hbw RIGENERA SICURDRILL 2.0 RECHARGEABLE User manual

SICURDRILL
Rev 00/ November 2019
SICURDRILL
2.0
RECHARGEABLE
USER’S MANUAL
RECHARGEABLE

Human
Brain
Contacts:
Registered
Operational
Italy
Phone:
+39.011.99.34.508
Web:
www.rigenerahbw.co
Translation
Brain
Wave S.r.l.
Registered
office: C.so Galileo Ferraris, 63 –
10128
Operational
headquarters and offices: Via Pinerolo,
+39.011.99.34.508
E-mail:
[e-mail]
www.rigenerahbw.co
m
Translation
of original instructions
10128
Turin, Italy
101 – 10060 Candiolo (To),
[e-mail]

:
1
Use this device correctly and safely.
Safety precautions
READ THIS MANUAL BEFORE USE.
This user’s manual includes operating procedures, safety precautions and specifications
for Sicurdrill 2.0 rechargeable, made by Human Brain Wave S.r.l.
Safety rules and operating procedures must be fully understood before using this device.
Keep this manual handy for future reference.
Use of the device outside the intended use specified in this manual may cause unexpected
adverse events or damage to the device.
There are no parts within the device that require maintenance by the user.
If you have any problems or questions about your device, please contact Human Brain
Wave S.r.l. or the authorized distributor.
READ
THIS
MANUAL
BEFORE
USE.
In this manual, a keyword is used to indicate the degree or level of safety alarm. The definition is as
follows:
ATTENTION : Indicates a potentially dangerous situation which, if not avoided, can cause mild
to moderate injuries or accidents with consequent property damage.
Even the situations indicated by “ ATTENTION” may cause serious injury under certain conditions.
Safety precautions must always be strictly adhered to.

:
2
Precautions for use
Before use
WARNING
 Never use the appliance for purposes other than those intended.
Human Brain Wave s.r.l. denies all liability for accidents or malfunctions caused by
improper use.
 Read this manual before using the device. In particular, safety warnings and operational procedures must
be fully understood. Do not use accessories that are not specified by Human Brain Wave s.r.l. for the
device.
Using the appliance outside the specified intended use may cause unexpected problems and adverse events.
 Never change or touch the internal structure of the device.
Electric shock or malfunctions may occur.
 When unpacking the appliance, make sure you have enough space.
 Conditions of transport and storage
Ambient temperature: (-20 ÷ +60)°C
Atmospheric pressure: (70 ÷ 106) kPa
 Do not install the device in a place where it can be exposed to strong electromagnetic waves during operation.
Install the device in an environment where the air does not contain contaminants such as gases, acids or
corrosive salts.
 Be sure to use a power outlet that meets the specified power supply requirements.
If the supplied voltage is too high or too low, the device may not work according to the specifications,
with consequent malfunction or fire.

3
WARNING
▪ Never use multiple sockets or extension cables to power the appliance.
Overcharging of the electrical outlet can cause overheating and fire.
▪ Fully plug the USB cable into the respective USB socket.
An incomplete connection can cause fires.
▪ Do not use a USB cable other than the one supplied. Do not use the supplied USB cable for other tools.
Malfunctions or fires may occur.
▪ Before connecting any cable to the device, be sure to turn off the device and disconnect the power cord.
Malfunctions may occur.
▪ Never squeeze or pinch the power cord with heavy objects.
Damage can cause electric shock or fire.
▪ Do not connect anything other than the USB socket to the USB cable.
Failure, electric shock or fire may occur.
▪ Before transporting the device to another location, disconnect all cables.
If the cables get caught or trampled, the device can fall, causing injury or failure.
▪ Carry out visual and operational checks before using the device. Do not use the device if an error is
detected.
Using a malfunctioning device does not produce the expected results and can cause problems.
▪ Be sure to use the accessories/devices specified by Human Brain Wave s.r.l.
The use of accessories/devices not specified by Human Brain Wave s.r.l. may cause malfunctions or adverse
events.

4
Contents
BEFORE USE ................................................................................... 5
1.1 Intended use ......................................................................................................... 5
1.2 Device configuration1 ............................................................................................ 5
1. Sicurstick Adapters..................................................................................................................................... 5
2. USB cable ................................................................................................................................................... 6
1.3 Labels and symbols .............................................................................................. 7
1.4 Packaging contents ............................................................................................... 9
OPERATIONAL PROCEDURE ...................................................... 10
2.1 Overview of operations ....................................................................................... 10
2.2 Battery charging .................................................................................................. 10
MAINTENANCE ............................................................................. 11
3.1 Maintenance and cleaning .................................................................................. 11
STANDARDS AND SPECIFICATIONS ......................................... 12
4.1 Applicable rules ................................................................................................... 12
4.2 Product specifications ......................................................................................... 12
DISPOSAL OF THE DEVICE ......................................................... 13
5.1 Disposal .............................................................................................................. 13

5
BEFORE USE
1.1 Intended use
SICURDRILL 2.0 allows the rotation of the device RIGENERACONS/ADIPECONS intended for the
temporary storage of biological samples taken from the patient and the subsequent disintegration
thereof, to obtain micro grafts according to HBW specifications.
Contraindications: none (it should be used according to specifications).
Type of operator: doctor or specialist in the field.
Place of use: within healthcare facilities.
1.2 Device configuration1
 1 Sicurdrill 2.0 Rechargeable device
 1 to 3 adapters (SICURSTICK), depending on the intended use.
 1 USB cable
1. Sicurstick Adapters
SICURSTICKs are intended to connect the RECHARGEABLE SICURDRILL to the devices
REMERACONS/ADIPECONS, specifically:
- code 10126 connects the SICURDRILL to the Rigeneracons code 7945DS, 7945AS
(lots AS)
- code 10127 connects the SICURDRILL to the Rigeneracons code 7945AS (lots
ASGP), 7945RS, 79450S.
- code 10128 connects the SICURDRILL to the ADIPECONS (code 79560S).
1.

6
Sicurdrill 2.0
2. USB cable
The product comes with a
USB
CODE 10126 CODE 10127
CODE
USB
cable for charging.
CODE
10128

7
1.3 Labels and symbols
To draw the attention of users, there are labels and instructions affixed to the device. If labels
come off, characters fade or become unreadable, contact HBW or your authorized distributor.
Manufacturer
Date of manufacture
Refer to the instruction manual
Catalogue number
Symbol of the crossed-out bin WEEE
directive
Attention
CE conformity marking
Serial number
Switching on

8
SICURDRILL
BATTERY
SICURDRILL
2.0
BATTERY
1X3.7V TYPE CRI23
LITHIUM
LITHIUM

9
1.4 Packaging contents
Remove the contents of the shipping box, then check the contents of the package.
 1 Sicurdrill 2.0 Rechargeable device
 1 to 3 adapters (SICURSTICK), depending on the intended use.
 1 USB cable
 1 user’s manual

10
OPERATIONAL PROCEDURE
2.1 Overview of operations
To ensure proper use, follow the steps below:
1. Before each use, charge the battery for at least 15 minutes;
2. Connect the Sicurdrill 2.0 Rechargeable device to the Sicurstick and the
Rigeneracons/Adipecons device;
3. Press the start button to enable rotation;
4. The cycle will last one minute, the interruption is automatic and not changeable;
5. At the end of the cycle, separate the components.
2.2 Battery charging
- The lithium battery of the sicurdrill 2.0 rechargeable device must be recharged using exclusively
the USB cable supplied, which should be plugged into a standard USB socket (car charger, PC,
mobile charger) 5V, with at least 0.5A.
- When fully charged, the LED turns from red to green.
2.

11
MAINTENANCE
3.1 Maintenance and cleaning
- Carry out an overhaul of the Sicurdrill 2.0 every 5000 work cycles or every 5 years.
- For cleaning, use a clean cloth soaked in hydrogen peroxide or any regular disinfectant provided
that it does not contain chlorine or its compounds, such as bleach and muriatic acid.
- Dry with a clean cloth.
- Do not immerse the device in water or liquids in general.
- Do not use steel wool or other abrasive materials that could inevitably scratch the plastic surface.
Caution: Sicursticks can be steam sterilized at 134°C at 2.1 bar for 3 minutes.
3.

12
STANDARDS AND
SPECIFICATIONS
4.1 Applicable rules
 Electromagnetic Compatibility Directive (EMC) 2014/30/EU
 Machinery Directive 2006/42/EC
 Low Voltage Directive (LVD) 2014/35/EU
4.2 Product specifications
Operating conditions
Rotation time: 1 minute
Ambient temperature: + (0 ÷ 40)° C
Atmospheric pressure: (70 ÷ 106) kPa
Conditions of transport and storage
Ambient temperature: (-20 ÷ +60)°C
Atmospheric pressure: (70 ÷ 106) kPa
4.

13
DISPOSAL OF THE DEVICE
5.1 Disposal
The Sicurdrill 2.0 rechargeable device must be disposed of in accordance with the regulations in
force in the country of use.
Caution: For the correct disposal of the rechargeable Sicurdrill 2.0 device, consider also applicable
hospital laws and procedures relating to contaminated devices.
NOTES:
To make the Sicurdrill 2.0 sterile it is recommended to always use it with the COVER
accessory of HBW (sterile sheath).
Rigeneracons - Adipecons disposable device does not come with the rechargeable
Sicurdrill 2.0.
5.