Draeger JM-105 User guide
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
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
iv
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".
2
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.
4
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
Use of the product in
accordance with the
intended use
Reprocessing personnel
Task Requirement
Reprocessing Specialist knowledge in the
6
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.
8
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.)
12
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
A
B
C
D
003
A
B
C
D
E
Device views
Jaundice meter JM-105 - Front Jaundice meter JM-105 - Rear
A
Power button
B
Measuring probe
C
Display/Touch panel
D
READY lamp
16
A
Screen LOCK button
B
Charging contact
C
Communication port
D
Battery cover
E
Barcode reader
Instructions for Use JM-105
Docking station JM-A33 - Front Docking station JM-A33 - Rear
004
A
B
C
D
E
005
A
B
A
USB connector
B
DC jack
Overview
A
Checker cover
B
Standard checker values
C
Reading checker
D
Communication window
E
Charger jack
Instructions for Use JM-105 17
Overview
006
A
B
C
D
AC adapter JM-A32
A
AC power cable plug
B
AC power cable
C
AC adapter
D
DC plug
18
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
20
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
N
B
L
S
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
Menu
Key
Go BACK to previous screen
EDIT the selected item
CLEAR the entry
Proceed to the NEXT BABY
Nurse ID
Baby ID
22
DEL
Scan
Sent to chart
Delete
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
OK
Confirm the entry
Busy
Symbols on the PC
JM-S1w
Overview
JM-S1w error
Instructions for Use JM-105 23
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24 Instructions for Use JM-105
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