jm-105_instructions_for_use_edition_1_march_2013.pdf
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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
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Instructions for Use JM-105
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Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
These target groups must have received instruction
in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined target groups.
Users
Service personnel must be trained in the maintenance of medical devices and install, reprocess,
and maintain the product.
Experts
Experts are persons who perform repair or complex
maintenance work on the product.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
Users are persons who use the product in accordance with its intended use.
Screen reproductions
Service personnel
The reproductions of screen content in the instructions for use can differ from the content shown on
the screen.
Service personnel are persons who are responsible
for the maintenance of the product.
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
z Bullet points indicate individual actions or different 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.
Instructions for Use JM-105
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for example, AVERAGE, Air, or 5 MIN.
The "greater than" symbol > indicates the navigation path in a dialog window, for example, System
setup > Ventilation > Basic settings.
Trademarks
Trademark
Trademark owner
Adobe
Reader®
Adobe Corporation
Windows®
Microsoft Corporation
i
Page 4
Trademark
Trademark owner
Windows
Vista®
Microsoft Corporation
Windows
XP® operating system
Microsoft Corporation
Windows 7®
operating
system
Microsoft Corporation
Pentium®
Intel Corporation
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.
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Instructions for Use JM-105
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Contents
Contents
Definition of target groups . . . . . . . . . . . . . . . . i
Typographical conventions . . . . . . . . . . . . . . . i
Safety information definitions . . . . . . . . . . . . . ii
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iii
For your safety and that of your patients. . .
1
General safety information . . . . . . . . . . . . . . . .
Product-specific precautions . . . . . . . . . . . . . .
2
4
Application . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications/contraindications . . . . . . . . . . . . . .
Further information on application . . . . . . . . . .
8
8
9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Device views. . . . . . . . . . . . . . . . . . . . . . . . . . .
External devices . . . . . . . . . . . . . . . . . . . . . . . .
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
15
15
16
17
Operating concept . . . . . . . . . . . . . . . . . . . . . 21
Screen layout for device . . . . . . . . . . . . . . . . . . 22
Screen layout for data transmission
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Assembly and preparation . . . . . . . . . . . . . . 27
Charging the battery . . . . . . . . . . . . . . . . . . . . . 28
Unpacking the data transmission software . . . . 30
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 31
Switch on and pre-set the device for the
first time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Pre-use checkout . . . . . . . . . . . . . . . . . . . . . . . 33
Data transmission software . . . . . . . . . . . . . . . 35
Instructions for Use JM-105
39
Ensuring correct measurement . . . . . . . . . . . . 40
Choosing settings for measurement . . . . . . . . 41
Measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Storing the device . . . . . . . . . . . . . . . . . . . . . . 48
Switching off the device. . . . . . . . . . . . . . . . . . 48
Quick guide for measuring . . . . . . . . . . . . . . . 49
Trends and Data. . . . . . . . . . . . . . . . . . . . . . .
51
Viewing measurements stored in the data
log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Deleting individual measurements in the
data log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Deleting all measurements in the data log . . . 53
Transmitting data to electronic charts . . . . . . . 54
Configuration. . . . . . . . . . . . . . . . . . . . . . . . .
57
Changing settings on the JM-105 . . . . . . . . . .
System and default settings for the JM-105 . .
58
58
Problem solving . . . . . . . . . . . . . . . . . . . . . .
61
Fault – Cause – Remedy. . . . . . . . . . . . . . . . .
62
Cleaning and disinfection. . . . . . . . . . . . . . .
67
Safety information . . . . . . . . . . . . . . . . . . . . . .
Reprocessing procedures . . . . . . . . . . . . . . . .
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . .
Before reuse on patients . . . . . . . . . . . . . . . . .
68
68
70
70
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . .
71
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preventive maintenance . . . . . . . . . . . . . . . . .
Performing service . . . . . . . . . . . . . . . . . . . . .
72
72
73
74
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
75
Disposing of the medical device . . . . . . . . . . .
76
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Contents
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 77
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .
Ambient conditions . . . . . . . . . . . . . . . . . . . . . .
Standards compliance . . . . . . . . . . . . . . . . . . .
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . .
78
79
80
81
Principles of operation . . . . . . . . . . . . . . . . . 85
Measuring principle . . . . . . . . . . . . . . . . . . . . . 86
Test results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
List of accessories . . . . . . . . . . . . . . . . . . . . . 91
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
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Instructions for Use JM-105
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For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . .
2
Strictly follow these instructions for use . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connection to other devices . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Information on electromagnetic compatibility . .
Storing the instructions for use . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
2
2
3
3
3
3
3
4
4
4
Product-specific precautions . . . . . . . . . . . .
4
Electrical precautions . . . . . . . . . . . . . . . . . . . .
General precautions . . . . . . . . . . . . . . . . . . . . .
Storage and transportation precautions . . . . . .
4
5
6
Instructions for Use JM-105
1
Page 8
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 8 and in conjunction with appropriate
patient monitoring (see page 3).
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.
2
Maintenance
WARNING
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
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
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.
Connected devices
WARNING
Risk of electric shock and of device malfunction
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.
Instructions for Use JM-105
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For your safety and that of your patients
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
Device combinations (Dräger devices + Dräger
devices or Dräger devices + third-party devices)
approved by Dräger (see instructions for use of
individual devices) meet the requirements of the
following standards:
–
–
IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility Requirements and tests.
IEC60601-1:2005, Medical electrical equipment
- Part 1: General requirements for basic safety
and essential performance
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.
Instructions for Use JM-105
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 different underlying diseases
Medical device modification or misuse can be dangerous.
Patient monitoring
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
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.
3
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For your safety and that of your patients
Information on electromagnetic
compatibility
General information on electromagnetic compatibility (EMC) according to international EMC standard
IEC 60601-1-2:
Medical electrical equipment is subject to special
precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and
put into operation in accordance with the EMC
information provided on page 81.
Portable and mobile radio frequency communication equipment can affect medical electrical equipment.
Training
Training for users is available via the Dräger organization responsible (see www.draeger.com).
WARNING
Risk of device malfunction
Electromagnetic fields can compromise
proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as:
- Mobile phones
- Radio frequency electrosurgical equipment
- Defibrillators
Storing the instructions for use
- Shortwave therapy equipment
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
Product-specific precautions
Electrical precautions
WARNING
Risk of fire, electric shock, or equipment damage
Using a docking station or AC adapter other
than JM-A33 provided with the device could
damage the device.
WARNING
Risk of fire, electric shock, or equipment damage
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.
Use only the docking station JM-A33 and the
AC adapter JM-A32 with the device.
4
Instructions for Use JM-105
Page 11
For your safety and that of your patients
WARNING
Risk of fire, electric shock, or equipment damage
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
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.
General precautions
Dust or water could collect at the plug of the
power cable.
WARNING
Risk of injury
Disconnect the power cable when the device
is not being used or charged for any length of
time.
Operating the device while the probe is
directed at the eyes can cause eye damage.
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 press the measuring probe when it is
directed at the eyes.
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.
Do not operate the device or its accessories if
any of them are damaged, or if there is smoke
or an odd odor.
Instructions for Use JM-105
5
Page 12
For your safety and that of your patients
CAUTION
Risk of equipment damage
CAUTION
Risk of equipment damage
Excessive vibration or impact could damage the
device.
Avoid vibration and physical shock during transportation.
Handle the device gently, and avoid excessive
impact or vibration.
NOTE
Ensure that the device is placed near the AC
power source. Also ensure the AC power cable
can be easily connected and disconnected.
NOTE
Thoroughly clean the device and accessories
before storing.
NOTE
To prove measuring reliability of the device, compare TcB value (Transcutaneous Bilirubin) measured by the device and TsB value (Total Serum
Bilirubin) measured from collected blood samples.
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.
6
Instructions for Use JM-105
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Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . .
8
Indications/contraindications . . . . . . . . . . . .
8
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications . . . . . . . . . . . . . . . . . . . . . . .
8
8
Further information on application. . . . . . . .
9
Limitations (Doctors Office Use). . . . . . . . . . . .
9
Instructions for Use JM-105
7
Page 14
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 not intended as a standalone screening device for diagnosis of hyperbilirubinemia. It is used as a screening device with other
clinical signs and laboratory measurements.
Indications/contraindications
Indications
Contraindications
The Jaundice Meter is indicated for use in neonatal
patients born >24 weeks gestation who have not
undergone transfusion or phototherapy treatment.
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 device is indicated only for use before phototherapy treatment.
The Jaundice Meter is not intended for home use.
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.
8
Instructions for Use JM-105
Page 15
Application
Further information on application
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.
Limitations (Doctors Office Use)
Use only on infants up to 14 days of age.
For doctors office application, use only the sternum
location when taking measurements.
Please be aware, performance in doctors offices
may vary from performance in hospitals.
Measuring Point
Measurements must be taken only on the infant’s
sternum (at hospital sites or physicians’ offices) or
forehead (at hospital sites only) where a sufficient
amount of blood is circulated. A possibility exists
that the bilirubin in the subcutaneous tissue may
measure low for areas with minimal blood flow or
areas in which the subcutaneous tissue is subject
to keratinization.
Although correlation with serum bilirubin was
observed for both sternum and forehead measurements, the clinical studies performed with the Jaundice Meter JM-103 show consistently better results
with measurements taken at the sternum versus
the forehead. There is a possibility that this difference may be more pronounced for infants that have
been exposed to sunlight, such as infants seen at
doctors’ offices. Only sternum measurements were
evaluated during the studies conducted at doctors’
offices; correlation of forehead measurements with
serum bilirubin has not been evaluated, and the
device is not intended for forehead measurements
at doctors’ offices.
Instructions for Use JM-105
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Instructions for Use JM-105
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Overview
Overview
Device views . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Jaundice meter JM-105 - Front . . . . . . . . . . . .
Jaundice meter JM-105 - Rear . . . . . . . . . . . . .
Docking station JM-A33 - Front . . . . . . . . . . . .
Docking station JM-A33 - Rear. . . . . . . . . . . . .
AC adapter JM-A32 . . . . . . . . . . . . . . . . . . . . .
12
12
13
13
14
External devices . . . . . . . . . . . . . . . . . . . . . . . 15
Valid device combinations . . . . . . . . . . . . . . . . 15
Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Device software . . . . . . . . . . . . . . . . . . . . . . . . 15
Data transmission software . . . . . . . . . . . . . . . 15
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Symbols on device . . . . . . . . . . . . . . . . . . . . . . 17
Symbols on touch screen . . . . . . . . . . . . . . . . . 18
Symbols on the PC. . . . . . . . . . . . . . . . . . . . . . 19
Instructions for Use JM-105
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Page 18
Overview
Device views
Jaundice meter JM-105 - Front
Jaundice meter JM-105 - Rear
D
E
A
A
D
C
C
A
B
C
D
12
Power button
Measuring probe
Display/Touch panel
READY lamp
003
B
002
B
A
B
C
D
E
Screen LOCK button
Charging contact
Communication port
Battery cover
Barcode reader
Instructions for Use JM-105
Page 19
Overview
Docking station JM-A33 - Front
Docking station JM-A33 - Rear
A
B
A
C
005
B
A USB connector
B DC jack
D
004
E
A
B
C
D
E
Checker cover
Standard checker values
Reading checker
Communication window
Charger jack
Instructions for Use JM-105
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Overview
AC adapter JM-A32
A
C
B
006
D
A
B
C
D
14
AC power cable plug
AC power cable
AC adapter
DC plug
Instructions for Use JM-105
Page 21
Overview
External devices
Valid device combinations
Interfaces
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.
The USB port provides a connection for transmitting data to electronic health records systems. It
also provides an alternate method to charge the
device.
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.
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
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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 Nomenclature
IEC
International Electrotechnical Commission
LCD
Liquid crystal display
PC
Personal computer
RH
Relative humidity
ROM
Read only memory
UMDNS
Universal Medical Device Nomenclature System
USB
Universal Serial Bus
16
Instructions for Use JM-105
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Overview
Symbols
Symbols on device
Standby or On/Off
Warning
Input
Caution
Circuit output terminal
Degree of protection against electric shock: Type BF
Refer to instructions for use
AC power
DC Power
Do not discard with regular waste
Date of manufacture
USB port
Instructions for Use JM-105
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Overview
Symbols on touch screen
Rechargeable battery
Go BACK to previous screen
BACK
EDIT the selected item
Priority flag
EDIT
CLEAR the entry
Lock
CLEAR
Proceed to the NEXT BABY
Not used at this time, for future use
NEXT
BABY
Menu
Key
Nurse ID
N
Baby ID
Scan
B
L Value (long)
…
Sent to chart
L
S Value (short)
Delete
DEL
Delete
S
Delta Value (difference between
long value and short value)
DEL
18
Instructions for Use JM-105
Page 25
Overview
CANCEL the entry or stop the task
CANCEL
Confirm the entry
OK
Busy
Symbols on the PC
JM-S1w
JM-S1w error
Instructions for Use JM-105
19