PM 1:1 External Spray Instructions for Use Sept 2022

Packaging content (REF)

PM 1:1 EXT SPRAY

REF 1600052-001

Optional accessories

SLEEVE CONE PM 1:1 EXT SPRAY

RING WITH SPRAY TUBE

PACK OF 10 DISPOSABLE STERILE IRRIGATION LINES

REF 1500003-001

REF 1500552-001

REF 1500984-010

MAINT SPRAYNET® (BOX OF 6 CANS)

MAINT LUBRIFLUID® (BOX OF 6 CANS)

MAINT AQUACARE (BOX OF 6 CANS)

REF 1600036-006

REF 1600064-006

REF 1600617-006

REF 2100046-0003/2022.09

PM 1:1 External spray • © Bien-Air Dental SA

Table of contents 1 Symbols 1.1 Description of symbols used

4 4

2 Identification & Intended Use 5 2.1 Identification 2.2 Intended use 2.3 Intended patientpopulation 2.4 Intended user 2.5 Use environment 2.6 Intended medicalconditions 2.7 Patient contra-indications and side effects 2.8 In case of accident

5 5 5 5 5 5 5 5

User and Patient Safety: 3 Warnings and Precautions for use

6

4 Description

8

4.1 Overview 4.2 Technical data 4.3 Classification 4.4 Performances 4.5 Operating conditions

5 Operation

6.3 Disinfection 6.4 Lubrication 6.5 Sterilization 6.5.1 Procedure

16 18 19 19

6.6 Packing and storage 6.7 Servicing

21 21

7 Transport & disposal

22

7.1 Transport 7.2 Disposal

22 22

8 General information

23

8.1 Terms of guarantee 8.2 References

23 24

8 9 10 10 10

11

6 Maintenance and servicing 14 6.1 Maintenance - General information 6.1.1 Suitable maintenance products

6.2 Cleaning

14 14

15

3

ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Symbol

4

Description

Symbol

Description

Manufacturer.

Catalogue number.

CE Marking with number of the notified body.

Serialnumber.

WARNING: hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed.

MedicalDevice.

CAUTION: hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly followed.

Authorized EC Representative in the European Community.

Wear protective gloves.

Thermo washer disinfectable.

Data Matrix code for product information including UDI (Unique Device Identification).

Sterilizable in a steam sterilizer (autoclave) at the specified temperature.

Warning: in accordance with federal law (USA), this device is only available for sale upon recommendation by an accredited practitioner.

Consult instructions for use or consult electronic instructions for use.

2.1 Identification Medical devices manufactured by BienAir Dental SA.

environment.

2.6 Intended medical conditions l

Type: Straight handpiece PM 1:1, external irrigation, without light, direct ratio, interchangeable nose with or without irrigation tube.

l

Description: Bien- Air Dental contra- angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.

2.2 Intended use Product intended for use in general dentistry which includes restorative dentistry and dental prophylaxis as well as in oral and maxillofacial surgery.

l

General dentistry which includes restorative dentistry, dental prophylaxis, and addresses the maintenance or reestablishment of dental health. Oral surgery treatments include impacted teeth extraction, wisdom teeth extraction, nonsalvageable decayed teeth extraction, Guided and not- guided bone regeneration, apicoectomy, osteotomy, sequestrectomy and hemisection. Maxillofacial surgery includes procedures such as Orthognathic surgery, genioplasty and rhinoplasty.

ENG

2 Identification & Intended Use

2.7 Patient contra -indications and side effects No specific patient contra- indication, side effects nor warning exist for the device when it is used as intended.

2.8 In case of accident

2.3 Intended patient population

If an accident occurs, the device must

The intended patient population for the not be used until repairs have been device includes any person visiting a completed by a qualified, authorized dental practitioners’ office to receive and trained technician in a repair centreatment in line with the intended med- ter. ical condition. There is no restriction If any serious incident occurs in relation concerning subject age, race, or cul- to the device, report it to a competent ture. The intended user is responsible authority of your country, as well as the to select the adequate device for the pa- manufacturer through your regional tient according to the specific clinical distributor. Observe relevant national application. regulations for detailed procedures.

2.4 Intended user Product intended for professional use only. Used by dentists, dental professionals and oral surgeon.

WARNING Any use other than that for which this device is intended is unauthorised and may be dangerous.

2.5 Use environment Professional healthcare

facility 5

contamination of the area being 3 User and Patient treated. Safety: Warnings and prevent any risk of injury and/or Precautions for use To material damage the cautions below This medical device must be used by professionals in compliance with the legal provisions in force regarding occupational safety, health and accident prevention measures, and these instructions for use. In accordance with these provisions, the user is responsible for ensuring he or she only uses devices which are in perfect working order.

To prevent any risk of infection, the warnings below must be observed: WARNING Rest the device on a cleanable support to avoid risks of infection for yourself, the patient or third parties. l Medical personnel using or performing maintenance on medical devices that are contaminated or potentially contaminated must comply with universal precautions, in particular the wearing of personal protective equipment (gloves, goggles, etc.). Pointed and sharp instruments should be handled with great care. l Respect the cleaning, sterilization and maintenance procedure detailed in section 6. Sterilization before first use is mandatory. l When disposing of the device, the user must return it sterilized to their dealer or contact an authorized body for the treatment and recovery of this type of equipment. l While performing surgical treatment, the handpiece must not receive pressurised cooling air from the unit, to prevent l

6

must be observed: WARNING The device is intended for professional use only. l Respect the cleaning, sterilization and maintenance procedure detailed in section 6. l In the event of excessive vibrations, abnormal heating, unusual noise or other signs suggesting that the device is malfunctioning, work must be suspended immediately. In this case, contact a repair center approved by Bien-Air Dental SA. l Never insert or remove a device while the micromotor is rotating. l Do not touch the dental bur while it is rotating. l Never rotate the locking ring while the PM (straight handpiece) is in operation. l Each time a bur is inserted, check that the bur is fully inserted to the stop and rotates freely. If it is blocked, contact your usual supplier or Bien-Air Dental SA for repair. l Always check that the bur is locked by gently pushing and pulling the bur. l Always check that the or locking ring is fully tightened, passing the initial mechanical resistance to meet the abutment. l Follow the guidelines for use, according to the bur manufacturer's instructions. Never use a bur if the shaft is not compliant, as there is a risk it can become detached during the procedure and injure the practitioner, the patient or third parties. l

l

l

Comply with maximum lengths by To prevent any risk of device malalways inserting the bur as far as function the caution below must be possible into the locking mech- observed: anism. If a bur is operated at high speeds when incorrectly mounted CAUTION (i.e. not fully inserted into the lockl Before performing any clinical aping mechanism, or being longer plication, always test your device than the values specified in secto ensure its proper operation. tion 4.2) a centrifugal force may l Only use original Bien-Air Dental be exerted which may bend or SA devices and accessories or break the bur. those recommended by Bien-Air Good practices of use (e.g. for reDental SA. moving metal bridges, adjusting l Respect the cleaning, sterilization ceramic crowns or other milling and maintenance procedure deoperations on hard materials) tailed in section 6. should always be followed. They include but are not limited to: following the recommendation of the cutting- tool/bur manufacturer, checking the integrity of the bur and adapting the clinical protocol in order to avoid any risk of excessive vibration and damage to the device’s integrity. Always ensure that the coolant supply provided by the motor is sufficient and adequate.

ENG

l

To prevent any risk of contraangle/handpiece overheating, the cautions below must be observed:

l

CAUTION Respect the cleaning, sterilization and maintenance procedure detailed in section 6.

7

4 Description

FIG. 1

4.1 Overview FIG. 1 (1) Bur (not supplied) (2) Transmission ratio (3) Micromotor connection (4) Irrigation tube (5) Locking ring

Note : The technical specifications, illustrations and dimensions contained in these instructions are given merely as an indication. They may not give rise to any claim. The original language of those instructions for use is English. For any further information, please contact Bien-Air Dental SA at the address given on the back cover. 8

ENG

FIG. 2

4.2 Technical data Technical data

PM 1:1 EXT SPRAY Coupling according to ISO 3964

Motor coupling compatibility

- MS & MICRO-SERIES can be coupled to short and extra short Motor coupling - Other CA & PM can be coupled with all coupling type

Lightning

“L” letter means lightning CA & PM without L letter means no lightning

Transmission ratio according to ISO14457

Speed direct ratio 1:1 (blue color)

Motor max speed

40'000 rpm

Tool max speed

40'000 rpm

Irrigation type

External irrigation KM = Kirschner-Meyer

Cutting tool compatibility Shaft diameter ISO 1797-1

2.35 mm (Type 2)

Shaft length ISO 1797-1

≥ 30 mm

Cutting tool diameter ISO 6360-1

≤ 4 mm

Total length ISO 6360-1

≤ 44.5 mm (Code 4)

9

4.3 Classification Class IIa in accordance with European Medical Regulation (EU) 2017/745.

4.4 Performances Performances Irrigation flow 5 levels*

25 - 110 ml/min

Speed & torque transmission ratio

1:1 +- 10%

*In combination with Chiropro peristaltic pumps.

4.5 Operating conditions Operating conditions

10

Temperature range:

+10°C - +35°C (+50°F - +95°F)

Relative humidity range:

30% - 80%

Air pressure range:

700 hPa - 1060 hPa

ENG FIG. 3

FIG. 4

5 Operation Pictogram used

To-and-fro movement.

Move in the direction indicated.

After initialmechanicalresistance, fully tighten in the direction indicated.

Move fully to the stop, in direction indicated.

Irrigation / detachable noses Both with and without irrigation tube noses (see the section “optional accessories” or FIG. 3 & FIG. 4 can be connected to the handpiece. The irrigation tube cannot be detached from its nose and is not meant to be bent by the user. A sterile external irrigation line should be connected to the irrigation tube.

11

FIG. 5

FIG. 6

Changing the bur Turn the locking ring completely in the direction of the arrow, insert the new cutting tool until the stop: 1. Unlocking FIG. 5. 2. Locking FIG. 6. Once locked in, exert traction on the tool to check that it is correctly in place.

12

ENG FIG. 7

Bur locking operation check: FIG. 7 Hold the handpiece upright by the bur between your thumb and index finger and rotate the handpiece; the handpiece should rotate freely (more than 3 rotations).

13

6 Maintenance and servicing 6.1 Maintenance - General information Clean, dry, lubricate and sterilize the device prior to first use. Within a maximum of 30 minutes after each treatment, clean, disinfect and lubricate the instrument. Observing this procedure eliminates any blood or saliva residues and prevents the transmission system from being blocked. Before surgical treatment, the handpiece must be sterilized.

The following procedure applies to both the handpiece and the nose. WARNING Follow your national directives, standards and guidelines for cleaning and sterilization recommendations. l The irrigation tube must be cleaned, disinfected and, if required by countryspecific directives or by a surgical procedure, sterilized. l

6.1.1 Suitable maintenance products Only use original Bien-Air Dental SA maintenance products and parts or those recommended by Bien-Air Dental SA. Using other products or parts may cause faults during operation and/or void the warranty. l l l

14

Spraynet® Aquacare Alkaline detergent or detergent disinfectant (pH 8-11) recommended for cleaning-disinfection of dental or surgical instruments. Disinfectant products composed either of didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral enzymatic product. (e.g. neodisher® Mediclean) are also allowable.

ENG FIG. 8

6.2 Cleaning CAUTION Do not submerge in physiological liquid (NaCI) nor use saline solution to keep the device moist until it can be cleaned. l Clean using manual cleaning or automated washer/disinfector only (do not use ultrasonic cleaner). l Carry out the cleaning, disinfection and sterilization processes without a bur in the chuck mechanism.

Remove dirt / deposits: FIG. 8.

l

Preparation: l

l

Disconnect the drive motor attachment, rotate the locking ring, remove the bur and leave the locking ring loosened FIG. 5. Disconnect the irrigation line, remove the detachable nose.

1. Clean the exterior and interior of the device under tap water between 15°C - 38°C (59°F - 100°F) provided that the local tap water has a pH within the range of 6.5 - 8.5 and a chloride content below 100 mg/l. If the local tap water does not meet these requirements, use demineralized (deionized) water instead. 2. After selecting the appropriate nozzle, perform preliminary cleaning of the device by using the product Aquacare. Spray the inside and the outside of the device and inside the irrigation tube.

15

FIG. 9

6.3 Disinfection Manual cleaning and disinfection 1. Dip the device in a bath containing a cleaning and disinfectant product (e.g. didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral enzymatic product which are allowable chemical agents). Follow the concentration and duration recommended by the fabricant of the disinfection product. 2. Brush the device with a smooth, flexible brush (e.g. soft- bristled toothbrush). DO NOT USE a wire brush. 3. Optional: perform additional cleaning and disinfection of the external surfaces with non- woven wipes impregnated with a disinfection product (e.g. didecyldimethylammonium chloride). 4. Rinse the device twice with running tap water (15°C - 38°C) (59°F 100°F) provided that the local tap water has a pH within the range of 6.5 8.5 and a chloride content below 100 mg/l. If the local tap water does not meet these requirements, use demineralized (deionized) water instead. 5. After selecting the appropriate 16

nozzle, spray inside the device with Spraynet® (FIG. 9). 6. Dry the external surfaces with sterile non-woven compresses (low linting textiles).

Automatic disinfection: Note : Automatic cleaning-disinfection can replace the previous steps 4 et 6.

Washer-disinfector: Carry out automatic cleaning- disinfection using an approved washerdisinfector which complies with ISO standard 15883-1.

Detergent and washing cycle: Use an alkaline or detergent recommended for cleaning in a washerdisinfector for dental or surgical instruments (pH 8-11).

Phase

Parameters

Pre-cleaning

<45°C (113°F); ≥ 2 minutes

Cleaning

55°C - 65°C (131°F - 149°F); ≥ 5 minutes

Neutralization

≥ 2 minutes

Rinsing

Tap water, ≤30°C (86°F), ≥ 2 minutes cold water

Thermal Disinfection

Demineralized water, 90°C - 95°C (194°F - 203°F), 5-10 minutes

Drying

18 - 22 minutes

ENG

Recommended specifications for the thermo-disinfection cycle:

CAUTION Never rinse the devices to cool them. CAUTION If an automatic washer is used at the place of the washer/thermo-disinfector, respect the previous program for the Pre-cleaning, Cleaning, Neutralization and Rinsing phases. If the local tap water has a pH outside the range of 6.5-8.5 or if it contains more than 100 mg/l chloride (Cl-ion), do not dry the device inside the automatic washer but dry it manually with low linting textiles. CAUTION If automatic cleaner/disinfector does not provide efficient drying and/or if traces of humidity remain after drying, dry the external surface of the motor with low linting textile impregnated with Spraynet®.

17

FIG. 10

6.4 Lubrication Verifying cleanliness: Visually inspect the device to ensure it is clean. Repeat the cleaning and disinfection procedure if necessary.

Lubrication: Lubricate before each sterilization or at least twice a day. Only the Lubrifluid® spray must be used. FIG. 10 1. Place the device in a sterile, nonwoven cloth to collect the excess of lubricant. 2. Select the appropriate nozzle. 3. Insert the nozzle of the Lubrifluid® can in the rear of the device's handle. 4. Activate the spray for 1 second and clean the excess oil on the exterior with a sterile, non-woven compress.

Note : If, during the test run of the handpiece before the clinical treatment, an excess of lubricant is ejected from the handpiece, prolongate the test run until the ejection stops. Then, modify the lubrication procedure, by reducing the quantity of lubricant inserted before sterilization or operate the handpiece for 2 seconds after lubrication and before sterilization. 18

6.5 Sterilization CAUTION The quality of the sterilization is highly dependent on how clean the device is. Only perfectly clean devices may be sterilized. l To improve the effectiveness of the sterilization, make sure the handpiece and the attachment are completely dry before and after the sterilization. l Do not use a sterilization procedure other than the one described below. l Only use dynamic air removal cycles: pre-vacuum or steam flush pressure pulse (SFPP) cycles. l If the sterilization is required by national directives, use only dynamic sterilizers: do not use a steam sterilizer with a gravity displacement system. As with all instruments, following each sterilization cycle, including drying, remove the device to avoid an excessive exposure to heat which can result in corrosion. l As with all instruments, following each sterilization cycle, including drying, remove the device to avoid excess exposure to heat which can result in corrosion.

ENG

l

6.5.1 Procedure 1. Pack the sleeve in a packaging approved for steam sterilization. 2. Sterilize using steam, following dynamic air removal cycle (ANSI/AAMI ST79, Section 2.19), i.e. air removal via forced evacuation (ISO 17665-1, ISO/TS 17665-2) at 135°C (275°F), for 3 minutes or at 132°C (269.6°F) for 4 minutes. In jurisdictions where sterilization for prions is required, sterilize at 135°C (275°F) for 18 minutes.

19

The recommended parameters for the sterilization cycle are: l

l

l

l

l

l

20

The maximum temperature in the autoclave chamber does not exceed 137°C (278.6°F), i.e. the nominal temperature of the autoclave is set between 132°C 135.5°C (269.6°F – 275.9°F) taking into account the uncertainty of the sterilizer with regard to temperature. The maximum duration of the interval at the maximum temperature of 137°C (278.6 °F) is in accordance with national requirements for moist heat sterilization and does not exceed 30 minutes. The absolute pressure in the chamber of the sterilizer is comprised in the interval 0.07 bar to 3.17 bar (1 psia to 46 psia). The rate of change of temperature does not exceed 15°C/min (59°F/min) for increasing temperature and 35°C/min (- 31°F/min) for decreasing temperature. The rate of change of pressure does not exceed 0.45 bar/min (6.6 psia/min) for increasing pressure and -1.7 bar/min (-25 psia/min) for decreasing pressure. No chemical or physical reagents are added to the water steam.