Acculan Battery GA666, GA676

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AESCULAP® Acculan Battery GA666, GA676 Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use. Two-dimensional machine readable code The code contains a unique serial number which can be used for electronic tracking of the individual instrument. The serial number is based on the global standard sGTIN (GS1). Manufacturer

Date of manufacture

Follow the instructions for use

Labeling of electrical and electronic devices pursuant to directive 2002/96/EG (WEEE)

Manufacturer's batch name Manufacturer serial number Manufacturer order number Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage According to US federal law, this product may only be sold by a physician or by the order of a physician CE mark according to Regulation (EU) 2017/745 Medical device

Keep dry

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Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.2 6.3 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8. 9. 10. 11. 12. 13. 13.1 13.2 13.3 14.

About this document Scope Warnings General information Use/intended use: Main functions and design characteristics Indications Contraindications Safe handling Product description Scope of Supply Components required to operate the device Operating principle Preparation Working with the device System set-up Functional test Safe operation Processing process General safety information General notes Reusable products Preparing for cleaning Cleaning/Disinfection Wipe disinfection of electrical equipment Inspection, maintenance and checks Maintenance Troubleshooting Storage and transport Accessories/Replacement Parts Technical Service Technical Data Classification in accordance with Regulation (EU) 2017/745 Performance data, information and standards Ambient conditions Disposal

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en 1.

About this document

3.

1.1

Scope

WARNING Risk of injury and damage to property due to improper handling of the product! ► Comply with instructions for use for the Acculan 4 machines and the Acculan 3Ti machines. ► Follow the instructions for use of all products used.

These instructions for use apply to the products listed below: Art. no.

Designation

GA666

Acculan battery

GA676

Acculan battery

Safe handling

Note For the instructions for use and further information on B. Braun / AESCULAP products please refer to the B. Braun eIFU website at eifu.bbraun.com.

WARNING Fire and explosion hazard due to battery poles shorted by fluids or metal components! ► Do not short-circuit, open, crush or incinerate battery.

1.2

CAUTION Damage to or destruction of the batteries due to reprocessing! ► Do not sterilize batteries.

Warnings

Warnings indicate risks to patients, users, and/or the product that could develop while using the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. Minor or moderate injuries may result if this is not prevented. CAUTION Indicates a potential damage to property. The product may become damaged if it is not prevented.

2.

General information

2.1

Use/intended use:

Task/Function The rechargeable batteries supply power to the Acculan units and contain the circuitry required to activate and control the electric motors of the Acculan units in accordance with operator commands. Application Environment The product fulfills the requirements of Type BF in accordance with IEC/DIN EN 60601-1. For use in operating rooms, outside of the explosive hazard zone (e.g. areas with highly pure oxygen or anesthetic gases).

2.2

Main functions and design characteristics

Art. no.

DC voltage

Capacity

GA666

9.6 V

1.05 Ah

GA676

9.6 V

1.95 Ah

2.3

prior to first use to ensure it is in good working order; fully charge using charger GA320 or GA677 and verify functionality. ► To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: – Use the product according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. – Follow the application advisories acc. to standard, see Extracts from relevant standards. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Do not use the product if it is damaged or defective. ► Set aside the product if it is damaged. ► Charge product fully after 3 months in storage. ► Keep product dry. ► Observe the instructions for use for the corresponding Acculan machines. Note The user must report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

4.

Product description

4.1

Scope of Supply

Art. no.

Designation

GA666

Acculan NiMH battery short

Indications

The indications can be found in the instructions for use for the corresponding Acculan machines.

2.4

► Inspect the new product after removing its transport packaging and

Contraindications

– or – GA676

Acculan NiMH battery

TA011867

Instructions for use, Acculan battery GA666, GA676

The contraindications can be found in the instructions for use for the corresponding Acculan machines.

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en 4.2

Components required to operate the device

■ Acculan 4 charger GA320 or Acculan 3Ti charger GA677 ■ Acculan 4 or Acculan 3Ti machine: Art. no.

Designation

GA330

Acculan 4 drill and reamer

GA331

Acculan 4 oscillating saw

GA334

Acculan 4 reciprocating saw

GA336

Acculan 4 oscillating saw straight

GA337

Acculan 4 oscillating sternum saw

GA340

Acculan 4 Dermatome

GA341

Acculan 4 Dermatome 0.1 mm

GA344

Acculan 4 small drill

GA668

Acculan 3Ti oscillating saw straight

GA670

Acculan 3Ti Dermatome

GA671

Acculan 3Ti small drill

GA672

Acculan 3Ti drill and reamer

GA673

Acculan 3Ti oscillating saw

GA674

Acculan 3Ti reciprocating saw

GT666

Acculan 4 TPLO saw

GT668

Acculan 3Ti TPLO saw

4.3

Preparation

► Prior to use, inspect the product and its accessories for any visible

damage. ► Use the products and their accessories only if they are in perfect tech-

nical condition.

6.

Working with the device

6.1

System set-up

► See instructions for use for the respective Acculan machine and the

Acculan 4 charger GA320 or Acculan 3Ti charger GA677.

6.2

Functional test

See the instructions for use for the respective Acculan machine.

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Safe operation

WARNING Risk of injury and material damage due to inappropriate use of batteries! ► Charge battery only in the Acculan 4 charger GA320 or Acculan 3Ti charger GA677. ► Insert battery correctly (Acculan machine and charger). WARNING Risk of injury and material damage due to damaged batteries! ► Check batteries for any damage before charging. ► Do not use or recharge damaged batteries. CAUTION Total battery failure can occur if the batteries are left in the charger while it is disconnected from the power supply! ► Always keep the charger connected to the power supply. Indicator light for readiness for service must be lit. ► Always remove batteries from the charger when it is disconnected from the power supply. CAUTION Loss of capacity/performance due to prolonged storage of discharged batteries! ► Leave the batteries in the functional charger after they have been successfully charged (trickle charging). ► For proper loading and removal of the battery from the Acculan

machine, see the instructions for use for the respective Acculan machine.

Operating principle

The Acculan NiMH battery supplies the Acculan machine with voltage. The battery is charged in the Acculan 4 charger GA320 or Acculan 3Ti charger GA677. The charging process of a completely discharged battery can take up to 120 min. The speed and rotational direction are set depending on the trigger setting of the machines: ■ for saws and Dermatome: speed clockwise ■ for drills: speed clockwise, counter-clockwise, oscillation and pilgrim step

5.

6.3

7.

Processing process

7.1

General safety information

Note Observe national statutory regulations, national and international standards and directives, and any proprietary hygiene instructions for processing. Note The applicable national regulations concerning the reprocessing of devices must be observed for patients having Creutzfeldt-Jakob disease (CJD), suspected of having CJD, or possible variants of CJD. Note It should be noted that successful processing of this medical device can only be guaranteed following prior validation of the processing method. The operator/processor shall be responsible. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFU at eifu.bbraun.com for current information on processing and compatibility of material

en 7.2

General notes

7.5

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 surface and could cause corrosion.

7.3

Device-specific safety information on the reprocessing method DANGER Risk of electric shock and fire hazard! ► 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.

Reusable products

CAUTION Risk of 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 introduce any fluid onto the electrical contacts of the battery.

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

7.4

Cleaning/Disinfection

Preparing for cleaning

► Remove the battery from the Acculan machine.

7.6

Wipe disinfection of electrical equipment

Phase

Step

T [°C/°F]

t [min] Conc. [%]

Water quality

Chemistry

I

Cleaning

RT

0.5

-

-

17 % 1-Propanol, 0.23 % Didecyldimethylammonium chloride*

II

Wipe disinfection

RT

≥3

-

-

17 % 1-Propanol, 0.23 % Didecyldimethylammonium chloride*

RT: Room temperature *Recommended: Meliseptol® Wipes sensitive (B. Braun) Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, dispos-

able disinfectant wipe. ► Observe contact time (at least 3min).

7.7

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is clean, functional and undamaged. ► Set aside the product if it is damaged.

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en 8.

Maintenance

The display "Battery replacement recommended" on the Acculan 3Ti charger GA320 (see TA014535) indicates when the battery should be replaced due to reduced capacity. No other maintenance measures must be performed on the battery. For corresponding services, contact your national B. Braun/Aesculap agency, see Technical Service.

9.

Troubleshooting

► Replace product: have defective products repaired by Aesculap Technical Service, see Technical Service.

Fault

Detection

Cause

Remedy

Battery not working

No signal tone when inserting the battery into the machine

Battery defective

Replace product.

Battery empties quickly

Symbol "Battery replacement recom- Battery cells at end of life mended" illuminated on the charger at the end of the charging process

Have battery cells replaced by Aesculap Technical Service.

10. Storage and transport

12. Technical Service

WARNING Risk of injury from burns and damage to product in case of short-circuit! ► When storing the product, ensure that the product cannot shortcircuit with other products or metal objects.

DANGER Danger to life of patients and users in case of malfunctions and/or failure of protective measures! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient.

► In order to prevent damage during transport, ship product in the orig-

inal packaging and in an outer carton. ► If the original packaging is no longer available, ensure the following when packaging the product: – The battery contacts are protected against short-circuit. – The packaging completely encloses the product. – The product is secured against movement within the packaging. ► Completely charge the product upon receipt and before extended periods of storage.

11. Accessories/Replacement Parts Art. no.

Designation

TA015514

Instructions for use, battery GA666, GA676 (A4)

TA011867

Instructions for use, battery GA666, GA676 (flyer)

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CAUTION Modifications of medical devices may result in a loss of potential guarantee/warranty claims and forfeiture of applicable licenses. ► Do not modify the product. ► Contact national B. Braun/Aesculap representative for service and repair. 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] Other service addresses can be obtained from the address indicated above.

en 13. Technical Data

14. Disposal

13.1 Classification in accordance with Regulation (EU) 2017/745

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packagings.

Art. no.

Designation

Class

GA666

Acculan battery

I

GA676

Acculan battery

I

13.2 Performance data, information and standards GA666

GA676

Cell type

NiMH

NiMH

DC voltage

9.6 V

9.6 V

Capacity

1.05 Ah

1.95 Ah

Weight

approx. 0.304 kg

approx. 0.425 kg

Dimensions (L x W x H)

approx. 120 mm x 43 mm x 50 mm

approx. 140 mm x 43 mm x 50 mm

EMC

IEC/DIN 60601-1-2 IEC/DIN 60601-1-2

Compliance with standards

IEC/DIN 60601-1

Note The operator must process the product before disposal, see Processing process. 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. ► For questions regarding the disposal of the product, please contact

your local B. Braun/Aesculap representative, see Technical Service.

IEC/DIN 60601-1

13.3 Ambient conditions Operation

Transport and storage

Temperature

10 °C to 40 °C

-10 °C to 40 °C Maximum recommended period of storage is 3 months; keep out of direct sunlight

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

Note The atmospheric pressure of 700 hPa correlates with a maximum operating altitude of 3 000 m.

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