Synthes Universal Battery Charger II User manual

Universal Battery
Charger II
Instructions for Use


Universal Battery Charger II Instructions for Use DePuy Synthes 1
Table of Contents
Introduction General Information 3
Description of the Device • Front view 7
• Rear view 7
Operating the Device Starting the System 8
Charging the Battery 9
• Charger bay 9
• Charging the battery 10
• Temperature monitoring 11
• Charging new batteries or batteries not recently used
11
• Errors during charging 11
Checking and Refreshing Batteries 12
• Battery Power Line and Colibri/SBD batteries 12
• Battery Power Line II and Colibri II /SBD II batteries 14
• Trauma Recon System power module 16
Storing Batteries 17
30% State of Charge 18
Care and Maintenance Cleaning 19
Repair and Technical Service 20
Disposal 21
Troubleshooting 22

2 DePuy Synthes Instructions for Use Universal Battery Charger II
Technical Data Device Specifications 25
Minimum required Firmware version of UBC II 26
Environmental Conditions 27
Applicable Standards 28
Electromagnetic Compatibility 29
Permissible Battery Types 33
• Battery for Battery Power Line 33
• Battery for Battery Power Line II 33
• Power module for Trauma Recon System 33
• Batteries for Colibri/Small Battery Drive 34
• Battery for Colibri II/Small Battery Drive II 34
Explanation of Symbols Used Symbols for Operating the Charger 35
Symbols on the Charger 36
Ordering Information 37
Table of Contents

Universal Battery Charger II Instructions for Use DePuy Synthes 3
Introduction
Associated device systems with these instructions for use
are the Universal Battery Charger II (05.001.204).
The Universal Battery Charger II consists of the charger
(05.001.204). This charger is also supplied with a
country-specicpowercordandfourslotcoversets
(05.001.228). The charger may only be used with the
supplied power cord.
Refertosection‘OrderingInformation’forspecic
devices in scope.
The Universal Battery Charger II (UBC II), allows the
following Synthes batteries/power modules to be auto-
matically charged and manually checked. The below
table further also highlights the compatibility between
handpieces and batteries/power modules.
Introduction
General Information
System Handpieces Battery/Power Module
Battery Power Line 530.605 530.620* (14.4 V, NiMH)
530.610
530.615
Battery Power Line II 530.705 530.630 (14.8 V, Li-Ion)
530.710
530.715
Trauma Recon System 05.001.201 05.001.202 (25.2 V, Li-Ion)
05.001.240
Colibri/Small Battery Drive 532.001/532.010 532.003* (12 V, NiCd)
532.033* (14.4 V, NiCd)
ColibriII/SmallBatteryDriveII 532.101/532.110 532.103(14.4V,Li-Ion)
If required, Battery Power Line battery (530.620*)
and Colibri/Small Battery Drive batteries (532.003*,
532.033*) can also be refreshed with the charger.
Intended Use
The Universal Battery Charger II (05.001.204) is intended
for charging and/or conditioning of authorized Synthes
batteries and power modules.
Warning: The battery for the Power Drive (530.200)
cannot be charged with the UBC II. Please use the
UBC item number 530.600 or 530.601.
* Phased-out and no longer available for order.

4 DePuy Synthes Instructions for Use Universal Battery Charger II
Indications
Therearenodevicespecicindicationsassociatedwith
the UBC II device as it is not patient contacting and is
not used during a surgical procedure.
Contraindications
Therearenodevicespeciccontraindicationsassociated
with the UBC II device as it is not patient contacting and
is not used during a surgical procedure.
Potential Adverse Events, Undesirable Side Effects
and Residual Risks
The UBC II device is not patient contacting and is not
used during a surgical procedure.
DePuy Synthes manufactures surgical instruments in-
tended to prepare the site and aid in implantation of
Synthes implants. The adverse events/side effects are
based upon the implant devices rather than the instru-
ments.Specicadverseevents/sideeffectsforthe
implants can be found in the respective Synthes implant
instructions for use.
Patient Target Group
There are no restrictions on patient population as the
UBC II device is not patient contacting and is not used
during a surgical procedure.
Introduction
General Information
Intended User
The Universal Battery Charger II is intended to be used
byqualiedhealthcareprofessionals.
Expected Clinical Benefits
Not applicable. The device is an accessory which is
usedtoenablespecicSynthesbatteries/power
modules to meet their function.
Treatment before Device is Used
Warning: For safety reasons, please read the IFU care-
fully before using UBC II.
Combination of Medical Devices
The UBC II is a standalone device, the compatible
batteries/power modules which can be charged and
refreshed, as well as the power cords are listed in the
section: ‘Ordering Information’.

Universal Battery Charger II Instructions for Use DePuy Synthes 5
General Warnings and Precautions
Warnings:
• Do not use the device in the direct vicinity of
radiators or other heat emitting devices, as these
can affect the device.
• The device must not come into direct or indirect
contact with the patient. As the charger is not a
sterile product, it must not be used in the sterile
area of the operating room. However, the device
may be used in the non-sterile part of the operat-
ing room.
• The use of high frequency (HF) equipment for
tissue coagulation can cause electromagnetic
interferences – in this case the cables should be
separated as far as possible.
• Do not sterilize, wash, rinse, drop or apply force
to the UBC II. This will destroy it with possible
secondary damage.
• Do not expose the device to direct sunlight or
moisture.
• Do not dismantle, open, short-circuit or manipu-
late the device.
• Before operating the device, visually inspect the
device for damage and wear (e.g. unrecognizable
markings, missing or removed part numbers,
corrosion, etc.). Do not use any component if dam-
age is apparent.
Precautions:
• The device may only be used with the supplied
power cord. Only connect to a power supply with
grounding, a rated voltage between 100 V and 240 V
and a network frequency range of 50 or 60 Hz.
• The device may only be operated on an even,
dry surface that is sufciently strong to hold its
weight. Place the device on a non-slip, stable base.
• Do not dismantle, open, short-circuit or manipu-
late the device. Risk of electric shock!
• The charging station should always be turned on
when a battery is in the charging bay. This ensures
availability and prevents discharge.
• If the device drops on the oor, fragments may
split off. This represents a danger for the user as
these fragments may be sharp.
• Should the device have corroded parts, do not use it
anymore and send it to the DePuy Synthes Service
Center.
• If the device is damaged, contact the DePuy Syn-
thes representative. Do not use damaged or faulty
devices. Send the device to the DePuy Synthes
representative for repairs.

6 DePuy Synthes Instructions for Use Universal Battery Charger II
Storage and Transport
All batteries /power modules should be removed for
transporting the charger.
The UBC II with a minimum of Firmware 17.2 allows the
usertochargespecicDePuySynthesLithiumIonbatter-
ies to 30% of their capacity for transportation in aircraft
cargo bays. Please refer to the section 30% State of
Charge within this IFU for detailed information.
Use the original packaging for shipping and transport.
If this is no longer available, please contact the
DePuy Synthes representative.
The same environmental conditions apply for transport
as for storage.
Warnings:
• The device is designed to be operated and stored in
closed rooms. Do not use the device in the direct
vicinity of radiators or other heat emitting devices,
as these can affect the device.
• Do not store/use the device in the presence of oxy-
gen, nitrous oxide or a mixture consisting of am-
mable anesthetics and air.
Warranty
The warranty for the device is null and void if the device
has not been used properly or the guarantee seal has
been damaged. The manufacturer does not accept lia-
bility for damage resulting from repairs or maintenance
carried out by unauthorized sites. For a complete
warranty statement, please contact DePuy Synthes
Customer Service.
Introduction
General Information

8
7
9
6
4
3
5
1
2
Universal Battery Charger II Instructions for Use DePuy Synthes 7
Front view
1Charger bays (24)
2Symbols for battery type
3ON/OFF blue LED
4Control symbols for each charging bay
5Ventilation holes
Description of the Device
Rear view
6Ventilation holes
7Power switch
8Fuses: 225 AT/250 V
9Power cord connection
The Slot Covers Set (05.001.228) consists of three plastic
elements which can be used to cover the non-used slots
of the charger.

8 DePuy Synthes Instructions for Use Universal Battery Charger II
Beforestartingforthersttime,ensurethatthepower
switch is set to . The device can only be connected to
the power supply using the supplied power cord. Set the
power switch to Itoturnthedeviceon(g.1).TheON/
OFF blue LED on the front of the device shows that it is
workingproperly(g.2).IftheblueLEDashes,the
device must be sent in for control.
If the symbol forasinglechargerbayisred(g.3)
before the battery is inserted, this charger bay is
faulty. In this case, batteries/power modules can still
be charged in the other charger bays, but it is recom-
mended that the device be sent to the local DePuy
Synthes representative for repairs.
Warning: Ensure that the ventilation holes in the
base and side of the device are not covered by tow-
els or other objects.
Precaution: Ensure that the power cord can always
be disconnected immediately from mains supply.
Operating the Device
Starting the System
Fig. 1
Fig. 2
Fig. 3

2
3
1
Universal Battery Charger II Instructions for Use DePuy Synthes 9
Operating the Device
Charging the Battery
Charger bay
Thedeviceisttedwithfourindependentchargerbays.
Each of these has three slots for the following batteries
( g . 1) :
1Battery Power Line and Battery Power Line II batteries
(530.620, 530.630)
2Trauma Recon System Power Module (05.001.202)
3Colibri /SBD and Colibri II /SBD II batteries (532.003,
532.033, 532.103)
Fig. 1

10 DePuy Synthes Instructions for Use Universal Battery Charger II
Fig. 2
Fig. 3
Charging the battery
Place the battery to be charged in the proper direction
into the corresponding slot of an empty charger bay.
Ensurethatthebatteryisttedcorrectlyandisidentied
by the device (symbol isyellow).Seeg.2.
Only one battery can be charged in each charger bay at
a time. All charger bays can, however, be used simulta-
neously with any combination of battery types.
Warnings:
• Insert the battery into the correct slot.
• Do not charge damaged batteries with UBC II.
Inspect battery for cracks and damage.
• Do not insert any objects other than authorized
Synthes batteries into the charger, as the contacts
may otherwise be damaged.
Precaution:
• If the symbol does not light up after the battery is
inserted, remove the battery and insert again or
insert into another charger bay.
• Only use fully charged batteries to avoid delays
during surgery.
Depending on the charge status and type of battery, it
can take from about 15 minutes to around 60 minutes
to charge.
Once the battery is fully charged, the symbol is green
and the charger switches to maintenance charge
(g.3).Thebatterycanbeleftinthecharger.Leavethe
device switched on to ensure that the battery is always
fully charged.
If the battery is removed from the charger before the
symbol lights up green, it will not be fully charged.
Operating the Device
Charging the Battery

Universal Battery Charger II Instructions for Use DePuy Synthes 11
ashing
Temperature monitoring
The battery and the charger heat up during the charging
process. The ventilation holes should therefore not be
covered.
If the battery temperature is too high, the symbol
startsashing(g.4).Toprotectthebattery,thedevice
stops charging until the battery has cooled down. Do
not remove the battery from the charger if this occurs
until the symbol stopsashingandstaysyellow.The
charging time will be longer in this case.
Warning: Always control the temperature of the
device to prevent overheating and possibly harming.
Charging new batteries or batteries not recently
used
Battery Power Line battery (530.620) or Colibri/SBD batter-
ies (532.003, 532.033) that have not been used for a long
period of time and that have not been stored in an acti-
vated charger do not reach their maximum performance
for several charging and discharging cycles. The charger
can be used to check the battery status and to refresh the
battery (see page 11).
Errors during charging
The following errors may occur while charging a battery:
Symbol flashes (fig. 4)
The battery is too hot and has to cool down before the
charging process can be automatically resumed. The
battery should be left in the charger until the battery
symbol lights up green. Otherwise, it is not ensured that
the battery is fully charged.
Symbol is red (fig. 5)
The battery is faulty and has to be replaced.
No symbol lights up
The battery has not engaged in the charging bay or has
not been recognized by the device. Remove the battery
and insert again or use another charger bay.
Fig. 4
Fig. 5

12 DePuy Synthes Instructions for Use Universal Battery Charger II
Operating the Device
Checking and Refreshing Batteries
1. Battery Power Line and Colibri/SBD batteries
The charger enables Battery Power Line battery
(530.620) and Colibri/SBD batteries (532.003, 532.033)
to be refreshed and checked.
Itwillbeindicatedifthebatteryperformanceissuf-
cient or if the battery needs to be replaced.
The following factors will affect the battery perfor-
mance:
• Unused, new battery
• Battery not used for a longer period
In these cases a battery will only reach its maximum
performance after several charging and discharging
cycles. The check and refresh function ensures that
the battery regains its maximum performance again.
• Old battery
The battery performance declines with age and usage.
With the check function it can be seen if the battery
performanceissufcient.Insomecases,batteriesthat
are too old can no longer be refreshed.
When required, the check and refresh function is started
manually, as outlined below.
After the battery is inserted, the symbol lights up
yellow. To refresh and check the battery, press the but-
ton with the exclamation mark for at least 2 seconds
(g.1)untilthesymbol lightsupyellow(g.2).The
device then carries out the process. The symbol is
yellow throughout this time.
Precautions:
• To recharge batteries normally, do not press the
exclamation mark button .
• Do not remove the battery from the charger bay as
long as the symbol is yellow. Wait until the pro-
cess has ended and the symbols or light up.
Only then is the battery status clearly assessed.
Fig. 1
Fig. 2

Universal Battery Charger II Instructions for Use DePuy Synthes 13
Completion of the process is indicated as follows:
• Symbol isgreen(g.3):Batteryhasbeensuccess-
fully refreshed, checked and charged.
• Symbol isred(g.4):Eitherthebatteryisfaultyor
performanceisinsufcient.Thebatterymustbedis-
posed of.
The entire process (refreshing and checking battery
status) takes around 10 hours and should only
be carried out if there is enough time to do so.
A battery can be charged, checked or refreshed inde-
pendently in each charger bay.
Precautions:
• Checking the battery status and refreshing the
battery have an impact on the battery. If this is
carried out frequently the lifespan of the battery
can be affected.
• The process is interrupted if there is a power cut
or a switch to the emergency power supply and
will then have to be restarted.
Fig. 3
Fig. 4

14 DePuy Synthes Instructions for Use Universal Battery Charger II
2. Battery Power Line II and Colibri II /SBD II
batteries
The charger enables Battery Power Line II and Colibri II /
SBD II batteries (530.630, 532.103) to be checked. It will
beindicatedifthebatteryperformanceissufcientorif
the battery needs to be replaced.
Due to the very low self-discharging rate of Lithium-
based batteries a refresh function is not required.
When required, the check function is started manually,
as outlined below.
After the battery is inserted, the symbol lights up
yellow. To check the battery, press the button with the
exclamation mark foratleast2seconds(g.5)until
the symbol lightsupyellow(g.6).Thedevicethen
carries out the process. The symbol is yellow through-
out this time.
Precautions:
• To recharge batteries normally, do not press the
exclamation mark button .
• Do not remove the battery from the charger bay as
long as the symbol is yellow (g. 6). Wait until
the process has ended and the symbols or
light up. Only then is the battery status clearly
assessed.
Fig. 5
Fig. 6
Operating the Device
Checking and Refreshing Batteries

Universal Battery Charger II Instructions for Use DePuy Synthes 15
Completion of the process is indicated as follows:
• Symbol isgreen(g.7):Batteryhasbeensuccess-
fully checked and charged.
• Symbol isred(g.8):Eitherthebatteryisfaultyor
performanceisinsufcient.Thebatterymustbedis-
posed of.
The entire process (checking battery status) takes around
3 hours and should only be carried out if there is enough
time to do so.
A battery can be charged or checked independently in
each charger bay.
Precautions:
• Checking the battery status has an impact on the
battery. If this is carried out frequently the lifes-
pan of the battery can be affected.
• The process is interrupted if there is a power cut
or a switch to the emergency power supply and
will then have to be restarted.
Fig. 7
Fig. 8

16 DePuy Synthes Instructions for Use Universal Battery Charger II
3. Trauma Recon System power module
To ensure that the Trauma Recon System (05.001.201,
05.001.240) can operate safely and reliably, the Trauma
Recon System power module (05.001.202) has to be
checked at periodical intervals. It will be indicated if the
powermoduleperformanceissufcientorifthepower
module needs to be replaced.
The charger will indicate the necessity, but the user can
choose a convenient time to check the power module,
as this can take around 4 hours.
When it needs to be checked, the symbol ashes
(g.9).Thecheckneedstobecarriedoutwithinthe
next 3 charging cycles. This is done by pressing the ex-
clamation mark button foratleast2seconds(g.10).
The symbol light goes out and the symbol stops
ashingandstaysyellow(g.11).Ifthecheckisnot
carried out within the next 3 charging cycles, the device
carries out the check automatically.
Completion of the process is indicated as follows:
• Symbol isgreen(g.7onpreviouspage):power
module has been checked, charged and is ready to use.
• Symbol isred(g.8onpreviouspage):power
module has been checked, is not charged and cannot
be used; the red service indicator lamp on the power
module lights up. Send in the power module for ser-
vicing.
A power module can be charged or checked indepen-
dently in each charger bay.
Fig. 9
Fig. 10
Fig. 11
ashing
ashing
Operating the Device
Checking and Refreshing Batteries

Universal Battery Charger II Instructions for Use DePuy Synthes 17
Immediately recharge batteries and the power module
after each use.
Any Colibri/SBD batteries (532.003, 532.033) or Battery
Power Line battery (530.620) that are not used should
always be stored in the activated charger (maintenance
charge). This guarantees that the batteries are always
fully charged and ready to use.
It is not necessary to store Trauma Recon System power
module (05.001.202), Battery Power Line II battery
(530.630) and Colibri II/SBD II battery (532.103) in the
charger. Once charged they can be stored outside the
charger without any noticeable charge difference due to a
very low self-discharging rate of Lithium-based batteries.
Warning: Unusable or faulty batteries/power mod-
ules must not be reused and should be disposed of
in an environmentally friendly manner and in
accordance with national regulations. For further
information, refer to the section ‘Disposal’ in this
IFU.
Operating the Device
Storing Batteries

Fig. 1
Fig. 3
Fig. 2
Fig. 4
18 DePuy Synthes Instructions for Use Universal Battery Charger II
When transporting Lithium Ion batteries in aircraft cargo
bays, rules and regulations require batteries to only have
a maximum of 30% state of charge.
TheUBCIIwithaminimumrmwareversion17.2allows
the user to charge the following Synthes Lithium Ion
batteries to 30% of their capacity for transportation:
• Battery Power Line II Battery (530.630)
• Colibri II Battery (532.103)
Operation Instructions
1. Insert the battery into the corresponding charger bay.
As soon as the battery is placed in the UBC II, the
symbol will light up yellow (Fig. 1).
2. To charge the battery to 30% state of charge (SOC),
the button with the exclamation mark has to be
pressedvetimes(5x)within5seconds(Fig.1).
3. Asaconrmationforthestartofthe30%SOC,
allLED’sashfourtimes(4x)(Fig.2).
4. When the yellow symbols and light up, the UBC II
is performing the 30% SOC function. This will take
between 30 and 90 minutes depending on the charge
status and type of battery (Fig. 3).
5. Once the battery has been charged to 30% SOC,
the green symbol lights up and the red symbol
ashes(Fig.4).
6. The batteries are now ready for transportation. They
must not be used in the OR in this status as they are
not fully charged. Once the battery has been removed
from the charger, the SOC function switches off.
Notes:
• If the battery has been left in the bay since the last
charge, the 30% SOC function can only be started
if the battery is removed from the charger and
placed once again into the charger bay by the user.
• If the exclamation mark was not pressed ve times
(5x) within 5 seconds, then the step must be re-
peated.
• If the battery is removed during the 30% SOC
function, then the process needs to be restarted.
• Please note that during the SOC function the other
charging bays can be used as usual.
Operating the Device
30% State of Charge
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