Patient Tracing System

6. Documentation System

6.1 Hand labelling devices

The gke Steri-Record® documentation system is used for batch and patient related traceability after sterilization of medical devices.
By using a gke labelling device a label of the same content including production and expiry date, batch number and responsible person is adhered on each pack and on the documentation sheet. After opening the sterile pack in the operation room the label can be removed from the package and adhered into the patient file. Thus all information provided on each pack can be traced back from the patient to the processing and approval.
The labels are available in different colours, optionally with or without indicator.

gke offers two versions of hand labelling devices:

Art.-No.	Product Code	1. Printing line	2. + 3. Printing line
240-820	D-G-NL	3 alpha-numeric and 9 numeric digits	12 numeric digits
240-830	D-G-AL	12 alpha-numeric digits	12 numeric digits
240-892	Ink roll	for all gke hand labelling devices

The following example shows a printed label by using a hand labelling device:

6.2 Double self-adhesive 3-line labels with advanced adhesion properties

The labels consist of a 3 layer material and can be directly adhered on packages or on other labels, e.g. container labels. Before the pack is opened in the operation theatre the double self-adhesive label can be taken off and ad-hered onto the patient documentation sheet. All indicators are tested according to EN ISO 11140-1 type 1 and come with a conformity declaration.
The labels are available in four different colours without (6.2.1) or with (6.2.2) process indicator for steam sterilization processes. The labels are also available with process indicator for ethylene oxide, formaldehyde/dry heat and hydro-gen peroxide sterilization processes. Each pack contains 2, 4 or 12 rolls with 750 labels and an ink roll for the hand labelling device.

6.2.1. without indicator

Art. No.	Product Code	Colour	Quantity
240-853	D-L-DA-R	red	4
240-861	D-L-DA-G	green	12
240-862	D-L-DA-B	blue
240-863	D-L-DA-R	red
240-864	D-L-DA-Y	yellow

6.2.2. with process indicator for steam sterilization processes

Art. No.	Product Code	Colour	Quantity
240-883	C-S-L-1-DA-R	red	4
240-871	C-S-L-1-DA-G	green	12
240-872	C-S-L-1-DA-B	blue
240-873	C-S-L-1-DA-R	red
240-874	C-S-L-1-DA-Y	yellow

6.2.3. with process indicator for different sterilization processes

Best Chemical Indicators & PCDS | BOWIE-DICK SIMULATION TEST

Art. No.	Product Code	Colour	Quantity	Process
242-885	C-E-L-1-DA-P	pink	2	EO
242-875	C-E-L-1-DA-P	pink	12	EO
243-884	C-F-L-1-DA-Y	yellow	2	FORM
243-874	C-F-L-1-DA-Y	yellow	12	FORM
244-881	C-V-L-1-DA-G	green	2	H2O2 SV = 6 min
244-871	C-V-L-1-DA-G	green	12	H2O2 SV = 6 min
244-883	C-V-L-1-DA-R	red	2	H2O2 SV = 2 min
244-873	C-V-L-1-DA-R	red	12	H2O2 SV = 2 min

6.3. Double self-adhesive 3-line ECO labels

The labels consist of a 3 layer material with standard adhesion properties and are available without and with process
indicator for steam and ethylene oxide. No conformity declaration and no test report available. Each pack contains
12 rolls with 750 labels, NO ink roll.

Art. No.	Product Code	Colour	Quantity	Process
000-863	D-L-DA-R-ECO	red	12	all (without indicator)
000-873	C-S-L-1-DA-R-ECO	red		Steam
000-875	C-E-L-1-DA-P-ECO	pink		EO

6.4. Single self-adhesive 3-line labels

The labels consist a 2 layer material and can be adhered.
The labels are available without (6.4.1) or with (6.4.2) process indicator for steam sterilization processes. Each pack
contains 12 rolls with 1.000 labels, NO ink roll.

6.4.1. without indicator

Art. No.	Product Code	Colour	Quantity	Process
230-864	D-L-SA-Y	yellow	12	all

6.4.2. with process indicator for steam sterilization processes

Art. No.	Product Code	Colour	Quantity	Process
230-872	C-S-L-1-SA-B	blue	12	steam