON power.

If the failure continues, switch off the device and remove it from service.

Switch off the device and remove it from service.

If the failure continues, switch off the device and remove it from service.

Switch off the device and remove it from service.

Review setup of PC and repeat data transmission.

If failure continues, replace battery

Instructions for Use JM-105

Battery indications

Fault Cause Remedy

Battery indicator is on. Battery power is low. Charge battery.

Backlight of touch screen illuminates for 5 s and then a shutdown occurs.

Battery power depletes quickly.

READY lamp blinks red during charging

Battery power is depleted. Charge battery.

Switch OFF power. Wait 10 s. Switch ON power.

If the failure continues, switch off the device and remove it from service.

Touch screen is used frequently. Establish measurement proce-

dures that reduce activation of the backlight of the touch screen. Backlight of touch screen consumes a lot of power.

Battery often recharged before power was fully discharged.

Battery is overdischarged when placed on the docking station.

Battery temperature too high. Allow battery to cool. Charging

No battery connected to the JM-

105.

Allow battery to discharge completely and then recharge. Repeat this procedure a few times.

Switch OFF power. Wait 10 s. Switch ON power.

If the failure continues, switch off the device and remove it from service.

Wait for a few minutes. The battery charge increases to 1.2 V or higher. The red READY lamp illuminates continuously.

starts automatically when battery has cooled.

If the failure continues, switch off the device and remove it from service.

Connect battery.

Problem solving

Instructions for Use JM-105 77

Problem solving

JM-S1w errors

When a data transfer error occurs, a balloon with an error message appears above the JM-S1w tray symbol. The symbol changes to include a red line through it. If a data transfer error occurs and the JM-S1w error symbol appears, check the JM-S1w settings, exit from the software, and restart the software.

Error symbol:

Fault Cause Remedy

Couldn't save Log data. Check HDD space.

Server couldn't receive data. Check Server setting or Message setting.

JM-S1w failed to save or delete cache file for sending/re-sending. Hard disk could be full or cache folder set to "read-only."

Settings for message or server are wrong and HL-7 server could not receive the data. The data are not stored on the server, and JM-S1w does not retry sending the data since the server does not accept the messages.

Check hard disk, cache folder CSV folder. Clear space on hard disk or reset cache folder to read/write.

Correct the server setting or message setting.

, or

Instructions for Use JM-105 79

Problem solving

Fault Cause Remedy

Server's response may be wrong. Check Server setting.

The format is wrong for the message received. Server may or may not have accepted the message,

Correct the server settings.

but JM-S1w cannot know the result and does not resend the data

Cannot connect to server. Check Network setting or Server setting.

JM-S1w cannot connect to the HL-7 server via the network:

-Wrong server address or port

Correct network setting or server setting.

-Connection is physically down. The data is resent.

Some data were not received. JM-S1w will retry with the same settings.

Server could not accept the message because server was processing. Server may accept the message later, so JM-S1w retries

Wait a little while and try again.

automatically.

Couldn't save Log data. Check HDD space.

JM-S1w could not save log data. HDD is full or cache folder is set to

Reset cache folder space on HDD.

or clear

"Read-only".

The Log files could not be created, but connections are OK and data transfer to the HL-7 server was successful.

When performing barcode settings, select only one COM port (Docking Station).

COMx Failure

(where x is the number of the communication port)

This message appears on the JMS1w Barcode screen when more than one port was selected on the Common JM-S1w screen.

An attempt was made to read current barcode 39 data, but there is no JM-105 connected or the connected JM-105 does not support

Select only one COM port on the Common JM-S1w screen.

Connect a JM-105 that supports the barcode 39 format, and attempt the reading again.

the barcode 39 format.

1) Cache folder: On Windows Vista, Windows 7, Windows 8, Windows 10 C:\ProgramData\Draeger\JM-S1w\

Instructions for Use JM-105

Reprocessing

Safety information . . . . . . . . . . . . . . . . . . . . . 82

Information on reprocessing. . . . . . . . . . . . . 82

Classifications for reprocessing. . . . . . . . . . 83

Classification of medical devices . . . . . . . . . . . 83

Classification of device-specific components . . 83

Before reprocessing. . . . . . . . . . . . . . . . . . . . 84

Device-specific components. . . . . . . . . . . . . . . 84

Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . 84

Validated reprocessing procedures . . . . . . . 85

Overview of the reprocessing procedures of

the components . . . . . . . . . . . . . . . . . . . . . . . . 85

Surface disinfection with cleaning . . . . . . . . . . 85

Storage and transport. . . . . . . . . . . . . . . . . . . . 86

Reprocessing

Other agents and reprocessing

procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Disinfectants. . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Reprocessing procedures. . . . . . . . . . . . . . . . . 88

After reprocessing . . . . . . . . . . . . . . . . . . . . . 88

Assembling and fitting device-specific

components . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Preparation before next use of device . . . . . . . 88

Instructions for Use JM-105 81

Reprocessing

Safety information

WARNING Risk due to inappropriately reprocessed prod-

ucts

Reusable products must be reprocessed, otherwise there is an increased risk of infection. – Follow the infection prevention policies

and reprocessing regulations of the health-care facility.

– Follow the national infection prevention

policies and reprocessing regulations.

– Use validated procedures for reprocess-

ing.

– Reprocess reusable products after every

use.

Follow the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing devices.

Information on reprocessing

Follow the national infection prevention policies and reprocessing regulations.

Follow the infection prevention policies and reprocessing regulations of the health-care facility (e.g., concerning the reprocessing cycles).

CAUTION

Risk due to faulty products

Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed products.

Check the products for signs of wear and replace them if necessary.

CAUTION

Risk due to faulty accessories

Even reusable accessories have a limited service life. External signs of wear can occur, e.g., cracks, deformations, discolorations, or peeling.

If there are external signs of wear, exchange affected accessories.

Instructions for Use JM-105

Reprocessing

Classifications for reprocessing

Classification of medical devices

The classification depends on the intended use of the medical device. The risk of infection transmission through the application of the product to the patient without proper reprocessing is the basis of the Spaulding classification.

Classification Explanation

Non-critical Components that come only into contact with skin that is intact

Semi-critical Components that carry breathing gas or come into contact with mucous mem-

branes or pathologically altered skin

Critical Components that penetrate skin or mucous membranes or come into contact with

blood

Classification of device-specific components

The following classification is a recommendation from Dräger.

Non-critical

– Device components

– JM-105 main device

– Chargers

– JM-A33 docking station

Instructions for Use JM-105 83

Reprocessing

Before reprocessing

Observe before disassembly

WARNING Risk of serious injury or equipment damage.

Disassembling or modifying the device or accessories could cause electric shock or fire.

Do not disassemble or modify the device or accessories.

WARNING Risk of serious injury or equipment damage.

Cleaning device while it is connected to power could cause electric shock or fire.

Disconnect all parts and accessories from AC outlet.

1 Switch off the device.

2 Disconnect all power plugs.

Device-specific components

The device-specific components must be removed from the device and, if necessary, disassembled.

Removing the [AC adapter]

1 Disconnect AC adapter from AC outlet.

2 Disconnect DC plug from device.

Disassembling the [docking station]

1 Remove the jaundice meter from the docking

station.

Visual inspection

Check all items for damage and external signs of wear, such as cracking, embrittlement, or pronounced hardening, and residual dirt.

Instructions for Use JM-105

Validated reprocessing procedures

Overview of the reprocessing procedures of the components

Reprocessing

Components Surface disin-

fection with cleaning

JM-105 main device

Yes No No No See page 85

Manual cleaning followed by disinfection by immersion

Machine cleaning with thermal disinfection

Steam sterilization

Description of the procedure

Surface disinfection with cleaning

Components:

– Device components

– JM-105 main device

Surface disinfectant Manufacturer Concentration Contact time

Dismozon pur Bode 1.6 % 15 min

Prerequisites:

– The surface disinfectant has been prepared in

accordance with the manufacturer's instructions.

– The manufacturer's instructions, e.g., regarding

shelf life or application conditions, are observed.

– An uncontaminated, lint-free cloth soaked in

surface disinfectant is used for the cleaning surface disinfection.

WARNING Risk due to penetrating liquid

Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions

Ensure that no liquid penetrates the device.

WARNING Risk of cross contamination

Reusable products must be reprocessed, otherwise there is an increased risk of infection. – Disinfect the measuring probe before and

after every use on a patient.

Cleaning

1 Wipe off obvious soiling with a disposable cloth

soaked in surface disinfectant. Dispose of the

cloth.

2 Wipe all surfaces. After that, there must no lon-

ger be any soiling visible.

Surface disinfection

3 Wipe cleaned surfaces again to visibly wet all

surfaces to be disinfected with surface disinfec-

tant.

4 Wait for the surface disinfectant contact time.

Instructions for Use JM-105 85

Reprocessing

5 At the end of the contact time, moisten a new

uncontaminated and lint-free cloth with water (at least drinking water quality).

6 Wipe all surfaces until no remains of the surface

disinfectant, such as foam residues or streaks, are visible.

7 Wait until the surfaces are dry.

8 Check the surfaces for visible damage and, if

necessary, replace the product.

Supplementary information

9 Wipe clean the measuring probe with alcohol

before and after taking a measurement on the next patient. Wipe dry with a dry cloth.

Storage and transport

After reprocessing, there are no special requirements for storage and transport of the product. However, the following must be observed: – Store dry and free of dust – Avoid recontamination and damage during

transport

All further information on storage and transport included in the accompanying documents must be observed.

Instructions for Use JM-105

Other agents and reprocessing procedures

Disinfectants

WARNING

Risk of equipment damage.

Benzene, solvents, and thinners may dissolve the case of the JM-105.

Do not use benzene, solvents, or thinners.

Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure.

Surface disinfectants

The manufacturers of the surface disinfectants have verified at least the following spectra of activity: – Bactericidal – Yeasticidal – Virucidal or virucidal against enveloped viruses

Follow the manufacturer's instructions for surface disinfectants.

The following surface disinfectants were compatible with the material at the time of testing:

Reprocessing

Class of active ingredient

Chlorine-releasing agents

Oxygen-releasing agents

Alcohol Alcohol, ethanol, 70% Various All

1) United States Environmental Protection Agency

Dräger states that oxygen-releasing agents and chlorine-releasing agents may cause color change in some materials. Color change does not indicate that the product is not functioning correctly.

Instructions for Use JM-105 87

Surface disinfectant Manufacturer Listing

Klorsept 17 Medentech EPA

Actichlor plus Ecolab USA EPA

Dismozon pur BODE Chemie CE

Oxycide Ecolab USA EPA

Periodox RTU Bio Med Protect CE

Other surface disinfectants are used at one's own risk.

Reprocessing

Reprocessing procedures

Surface disinfection with cleaning

Components:

– Chargers

– JM-A33 docking station

Cleaning

1 For docking station, remove dust and dirt from

the surface and from the bottom.

2 Wipe off obvious soiling with a disposable cloth

soaked in surface disinfectant. Dispose of the cloth.

3 Wipe all surfaces. After that, there must no lon-

ger be any soiling visible.

After reprocessing

Assembling and fitting device-specific components

Prerequisites:

– All components have been reprocessed and are

dry.

Assembling the JM-105

1 Prepare the device so that it is ready for use,

see chapter Assembly and preparation.

Preparation before next use of device

Checking the operational readiness

Prerequisites:

– The device has been assembled and prepared

so that it is ready for operation.

Procedure:

 Check the operational readiness, see chapter

"Getting started“.

 Clean measuring probe with alcohol before tak-

ing a measurement on the next patient. Wipe dry with a dry cloth.

Instructions for Use JM-105

Service

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Definition of service terminology . . . . . . . . . 90

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Performing the inspection. . . . . . . . . . . . . . . . . 91

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Performing service . . . . . . . . . . . . . . . . . . . . . 92

Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Service

Instructions for Use JM-105 89

Service

Overview

This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the personnel responsible.

WARNING Risk due to inappropriately reprocessed prod-

ucts

The product may be contaminated with infectious agents.

Before service is performed and before the product is sent back for repair, reprocess the product in accordance with the chapter "Reprocessing".

WARNING Risk when the housing is being opened

Under the housing, there are live electrical components, which may cause an electric shock. – The housing may only be opened by those

target groups that are assigned to that particular measure.

WARNI NG Risk if service is not performed properly

Personal injury and property damage may occur if service is not performed properly.

Service must be performed by those target groups that are assigned to the particular measure.

WARNI NG Risk if maintenance is not performed properly

If the device is connected to the power supply or the gas supply during maintenance, there is a risk of personal injury and property damage.

Before performing maintenance, disconnect all electrical connections from the power supply and all gas connections from the gas supply.

Definition of service terminology

Concept Definition

Service All measures (inspection, maintenance, repair) intended to maintain or re-

store the functional integrity of a product

Inspection Measures intended to determine and assess the current state of a product

Maintenance Regular specified measures intended to maintain the functional integrity of a

product

Repair Measures intended to restore the functional integrity of a product after a fail-

ure

Instructions for Use JM-105

Inspection

Checks Interval Personnel responsible

Inspection Every 1 year Service personnel

Service

Performing the inspection

1 Check that the respective instructions for use

are present.

2 Perform a functional test of the following func-

tions according to the instructions for use: – Light measurement – Internal battery

3 Check that the product is in good condition:

– All labels are complete and legible

– There is no visible damage

4 Observe the instructions for use and check that

all components and accessories needed to use

the product are present.

5 Check the electrical safety in accordance with

the IEC 62353 standard.

Maintenance

WARNING Risk if service is not performed regularly

Wear and material fatigue of the components may lead to device failure and malfunctions.

Perform service at the specified intervals.

Component Interval Task Personnel responsible

Internal battery Every 2 years Exchange Service personnel

WARNING Risk of electric shock

Before performing any maintenance work, disconnect all electrical connectors from power supply.

Instructions for Use JM-105 91

Service

Calibration

Dräger recommends that calibration is performed by DrägerService every 12 months. Return the device to DrägerService for calibration.

The initial calibration is valid for one year from the date of manufacture. Subsequent calibrations are valid for one year from the date of the prior calibration.

Performing service

Removing battery

1 Remove battery cover (refer to Jaundice meter

JM-105 - Rear on page 16).

2 Replace battery.

3 Charge battery for 2 hours.

4 Perform operational checkout.

Repair

Dräger recommends that all repairs are performed by DrägerService and that only authentic Dräger repair parts are used.

WARNING Risk of injury or equipment damage.

This device has a built-in battery.

Ensure only properly trained personnel open device or attempt to replace battery.

WARNING Risk if the battery is not replaced properly

If the battery is not replaced properly, short circuits and high temperatures leading to explosion or fire may occur.

The battery must be replaced by the assigned target groups.

Instructions for Use JM-105

Disposal

Disposal of the product . . . . . . . . . . . . . . . . . 94

Disposal

Instructions for Use JM-105 93

Disposal

Disposal of the product

 At the end of its useful life, dispose of the prod-

uct in accordance with the applicable legal provisions.

For countries subject to the EU Directive 2002/96/EC

This device is subject to EU Directive 2002/96/EC (WEEE). In order to comply with its registration according to this directive, this device may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate collection or for further information, visit Dräger on the Internet at www.draeger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger website is not possible, contact the local Dräger organization.

Disposing of batteries

WARNING Risk of explosion and of chemical burns

Improper handling of batteries can result in explosions and chemical burns.

Do not throw batteries into fire. Do not force batteries open.

Observe the applicable laws and regulations for battery disposal.

Instructions for Use JM-105

Draeger JM-105 User guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Typographical conventions

Trademarks

Trademarks owned by third-party manufacturers

Illustrations

Use of terms

Safety information definitions

Contents

For your safety and that of your patients

General safety information

Strictly follow these instructions for use

Maintenance

Service

Connected devices

Not for use in areas of explosion hazard

Safe connection with other electrical equipment

Connection to other devices

Patient safety

Patient monitoring

Electromagnetic compatibility (EMC)

Storing the instructions for use

Training

Service

Target groups

Duties of the operating organization

Description of target groups

User

Service personnel

Reprocessing personnel

Product-specific precautions

Electrical precautions

General precautions

Storage and transportation precautions

Restrictions for use

Accessories

Application

Intended use

Indications/contraindications

Indications

Contraindications/limitations

Limitations (During phototherapy)

Limitations (Doctors Office Use)

Measuring Point

Overview

Device views

Jaundice meter JM-105 - Front Jaundice meter JM-105 - Rear

Docking station JM-A33 - Front Docking station JM-A33 - Rear

AC adapter JM-A32

External devices

Valid device combinations

Software

Device software

Interfaces

Data transmission software

Abbreviations

Symbols

Symbols on device

Symbols on touch screen

Symbols on the PC

Operating concept

Screen layout for device

Main screen

MENU screen

Measured data screen

Averaging screen

Screen layout for data transmission software

JM-S1w menu

Common screen

Network screen

HL-7 screen

Edit custom message screen

Transmission log screen

Barcode reader screen

Assembly and preparation

Charging the battery

Unpacking the data transmission software

Package contents