Haiim

Haiim

Haiim is a handheld, vacuum-assisted capillary blood collection system for fingertip sampling. A disposable cassette docks to the main device; when started, the device generates negative pressure that draws blood directly into a compatible 0.5 mL micro-collection tube. It’s designed for IVD specimen collection by trained healthcare personnel (not for patient self-use). A simple light-guided workflow performs an airtightness pre-check and then collects a standard sample in about 2 minutes. The system is compact, light, and powered by a small AC adapter, with optional positioning pillow to stabilize the hand for reliable collections.

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System & components

  • Main device: Models referenced HD-002 (manual) and HD-001 (quotation); compact (~62×123×62 mm, ≈219 g).

  • Disposable cassettes: HC-001 / HC-002 / HC-003; single-use, non-sterile.

  • Compatible tubes (HC-002 example): BD Microtainer® with Microgard™ 0.5 mL (no gel), EV 0.5 mL single-use capillary blood containers, Greiner MiniCollect® (per appendix).

  • Accessories: Reusable Positioning Pillow (HP-001) for hand/wrist support; PET Positioning Pillow (quoted), blade lancet (e.g., BD #366594), optional “normal” blood collection pillow.

Intended use & users

  • Collect capillary blood from the fingertip for IVD testing in clinical settings.

  • Users: certificated healthcare professionals only.

  • Contraindications: bleeding/coagulation disorders, patients on anti-coagulants, or local infection/skin conditions at the puncture site.

Operation highlights

  • Indicator lights:

    • White = initiation, Green = standby, Yellow = alarm, Blue = collection.

  • Pre-test: automatic airtightness check before collection.

  • Collection time: about 2 minutes; keep hand relaxed, avoid pressing/moving finger.

  • Workflow (simplified): assemble cassette + tube → dock cassette → pre-test → disinfect & lance → wipe first drop → place finger on cassette → start → fill tube → cap tube.

Technical & environmental

  • Power: AC 100–240 V adapter (DC 12 V / 2 A output).

  • Operating conditions: ~0–40 °C, 30–75 % RH; IP21 ingress protection; operating altitude ≤ 2000 m.

  • Storage (device/cassettes): ~0–40 °C, 30–75 % RH, avoid sunlight.

  • Shelf life (cassettes): typically 3 years.

  • Product service life (device): 2 years.

Safety & standards

  • Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) family standards (EN harmonized versions listed in the manual).

  • Cleaning/disinfection supported with common medical wipes (e.g., CaviWipes®, Super Sani-Cloth®) with specified contact times.

Maintenance & hygiene

  • Cassettes: single-use; dispose as biohazard waste.

  • Positioning Pillow: reusable; clean before/after use and replace if contaminated or worn (recommended service life noted as 4 months of continuous use in manual).

  • Main device: wipe exterior; avoid liquids entering openings; do not use organic solvents.

Troubleshooting cues (most common)

  • No blue-light (collection) mode: check airtightness, cassette snaps/membrane, re-assemble.

  • Alarm (yellow) during collection: patient moved finger or applied pressure; restart with proper positioning.

  • Air bubbles / low volume: ensure finger fully covers pad, repeat with new cassette/tube; warm hand and massage to improve flow.

Packaging (from appendix)

  • Main device box: ~62×123×61.5 mm device inside; net ≈219 g.

  • Cassette-L (HC-002) piece: ~18×33×42 mm, ≈4 g; packed in non-sterile single packs.

Warranty & service (from quotation)

  • Warranty: 2 years for the main device (from shipment).

  • Coverage excludes consumables/accessories, software, misuse/abuse, and devices from unauthorized channels.

  • RMA process: eligibility check first; Winnoz diagnoses and typically replaces the device; customer ships the unit to Winnoz, return shipping of the replacement covered by Winnoz.

  • Out-of-warranty repairs: estimate provided after inspection; customer covers repair and round-trip shipping; a diagnostic fee applies if repair is declined.