DENTAL HI TEC QuickSleeper5 User Manual

User GUide
www.mydentalhitec.com
To be read before firsT use
V17/10/2014 - UK
Security Rules
(TO BE READ IMPERATIVELY BEFORE FIRST USE)
QuickSleeper® is an electronic dental anesthesia system designed for local injections before and/or during treatment. QuickSleeper® is a modern alternative to traditional anesthesia syringes. The practitioner should take the usual precautions to ensure the success of every dental anesthetic injection.
GENERAL RECOMMENDATIONS
· Keep mobile phones at a minimum of 1.5 metres (5 feet) from the control box, pedal or power supply; otherwise this could disrupt the wireless communication of QuickSleeper®.
· QuickSleeper® must only be used by a qualified dental surgeon.
· The anesthesia act requires constant supervision of the registered practitioner who can remove the handpiece from the injection site at anytime.
· Do not leave QuickSleeper® within reach of children.
· Do not expose your device to the sun or leave it near a radiator or an air-conditioner.
· Do not expose QuickSleeper® to water or chemical products.
· The plug of the power supply serves as a cut-off and must remain accessible.
2
· Imperatively wear disposable surgical gloves when manipulating and using QuickSleeper®.
PROTECTION AGAINST ELECTRIC
SHOCKS
· The connexion must be made on an alternative single-phase circuit.
· The external voltage should be identical to that on the material safety data sheet located under the control unit.
· The electrical installation must have a security circuit breaker.
· Before any use, check the condition of the plug and power cable.
· Do not pull on the cable to remove the plug from the power socket.
ANESTHETIC
· Only use 1.7ml or 1.8ml glass anesthetic cartridges, with
plastic protection film to easily withdraw the cartridge in case of breakage.
· Refer to the cartridge manufacturers’ recommendations to know the quantities that can be injected per session.
SECURITY
· For security reasons, do not screw or unscrew the needle close to your patients and protect them with safety glasses.
CONTAMINATION
· Each QuickSleeper® needle, cartridge and accessory must be used only on one single patient to prevent risks of cross contamination.
· Never re-use the needles and anesthetic cartridges, each of these items must be destroyed after use in an incinerator allocated for this purpose.
· Always replace the container by a sterile container in case of change of needle and/or cartridge during anesthesia.
· Do not leave the needles without protection. Systematically replace the protection after use, using the recapping system on the handpiece holder (p. 8).
DISINFECTION
· The containers must be disinfected and sterilised before each anesthesia (see procedure p.17).
· The holder and handpiece must be disinfected after each patient (see the indications of disinfectant product manufacturers).
FOR USE
RECOMMENDATIONS
SECURITY LEVELS:
· Handpiece and control box cables: very low security voltage (VLSV-24V).
NEEDLE BREAKAGE
· Needle breakage is the result of an incorrect manipulation.
This breakage may be caused by one or several parameters : see p. 21
WARNINGS
It is forbidden to alter your Quicksleeper without the permission of Dental Hi Tec. Should your QuickSleeper be modified, the modification must be performed by a service center approved by Dental Hi Tec, or by Dental Hi Tec’s technical Service. Control and appropriate testing must be performed to ensure that your device can still be used safely. Using QuickSleeper with other equipment is under the responsibility of the user dentist.
CONTRAINDICATIONS
There are no contraindications known until now.
Contents
Dear user,
QuickSleeper is going to enable you to perform all of your
anesthesias (intraosseous*, intraligamentary, intraseptal, infiltration,
ID Nerve Block…) with unmatched efficiency and comfort.
To prevent improper use of the device which could injure your
patient and damage your QuickSleeper, please read this
document carefully before first use.
* Intraosseous = osteocentral or transcortical (Refer to the clinical guide for more details)
Security rules 2
A progressive start up 3
Presentation of your QuickSeeper 4-5
DHT Needles 6
Installation 7-10
Functions 11-16
Maintenance 17-18
Annexes
Technical problems & solutions 19-24
Miscellaneous information 25-27
A progressive start up for a successful integration…
Master the device before performing your first osteocentral or
transcortical anesthesia. Continue performing your standard
techniques but using the QuickSleeper.
• Get used to working with the pen grip, always using
good support points and a comfortable position.
• Perform completely painfree attached gum
anesthesias, infiltrations, intraligamentaries using, if necessary,
the needle rotation…
After these days of initiation, perform your first osteocentral or
transcortical anesthesias starting with simple cases, on the anterior
sectors, where the access and visibility are good.
Complementary information available on the website
www.mydentalhitec.com.
We wish you lots of success with the QuickSleeper.
The functions of your QuickSleeper 5
Presentation
Screwing” key
(countinuous press)
Handpiece nose on which is screwed
a rotary or plastic container
Unscrewing” key
(countinuous press)
3 information windows (quantity and injection speed)
Return” key (short press)
Selected injection mode
4
Aspiration
(countinuous press)
Needle rotation
(countinuous press)
i
Information concerning the wireless, batter yless pedal
All of the pedals have an “all or nothing” function.
The wireless pedal comes from cutting-edge research. The wireless connection is very reliable but like any radio system, it can be disrupted by external factors: stainless steel furniture, close proximity to a high-power radio transmitter (mobile phone), a disruptive electronic equipment (computer...). We recommend to carefully choose the location of the control box and the wireless pedal so they can communicate without being disturbed.
Injection mode selection :
Slow / Intraosseous / Fast
(short press)
Injection
(countinuous press)
Your pedal does not contain a battery. Your foot motion on the pedal generates the energy required to operate the system. It is therefore mandatory to perform fast and frank pedal pressures and releases. Slow or incomplete motion may not create enough energy to transmit the wireless information to the control box. If a release of the pedal has no effect (rotation or injection remain active), simply press / release again the same pedal to stop operation. The handpiece is under the constant supervision of the practitioner who must withdraw it from the patient’s mouth in case of malfunction.
Description of the control box
Presentation
Power indicator
24V Electric power plug
Diagnostic maintenance (only for technical service)
Handpiece
24V Electric power plug
(Ref. SE M0143_xx)
QuickSleeper 5 accessories
Built-in lip-protector to prevent
hurting the patient during needle
rotation.
plug
Transparent container to
perform aspirations
Diagnostic maintenance
(only for technical service)
Choice of
injection varient
Maintenance plug
Control box fixing adhesives
(Ref. SA0226)
5
Handpiece
holder
Rotary container
(ref. SA5500)
Anesthesias with needle rotation.
(osteocentral, transcortical,
intraligamentary)
Plastic container
(Ref. SA5600)
Anesthesias without needle rotation.
(Infiltration, ID Nerve Block, palatal)
DHT Needles
3 available dimensions: Ø 0.30 (30G) - 9 mm Ø 0.30 (30G) - 16 mm Ø 0.40 (27G) - 16 mm
Needle cap
holder
Handpiece holder
(Ref. SA5610)
Rotary container lubricant
(Ref. SA5640)
DHT needles are the only ones responding to the constraints linked to bone perforation and offering such a fine bevel.
Their specific bevels, contrary to those of standard needles, present identical cutting
properties to a scalpel blade. This brings forward 2 advantages:
- DHT needles incise the tissues instead of tearing them, allowing a pain free penetration of the mucosa.
- They also have a superior perforation capacity than standard needles, with a much lower obstruction rate. DHT Needles also present a specific hub indicator enabling to correctly orientate the bevel during attached gum, palatal and intraligamentary anesthesias.
- Respect the model of needle corresponding to the type of anesthesia performed to obtain maximal results and prevent needle breakages.
- Never put over 16 mm long needles into rotation.
- Consult the instructions in the boxes before use and read the security rules, “recommendations for use” (p. 2) and “Needle breakage” (p. 21) chapters before using the needles.
6
Type of needle : Ø 0.30 (30G) - 16 mm Ø 0.30 (30G) - 9 mm Ø 0.40 (27G) - 16 mm Hub colour : White
Osteocentral Adults X X (1) Osteocentral Children X Transcortical X Infiltration (free mucosa) X Infiltration (attached mucosa) X X X Intraseptal X Intraligamentary X Palatal X X
(1) : To be priveliged when bone density is important and interdental space sufficient.
Green Yellow
Installation
Install your QuickSleeper
7
1. Put in place the pedal hoop
1 2 3
11
2 2
Never place the pedal under the dental chair during its descent to avoid crushing the pedal hoop and damaging the chair.
Installation
OK
2. Handpiece holder installation
QuickSleeper is going to become the only instrument for all of your anesthesias. The handpiece must therefore always be immediately accessible, as are your turbine and micromotor. The handpiece holder is designed to be stuck on the right or left hand side of a vertical flat surface.
8
Fixing the support
1 2 3 4 5 6
Always use this support to recap the needle without risk of cross­contamination.
To prevent any risk of accidental pricking, never leave a needle unprotected when the handpiece is in its holder. The holder must be disinfected after each patient (see the indications of disinfectant manufacturers).
1
min.
+ 24h
OK
Installation
3. Control box installation
The control box is supplied with nonslip feet enabling it to be placed on a horizontal surface. It can therefore be hidden below your instrument holder, on the side of a piece of furniture or of the unit (find some installation models on www.mydentalhitec.com).
Fix your control box
1 2 3 4 5
Unfix your control box
+2h
mini.
After fixing, wait 2
hours to not unstick
the adhesives.
1 2 3
Wireless communication between the control box and pedal
To ensure good communication between the control box and wireless pedal avoid obstacles between the 2 elements, especially metallic obstacles (computers, boxes). Do not fix /place the control box on an
electronic device (computer…). Keep mobile phones at a minimum of 1.5 metres (5 feet) from the control box, pedal or power supply.
OK
9
Installation
4. Connection
1 2 3 4
5. To start, pause and stop your QuickSleeper
START : QuickSleeper starts working as soon as you press one of the 4 pedals or handpiece buttons. PAUSE : QuickSleeper automatically goes into low-power mode as soon as the pedal is released. STOP : Turn off the main power supply of your installation or disconnect the QuickSleeper power supply. QuickSleeper can be plugged in to the main power supply of your installation to be turned off every night.
10
Functions
Your QuickSleeper functions
To perform an intraosseous anesthesia with QuickSleeper, use the following functions based on the chronology given:
1 Needle assembly ................................................................................................................................................ p.12
2 Injection mode selection .............................................................................................................................. p.13
3 Anesthetic injection (mucosa injection) ............................................................................................... p.13
4 Needle rotation (intraosseous penetration) ..................................................................................... p.14
5 Anesthetic injection (intraosseous injection) .................................................................................... p.13
6 Option : change needle (anesthesia on an other sector or obstructed needle)
and anesthetic injection ................................................................................................................................. p.12
7 Plunger return ...................................................................................................................................................... p.15
8 Needle disassembly ......................................................................................................................................... p.12
11
9 Cleaning, disinfection, sterilization ........................................................................................................... p.17
For the other types of anesthesia, adapt phases 2 to 6 ........................................................................ p.11
Needle assembly with a rotary container
(osteocentral, transcortical, intraligamentar y, intraseptal)
V Video version on www.mydentalhitec.com or QS5 application
Functions
12
Push in up to the stop
- Preferably use cartridges with a plastic film which limit the risk of breakage.
- Only use new 1.7 or 1.8 ml cartridges.
1 3
5
”Beep”
2
2
1
START (continuous press)
Needle dissassembly (or exchange) with a rotary container
(osteocentral, transcortical, intraligamentar y, intraseptal)
Axis to respect
Screwing OK
4
Hold the
needle cap
tightly
6
STOP
7
V Video version on www.mydentalhitec.com or QS5 application
21
Hold the
needle cap
tightly
STOP
i
To save time, it is possible to unscrew the neeedle during the return of the plunger.
If the needle is blocked in rotation, unscrew the container very slightly to proceed with the unscrewing.
It is also possible to assemble and disassemble the needle manually (see p. 20).
4
5
”Beep”
START (continuous press)
6
134°C
134°C
See p. 17 + 18
3
OK
7
Injection mode selection
V Video version on www.mydentalhitec.com or QS5 application
QuickSleeper features 3 injection modes to adapt itself for all your anesthesias. The injection mode selection is made by successively pressing the ”Injection mode” pedal.
Lo Mode (Low) :
slow speed intended for intraligamenatar y, intraseptal and palatal injections or very sensitive patients. The rotation is active. The speed of injection is slow (see diagram 1). This mode has an injection varient with a slower accelaration (dotted curve). This option can be selected on the control box as defined p.16.
IO Mode (IntraOsseous) :
speed intended for intraosseous injections (osteocentral and transcortical). The rotation is active. In this mode, QuickSleeper adapts the speed of injection based on the use of the rotation pedal. BEFORE using the rotation pedal, QuickSleeper injects in slow constant speed for a painfree attached gum anesthesia (see diagram 2). AFTER using the rotation pedal (cortical perforation), QuickSleeper injects in progressive speed for a comfortable, optimal, intraosseous injection (see diagram 3). This mode has an injection varient with a slower speed (dotted curve). This option can be selected on the control box as defined p.16. If you wish to reactivate the slow injection speed after using the rotation, use the ”injection mode” pedal until you have reselected the IO mode.
Hi Mode (High) :
fast speed intended for infiltration and ID Nerve Block injections. In this mode, the rotation is disabled. The injection speed is fast (see diagram 4). This mode has an injection varient with a slower start (dotted curve). This option can be selected on the control box as defined p.16.
Functions
Injection varient (option)
1
Lo Mode
Injection varient (option)
2
IO Mode : Injection speed BEFORE using the rotation pedal
Injection varient (option)
3
IO Mode : Injection speed AFTER using the rotation pedal
4
Injection varient (option)
13
You can change mode at any time.
i
Hi Mode
Anesthetic injection
V Video version on www.mydentalhitec.com or QS5 application
1
START (continuous press) STOP
Automatic
plunger
return
The flash rate of the 3 lights is proportional to the injection speed.
If the lights do not come on, stop the injection. Refer to the cartridge manufacturers’ recommendations to know the quantities that can be injected per session.
The sound signals are given as an indication only, use only the lights to confirm the quantity injected.
”Beep” ”Beep” ”Beep”
”Beep” ”Beep”
”Beep”
1
2
Needle rotation
Functions
V Video version on www.mydentalhitec.com or QS5 application
14
1 2
The rotation is discontinuous to feel the progress of the needle in the bone and to avoid overheating.
i
QuickSleeper injects all through the rotation phase to limit needle obstruction by osseous fragments.
QuickSleeper emits a ”beep” during the perforation? The rotation slows down?
You are pressing too hard on the needle, which reduces the efficiency of the perforation. Continue perforating while reducing the pressure on the needle until the sound signal stops and the speed returns to normal.
The sound signal persists? The rotation slows down?
QuickSleeper indicates that the needle is probably obstructed. Change needle, container and cartridge (see p.12) and start the perforation again by pressing as little as possible on the needle or by changing injection site. If the needle is blocked in rotation, unscrew the container very slightly to proceed with the needle screwing/unscrewing.
Recommended number of rotations :
- For osteocentrals or transcorticals, do not exceed 10 rotation cycles* to avoid bone heating. After 10 rotation cycles, a «beep» will be emitted for each extra rotation cycle.
- For intraligamentaries, do not exceed one rotation cycle* to obtain a deep penetration. For safety reasons, the needle rotation is disabled in «Hi» mode.
START (continuous press)
”Beep”
STOP
3
(* 1 rotation cycle = rotation during 1 sec. followed by an automatic stop during 1 sec.)
Rules to respect for the per foration :
1. Make sure that the needle is not eccentric by testing the perforation outside of the mouth.
2. Always make bone contact before starting the rotation to prevent damaging the superficial
tissues.
3. Use solid support points to prevent changing angulation during the perforation.
4. Do not use the rotation to withdraw the needle from the bone to prevent any risk of needle
breakage.
Osteocentral anesthesia without rotation for children:
Frequently with children the penetration into the cancellous bone can be made without needle rotation. In this case the intraosseous injection speed will not be activated. Therefore, for children where you believe it will be possible to penetrate the needle without rotation, you should:
• perform the attached gum anesthesia in IO mode.
• activate the intraosseous speed by a SHORT press on the rotation pedal. This speed will be
active as soon as you hear a «beep» (do not prolong the pressure to avoid starting the needle rotation).
• proceed with the penetration into the cancellous bone, using the rotation only if necessary.
• perform the intraosseous injection (the quantity lights flicker faster confirming the injection in osteocentral speed).
Plunger return (once the anesthesia is complete)
V Video version on www.mydentalhitec.com or QS5 application
Functions
1 3
The return is automatic when a complete cartridge is injected.
i
2
”Beep”
Needle screwing/unscrewing on transparent plastic container
(infiltration, ID Nerve Block, palatal)
The rotation and motor-assisted screwing do not work with the transparent plastic container.
Screwing
1 4
32
OK
15
5
Unscrewing
OK
1
2
3
4
134°C
134°C
See p.18
5
Aspiration before complete injection (infiltration, ID Nerve Block)
Functions
16
START (continuous press)
MARCHE
Injection varient selection
21
”Beep” ”Beep”
START (continuous press)
INJECT
MINIMUM
1/8 TO 1/4
5
Verify the
absence of
blood in the
anesthetic
cartridge
STOP
3 4
STOP
6
SELECT THE MODE
TO MODIFY
”Beep” ”Beep”
1
Speed details p.13
= injection varient
”Beep” = standard injection
2a
2b
To be given to the person in charge of sterilization
Steps for cleaning / disinfection / sterilization of the rotary containers
This is the procedure to follow before first use and after each anesthesia.
CHOICE 1 :
AUTOMATIC CLEANING
CHOICE 2 :
MANUAL CLEANING WITH ULTRASONICS
Clean by soaking. Place the container in a disinfectant
solution such as “Quaternary amonium” and use ultrasonics
during 8 min.
Maintenance
134°C
134°C
Place the container in demineralized water for 2 min.
and gently brush with a soft brush.
Put the container into the washer disinfector
(Disinfection phase for 5 min – 90°C (194°F))
Rince thoroughly with demineralized water*
for minimum 20 min.
Verify that the container is free of lubricant and dirt.
Spray the container with demineralized water.
Dry the container with a non-woven compress (or with
compressed air).
*Remove all traces of disinfectant
Verify that the container is free of lubricant and dirt .
to avoid an accelerated deterioration of plastic parts (cartridge
holder inside the container) during auto-claving.
Demineralized water prevents mineral deposits which can
affect the operation of rotary container.
These deteriorations are not covered by the warranty.
LUBRICATE BEFORE EACH STERILZATION (SEE LUBRICATION PROCEDURE ON THE NEXT PAGE)
17
Put the container in a sterile packaging according to EN 868-5.
Steam sterilization B class (pre and post vacuum) with an autoclave sterilizator in compliance with EN 13060 norm.
Sterilization time of minimum 18 min. at 134°C.
Check that the container retrieved is dry and sterile.
Store the sterile items in a dry and dustless place.
* Follow the standard compliances and specific guidelines of your country.
Download a copy of this document on www.mydentalhitec.com
QuickSleeper maintenance
Rotary container lubrication procedure
Maintenance
18
1 2 43
1
2
x 1
A lack of lubricant can considerably increase the noise during the rotation and rapidly degrade the rotation mechanism. This is not covered by the warranty. Consult the lubricant product sheet on page 27.
Steps for cleaning / disinfection / sterilization and storage of the plastic containers
134°C
Clean by soaking. Place the container in a disinfectant solution such as “Quaternary amonium”
and use ultrasonics during 8 min.
Place the container in demineralized water for 2 min. and gently brush with a soft brush.
Rince thoroughly with demineralized water for minimum 20 min.
Verify that the container is free of dirt.
Spray the container with demineralized water.
Dry the container with a non-woven compress (or with compressed air).
134°C
Put the container in a sterile packaging according to EN 868-5.
Steam sterilization B class (pre and post vacuum) with an autoclave sterilizator in compliance with EN 13060 norm.
Sterilization time of minimum 18 min. at 134°C.
Check that the container retrieved is dry. Store the sterile items in a dry and dustless place.
* Follow the standard compliances and specific guidelines of your country.
Control box, handpiece, handpiece holder and pedal cleaning
- Unplug the device from the mains before cleaning.
- Clean the handpiece holder with a disinfectant product after each patient.
- Clean the components (control box, pedal, handpiece) with a clean cloth and alcohol solution placed on the
cloth.
Never spray a cleaning product directly on components.
- Never use powerful solvents or aggressive chemical solutions.
- Never sterilize the control box, handpiece, handpiece holder or pedal.
- Avoid the projections of liquid on the control box, the handpiece or the pedal. Never immerse the control unit, handpiece or pedal in liquid.
Failure to respect these rules can produce irreversible deteriorations which are not covered by the warranty.
Annexes
Technical problems and solutions
QuickSleeper 5
19
Annexes
Accessories
To unscrew the needle manually
If it is impossible to unscrew the needle mechanically (due to a long perforation), unscrew the needle manually.
20
1
2
3 4
2
1
5 6
134°C
134°C
See p. 17
+ 18
Difficult insertion of the cartridges into the rotary container
The sizes of anesthetic cartridges vary a lot, even within the same box. Cartridges with a wider external diameter can be harder to insert into the rotary container. This can cause a reduction in the quality of rotation. In this case, change your cartridge and keep the non-compliant cartridges for anesthesias with the plastic container (infiltration and ID Nerve block).
Plastic cartridges are incompatible with the QuickSleeper rotation system.
Impossible / incomplete screwing of the container
2 possibilities:
1. Verify that the plunger is in its starting position by pressing on the ”plunger return” key.
2. The cartridge is too long or too full. In this case, perforate the cartridge cap with the needle to evacuate some anesthetic and enable the complete screwing of the container.
1 32
1
2
Find videos on www.mydentalhitec.com
Eccentric needle during rotation
There can be several causes:
- The needle has been incorrectly screwed on.
- Eccentric due to a manufacturing defect. This is generally slight , and thus acceptable.
- Excess pressure applied during anesthesia of the attached gum which curves and deforms the needle.
This phenomenon is not troublesome if it is of low amplitude and if you make sure that the needle is in contact with the bone before starting the rotation. Failure to comply with these rules could harm your patient and encourage needle breakages.
Needle breakage
A needle breakage is very rare and it is the result of an incorrect manipulation.
Annexes
This breakage may be caused by one or several of these parameters:
1. The most important factor is a change of angulation during the rotation of the needle. This point
is applicable during the perforation but also during the withdrawal of the needle. In this case, all of the efforts are focused on the small length of the needle which is outside of the bone. The cannula therefore less easily accepts angulation variations. It is therefore essential to always work with good support points and to ensure that the needle remains in the same axis during the complete anesthesia protocol, and more particularly when using the needle rotation.
At the end of the anesthesia, remove the needle without rotation.
2. Distortion of the needle due to radial pressure during the attached gum anesthesia. This action may deform the needle and generate vibrations during the rotation, contributing to weaken the needle during the bone perforation.
3. Excessive pressure on the needle during the cortical penetration. This action can concentrate the efforts on a specific zone and weaken the needle at this point.
Solutions in case of breakage
- If the needle protrudes from the mucosa membrane, remove it, in the axis, with a clamp. Make sure
that all of the needle is removed.
- If the needle does not protrude from the mucosa membrane, have it removed or withdrawn by a
stomatologist and minimize the osseous decay.
21
Clinical or technical information: +33 241 560 590 or www.mydentalhitec.com
Cartridge breakage
The following procedure must be respected in order to prevent serious damage to the equipment that is not covered by the manufacturer’s warranty.
Annexes
22
1
2
3
1
Keep the handpiece pointing
downwards in order to prevent
the diffusion of the anesthetic
liquid into the handpiece.
- Always use a clean and dr y cloth to protect the body and cable of the handpiece.
- Carry out actions from 1 to 6.
- Inject to bring out the plunger and make sure there are no pieces of glass on this part.
If there are, break off the remaining pieces using pliers (do not let the pieces of glass touch the O-ring to avoid damaging it) being careful not to bend the plunger (photo 7).
- Check that the plunger seal (O-ring) is not deteriorated (cuts…); this will lead to rotation failure or faulty rotation (photo 8).
- Keep the handpiece pointing downwards; pass the water spray over the plunger and inside the handpiece nose to remove any anesthetic residue that could interfere with the functioning when dry.
- Remove any glass debris present.
Dry the equipment with a low pressure air spray or wipe it with a dry, alcohol free cloth, being careful not to bend the plunger.
- Press the ”plunger return” key.
In case of any doubt the device has to be sent to the manufacturer for a complete verification.
2
4
No. 17 explorer
134°C
134°C
5
6
See p.17
+ 18
7
8
- Never run the handpiece under water.
- Never grease or lubricate the plunger.
Deterioration of the plastic container
The appearance of white traces or cracks in the plastic accessories indicates faulty maintenance. The containers were put into an autoclave when chemicals were still present on their surface. If you clean the accessories by soaking them in a chemical solution or using an ultrasonic bath before putting them in the autoclave, be sure to rinse them thoroughly in demineralized water before sterilization (see procedure p.18).
Annexes
Control box, Handpiece, Pedal
The handpiece does not work
Verify that the power diagnostic LED is lit. If this is not the case:
- Check that the power supply is connected to the mains.
- Check that the power supply used is the original model supplied with the QuickSleeper.
- Check the connection between the handpiece and control box. If the
connection is faulty the lights on the handpiece will not light up. If the problem persists, see Chapter “The handpiece does not respond to the pedal’s instructions”. If the problem persists, contact the service center approved by Dental Hi Tec or your authorized Dental Hi Tec distributor.
The handpiece does not respond to the pedal’s instructions
If the handpiece does not respond to a press on the pedal, repeat the action. This phenomenon may exceptionally occur if other electric devices (mobile phone…) disrupt the communication between the pedal and control box. If this problem occurs frequently, validate the following points:
- There must not be any metallic elements placed between the pedal and control unit.
- The control box must not be close to another electronic device (computer, apex locator, dental scaler…).
- The pedal must not be placed on a metallic support .
- The pedal must be at less than 3 metres from the control box.
If the problem persists, contact the service center approved by Dental Hi Tec or your authorized Dental Hi Tec distributor.
Diagnostic LEDS:
power
23
Untimely automatic return of the plunger
This phenomenon can occur following a power cut or micro-interruption of the electricity supply during the functioning of the device. Have your electrical installation checked.
Restart after handpiece fall
- Do not use containers or a handpiece damaged after a fall.
If the cartridge is broken, refer to chapter ”cartridge breakage” and :
- Check the plunger motion and check the indicator light of the device.
To do this, the container has to be placed with a new cartridge and a new needle. All parameters have to be checked far from the patient. This check point must be done before any use on a patient.
Never degrease the plunger of the device.
24
Annexes
The injection is impossible
If the handpiece goes into security mode (impossible injection, long beep), it generally indicates that the needle is obstructed. This is due to excessive pressure being put on the needle during the perforation, causing bone fragments to obstruct the needle. If these fragments cannot be evacuated by the injection, you must change the needle, the rotary container and anesthetic cartridge as indicated in chapter “Screwing/Unscrewing” on page 12.
The rotation does not work and a continuous sound signal can be heard when pressing the pedal
The «Hi» injection mode is selected. Change mode to activate the rotation.
The aspiration does not work and a sound signal is emitted when pressing the pedal
The ”IO” or ”Lo” injection mode is activated. Select the ”Hi” mode to activate the aspiration. Check that the handpiece is connected to the control box.
The rotation is defective
Verify the following points:
- Use of the rotary container, not plastic
- Always use a new glass cartridge. QuickSleeper will not work with used, incorrectly filled or
plastic cartridges.
- After assembling a needle onto the rotary container (protective cap in place), make sure manually that the needle is turning freely. If this is not the case, clean the container in an ultrasonic bath according to the procedure on page p.17. If the problem persists contact Dental Hi Tec or your authorized Dental Hi Tec dealer.
- The plunger of the handpiece must not be bent (after a fall). If it is, contact Dental Hi Tec or your authorized Dental Hi Tec dealer.
- Check the rubber O’ring on the handpiece plunger and verify that it is not deteriorated (cuts, tears, worn external surface). This malfunction can appear following a cartridge breakage. In this case contact Dental Hi Tec or your authorized Dental Hi Tec dealer.
If, after trying all these solutions, the device still does not work,
please contact your distributor or Dental Hi Tec (00 33 241 560 590).
Clinical or technical information: +33 241 560 590 or www.mydentalhitec.com
Miscellaneous information
Protection against lightning
Unplug the connection to the mains at the end of every day or when there is a storm.
Warranty conditions
Annexes
DENTAL Hi Tec offers a two-year warranty for QuickSleeper from the date of purchase. This warranty does not apply to the sterilizable accessories: plastic container, rotar y container. The implementation of the warranty requires the submission of the original proof of purchase indicating the date of purchase. This warranty only applies if the QuickSleeper is used in compliance with the operating instructions and tolerances as indicated in this manual. The warranty is invalid if:
• a technical repair is made to the device by an unapproved person.
• the device is damaged by an external source (lightning, fire, water damage, negligence or accident), by improper use or non­compliant installation.
• the device is adapted to operating norms that are different from those indicated on the material safety data sheet located under the control unit.
• the purchase documents are changed or altered.
• the serial number of the device has been made unreadable.
In no case shall the application of this warranty constitute an entitlement to complete replacement of the device or give the right to claim damages. QuickSleeper cannot be subject to return outside of the warranty clauses.
Repairing the device
If there is a problem, contact your authorized dealer or the DENTAL Hi Tec company headquarters.
EC : Compliance declaration
We declare on our own liability that this product complies with the EC regulatory provisions. In the interest of product improvement, Dental Hi Tec reserves the right to make modifications to its products without prior notice.
Spare parts
You can order the following accessories by contacting your local dealer, or the DENTAL Hi Tec company headquarters (Tel : +33 241 560 590 or mail@dentalhitec.com).
25
3 rotary containers
Réf. SA5500/3
ø 0,40 (27G) - 16 mm
3 plastic containers
Réf. SA5600/3
Ref. C3009
Rotary container
lubricant
Ref. SA5640
ø 0,30 (30G) - 16 mm
Ref. C3005
Extension low voltage
supply 2.5 m
Ref. C2904
ø 0,30 (30G) - 9 mm
Ref. C3002
3 washer disinfector
adapters for rotary
containers (SMEG, Miele,
Steelco ...)
Ref. SA150 / 3
26
Technical Data Sheet
Name: QuickSleeper Model: 5 Device classification: IIA Nominal voltage: CA 100-240 V 50/60 Hz Tmi : 10°C//50°F (minimum ambiant temperature) Tma : 30°C//86°F (maximum ambiant temperature) Relative humidity : 75% Maximum altitude: 3000 meters Class II power supply enclosed: 24V 30 VA Characteristics of the radio transmitter: Frequency / Transmission power: 868.3MHz / max. 10mW EIRP Data rate / Channel bandwidth / Modulation type: 120 kbps / 280 kHz / ASK
We declare on our own liability that this product complies with the EC and CSA regulatory provisions. In the interest of product improvement, Dental Hi Tec reserves the right to make modifications to its products without prior notice. Do not modify the length/replace/repair the c ables (handpiece c able and power supply cable) constituting the device. The use of cables other than the ones specified, except cables sold by Dental Hi Tec as replacement pieces for internal components, can be the cause of an increase of EMISSIONS or a reduction of the IMMUNITY of the DEVICE.
MANUFACTURER’S DECLAR ATION AND DIRECTIVES – ELECTROMAGNETIC EMISSIONS
Emission tests Compliance Electromagnetic environment – Directives
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B Harmonics transmission
IEC 61000-3-2 Voltage fluctuations / Flicker emissions
IEC 61000-3-3
MANUFACTURER’S DECLAR ATION AND DIRECTIVES – ELECTROMAGNETIC IMMUNIT Y
Immunity test IEC 60601-1-2 - test level Compliance level Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient /burst IEC 61000-4-4
Surge IEC 61000-4-5
±6 kV contact ±8 kV air
± 1 kV for input/output lines
± 1 kV differential mode ± 2 kV common mode
QuickSleeper is intended for use in the electromagnetic environment described below.
The QuickSleeper user should assure that it is used in such an environment.
Class A
Complies
QuickSleeper is intended for use in the electromagnetic environment described below.
The QuickSleeper user should assure that it is used in such an environment.
Use only with the following power supply:
CINCON - TR30RAM240
Dimensions:
Handpiece : Diameter: 24 mm · Length: 198 mm · Weight: 223 g Handpiece holder : Length: 78 mm · Diameter: 47 mm Control box : Length: 109 mm · Width: 78 mm · Height: 24 mm · Weight: 113 g Pedal : Length: 250 mm · Width: 180 mm · Height: 63 mm · Weight: 613 g
Cartridge to be used: 1.7 ml or 1 .8 ml cartridge (ISO 11499) Auto-off: After 10 minutes without use
In certain cases, if it is necessary for the DEVICE to be used close to other devices or stacked with the latter, and that it is not possible to do otherwise, the DEVICE should be surveyed to verify the normal functioning (in the envisaged configuration). The ESSENTIAL PERFORMANCES of QuickSleeper are described in this manual. The DEVICE can be subject to interferences due to other devices, even if they comply with the CISPR EMISSION requirements. The QuickSleeper is an elec tromedical device. It therefore requires special precautions with regards to the E MC (Elec tromagnetic compatibility) and it must be installed and put into service according to the EMC information supplied in this document. Portable and mobile RF communication devices can af fect electromedical devices.
The QUICKSLEEPER uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment .
The use of QUICKSLEEPER is suitable for use in all types of establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes .
±6 kV contact ±8 kV air
± 2 kV for power supply lines
Not applicable for input/output lines
± 1 kV Not applicable (Class 2)
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
0459
‹ 5 % UT (› 95 % dip in UT)
Voltage drops, short interruptions and voltage variations on input power supply lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
is the a.c mains voltage prior to application of the test level.
NOTE : U
T
MANUFACTURER’S DECLARATION AND DIRECTIVES – ELECTROM AGNETIC IMMUNITY
Immunity test IEC 60601-1-2 - Test level Level of compliance Electromagnetic environment – guidance
Conducted RF CEI 61000-4-6
Radiated RF CEI 61000-4-3
NOTE 1 : At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and T V broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the QuickSleeper is used exceeds the applicable RF compliance level above, the QuickSleeper should be observed to verify the normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the QuickSleeper. b) Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles ‹ 5 % UT (› 95 % dip in UT) for 5 s
3 A/m
3 Vms 150 kHz to 80 MHz
3 V/m 80 MHz to 2.5 GHz
QuickSleeper is intended for use in the electromagnetic environment described below.
The QuickSleeper user should assure that it is used in such an environment.
‹ 5 % UT (› 95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles ‹ 5 % UT (› 95 % dip in UT) for 5 s
3 A/m
3 V
3 V/m
Mains power quality should be that of a typical commercial or hospital environment. If the user of the QuickSleeper requires continued operation during power mains interruptions, it is recommended that the QuickSleeper be powered from an uninterruptible power supply.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Portable or mobile RF communications equipment should not be used no closer to any part of the QuickSleeper, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
P
d =1,17
d = 1,17 √P 80 MHz to 800 MHz
P 800 MHz to 2,5 GHz
d = 2,33
Where P is the maximum output power rating of the transmitter in watts (W), according to the transmitter manufacturer and d is the recommended separation distance in metres (m)b. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Annexes
Recommended separation distances between portable & mobile RF communications equipment and QUICKSLEEPER
QUICKSLEEPER is designed to be used in an electromagnetic environment where the RF perturbations are controlled. The QUICKSLEEPER user can contribute to preventing electromagnetic interferences by maintaining a minimum distance between portable, mobile RF communication devices (transmitters) and QUICKSLEEPER, as recommended below, depending on the maximum transmission power of the communication device.
Rated maximum output power of
transmitter (W)
0.01 0,12 0,12 0, 23
0.1 0,37 0,37 0, 74 1 1,17 1,17 2, 33
10 3 ,69 3,69 7, 38
100 11,67 11,67 23,33
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 : At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
150 kHz to 80 MHz
P
d =1,17
Separation distance according to frequency of transmitter (m)
80 MHz to 800 MHz
d =1,17 √P
800 MHz to 2,5 GHz
d = 2,33 √P
Symbols used on plating
R&TTE 99/5/EC
0459
Applied part of type BF
Manufacturer
EC mark compliance to 99/5/CEE R&TTE
EC mark compliance to 93/42/CEE Medical devices
Radio Transmitter
SN
i
ATTENTION
Direct current
Refer to the user manual
Serial Number
Product shall not be used if the box is damaged
Information
DHT Lubricant
Hazards identification:
Main hazards : none
First aid measures : Skin contact : Remove contaminated clothing. Wash with water and soap. If grease has
penetrated skin by force (in case of misuse of a grease press), seek a physician* immediately. Eye contact : Flush with plenty of water for at least 15 minutes. See a physician* if the eye irritation remains. Ingestion : Seek a physician* if ingested in large quantities or in case of nausea. In case of unconsciousness do not induce vomiting. Inhalation : Move the affected person to fresh air. Give artificial respiration if not breathing. Seek a physician* if necessary.
*Show the physician this safety dat a sheet.
Fire fighting measures :
Suitable extinguishing media: all (water, powder, foams, carbon dioxide). Do not use full water-jet. Grease for QuickSleeper is not inflammable. But in the case of fire, the vapour can involve toxic and corrosive compounds (carbon monoxide, fluorine decomposition compounds). Use self-contained breathing apparatus and skin protection to protect from vapours.
Accidental release measures :
Clean releases of minimal importance with a cloth and dispose of in compliance with the information provided in the «Disposal considerations» heading. Remove the important releases by mechanical means and wipe the residus with a cloth. Beware of slippery floor following product release. Remove all sources of ignition and protect from sunlight.
Handling and store measures :
Store the hermetically sealed containers in cool and dry areas. Provide adequate ventilation. Prevent the formation of oil mist. Keeping quality in original drums for the storage conditions mentioned above: minimum 5 years. If the oil is exposed to high temperatures, good ventilation in the working areas is necessary. Respect the usual security measures for the use of chemical products in the mineral oil industry.
Exposure control / Personal protection : Hand protection : Product to manipulate observing good industrial hygene and security
protocols. In case of long or repeated contact, use gloves (example : butylrubber for a time ‹ 30 min. and neoprene for a time › 8 hours). Respiratory protection : Not necessary in normal use. Avoid breathing the vapours. If the concentration exceeds the authorized maximal amounts on the work place (OEL), use a protection mask with a ABEK-ST filter and take the necessary measures to ensure good ventilation. Eye protection : Not necessary in normal use. Wear safety glasses, if necessar y. Keep away from foodstuffs. Wash your hands before making a break and when you finish the work. Separate your working clothes from other clothes. Change dirt y clothes. Observe also the ordinary precaution instructions, which describe the sure handling with chemicals.
This appliance must not be
Sterilization at 134°C with
134°C
an autoclave sterilizator in compliance with established legislation
To observe
Incinerate in compliance with the protocol for infectious waste
Physical and chemical properties :
Physical state : liquid Colour : colourless - slightly yellow Odour : none Dropping point : ‹ -20°C (‹ -68°F) DIN 51597 Boiling point : › -250°C (‹ -482°F) Density : 0,828-0,875 g/cm3 à 20°C (68°F) DIN 51757 Vapour pressure : ‹ 0,1 mbar à 20°C (68°F) Viscosity (base oil) : 10-1500 mm2/s à 40°C (104° F) DIN EN ISO 3104 Solubility in water : insoluble pH-value: not determined Flash point : › 180°C (› 356°F) DIN EN ISO 2592 Ignition temperature: › 250°C (› 482°F) Explosion limits: lower : 2,8 vol-% upper : 11 ,5 vol-% (oil mist)
Stability and reactivit y :
Thermal decomposition : › 180°C (356°F) Dangerous decomposition products: unknown in normal use and and storage conditions. In case of non compliant use (for example high temperature) or fire, risk of vapor formation dangerous for health. Dangerous reactions : with strong oxydation agents (for example liquid or compressed oxygen)
Toxicological information : Experimental toxicological data.
› 5000 mg/kg (mouse)
oral*: LD
50
dermal*: LD The series of Turmosynth VG oils comply with the demands of the international NSF (NSF/ H1 homologation). The occasional contact with food supplies does not present any health hazard. Registration number : 127133, 132163, 139108, 127132, 127138, 127139, 132160, 132161, 127122, 132162, 127131. Turmosynt VG 10 is not listed in the NSF list. Its components are the same as all other oils from the Turmosynth VG series. They do not present any health risk when used in normal conditions. TLV value for oil mist : 5 mg/m
* Similar to a product with same composition.
Ecotoxicological informations :
Use the product according to the good working practices avoiding polluting the environment. Water Pollution Class WGK 1: Slightly water endangering (Classification according to German VwVwS from May, 1999): Avoid the contamination of soil and water.
Further Information :
It is given in good faith and based on the best knowledge and experience of the company at the date of issuing. All data refer to the product in the delivering condition. The information given in this safety data sheet is for safet y purpose only. The company is not responsible for damages caused by the use of the product in applications for which it was not intended or for conditions of use outside its control. Former versions of this safety data sheet are no longer valid.
› 5000 mg/kg (rabbit)
50
If you are concerned by the European WEEE directive, please contact your distributor or the Dental Hi Tec company who will take all of the
necessary measures towards the collection and
3
disposed of with household
waste.
It contains dangerous
substances, which can have
environment and human health. It must be
important consequences for the
recycled in a specific treatment facility.
recycling of the device.
Dental Hi Tec - ZI de l’Appentière
49280 Mazières en Mauges - France
+33(0) 241 561 616
27
For any complementary information,
Photos : DHT / Stéphane Rivière. Non-contractual document and photos NOQS5 - V17/10/2014 - UK
contact our advisors :
0033 241 560 590
or www.mydentalhitec.com
Innovation for dental anesthesia
ZI de l’Appentière · 49280 Mazières en Mauges · FRANCE
mail@dentalhitec.com
www.mydentalhitec.com
© Copyright DENTAL HI TEC, Cholet, France All rights reserved. Texts, pictures, graphics, and their arrangement on DENTAL HI TEC documents are protected by copyright and other protection laws. The contents of this document may not be copied, distributed, changed or made available to third parties for commercial purposes.
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