Manual Documentation System
The documentation system consists of a 3-line alpha-numeric hand labelling gun, documentation label rolls and documentation sheet available in a log book.
According to EN ISO 11140-1, it is required that all sterile packs must be labelled with a Type 1 process indicator – to clearly differentiate sterile and non-sterile packs.
The Type 1 chemical indicators will exhibit a colour change when exposed to the sterilant. Colour changes are as indicated in the images on this page.
Use of a the gke Type 1 documentation labels negates the need for autoclave tape with indicator.
The gke Steri-Record® documentation system is used for patient related traceability of all medical sterilisation processes. The documentation sheets contain all necessary fields to release a sterilisation batch. Information can be recorded included production and expiry date, responsible person, content of the pack, steriliser and batch number. All packs in the batch and the documentation sheets have the same label content and batch number.
After opening a sterile pack in the operating theatre, the label may be peeled off and adhered to patient or operation documentation. The information on the label allows patient related tracing back to the batch-related documentation in the sterilizing department. In the case of a nosocomial infection the sterilisation information is available to exclude that the infection was caused by non-sterile instruments.
- Self-adhesive label offers patient related documentation without additional paperwork
- No need for use of additional process indicator
- Different colours available
- The indicator colour chemistry is a non-reversible chemical reaction. The indicator strip can be documented proof for several years without changing back.
|Sterilisation Process||Product Code||Description||Quantity|
|All Processes||LG001||Alpha Numeric Labelling Gun||1|
|All Processes||LOG1||Log book for gke Documentation System||1|
|Steam||L240-571||Type 1 Documentation Label – Green||12 pack of rolls, 750 labels per roll|
|Steam||L240-572||Type 1 Documentation Label – Blue||12 pack of rolls, 750 labels per roll|
|Steam||L240-573||Type 1 Documentation Label – Red||12 pack of rolls, 750 labels per roll|
|Steam||L240-574||Type 1 Documentation Label – Yellow||12 pack of rolls, 750 labels per roll|
|All processes||L240-861||Documentation Label (no indicator) – Green||12 pack of rolls, 750 labels per roll|
|All processes||L240-862||Documentation Label (no indicator) – Blue||12 pack of rolls, 750 labels per roll|
|All processes||L240-863||Documentation Label (no indicator) – Red||12 pack of rolls, 750 labels per roll|
|Ethylene Oxide||L242-875||Type 1 Documentation Label – ETO, purple||12 pack of rolls, 750 labels per roll|
|Formaldehyde||L243-874||Type 1 Documentation Label – Formaldehyde, yellow||12 pack of rolls, 750 labels per roll|
|Hydrogen Peroxide||L244-873||Type 1 Documentation Label – hydrogen peroxide, red||12 pack of rolls, 750 labels per roll|