Acculan 3Ti Charger Instructions for Use Ver 4.0 June 2021

en 11. 12.

1.

Disposal... 17 Distributor in the US/Contact in Canada for product information and complaints... 17

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

DANGER

WARNING

Risk of fatal injury from electric shock! ► Do not open the product (except for changing a charging bay). ► Connect the product only to a grounded power supply. Risk of injury and material damage due to inappropriate use of the product. ► Use the product only in accordance with the intended purpose.

► Prior to use, check that the product is in good work-

ing order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see TA022451. ► To prevent damage caused by improper setup or use and in order not to compromise the warranty and liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. – Ensure the manufacturer's approval before using accessories that are not mentioned in the instructions for use. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Ensure that the user does not come into contact with the patient while using the product. ► Use the product in unsterile areas only. ► Keep the instructions for use accessible for the user.

► Always adhere to applicable standards. ► Ensure that the electrical facilities in the room in

which the device is being used conform to IEC/DIN EN norms. ► Disconnect from the power supply by pulling on the plug, never on the power cord. ► Do not operate the product in explosion-hazard areas. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Always observe the instructions for use of the Acculan rechargeable batteries.

2.

Product description

2.1

Scope of supply

Art. no.

Designation

GA677

Acculan 3Ti charger

TA012093

Folder for Acculan 3Ti instructions for use

TA022160

Instructions for Use

2.2

Components required for operation

■ Acculan 3Ti charger ■ Mains power cord 2.3

Intended use

Task/Function The Acculan 3Ti charger GA677, referred to as the charger or product in the following, is used exclusively with the corresponding charging bay to charge AesculapAcculan 3Ti batteries GA676 and GA666 and the Acculan batteries GA646, GA626, and GA616. Note Other batteries must not be charged with this product!

Application Environment For use in enclosed spaces: ■ Outside of the explosion-hazard area ■ Not in the vicinity of patients Installation location: Table or shelf

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en 2.4

Explanation of charging bay indicators/symbols Charging progress indicator (illuminated in green) The symbol is divided in 4 sections and indicates the progress of charging. Minimal illumination: Start of automatic charging Complete illumination: Charging completed Symbol "Action request" (illuminated in orange) Charging could not be completed normally, see Troubleshooting list. Symbol "Battery change recommended" (illuminated in orange) Automatic battery check failed. This function is only available with Acculan 3Ti rechargeable battery GA666 and GA676, see Charging of Acculan 3Ti rechargeable batteries GA676 and GA666

2.5

Operating principle

The charger is designed for a mains voltage range of 100 V to 240 V and 50 Hz to 60 Hz. The mains voltage is converted into a protective extra-low voltage. To make the charger ready for operation, connect it to mains power using the mains power cord. No other action is required to activate or deactivate the console. The charger performs a self-test, which takes approx. 3 qqqseconds. During this test, all indicator elements at the front panel of the charger are illuminated. The charger is equipped with four independent slots for charging bays for Acculan 3Ti rechargeable batteries GA676 and GA666 or for charging bays for Acculan rechargeable batteries GA646, GA626 and GA616. Each charging bay has an indicator field on the charger front panel assigned to it. Charging starts automatically as soon as a battery is inserted in a charging bay. The charging time in all four charging bays depends on the charge state and capacity of the batteries. After a successfully completed charging process, the charger switches to trickle charging. Note If the battery is left in the charger, it is ensured that the battery is fully charged at all times. This prevents any self-draining of the battery.

Charging principle The batteries are charged very gently with constant current pulses. The charge state of the battery is continuously monitored throughout charging. Monitoring of the charging curve ensures that the battery is fully charged without overcharging. The battery temperature and charging time are monitored, too. The Acculan 3Ti rechargeable batteries GA676 and GA666 undergo an automatic battery check during charging. This check assesses the battery condition. If this assessment yields a negative result, the "Battery change recommended" symbol (in the respective indicator field 2) is illuminated to alert the user. This battery can still be used to work with. However, it must be taken into account that an intraoperative battery change may be necessary due to the reduced performance.

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en Battery temperature

3.

Each charging bay is equipped with a fan, which works independently of the battery temperature. The charging of the battery is aborted as soon as a battery temperature of >47 °C is detected. Excessive battery temperature is indicated by the “Action request” symbol illuminated in indicator field 2. When the battery temperature drops below 45 °C, the "Action request" symbol in indicator field 2 still remains illuminated. The battery must be removed from the respective charging bay and plugged in again to restart charging.

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – the national regulations on fire and explosion protection, – Instructions for use according to IEC/DIN EN regulations.

AC frequency

We provide the following information on the basis of the IEC/DIN EN regulations valid at the present time:

Charging is stopped as soon as the maximum charging time is reached. The permanent monitoring of the battery also allows detecting faults in the battery block. When a battery fault or a charging fault is detected, this is indicated by the “Action request” symbol illuminated in indicator field 2 and charging is aborted. The charging bays can be ordered separately, see Accessories/Spare parts.

Preparation and setup

DANGER

CAUTION

3.1

Fire and explosion hazard! ► Do not operate the product in explosion-hazard areas. Malfunction of, or damage to the product caused by improper setup! ► Do not expose the product to direct sunlight or moisture. ► Do not cover the ventilation slots of the product. ► Only connect the product to a mains power system with an equipment grounding conductor and with a voltage rating 100 V to 240 V and a mains power frequency range of 50 Hz to 60 Hz. ► Ensure that the mains power socket used for supplying the product is freely accessible.

First use

Note The charger is designed for use outside of the patient environment, on a table or shelf. ► Place the charger on a sufficiently stable and non-

slip support (e.g. table or shelf). ► Ensure that the ventilation slots on the underside

of the charger are not covered.

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en 4.

Working with the Acculan 3Ti charger

4.1

System set-up

Connecting the power supply

DANGER

CAUTION

Risk of fatal injury from electric shock! ► Connect the product only to a grounded power supply. Malfunction of, or damage to the product caused by improper setup! ► Do not expose the product to direct sunlight or moisture. ► Do not cover the ventilation slots of the product. ► Only connect the product to a mains power system with an equipment grounding conductor and with a voltage rating 100 V to 240 V and a mains power frequency range of 50 Hz to 60 Hz. ► Ensure that the mains power socket used for supplying the product is freely accessible.

► Carry out a visual inspection before connecting the

product to the mains power: – Check the mains power cord for any damage. – Check the charger for any damage (e.g. bent, short-circuited contacts of the charging bays). ► Do not use the product if it is damaged, defective or dirty. Immediately separate out any damaged product and clean any dirty product, see Validated reprocessing procedure. ► Plug in the mains power cord at device socket 5. ► Plug in the mains plug at the mains power socket.

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► Carry out a visual inspection of the "Power On"

indicator 3 and the indicator fields for charging bays 2. After being connected to the mains power, the charger performs a self-test. During this time the "Power On" indicator 3 and the indicator fields for charging bays 2 must be illuminated on the front panel of the charger, then only the "Power On" indicator 3 is illuminated. The product is ready for operation. Note If an error occurs, see Troubleshooting list.

Disconnect the charger from the mains power Note The charger does not have a power ON/OFF switch. ► To disconnect the charger from the mains power,

detach the mains power cord.

en 4.2

Function checks

4.3

Safe operation

► Carry out a visual inspection before connecting the

product to the mains power: – Check the mains power cord for any damage. – Check the charger for any damage (e.g. bent, short-circuited contacts of the charging bays). ► Do not use the product if it is damaged, defective or dirty. Immediately separate out any damaged product and clean any dirty product, see Validated reprocessing procedure. ► Plug in the mains power cord at device socket 5. ► Plug in the mains plug at the mains power socket. ► Carry out a visual inspection of the "Power On" indicator 3 and the indicator fields for charging bays 2. After being connected to the mains power, the charger performs a self-test. During this time the "Power On" indicator 3 and the indicator fields for charging bays 2 must be illuminated on the front panel of the charger, then only the "Power On" indicator 3 is illuminated. Note If an error occurs, see Troubleshooting list. ► Ensure that all components to be used function

properly and are properly connected.

WARNING

WARNING

CAUTION

Risk of injury and material damage due to inappropriate use of batteries! ► Always observe the instructions for use of the rechargeable batteries. Risk of injury and material damage due to damaged batteries! ► Check batteries for any damage before charging. ► Do not use or recharge damaged batteries. Loss of capacity/performance due to prolonged storage of discharged batteries! ► After a successfully completed charging process, leave the battery in the operational charger (trickle charging).

► As excessive battery temperatures will prolong the

charging time, allow batteries to cool down prior to charging. ► To remove the battery, if necessary use a cloth as the batteries become heated during the charging process. ► Remove batteries from the charging bays if the charger is not operational, as otherwise the charger will drain the batteries. ► Disconnect the charger from mains power by unplugging the mains power cord at the mains power socket.

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en Charging of Acculan 3Ti rechargeable batteries GA676 and GA666

CAUTION

Destruction of the product, charging bay or battery due to inserting the wrong type of battery in the charging bay! ► Insert batteries only in their appropriate charging bays. ► Insert batteries in their correct position.

► Insert the battery into the charging bay with the

contacts pointing downwards, so that the marking on the battery A corresponds with the marking on the charging bay B, see Fig. 1.

A B

Fig. 1 Legend A Marking on the battery B Marking on the charging bay

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"Charging progress” indicator Battery charging starts automatically.

"Charging progress” indicator Charging has been completed; remove the battery from the charging bay. The charging time depends on the charge state and capacity of the batteries. "Battery change recommended" indicator Symbol is illuminated in addition to "Charging completed“ indicator. The battery failed the automatic battery check. This battery can nevertheless still be used to work with. However, it must be taken into account that an intraoperative battery change may be necessary due to the reduced performance. "Action request“ indicator Charging cannot be performed normally; the “Charging progress” indicator goes dark. Possible cause: bad contacts; excessive battery temperature during charging, see Troubleshooting list.

en Charging of Acculan rechargeable batteries GA646, GA626 and GA616

CAUTION

Destruction of the product, charging bay or battery due to inserting the wrong type of battery in the charging bay! ► Insert batteries only in their appropriate charging bays. ► Insert batteries in their correct position.

► Insert batteries with their contacts pointing down

in the charging bay, see Fig. 2.

"Charging progress” indicator Battery charging starts automatically.

"Charging progress” indicator Charging has been completed; remove the battery from the charging bay. The charging time depends on the charge state and capacity of the batteries. "Action request“ indicator Charging cannot be performed normally; the “Charging progress” indicator goes dark. Possible cause: bad contacts; excessive battery temperature during charging, see Troubleshooting list.

Fig. 2

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en 5.

Validated reprocessing procedure

5.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

5.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel.

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Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

5.3

Preparations at the place of use

► Remove any visible surgical residues to the extent

possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste con-

tainer for cleaning and disinfection within 6 hours.

5.4

Dismantling prior to carrying out the reprocessing procedure

► Disconnect the product from the mains power sup-

ply immediately after use.

en 5.5

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

DANGER

CAUTION

Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product.

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances.

Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. ► Do not immerse the product in fluids. ► Do not introduce any fluid into the charging bays. ► Clean the contacts in the charging bays, applying extreme care.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Wipe disinfection for electrical devices without sterilization

■ Clean the contacts in the charg-

Chapter Wipe disinfection for electrical devices without sterilization

5.6

ing bay with isopropanol or ethyl alcohol and a cotton swab. Do not use corrosive chemicals.

Wipe disinfection for electrical devices without sterilization

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Wipe disinfection

RT

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

RT:

Room temperature

Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe.

► Observe the specified application time (1 min min-

imum).

11

en 5.7

Inspection, maintenance and checks

► Inspect the product after each cleaning and disin-

fecting cycle to be sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

6.

Maintenance

To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

7.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Charger not starting up

“Power On” indicator 3 not illuminated

Mains power cord not plugged in

Plug mains power cord into device socket 5 on the charger and into the mains power socket

Defective mains power cord

Replace the mains power cord

Fuses blown

Replace fuses, see Fuse replacement

Defective charger

Send charger to manufacturer for repair

Defective charger

Send charger to manufacturer for repair

Defective indicator

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During the switch-on check, not all indicator elements are illuminated ("Power On" 3 indicator and indicator fields for charging bays 2)

en Malfunction

Detection

Cause

Remedy

Battery is not charged

Battery inserted, Charging progress indicator not illuminated

Charger contacts dirty

Clean the contacts, see Validated reprocessing procedure

Defective battery

Repeat the charging process in another charging bay. If there is still a fault, send the battery to the manufacturer for repair

Defective charger

The charging process does not start up either with a different battery. Send charger to manufacturer for repair

Excessive battery temperature detected during charging

Remove the battery from the charging bay, let it cool down and restart charging. If there is still a fault, send the battery to the manufacturer for repair

Defective battery

Repeat the charging process in another charging bay. If there is still a fault, send the battery to the manufacturer for repair

Defective charger

There is a charging fault even after the battery has been replaced. Send charger to manufacturer for repair

Battery inserted, “Action request” indicator illuminated

13

en 7.1

Fuse replacement

DANGER

► Loosen the eight screws of charging bay cover 6.

6

Risk of fatal injury from electric shock! Touchable components can cause fatal injury due to mains voltage. ► Pull the mains plug before replacing the fuse sets.

Specified fuses: 2 x IEC 127 - T 1.25 A breaking capacity H (1 500 A) ► Pull the mains plug before replacing the fuse sets. ► Use a small screwdriver to release the clip on the fuse holder. ► Pull out the fuse holder. ► Replace both fuses. ► Reinsert the fuse holder in such a way that it audibly snaps into place.

6 Fig. 3 ► Remove the charging bay cover.

Note If the fuses blow frequently, the product is defective and must be repaired, see Technical Service.

Fig. 4

7.2

► Pull out the old charging bay.

Changing a charging bay

CAUTION

Damage to the product during charging bay change! ► Charging bay changes may only be carried out by persons who, due to their training and practical experience, are equipped with the requisite expertise in the maintenance of medical products. ► Disconnect the product from mains power.

Note A Pozidrive cross slot screwdriver size 1, blade length 140 mm is required for installing and uninstalling the charging bay cover!

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Fig. 5 ► Insert the new charging bay. ► Position and screw on the charging bay cover. ► Carry out function checks, see Function checks.

en 8.

Technical Service

WARNING

Risk of injury and/or malfunction! ► Do not modify the product, except for changing the charging bay.

► For service and repairs, please contact your

national B. Braun/Aesculapp agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

9.

Accessories/Spare parts

9.1

Mains power cord

Art. no.

Approvals

Colour

Length (in m)

TE780

Europe

black

1,5

TE730

Europe

black

5,0

TE734

Great Britain

black

5,0

TE735

USA, Canada, Japan

gray

3,5

9.2

Spare parts

Art. no.

Designation

TA020112

Fusible cartridge T 1.25 AH

GA677830

Charging bay complete, for Acculan rechargeable batteries GA646, GA626, GA616

GA677831

Charging bay complete for Acculan 3Ti rechargeable batteries GA666, GA676

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en 10. Technical data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GA677

Acculan 3Ti charger

I

10.1 Ambient conditions Operation

Temperature GA677 Mains voltage ranges (Current intake)

100–120 V~ (1.1-0.9 A)/ 220–240 V~ (0.5–0.45 A)

Frequency

50–60 Hz

Safety rating (according to IEC/DIN EN 60601-1)

Ι

Charging/output voltage

max. 12.5 V

Charging/output current

max. 1.2 A

Device protection Breaking capacity

T 1.25 A H (1 500 A at 250 V/50 Hz)

Weight

3.5 kg

Dimensions (L x W x H)

440 mm x 140 mm x 180 mm

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

Type

Technology

Voltage

Nominal capacity

GA676

NiMH

9.6 V

1 950 mAH

GA666

NiMH

9.6 V

1 100 mAH

GA646

NiCd

9.6 V

500 mAH

GA626

NiCd

9.6 V

800 mAH

GA616

NiMH

9.6 V

1 700 mAH

16

Relative humidity Atmospheric pressure

Transport and storage

en 11. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. Adhere to national regulations when disposing of or recycling the product, its components and its packaging! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► Detailed information concerning the disposal of the

product is available through your national B. Braun/Aesculap agency, see Technical Service.

12. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

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