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